Cal Cont Enz Sub p400 en

ABX Pentra CO2 Cal Ref.
: A11A01648 Volume: 3 x 3 ml
ABX Pentra CO2 Cal
Calibrator for the measurement of bicarbonate / total CO2.
2006/04/10 A93A00702C EN
A11A01648
3 x 3 ml Intended use
ABX Pentra CO2 Cal is used to calibrate ABX Pentra CO2 RTU, Ref. A11A01645.
Characteristics
ABX Pentra CO2 Cal is a calibrator solution containing 30 mmol/l of bicarbonate. ABX Pentra CO2 Cal is ready-to-use. ABX Pentra CO2 Cal should be used according to this calibrator notice. HORIBA ABX cannot guarantee its performance if used otherwise.
HORIBA ABX BP 7290 34184 Montpellier - cedex 4 - France
Handling
Remove the cap of the vial, transfer the calibrator in a sample cup and place in the correct position on the ABX Pentra 400 or on the Mira.
Materials required but not provided

Automated clinical chemistry analyser. Standard laboratory equipment.
Assigned values
The assigned values are determined with a reference material in accordance with an established protocol (traceable to gravimetric procedure). Please refer to the vial label for the exact concentration.
Storage and Stability

Calibrators, in unopened vials, are stable up to the expiry date on the label if stored at 2-25 C and protected from light. Once opened, ABX Pentra CO2 Cal is stable for 3 months if recapped immediately after use and stored at 2-8C. Do not freeze.
Waste Management
Please refer to local legal requirements.
General Precautions
1. ABX Pentra CO2 Cal should be used only for the determination of the calibration curve. 2. This calibrator is for professional in-vitro diagnostic use only. 3. The calibrator vials should be discarded after use. 4. Please refer to the MSDS associated with the calibrator.
Form-0849 Rev. 2
Warning
It is the users responsibility to verify that this document is applicable to the calibrator used.
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B
Latest version documents on www.horiba-abx.com
ABX Pentra CO2 Cal
ABX Pentra Fructo Cal Ref.: A11A01680 Volume: 3 x 1 ml
ABX Pentra Fructo Cal
Calibrator for the determination of Fructosamine by colorimetry.
2006/04/10 A93A00812C EN
A11A01680
ABX Pentra Fructo Cal is used for the determination of the calibration curve of ABX Pentra Fructosamine, Ref. A11A01679.
Characteristics
ABX Pentra Fructo Cal is a calibrator obtained from human serum. The concentration of fructosamine is found in an easily measured zone. ABX Pentra Fructo Cal is lyophilised. ABX Pentra Fructo Cal should be used according to this calibrator notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Waste Management Handling

1. Reconstitute the contents of one vial with exactly 1.0 ml of distilled water. Carefully open the vial, taking care not to spill lyophilisate. 2. Recap the vial with care, and dissolve the contents by successively inverting the vial. 3. Allow the solution to rest for at least 60 minutes before use. 4. Use a pipette to transfer the required volume into a sample cup and place it in the correct position on the ABX Pentra 400 or on the Mira. Please refer to local legal requirements.
General Precautions
1. Calibrator, for professional in-vitro diagnostic use only. 2. Follow proper laboratory handling precautions. 3. This product has been prepared exclusively with blood proceeding from donors who were tested negative for the HBs antigen and HIV 1, HIV 2 and HCV antibodies. Since the absence of an infection risk cannot be completely assured, this product should be handled with the same caution that is applied to patient samples. In case of exposure, follow local health authority regulations (2,3). 4. The calibrator vials should be discarded after use. 5. Please refer to the MSDS associated with the calibrator.

Automated clinical chemistry analyser. Standard laboratory equipment. Distilled water.
Warning
It is the user's responsibility to verify that this document is applicable to the calibrator used.
Assigned values
The calibration value has been determined under strictly standardised conditions, using the specified method. The values have been obtained in external laboratories, and the specified calibration value corresponds to the mean value of the levels obtained in at least seven laboratories and at least three independent test series. The fructosamine concentration is lot-specific. The theoretical values are indicated in the enclosed annex, Ref. 04710792.
Reference
1. Schleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990 ; 36 : 136-139. 2. Occupational Safety and Health Standards : bloodborne pathogens. (29 CFR 1910. 1030). Federal register. July 1, 1998 ; 6 :267-280 3. Directive du Conseil de lEurope (90/679/CEE). Journal Officiel de la Communaut Europenne nL374 du 31.12.1990, p. 1-12.

