HEMOGLOBIN A1C REAGENT SET by POINTE SCIENTIFIC, INC.

This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a Hemoglobin A1c Reagent Set. It primarily confirms that the device is substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

The FDA 510(k) clearance process relies on demonstrating substantial equivalence, often by comparing the new device's performance to an already cleared predicate device. The specific performance data and studies used to establish this equivalence are typically found in the full 510(k) submission, which is not publicly available in this extract.

Therefore, many of your questions cannot be answered from the provided text.

Here's what can be inferred or stated about the lack of information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in the provided document. The 510(k) focused on "substantial equivalence" to a predicate device, implying the predicate's performance served as the benchmark.
Reported Device Performance: Not detailed in the provided document.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not mentioned.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set

Adjudication Method: Not mentioned.

5. 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

This device is a reagent set for a laboratory test, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is a reagent set, not an algorithm. The concept of "standalone algorithm performance" is not applicable. The device's performance would be evaluated in a laboratory setting, likely against reference methods or established predicate devices.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For a diagnostic reagent set like Hemoglobin A1c, ground truth would typically be established by a reference method for HbA1c measurement, or possibly correlation with patient clinical status/outcomes (though the latter is less direct for a single assay validation). The specific ground truth method used is not detailed in the provided document.

8. The sample size for the training set

For a reagent set, the concept of a "training set" as it applies to machine learning algorithms is not directly applicable. Performance validation relies on clinical sample testing and analytical studies rather than algorithm training. Any "training" would pertain to optimizing reagent formulations or assay parameters, not a data set for an AI model.

9. How the ground truth for the training set was established

See answer to #8. Not applicable in the context of AI development.

In summary, the provided FDA 510(k) clearance letter confirms regulatory approval based on "substantial equivalence" but does not offer the detailed technical and clinical study information needed to address your specific questions about acceptance criteria, performance metrics, and study methodology. This information would typically be found in the comprehensive 510(k) submission document itself, which is not included here.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the symbol of the U.S. Department of Health and Human Services in the center. The text "U.S. Health & Human Services" is written around the perimeter of the circle.

AUG - 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. William F. Walters, Jr. V.P. - Technical Operations Pointe Scientific, Inc. 1025 John A Papalas Drive Lincoln Park, MI 48146

Re: K031539

Trade/Device Name: Hemoglobin A 1 c Reagent Set Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 02, 2003 Received: May 16, 2003

Dear Mr. Walters:

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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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510 (k) Number (if known): Unknown at this time

Device Name: Hemoglobin A1c Reagent Set

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use

Jean Cooper

Division Sign-Off

(Optional Format 1-2-96)

ro Diagnostic Device fice of In Vit tion and l

510(k) K 031539

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).