RANDOX HAEMOGLOBIN A1C by RANDOX LABORATORIES, LTD.

The Randox Laboratories Limited Haemoglobin Are Test Kit is an in vitro diagnostic reagent for the quantitative determination of haemoglobin Ay, (HbAz) in whole blood. The method is an immunological assay. Both the concentration of HbAr, and the concentration of total haemoglobin are measured. The reported HbAzz result is calculated as a percentage of the total haemoglobin concentration.

Measurements of percentage HbAy, are effective in monitoring long-term glucose control in individuals with diabetes mellitus.

This application sheet has been developed for the Hitachi 717 clinical chemistry analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.

Device Description

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device named "HAEMOGLOBIN Asc" (also referred to as "HAEMOGLOBIN A1c"). This letter primarily addresses the substantial equivalence determination for the device. Clinical studies information, including acceptance criteria and detailed study data, is typically found in the 510(k) summary or other supporting documents submitted by the manufacturer, which are not present in the provided excerpts.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth types cannot be extracted from the given text.

However, based on the document, I can provide the following:

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

This information is not provided in the given FDA letter or the "Indications For Use" statement. The letter primarily confirms the substantial equivalence of the device to a predicate and does not detail performance characteristics or acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given text.

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 an "in vitro diagnostic reagent for the quantitative determination of haemoglobin A1c." It is a laboratory assay, not an AI-assisted diagnostic imaging device or one that involves human "readers" in the context of MRMC studies. Therefore, an MRMC study and related effect sizes are not applicable to this type of device.

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

The device is described as an "immunological assay" and an "in vitro diagnostic reagent." As such, its performance is typically evaluated as a standalone analytical device, measuring a biomarker. It's not an algorithm in the sense of AI software, though it's designed to perform its function without human interpretation of raw data beyond reading the final result. Therefore, a "standalone" performance evaluation in the context of analytical accuracy and precision would have been conducted, but specific details are not provided.

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

For a glycosylated hemoglobin assay, the "ground truth" for assessing its performance would typically involve comparison against a reference method or a gold standard method for measuring HbA1c, along with samples characterized by known HbA1c levels or clinical diagnoses of diabetes. Details on the specific ground truth used are not provided in the given document.

8. The sample size for the training set:

This information is not provided in the given text. (Note: For an in vitro diagnostic assay, the concept of a "training set" as understood in machine learning might not directly apply. Instead, there would be validation studies using numerous samples.)

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

This information is not provided in the given text, and the concept of a "training set" ground truth is less directly applicable for this type of device as explained above.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 6 2002

Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories Ltd. Ardmore, Diamond Road, Crumlin, Co. Antrim United Kingdom BT29 4QY

Re: K021897

Trade/Device Name: HAEMOGLOBIN Asc Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: November 15, 2002 Received: November 19, 2002

Dear Dr. Hamilton:

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 (OS) 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). Other general information on your responsibilities under the Act may be obtained 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 Sutman

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)	Not Known
Device Name	HAEMOGLOBIN A1c

Indications For Use :

Measurements of percentage HbAy, are effective in monitoring long-term glucose control in individuals with diabetes mellitus.

This application sheet has been developed for the Hitachi 717 clinical chemistry analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional format 1-2-96)

(Division Sign-Off)	J P Reeves for J. Bautista
Division of Clinical Laboratory Devices
510(k) Number	14021897

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).