Unopened calibrators are stable up to the expiry date stated on the label if stored at 2-8 C. Following reconstitution, ABX Pentra Fructo Cal is stable for:
Form-0849 Rev. 2
7 days at 15-25 C 28 days at 2-8 C
ABX Pentra Fructo Cal
ABX Pentra HDL Cal Ref.: A11A01647 Volume: 2 x 1 ml
ABX Pentra HDL Cal
Calibrator for the measurement of High-Density Lipoprotein Cholesterol (HDL-C) by colorimetry.
2006/04/10 A93A00682C EN
A11A01647
ABX Pentra HDL Cal is used to determine the calibration curve of ABX Pentra HDL Direct CP, Ref. A11A01636.
Characteristics
ABX Pentra HDL Cal is lyophilized. It is composed of two vials of 1ml. It is a preparation of lyophilized human serum containing lipoproteins from the various lipoprotein classes including highdensity lipoproteins. Note: The HDL cholesterol value is traceable to the Center for Disease Control (CDC) described reference method for determination of HDL cholesterol. ABX Pentra HDL Cal should be used according to this calibrator notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Waste Management
1. Please refer to local legal requirements. 2. This calibrator contains less than 0.1 % of sodium azide as a preservative. As sodium azide may react with lead and copper to form explosive metal azides, this calibrator should be disposed of by flushing with copious amounts of water.
Handling
1. Reconstitute the contents of one vials with 1.0 ml of distilled or deionized water. Be careful when opening the rubber caps as some lyophilized material may be lost. 2. Close the vial and let stand for 20 minutes. 3. Dissolve the contents of the vial by inverting it gently to avoid the formation of foam. Do not shake. 4. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira.
General Precautions
1. ABX Pentra HDL Cal should be used only for the determination of the calibration curve. 2. This calibrator is for professional in-vitro diagnostic use only. 3. Do not pipette by mouth. 4. Warning: Human source material. Treat as potentially infectious. Each plasma donor unit used in the preparation of this product has been tested by an FDA-approved method and found nonreactive for the presence of HBsAg, HCV, and antibody to HIV 1/2. Because no known test method can offer complete assurance that hepatitis B virus, Human Immunodeficiency Virus (HIV) or other infectious agents are absent, the calibrators should be treated like patient specimens as potentially infectious and handled with appropriate cautions in accordance with good laboratory practices. 5. The calibrator vials should be discarded after use. 6. Please refer to the MSDS associated with the calibrator.

Assigned values
The value of ABX Pentra HDL Cal is assigned by procedures traceable to the National Reference System for Cholesterol (NRS/CHOL). Calibration materials have concentrations around the medical decision level. The assigned values are indicated in the enclosed annex, Ref. 04710800.
Warning

Calibrators, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C and protected from light. Once reconstituted, ABX Pentra HDL Cal is stable for 14 days at 2-8 C. Reconstitution stability of the calibrator may be extended by aliquoting and freezing the reconstituted calibrator preparation at less than -70 C for up to 4 weeks.
Form-0849 Rev. 2
ABX Pentra HDL Cal
ABX Pentra LDL Cal Ref.: A11A01678 Volume: 2 x 1 ml
ABX Pentra LDL Cal
Calibrator for the measurement of Low Density Lipoprotein Cholesterol (LDL-C).
2006/04/10 A93A00692C EN
A11A01678
ABX Pentra LDL Cal is used to determine the calibration curve of ABX Pentra LDL Direct CP, Ref. A11A01638.
Characteristics
ABX Pentra LDL Cal is lyophilized. It is composed of two vials of 1ml. It is a preparation of lyophilized human serum containing lipoproteins from the various lipoprotein classes including lowdensity lipoproteins. Note: The LDL cholesterol value is traceable to the Reference Method (Ultracentrifugation) for the determination of LDL Cholesterol. ABX Pentra LDL Cal should be used according to this calibrator notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Waste Management
Handling
1. Reconstitute the contents of one vial with 1.0 ml of distilled or deionized water. Be careful when opening the rubber cap as some lyophilized material may be lost. 2. Close the vial and let stand for 5 minutes. 3. Dissolve the contents of the vial by agitate it slowly, avoiding the formation of foam. Do not shake. 4. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira.
General Precautions
1. ABX Pentra LDL Cal should be used only for the determination of the calibration curve. 2. This calibrator is for professional in-vitro diagnostic use only. 3. Warning: Human source material. Treat as potentially infectious. Each plasma donor unit used in the preparation of this product have been tested by an FDA approved method and found nonreactive for the presence of HBsAg, HCV and antibody to HIV1/2. Because no known test method can offer complete assurance that hepatitis B virus, Human Immunodeficiency Virus (HIV) or other infectious agents are absent, the calibrators should be treated like patient specimens as potentially infectious and handled with appropriate cautions in accordance with good laboratory practices. 4. The calibrator vials should be discarded after use. 5. Please refer to the MSDS associated with the calibrator.

Assigned values
The value of ABX Pentra LDL Cal is assigned by procedures traceable to the National Reference System for Cholesterol (NRS/Chol). Calibration materials have concentrations around the medical decision level. The assigned values are indicated in the enclosed annex, Ref. 04710801.
Warning

Calibrators, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C and protected from light. Once reconstituted, ABX Pentra LDL Cal is stable for 2 weeks at 2-8C. The reconstituted calibrator may be aliquoted and stored at -80C.
Form-0849 Rev. 2
ABX Pentra LDL Cal
ABX Pentra MultiCal Ref.: A11A01652 Volume: 10 x 3 ml
ABX Pentra MultiCal
Calibrator for the measurement of substrates and enzymes by colorimetry.
2009/10/05 A93A00672E EN
A11A01652
ABX Pentra MultiCal is used to calibrate substrates and enzymes assays on clinical chemistry analysers.
Characteristics
ABX Pentra MultiCal is lyophilized. The kit is composed of 10 vials of calibrator (lyophilizate for 3 ml) The concentrations and activities have been adjusted to ensure optimum calibration of automatic analysers. The origin of the biological additives is as follows: ALT (GPT) AST (GOT) Albumin Aldolase Alkaline phosphatase Amylase (total) Amylase (pancreatic) Cholesterol Cholinesterase Creatine kinase -GT GLDH LD (LDH) Lipase Acid phosphatase Triglycerides Porcine heart Porcine heart Bovine plasma Rabbit muscle Placenta (human, recombinant) Porcine pancreas Porcine pancreas Bovine plasma Human serum Rabbit muscle Porcine kidney Bovine liver Porcine heart Human pancreas (recombinant) Human prostate / Potato Chicken egg yolk
HORIBA ABX SAS BP 7290 34184 Montpellier - cedex 4 - France
Be careful when opening the rubber cap as some lyophilized material may be lost. 2. Close the vial carefully and dissolve the contents within 30 minutes by turning the vial upside down, making sure that no foam is produced. 3. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira.

