ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

K073309 · Horiba Abx · LCP · Oct 17, 2008 · Hematology

Device Facts

• Record ID: K073309
• Device Name: ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
• Applicant: Horiba Abx
• Product Code: LCP · Hematology
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

ABX Pentra HbA1c WB reagent is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of HbA1c using whole blood and hemolysate. The controls, calibrators and additional reagents are intended for use in association with the above reagents.

Device Story

The ABX PENTRA HbA1c WB system is an in vitro diagnostic assay for quantitative determination of Hemoglobin A1c in human whole blood. The device utilizes a turbidimetric and colorimetric test principle on the ABX PENTRA 400 benchtop clinical chemistry analyzer. The system processes whole blood samples, which are lysed using the provided hemolysis reagent. The analyzer performs photometric measurements to determine HbA1c levels. Results are used by clinicians to monitor long-term diabetic control and assess treatment efficacy. The system includes specific calibrators and assayed controls to ensure measurement accuracy and precision. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Precision assessed via CLSI EP05-A2 (n=80 per method); linearity via CLSI EP06-A; interference testing per CLSI guidelines. Method comparison study (n=144) against predicate (Olympus AU400) showed strong correlation (r=0.98) for both manual and automated hemolysis methods. No clinical studies performed.

Technological Characteristics

Turbidimetric and colorimetric assay. Reagents include animal-derived substances, purified human material, and chemical solutions. System is a discrete photometric benchtop clinical chemistry analyzer. Calibrators are liquid chemical solutions; controls are lyophilized human whole blood. Reagents stored at 2-8°C. No specific ASTM standards cited.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbA1c) in human whole blood to assess long-term glycemic control in patients with diabetes. Used on the ABX PENTRA 400 Clinical Chemistry Analyzer.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• K031380 (Olympus)
• K955087 (Bayer)
• K951361 (Bayer)

Submission Summary (Full Text)

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## Premarket Notification [510(k)] Summary

## OCT 1 7 2008

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is : K073309

Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 92 Telephone: + (33) 4 67 14 15 17 Fax:

> Olivier Ducamp (oducamp(@fr.abx.fr) Contact Persons: Caroline Ferrer (cferrer(a)fr.abx.fr)

Date Prepared: 24th June 2008

#### Device Names:

The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.

#### REAGENTS :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

#### ABX PENTRA HbA1c WB

Hemoglobin Alc Class II §864.7470 : Glycosylated hemoglobin assay LCP ; Assay, Glycosylated hemoglobin

#### CALIBRATOR:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

#### ABX PENTRA HbA1c WB Cal

HbA1c Calibrator Class II \$862.1150 : Calibrator JIX ; Calibrator, Multi-analyte mixture

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| CONTROLS : | |
|-------------------------|------------------------------------------------------|
| Trade/Proprietary Name: | ABX PENTRA HbA1c WB Control |
| Common or Usual Name: | Hemoglobin A1c Control |
| Device Class | Class 1 |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-analyte controls (Assayed and Unassayed) |
| ADDITIONAL REAGENTS: | |
| Trade/Proprietary Name: | ABX PENTRA HbA1c WB Hemolysis Reagent |
| Common or Usual Name: | Hemolysis reagent |
| Device Class | Class 1 : Exempt from Premarket notification |
| Classification Name: | §862.8540 : Red cell lysing product |
| Product Code: | GGK : Products, Red-cell lysing products |

### Substantial Equivalence:

The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices :

| Submission device | Substantially equivalent<br>Predicate device |
|--------------------------|----------------------------------------------|
| ABX PENTRA HbAlc WB | K031380 (Olympus)<br>K955087 (Bayer) |
| ABX PENTRA HbA1c Cal | K031380 (Olympus)<br>K955087 (Bayer) |
| ABX PENTRA HbA1c Control | K031380 (Olympus)<br>K951361 (Bayer) |

### Description:

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA HbA1c WB is an in vitro diagnostic assay for the quantitative determination of Hemoglobin A1c in human whole blood based on a turbidimetric and colorimetric test. The assay is composed of the following vials:

- 1 x 23 ml vial (R1) 1 x 23 ml vial (R2) 1 x 110 ml vial (R3) 2 x 21 ml vials (R4) 1 x 25 ml vial (R5)

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Reagent R1 is prepared from substances of animal origin and purified with human material. Reagents R2 and R3 are prepared from substances of animal origin and chemical solutions. R4 and R5 are chemical solutions with additives.

The ABX PENTRA HbA1c Cal is a liquid multi-calibrator prepared from chemical solutions. It is used for the calibration of the HbA1c assays. The assigned values are given in the notice. This calibrator has six levels and is provided in one vial of 8 ml and five vials of 2 ml.

