A1CNOW FOR PROFESSIONAL USE by METRIKA, INC.

The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding the A1cNow™ device, focusing on the requested information about acceptance criteria and the supporting study:

The provided text only contains the FDA 510(k) clearance letter for the A1cNow™ device, along with its statement of intended use. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the 510(k) summary or the actual study report. The FDA letter merely states that the device was deemed substantially equivalent to legally marketed predicate devices.

Therefore, for most of your requested points, the information is not available in the provided document.

Here's what can be extracted and what information is missing:

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

Acceptance Criteria	Reported Device Performance
Not provided in the document. The FDA letter indicates the device was found substantially equivalent, implying it met certain criteria, but the specific criteria and performance values are not listed.	Not provided in the document. The FDA letter doesn't include performance metrics like accuracy, precision, or comparison to a reference method.

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

Not available in the document.

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)

Not available in the document. For a glycated hemoglobin assay, "ground truth" would typically be established by a reference method (e.g., HPLC) rather than human experts interpreting images, but the specifics are not mentioned.

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

Not available in the document. This concept is more applicable to studies involving human interpretation (like imaging studies) rather than a quantitative assay.

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

Not applicable and not available in the document. The A1cNow™ is a quantitative assay, not an AI-assisted diagnostic imaging device that involves human readers in the traditional MRMC sense.

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

Not applicable and not available in the document. The A1cNow™ is a diagnostic assay, where "standalone performance" generally refers to the device's accuracy and precision using laboratory methods, which would have been part of the substantial equivalence submission but are not detailed here.

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

Not available in the document. For a blood test like HbA1c, the "ground truth" would likely be a highly accurate reference method (e.g., HPLC) for measuring glycated hemoglobin.

8. The sample size for the training set

Not applicable/Not available in the document. This device is a quantitative assay, typically calibrated according to established laboratory procedures using calibrators and controls, rather than "trained" in the machine learning sense with a "training set."

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

Not applicable/Not available in the document. As above, the concept of a training set and its ground truth in the machine learning context does not directly apply to this type of device. Calibration would be performed using materials with known values derived from reference methods.

In summary, the provided FDA clearance letter and statement of intended use confirm the FDA's decision to clear the A1cNow™ device for marketing based on substantial equivalence. However, it does not provide the detailed study results, specific acceptance criteria, or the methodology of the studies that supported this clearance. To find that information, one would typically need to consult the 510(k) summary document filed with the FDA, which is usually publicly available through the FDA device database.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 5 2002

Ms. Erika Ammirati Regulatory Consultant to Metrika Metrika, Inc. 510 Oakmead Parkway Sunnyvale, California 94086

Re: K020235

Trade/Device Name: A1cNow™ Professional Use Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: II Product Code: LCP Dated: January 22, 2002 Received: January 23, 2002

Dear Ms. Ammirati:

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 for ass stated in 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). and Oosmeter For (110) has 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 rr your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INTENDED USE

510(K) Number (if known):

Device Name: A1cNow™

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over -the-Counter Use

Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020235

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).