Automated clinical chemistry analyser. Standard laboratory equipment. Distilled or deionised water.
Assigned valuesa
The calibrator values were determined using the method mentioned in the enclosed annex. Determinations were performed under strictly standardized conditions on HORIBA Medical analyzers using HORIBA Medical reagents and HORIBA Medical master calibrator. The calibration values were obtained via multiple assays performed in different analysers in several independent series. The calibration value specified is the median of the values obtained. Assigned values are indicated in the enclosed annex, Ref. 04710797. Traceability of the assigned values are given in the tables below.
Reactive components: Human serum with chemical additives and tissue extracts of human and animal origin. Non-Reactive components: Stabilizers. The concentrations/activities of the components are lot-specific. The exact calibration values are listed in the enclosed annex, Ref 04710797. ABX Pentra MultiCal should be used according to this calibrator notice. The manufacturer cannot guarantee its performance if used otherwise.
Handling
Form-0849 Rev. 3
1. Reconstitute the contents of one calibrator vial with 3ml of distilled/deionised water.
a. Modification from index D to E: modification of Assigned values.
Latest version documents on www.horiba.com
ABX Pentra MultiCal
List of parameters standardized by the calibrator comparison method: Parameter ALT Albumin Amylase Total Bilirubin Total Protein Calcium Cholesterol CK-NAC Creatinine GGT Glucose PAP Glucose HK Iron LDH ifcc Magnesium Urea / BUN Uric Acid Triglycerides Reference material ERM-AD454 ERM-DA470 IRMM/IFCC-456 SRM916a SRM927/VERICHEM 9460 SRM909b SRM909b ERM-AD455 SRM967 ERM-AD452 SRM965a SRM965a SRM937 ERM-AD453 SRM909b SRM909b SRM913a SRM909b
Stability of direct bilirubin after reconstitution (when stored protected from light): 3 hours at 15C to 25C 8 hours at 2C to 8C 2 weeks at -25C to -15C (only one freezing session) Stability of total bilirubin after reconstitution (when stored protected from light): 6 hours at 15C to 25C 1 day at 2C to 8C 2 weeks at -25C to -15C (only one freezing session) Store calibrators tightly capped when not in use.
Waste Management
General Precautions
1. This calibrator is for professional in-vitro diagnostic use only. 2. Observe the standard laboratory precaution for use. 3. All products derived from blood are prepared exclusively from the blood of donors tested individually and shown by FDA-approved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as patient specimen, as potentially infectious and handled with appropriate caution. In case of exposure, follow the guidelines of the competent health authorities (1,2). 4. The calibrator vials should be discarded after use. 5. Please refer to the MSDS associated with the calibrator.
List of parameters standardized by comparison of methods with pools of human serum: Parameter ALP AST Direct Bilirubin Lactate LDH Lipase Phosphorus Reference method IFCC Reference Measurement Procedure (37C) for ALP IFCC Reference Measurement Procedure (37C) for AST Primary reference material (weighed in purified material) Bilirubin ditaurate Primary reference material (weighed in purified material) HORIBA Medical Reagent/manual measurement; Epsilon of NADH HORIBA Medical Reagent/manual measurement; Epsilon of methylresorufin Primary reference material (weighed in purified material) NERL
Warning
Reference
1. Department of Labor, Occupational Safety and Health Standards: bloodborne pathogens. (29 CFR Part 1910.1030). Federal Register July 1, 1998; 6: 267-280. 2. Council Directive (90/679/EEC). Official Journal of the European Communities. No. L374 from December 31, 1990: 1-12.

Calibrators, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Stability of components* after the reconstitution of ABX Pentra MultiCal: 8 hours at 15C to 25C 2 days at 2C to 8C 2 weeks at -25C to -15C (only one freezing session) *Exceptions : see below.
ABX Pentra TPU Cal Ref.: A11A01898 Volume: 3 x 3 ml
ABX Pentra TPU Cal
Calibrator for the quantitative in vitro determination of urinary proteins by colorimetry.
2009/04/02 A93A01220A EN
A11A01898
ABX Pentra TPU Cal is used to calibrate ABX Pentra Urinary Proteins CP, Ref. A11A01642.
Characteristics
ABX Pentra TPU Cal is a liquid ready-to-use calibrator based on a aqueous solution containing human serum. The kit is composed of 3 vials of 3 ml. ABX Pentra TPU Cal should be used according to this calibrator notice and as specified in the respective instructions for use of the reagent. The manufacturer cannot guarantee its performance if used otherwise.
HORIBA ABX SAS BP 7290 34184 Montpellier - cedex 4 - France
General Precautions
1. This calibrator is for professional in-vitro diagnostic use only. 2. Observe the standard laboratory precaution for use. 3. All human material should be considered as potentially infectious. All products derived from blood are prepared exclusively from the blood of donors tested individually and shown by approved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as patient specimen, as potentially infectious and handled with appropriate caution. In case of exposure, follow the guidelines of the competent health authorities (1,2). 4. The calibrator vials should be discarded after use. Disposal of all waste material should be in accordance with local guidelines. 5. Please refer to the MSDS associated with the calibrator.
Handling
ABX Pentra TPU Cal is ready-to-use. Mix carrefully before use. Avoid the formation of foam. Remove the cap of the vial, transfer the calibrator in a sample cup and place in the correct position on the ABX Pentra 400.