The ABX PENTRA HbA1c Control is a lyophilized assayed control prepared from human whole blood. It has 2 levels (Normal and Pathological) to be used for the quality control of HbA 1c assays. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 0.25 ml. The kit contains also a 2 ml reconstitution buffer vial.

The ABX PENTRA HbA1c WB Hemolysis Reagent is a chemical solution for use in the lysis of red blood cells with the HbA1c HORIBA ABX methods on the ABX Pentra 400 system. It is provided in a 110 ml vial.

## Intended Use:

ABX Pentra HbA1c WB reagent is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of HbA1c using whole blood and hemolysate. The controls, calibrators and additional reagents are intended for use in association with the above reagents.

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## Discussion of Performance Data:

# REAGENT

| ABX PENTRA HbA1c WB (Hemolysate/Manual hemolysis method) : | | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Sample type | Whole blood | |
| Accuracy and Precision | CV Total < 2.72% | |
| Linearity | For Total Hemoglobin : 2.07 g/dl - 20.00 g/dl<br>For HbAlc : 0.16 g/dl - 2.85 g/dl | |
| Measuring range | For HbAlc % : 4.98 % - 15.16 % | |
| Correlation (n=144) | Y = 0.97 x + 0.36 with a correlation coefficient r2 = 0.9673 | |
| Calibration stability | 3 weeks | |
| Reagent stability | closed stability: 24 months at 2-8°C<br>open stability of the reagents : up to the expiration date at 2-8°C<br>stability after reconstitution of the latex antibody complex : 2<br>months at 2-8°C | |

| ABX PENTRA HbA1c WB (Whole Blood/Automated hemolysis method) : | |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Whole blood |
| Accuracy and Precision | CV Total <3.71% |
| Linearity | For Total Hemoglobin : 105 g/dl - 1027 g/dl<br>For HbA1c : 8.13 g/dl - 145.3 g/dl |
| Measuring range | For HbA1c % : 4.98 % - 15.16 % |
| Correlation (n=144) | Y = 0.98 x + 0.41 with a correlation coefficient r² = 0.9561 |
| Calibration stability | 3 weeks |
| Reagent stability | closed stability: 24 months at 2-8°C<br>open stability of the reagents : up to the expiration date at 2-8°C<br>stability after reconstitution of the latex antibody complex : 2<br>months at 2-8°C |

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# CALIBRATOR

| ABX PENTRA HbA1c Cal: | |
|-----------------------|------------------------------------------------------------------------------------------------|
| Analytes | Hemoglobin A1c<br>Total Hemoglobin |
| Format | Liquid chemical solutions |
| Stability | Closed stability: 24 months<br>Open stability: until the expiry date when stored at 2°C to 8°C |

## CONTROLS

| ABX PENTRA HbA1c Control : | |
|----------------------------|--------------------------------------------------------------------------------------------|
| Analytes | Hemoglobin A1c % : 2 levels (normal and pathological) |
| Format | Lyophilized preparation of human whole blood |
| Stability | Closed stability: 36 months<br>Open stability after reconstitution: 3 months at 2°C to 8°C |

## ADDITIONAL REAGENT

| ABX PENTRA HbA1c WB Hemolysis Reagent: | |
|----------------------------------------|-----------------------------------------------------------------------------------------------|
| Analyte | HbA1c assays |
| Format | Chemical hemolysing solution |
| Stability | Closed stability: 18 months<br>Open stability : until the expiry date when stored at 2℃ to 8℃ |

## Conclusions for Performance Testing:

The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Horiba ABX SAS c/o Mr. Olivier Ducamp Regulatory Affairs Manager Parc Euromédecine Rue du Caducée - BP 7290 Montpellier, Hérault, France 34184

OCT 1 7 2008

k073309 Re:

Trade/Device Name: HbA1c Reagent on the ABX Pentra Clinical Chemistry Analyzer Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIX, JJY Dated: September 30, 2008 Received: October 2, 2008

Dear Mr. Ducamp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known): K073309

Device Name: HbA1c reagent on ABX PENTRA Clinical Chemistry Analyzer

Indication For Use:

ABX PENTRA HBAIc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer

Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.

The ABX PENTRA HbAIc WB Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HbAIc WB method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA HbAlc WB Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA HbA1c WB method.

The ABX PENTRA HbA1c WB Hemolysis Reagent is an additional reagent for use in combination for the quantitative ABX PENTRA HbA1c WB method.

Prescription Use x (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Rinol Bern

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073309