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.

Device 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)

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA HbA1c WB device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	ABX PENTRA HbA1c WB (Hemolysate/Manual hemolysis method) Performance	ABX PENTRA HbA1c WB (Whole Blood/Automated hemolysis method) Performance
Accuracy	Y = 0.97 x + 0.36 (r² = 0.9673)	Y = 0.98 x + 0.41 (r² = 0.9561)
Precision (CV Total)	< 2.72%	< 3.71%
Linearity (Total Hemoglobin)	2.07 g/dl - 20.00 g/dl	105 g/dl - 1027 g/dl
Linearity (HbA1c)	0.16 g/dl - 2.85 g/dl	8.13 g/dl - 145.3 g/dl
Measuring Range (HbA1c %)	4.98 % - 15.16 %	4.98 % - 15.16 %
Calibration Stability	3 weeks	3 weeks
Reagent Stability (Closed)	24 months at 2-8°C	24 months at 2-8°C
Reagent Stability (Open)	Up to expiration date at 2-8°C	Up to expiration date at 2-8°C
Reagent Stability (Latex antibody complex after reconstitution)	2 months at 2-8°C	2 months at 2-8°C

The document states that 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." This implies that the reported performance values across these metrics met the predefined acceptance criteria.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: 144 samples were used for the correlation studies (Accuracy). The document does not explicitly state the sample sizes for other performance characteristics like precision or linearity, but it can be inferred that samples were also used for these tests.
- Data Provenance: Not explicitly stated. The document is a 510(k) summary from Horiba ABX, a company based in France. It doesn't specify if the clinical samples were collected in France, the US, or elsewhere, nor does it explicitly state if the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. For an in vitro diagnostic (IVD) device like this, the "ground truth" for a calibrator or control would typically be established through highly accurate reference methods or by comparison to certified reference materials. For patient samples, the reference method used for comparison (e.g., HPLC, another cleared HbA1c assay) would serve as the ground truth. The summary refers to the predicate device for substantial equivalence, implying the comparison was against a previously cleared method.
Adjudication method for the test set:
- This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human interpretation of results is involved and discrepancies need to be resolved. For an IVD assay, the comparison is typically against a reference measurement, not subjective expert assessment.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic aids where human readers interpret results, often with and without AI assistance. The ABX PENTRA HbA1c WB is an automated in vitro diagnostic assay, not an AI-assisted interpretation tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (accuracy, precision, linearity, measuring range, stability) are for the standalone algorithm/device performance. This device operates as an automated clinical chemistry analyzer, and its performance characteristics are intrinsic to the device itself without direct human interaction varying the outcome beyond sample preparation and loading.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy/correlation study, the ground truth would have been established by comparison to a reference method or predicate device. The summary states the device demonstrated "substantial equivalence" to predicate devices (K031380 (Olympus) and K955087 (Bayer)). This implies the correlation studies were performed by comparing results from the ABX PENTRA HbA1c WB against results obtained from these established, legally marketed HbA1c assays, which are themselves considered reliable "ground truth" for clinical use.
The sample size for the training set:
- This information is not applicable and not provided. This device is a reagent and associated components for an existing clinical chemistry analyzer (ABX PENTRA 400). It's an in vitro diagnostic assay, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense of AI development. The development of such assays involves chemical and biochemical optimization, not an algorithmic training phase with a labeled dataset.
How the ground truth for the training set was established:
- This information is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The development and validation of the reagents, calibrators, and controls would involve rigorous analytical methods to ensure their chemical and functional properties meet specifications.

Summary

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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 equivalentPredicate device
ABX PENTRA HbAlc WB	K031380 (Olympus)K955087 (Bayer)
ABX PENTRA HbA1c Cal	K031380 (Olympus)K955087 (Bayer)
ABX PENTRA HbA1c Control	K031380 (Olympus)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.

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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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/dlFor 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°Copen stability of the reagents : up to the expiration date at 2-8°Cstability after reconstitution of the latex antibody complex : 2months 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/dlFor 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°Copen stability of the reagents : up to the expiration date at 2-8°Cstability after reconstitution of the latex antibody complex : 2months at 2-8°C

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CALIBRATOR

ABX PENTRA HbA1c Cal:
Analytes	Hemoglobin A1cTotal Hemoglobin
Format	Liquid chemical solutions
Stability	Closed stability: 24 monthsOpen 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 monthsOpen 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 monthsOpen 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
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.(b)
Classification. Class II (performance standards).