HORIBA Medical reagents and automated clinical chemistry analyser. Standard laboratory equipment.
Assigned values
The calibrator value is traceable with SRM927. Please refer to the vial label for the exact concentration.
Warning

Calibrators, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Stability after opening: 9 weeks at 2-8C. Store calibrator tightly capped when not in use.
Reference
1. Department of Labor, Occupational Safety and Health Standards: bloodborne pathogens. (29 CFR Part 1910.1030). Federal Register July 1, 1998; 6: 267-280. 2. Council Directive (2000/54/EC). Official Journal of the European Communities. No. L262 from October 17, 2000: 21-45.
Waste Management
Form-0849 Rev. 3
ABX Pentra TPU Cal
ABX Pentra Urine Cal Ref.: A11A01673 Volume: 3 x 1 ml
ABX Pentra Urine Cal
Calibrator for the measurement of urinary proteins by colorimetry.
2005/10/18 A93A01195A EN
A11A01673
ABX Pentra Urine Cal is used to calibrate ABX Pentra Urinary Proteins CP, Ref. A11A01642.
Characteristics
ABX Pentra Urine Cal is a liquid ready-to-use calibrator based on a buffered aqueous solution. The concentrations of the calibrator components have been adjusted to ensure optimal calibration on clinical chemistry analysers. - Reactive components: HEPES buffer: 20 mmol/l, Ph 7.5 Chemical additives and material of biological origin as specified below: Analyte Albumin 1-Microglobulin Immunoglobulin G Total protein origin Human serum Human urine Human serum Human serum/sheep serum

Calibrators, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Stability after opening: 4 weeks at 2-8 C , provided that dispensing of the calibrator takes place without microbial contamination, e.g. by pouring out. Store calibrator tightly capped when not in use.
- Non-reactive components: Preservatives and stabilizers. ABX Pentra Urine Cal should be used according to this calibrator notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Waste Management
1. Please refer to local legal requirements.
General Precautions
1. This calibrator is for professional in-vitro diagnostic use only. 2. Observe the standard laboratory precaution for use. 3. All human material should be considered as potentially infectious. All products derived from blood are prepared exclusively from the blood of donors tested individually and shown by FDA-approved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as patient specimen, as potentially infectious and handled with appropriate caution. In the event of exposure, the directives of the responsible health authorities should be followed (1,2). 4. The calibrator vials should be discarded after use. Disposal of all waste material should be in accordance with local guidelines. 5. Please refer to the MSDS associated with the calibrator.
Handling
ABX Pentra Urine Cal is ready-to-use. Mix carrefully before use. Avoid the formation of foam. Remove the cap of the vial, transfer the calibrator in a sample cup and place in the correct position on the ABX Pentra 400 or on the Mira.

Assigned values
The calibrator values were obtained via single determinations performed in different laboratories in several independent series. The calibrator value specified is the median of all values obtained. The concentrations of the components are lot-specific and may vary from lot to lot. The exact calibration values are listed in the enclosed annex, Ref 04710799.
Form-0849 Rev. 2
Warning
ABX Pentra Urine Cal
Reference
1. Department of Labor, Occupational Safety and Health Standards: bloodborne pathogens. (29 CFR Part 1910.1030). Federal Register July 1, 1998; 6: 267-280. 2. Council Directive (2000/54/EC). Official Journal of the European Communities. No. L262 from October 17, 2000: 21-45.
ABX Pentra CK Control Ref.: A11A01786 Volume: 4 x 3 ml
ABX Pentra CK Control
Control serum for the measurement of CK-NAC and CK-MB.
2006/04/14 A93A01152C EN
A11A01786
ABX Pentra CK Control is a control used to monitor the performances of CK-NAC and CK-MB determination.
Characteristics
ABX Pentra CK Control is a lyophilized control based on bovine serum albumin. The adjusted concentrations and activities of the control components are usually in the normal range or at the normal/pathological threshold. Reactive components: Bovine serum albumin with chemical additives and material of biological origin as specified. Origin of biological substances: Analyte CK-MM CK-BB Origin human porcine brain
Assigned values
Assigned values have been determined by calibration with a reference material in accordance with established protocols. Assigned values for the ABX Pentra CK Control vary from lot to lot. The control values are indicated in the enclosed annex, Ref. 04710805.
Non-reactive components: Preservatives and stabilizers. ABX Pentra CK Control should be used according to this control notice. HORIBA ABX cannot guarantee its performance if used otherwise.

Controls, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C . Once reconstituted, ABX Pentra CK Control can be used within the period reported below if stored tightly closed at the indicated temperature: 24 hours at 15-25 C 3 days at 2-8 C 4 weeks at -15/-25 C (only one freezing session)
Handling
1. Reconstitute the content of one vial with 3.0ml of distilled/ deionized water. Be careful when opening the rubber cap as some lyophilised material may be lost. 2. Close the vial carefully and allow it to stand for 30 minutes, gently invert the vial to facilitate the dissolution. Avoid foaming. Do not shake. 3. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira. 4. Once reconstituted, treat the control as a patient specimen. The control should be run daily in parallel with the patient samples and after every calibration. The control intervals should be adapted to each laboratorys individual requirements. Each laboratory should established QC procedures that conform with pertinent regulations or accreditation requirements.
Waste Management
General Precautions
1. This control is for professional in-vitro diagnostic use only. 2. Follow proper laboratory handling precautions. 3. All human material should be considered as potentially infectious. This product has been prepared exclusively from blood proceeding from donors which has been analysed individually in accordance with the FDA-approved method. No HBsAg and antibodies to HCV and HIV has been detected. However, since the absence of an infection risk cannot be completely assured, this product should be handled with the same precautions that are applied to patient samples. In case of exposure, follow local health authority regulations (1,2). 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.

Form-0850 Rev. 2
Automated clinical chemistry analyser Standard laboratory equipment Distilled or deionized water
ABX Pentra CK Control
Warning
It is the users responsibility to verify that this document is applicable to the control used.
Reference
1. Occupational Safety and Health Standards: bloodborne pathogens. (29 CFR Part 1910.1030). Federal Register. July 1, 2001; 17:260273. 2. Council Directive (2000/54/EC). Official Journal of the European Communities No. L262 from October 17, 2000.
ABX Pentra CO2 Control Ref.: A11A01650 Volume: 3 x 3 ml
ABX Pentra CO2 Control
Control for the measurement of Bicarbonate/Total CO2.
2006/04/14 A93A00852C EN
A11A01650
ABX Pentra CO2 Control is a control used to monitor the performances of Bicarbonate/Total CO2 determination.
Characteristics
ABX Pentra CO2 Control is liquid and ready-to-use. ABX Pentra CO2 Control should be used according to this control notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Handling
Remove the cap of the vial, transfer the control in a sample cup and place in the correct position on the ABX Pentra 400 or on the Mira.

Assigned values
Assigned values have been determined by calibration with a reference material in accordance with established protocols. The assigned values are indicated in the enclosed annex, Ref. 04710802.

Controls, in unopened vials, are stable up to the expiry date on the label if stored at 2-25 C and protected from light. Once opened, ABX Pentra CO2 Control is stable for 3 months, at 2-8C, if recapped immediately after use. Proper storage and handling of this product must be observed.
Waste Management
General Precautions
1. This control is for professional in-vitro diagnostic use only. 2. The control vials should be discarded after use. 3. Please refer to the MSDS associated with the control.
Warning
Reference
Form-0850 Rev. 2
1. Rhle G., Siekmann L. Quality assurance of quantitative determination. In: Thomas L., editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 1393-1401.
ABX Pentra CO2 Control
ABX Pentra Fructo Control N Ref.: A11A01681 Volume: 3 x 1 ml
ABX Pentra Fructo Control N
Control serum for the determination of fructosamine by colorimetry (normal level).
2006/04/14 A93A00932C EN
A11A01681
ABX Pentra Fructo Control N is used to verify the accuracy and precision of the fructosamine determination.
Characteristics
ABX Pentra Fructo Control N is a lyophilised control serum obtained from human serum. The fructosamine concentrations are lot-specific and are within the normal range or at the normal range limit. ABX Pentra Fructo Control N should be used according to this control notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Handling
1. Reconstitute the contents of one vial with exactly 1.0 ml of distilled water. Carefully open the vial, taking care not to spill lyophilisate. 2. Mix well. Avoid the formation of foam. 3. Allow the solution to rest for at least 60 minutes before use. 4. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira. 5. Once reconstituted, treat the control serum like a patient specimen. The frequency of controls should correspond to the guidelines of the individual laboratory.
Each laboratory should establish a procedure to follow if the results exceed the specified dispersion interval. The theoretical values, along with the exact dispersion intervals, are specified in the enclosed annex, Ref. 04710793.

Unopened controls are stable up to the expiry date stated on the label. Following reconstitution, the control serum is stable for: 1 week at 25 C 4 weeks at 2-8 C
Waste Management

Automated clinical chemistry analyser. Standard laboratory equipment. Bidistilled water.
General Precautions
1. Control, for professional in-vitro diagnostic use only. 2. Follow proper laboratory handling precautions. 3. This product has been prepared exclusively from blood proceeding from donors which has been analysed individually in accordance with the FDA-approved method. No HBs antigen or HIV / HCV antibody has been detected. However, since the absence of an infection risk cannot be completely assured, this product should be handled with the same precautions that are applied to patient samples. In case of exposure, follow local health authority regulations (1,2). 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.
Assigned values
The theoretical values and dispersion intervals have been obtained by single determinations performed in at least 7 laboratories and in at least 3 independent series. Theoretical value = mean value of the measurements. Dispersion interval = theoretical value 3s (s: standard deviation found by means of multiple determinations of theoretical values). The reagents and analysers used for the determinations have been the ones available at the time. The results must be within the range of the defined confidence limits. If a tendency towards higher or lower values is observed, or if the values are even above the dispersion limits, it is necessary to verify each step of the measurement process.
Warning
It is the user's responsibility to verify that this document is applicable to the control used.
Form-0850 Rev. 2
ABX Pentra Fructo Control N
Reference
1. Occupational Safety and Health Standards : bloodborne pathogens. (29 CFR 1910. 1030). Federal Register. July 1, 1998 ; 6 : 267-280. 2. Council Directive (90/679/EEC). Official Journal of the European Communities No. L374 from Dec. 31, 1990 : 1-12.
ABX Pentra Fructo Control P Ref.: A11A01682 Volume: 3 x 1 ml
ABX Pentra Fructo Control P
Control serum for the determination of fructosamine by colorimetry (pathological level).
2006/04/18 A93A00942C EN
A11A01682
ABX Pentra Fructo Control P is used to verify the accuracy and precision of the fructosamine determination.
Characteristics
ABX Pentra Fructo Control P is a lyophilised control serum obtained from human serum. The fructosamine concentrations are lot-specific and are within the pathological range. ABX Pentra Fructo Control P should be used according to this control notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Storage and Stability Handling

1. Reconstitute the contents of one vial with exactly 1.0 ml of distilled water. Carefully open the vial, taking care not to spill lyophilisate. 2. Mix well. Avoid the formation of foam. 3. Allow the solution to rest for at least 60 minutes before use. 4. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira. 5. Once reconstituted, treat the control serum like a patient specimen. The frequency of controls should correspond to the guidelines of the individual laboratory. Unopened controls are stable up to the expiry date stated on the label. Following reconstitution, the control serum is stable for: 1 week at 25 C 4 weeks at 2-8 C
Waste Management
General Precautions
1. Control, for professional in-vitro diagnostic use only. 2. Follow proper laboratory handling precautions. 3. This product has been prepared exclusively from blood proceeding from donors which has been analysed individually in accordance with the FDA-approved method. No HBs antigen or HIV / HCV antibody has been detected. However, since the absence of an infection risk cannot be completely assured, this product should be handled with the same precautions that are applied to patient samples. In case of exposure, follow local health authority regulations (1,2). 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.

Automated clinical chemistry analyser. Standard laboratory equipment. Bidistilled water.
Assigned values
The given intervals and theoretical values have been determined and calculated as follows: mean value 3 s (s corresponds to a value derived from different determinations of theoretical values) measured in at least 7 laboratories and in at least 3 independent series by means of single determinations. The values have been obtained using test reagents and analyser systems available at the time of determination. The results must be within the range of the defined confidence limits. If a tendency towards higher or lower values is observed, or if the values are even above the dispersion limits, it is necessary to verify each step of the measurement process. Each laboratory should establish a procedure to follow if the results exceed the specified dispersion interval. The theoretical values, along with the exact dispersion intervals, are specified in the enclosed annex, Ref. 04710794.
Warning
It is the user's responsibility to verify that this document is applicable to the control used.
Reference
1. Occupational Safety and Health Standards : bloodborne pathogens. (29 CFR 1910. 1030). Federal Register. July 1, 1998 ; 6 : 267-280. 2. Council Directive (90/679/EEC). Official Journal of the European Communities No. L374 from Dec. 31, 1990 : 1-12.
Form-0850 Rev. 2
ABX Pentra Fructo Control P
ABX Pentra N Control Ref.: A11A01653 Volume: 10 x 5 ml
ABX Pentra N Control
Normal control serum for the quality control of substrate, electrolyte, lipid, enzyme and protein assays.
2007/05/24 A93A00822D EN
A11A01653
10 x 5 ml
Intended use
ABX Pentra N Control is a serum for the quality control of substrate, electrolyte, lipid, enzyme and protein assays. It can be used for checking the accuracy and precision of assays carried out using the ABX Pentra reagent range, for checking automated analytical methods.
Characteristics
ABX Pentra N Control is made of human serum. Its concentrations and activities are mostly in the normal or near-normal range. ABX Pentra N Control is lyophilized. It is composed of human serum to which chemical substances and extracts from human - or animal derived tissue have been added. Origin of biological substances: Porcine heart Porcine heart Human serum Rabbit muscle Human placenta, recombinant alkaline phosphatase Amylase (total) Human saliva, pigs pancreas Amylase (pancreatic) Porcine pancreas Cholesterol Bovine plasma Cholinesterase Human serum Creatine kinase Rabbit muscle -GT Porcine kidneys GLDH Bovine liver LD (LDH) Porcine heart Lipase Human rek. pancreas lipase Acid phosphatase Human prostate, potato Total proteins Human serum The concentrations of the constituents are lot-specific. Theoretical values and their precise confidence intervals are given in the ABX Pentra N Control enclosed annex, Ref. 04710795. ABX Pentra N Control should be used according to this control notice. HORIBA ABX cannot guarantee its performance if used otherwise. ALT (GPT) AST (GOT) Albumin Aldolase Alkaline phosphatase
2. Close the vial carefully and dissolve the contents within 30 minutes by turning the vial upside down, making sure that no foam is produced. Important: The determination of enzyme activity may be carried out immediately in the case of all enzymes except for alkaline phosphatase. To reactivate alkaline phosphatase, incubate the reconstituted control serum for one hour at 25 C. 3. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira. 4. Once reconstituted, treat the control as a patient specimen. An analysis of the control serum must be carried out on a daily basis at the same time as the patient samples, including each time a calibration is carried out. The frequency of the controls depends on the laboratory requirements. Each laboratory must establish the quality assurance procedures to be followed. These must conform to the current accreditation requirements.

Assigned valuesa
The assigned values were determined using the method stated in the enclosed annex. Determinations were performed under strictly standardized conditions on HORIBA ABX analyzers using HORIBA ABX reagents and HORIBA ABX master calibrator. The target value is the median of all values obtained. The corresponding control range is calculated as the target value 3
a.Modification from index C to D: addition of informations.
Handling
Form-0850 Rev. 2
1. Reconstitute the contents of one vial with 5.0 ml of distilled water or deionised water. Be careful when opening the rubber cap as some lyophilized material may be lost.
ABX Pentra N Control
standard deviations (with the standard deviation being the value obtained from several target value determination). Results must be within the range of the defined confidence limits. Each laboratory must establish the procedure to be followed in case the results are outside of the confidence interval given. The control values are indicated in the enclosed annex, Ref. 04710795. The traceability of the target values is given in the instructions for use of the calibrator, ABX Pentra Multical, Ref. A11A01652.
Reference
1. Occupational Safety and Health Standards : bloodborne pathogens. (29 CFR 1910. 1030). Federal Register July 1, 1998 ; 6 :267-280. 2. Directive of the European Council (90/679/CEE). Official Journal of the European Community no. L374, 31.12.1990, pp. 1-12.

Controls, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Stability of the parameters* after the reconstitution of ABX Pentra N Control: 12 hours at 25C 5 days at 2 - 8C 1 month at -20C (only one freezing session) *Exceptions : see below. Stability of bilirubin following reconstitution away from light: 2 hours at 25C 6 hours at 2 - 8C 2 weeks at -20C (only one freezing session) A slight green coloration of the control serum does not in any way affect theoretical values. Keep the reconstituted control serum vials tightly shut.
Waste Management
General Precautions
1. This control is for professional in-vitro diagnostic use only. 2. Observe the standard laboratory precautions for use. For France: please refer to the Good Analytical Practice Handbook ( Guide de Bonne Excution des Analyses). 3. Although the controls have been prepared from blood derived from donors negative for HBs antigen, HIV1/2 antibody and HCV antibody, and because no test method can completely assure the absence of HIV1/2, hepatitis B virus, hepatitis C virus, or other infectious agents, the controls should be treated like patient specimens as potentially infectious and handled with appropriate caution. In case of exposure, follow the guidelines of the competent health authorities (1,2). 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.
Warning
ABX Pentra P Control Ref.: A11A01654 Volume: 10 x 5 ml
ABX Pentra P Control
Pathological control serum for the quality control of substrate, electrolyte, lipid, enzyme and protein assays.
2007/05/24 A93A00832D EN
A11A01654
10 x 5 ml
Intended use
ABX Pentra P Control is a serum for the quality control of substrate, electrolyte, lipid, enzyme and protein assays. It can be used for checking the accuracy and precision of assays carried out using the ABX Pentra reagent range, for checking automated analytical methods.
Characteristics
ABX Pentra P Control is made of human serum. Its concentrations and activities are mostly in the pathological range. ABX Pentra P Control is lyophilized. It is composed of human serum to which chemical substances and extracts from human - or animal derived tissue have been added. Origin of biological substances: ALT (GPT) AST (GOT) Albumin Aldolase Alkaline phosphatase Porcine heart Porcine heart Human serum Rabbit muscle Human placenta, recombinant alkaline phosphatase Amylase (total) Human saliva, pigs pancreas Amylase (pancreatic) Porcine pancreas Cholesterol Bovine plasma Cholinesterase Human serum Creatine kinase Rabbit muscle -GT Porcine kidneys GLDH Bovine liver LD (LDH) Porcine heart Lipase Human rek. pancreas lipase Acid phosphatase Human prostate, potato Total proteins Human serum The concentrations of the constituents are lot-specific. Theoretical values and their precise confidence intervals are given in the ABX Pentra P Control enclosed annex, Ref. 04710796. ABX Pentra P Control should be used according to this control notice. HORIBA ABX cannot guarantee its performance if used otherwise.
2. Close the vial carefully and dissolve the contents within 30 minutes by turning the vial upside down, making sure that no foam is produced. Important: The determination of enzyme activity may be carried out immediately in the case of all enzymes except for alkaline phosphatase. To reactivate alkaline phosphatase, incubate the reconstituted control serum for one hour at 25 C. 3. Use a pipette to transfer the required volume into a sample cup and place it on the appropriate rack of the ABX Pentra 400 or Mira. 4. Once reconstituted, treat the control as a patient specimen. An analysis of the control serum must be carried out on a daily basis at the same time as the patient samples, including each time a calibration is carried out. The frequency of the controls depends on the laboratory requirements. Each laboratory must establish the quality assurance procedures to be followed, which must conform to the current accreditation requirements.

Assigned valuesa
The assigned values were determined using the method stated in the enclosed annex. Determinations were performed under strictly standardized conditions on HORIBA ABX analyzers using HORIBA ABX reagents and HORIBA ABX master calibrator. The target value is the median of all values obtained. The corresponding control range is calculated as the target value 3
a.Modification from index C to D: addition of informations.
Handling
Form-0850 Rev. 2
1. Reconstitute the contents of one vial with 5.0 ml of distilled water or deionised water. Be careful when opening the rubber cap as some lyophilized material may be lost.
Reference

Controls, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Stability of the parameters* after the reconstitution of ABX Pentra P Control : 12 hours at 25C 5 days at 2 - 8C 1 month at -20C (only one freezing session) *Exceptions: see below. Stability of bilirubin following reconstitution away from light: 2 hours at 25C 6 hours at 2 - 8C 2 weeks at -20C (only one freezing session) A slight green coloration of the control serum does not in any way affect theoretical values. Keep the reconstituted control serum vials tightly shut.
Waste Management
General Precautions
1. This control is for professional in-vitro diagnostic use only. 2. Observe the standard laboratory precautions for use. For France: please refer to the Good Analytical Practice Handbook (Guide de Bonne Excution des Analyses). 3. Although the controls have been prepared from blood derived from donors negative for HBs antigen, HIV1/2 antibody and HCV antibody, and because no test method can completely assure the absence of HIV1/2, hepatitis B virus, hepatitis C virus, or other infectious agents, the controls should be treated like patient specimens as potentially infectious and handled with appropriate caution. In case of exposure, follow the guidelines of the competent health authorities (1,2). 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.
Warning
ABX Pentra Urine Control L/H Ref.: A11A01674 Volume R1: 1 x 10 ml Volume R2: 1 x 10 ml
ABX Pentra Urine Control L/H
Control urine for the quality control of HORIBA ABX methods.
2008/05/15 A93A00862C EN
A11A01674
ABX Pentra Urine Control L/H is a urine for the quality control of substrate, enzyme and protein assays. It can be used for checking the accuracy and precision of assays carried out using the ABX Pentra reagent range, for checking automated analytical methods.
1 x 10 ml
Characteristics
ABX Pentra Urine Control L/H is liquid and ready-to-use. It is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. This kit is composed of 2 vials: 1 vial of control low (10 ml) 1 vial of control high (10 ml) ABX Pentra Urine Control L/H should be used according to this control notice and as specified in the respective instructions for use of the reagent. HORIBA ABX cannot guarantee its performance if used otherwise.

Controls, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Once opened, ABX Pentra Urine Control L/H is stable for 30 days, at 2-8C, if recapped immediately after use. Proper storage and handling of this product must be observed.
Handling
Before sampling, allow the control to reach room temperature (1825C) and swirl gently to ensure homogeneity. Remove the cap of the vial, transfer the control in a sample cup and place in the correct position on the ABX Pentra 400 or Mira.
Waste Management
1. Please refer to local legal requirements. 2. This control contains less than 0.1 % of sodium azide as a preservative. As sodium azide may react with lead and copper to form explosive metal azides, this control should be disposed of by flushing with copious amounts of water.

HORIBA ABX reagents and clinical chemistry analyser. Standard laboratory equipment.
General Precautionsa
1. ABX Pentra Urine Control L/H should be used only for quality control purpose only. 2. This control is for professional in-vitro diagnostic use only. 3. Warning: Biological source material. Treat as potentially infectious. The serum from each donor contributing urine for this product was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests. The control should be treated like patient specimens as potentially infectious and handled with appropriate cautions in accordance with good laboratory practices. 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.
Assigned values
Determinations were performed under strictly standardized conditions on HORIBA ABX analyzers using HORIBA ABX reagents and HORIBA ABX master calibrator. The target value is the median of all values obtained. Assigned values for both the high (H) and low (L) controls are lotspecific. Assigned values and precise confidence interval are indicated in the ABX Pentra Urine Control L/H enclosed annex, Ref. 04710798. Note: Creatinine values may gradually decrease over the product shelf life. Individual laboratory means may eventually fall outside of the corresponding ranges printed in the enclosed annex.
Warning
Form-0850 Rev. 2
a.Modification from index B to C: suppression of Irritant.

ABX Pentra Urine Control L/H
Reference

Controls, in unopened vials, are stable up to the expiry date on the label if stored at 2-8 C. Stability of the parameters* after the reconstitution of ABX Pentra P Control : 12 hours at 25C 5 days at 2 - 8C 1 month at -20C (only one freezing session) *Exceptions: see below. Stability of bilirubin following reconstitution away from light: 2 hours at 25C 6 hours at 2 - 8C 2 weeks at -20C (only one freezing session) A slight green coloration of the control serum does not in any way affect theoretical values. Keep the reconstituted control serum vials tightly shut.
Waste Management
General Precautions
1. This control is for professional in-vitro diagnostic use only. 2. Observe the standard laboratory precautions for use. For France: please refer to the Good Analytical Practice Handbook (Guide de Bonne Excution des Analyses). 3. Although the controls have been prepared from blood derived from donors negative for HBs antigen, HIV1/2 antibody and HCV antibody, and because no test method can completely assure the absence of HIV1/2, hepatitis B virus, hepatitis C virus, or other infectious agents, the controls should be treated like patient specimens as potentially infectious and handled with appropriate caution. In case of exposure, follow the guidelines of the competent health authorities (1,2). 4. The control vials should be discarded after use. 5. Please refer to the MSDS associated with the control.
Warning
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ABX Pentra CO2 Cal Ref.

ABX Pentra CO2 Cal

Calibrator for the measurement of bicarbonate / total CO2.

HORIBA ABX BP 7290 34184 Montpellier - cedex 4 - France

Materials required but not provided

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ABX Pentra CO2 Cal

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Waste Management Handling

Materials required but not provided

Storage and Stability

7 days at 15-25 C 28 days at 2-8 C

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ABX Pentra Fructo Cal

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ABX Pentra HDL Cal Ref.: A11A01647 Volume: 2 x 1 ml

ABX Pentra HDL Cal

Calibrator for the measurement of High-Density Lipoprotein Cholesterol (HDL-C) by colorimetry.

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Materials required but not provided

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ABX Pentra HDL Cal

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ABX Pentra LDL Cal Ref.: A11A01678 Volume: 2 x 1 ml

ABX Pentra LDL Cal

Calibrator for the measurement of Low Density Lipoprotein Cholesterol (LDL-C).

HORIBA ABX BP 7290 34184 Montpellier - cedex 4 - France

Materials required but not provided

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Latest version documents on www.horiba-abx.com

ABX Pentra LDL Cal

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ABX Pentra MultiCal Ref.: A11A01652 Volume: 10 x 3 ml

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Calibrator for the measurement of substrates and enzymes by colorimetry.

HORIBA ABX SAS BP 7290 34184 Montpellier - cedex 4 - France

Materials required but not provided

Latest version documents on www.horiba.com

ABX Pentra MultiCal

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ABX Pentra TPU Cal Ref.: A11A01898 Volume: 3 x 3 ml

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Calibrator for the quantitative in vitro determination of urinary proteins by colorimetry.

Materials required but not provided

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ABX Pentra TPU Cal

Latest version documents on www.horiba.com

ABX Pentra Urine Cal Ref.: A11A01673 Volume: 3 x 1 ml

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Calibrator for the measurement of urinary proteins by colorimetry.

HORIBA ABX BP 7290 34184 Montpellier - cedex 4 - France

Storage and Stability

Materials required but not provided

Latest version documents on www.horiba-abx.com