The A1cNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in fingerstick (capillary) whole blood samples. The test is for home use by people with diabetes to monitor glycemic control.

Device Description

AlcNow™ for Home Use is a four-channel reflectance photometer that incorporates microelectronics, optics, and dry-reagent chemistry strips within a self-contained, integrated, single-use device. An unmeasured whole blood mixture (diluted) is applied directly to the sample port, and results are displayed in numeric form on the device's liquid crystal display after eight minutes. Having no switches or buttons, the device self-activates upon addition of the sample.

A1cNow™ for Home Use utilizes both immunoassay and chemistry technology to measure HbA1c and total hemoglobin, respectively. Upon the addition of a diluted blood sample, blue microparticles conjugated to anti-HbA1c antibody migrate along the reagent strips. The amount of blue microparticles captured on the strips reflects the amount of HbA1c in the sample.

For the total hemoglobin portion of the assay, the dilution of sample converts Hb to met-Hb, which is red-brown in color. The intensity of the red-brown color measured on the reagent strips is proportional to the concentration of hemoglobin in the sample.

AI/ML Overview

Acceptance Criteria and Device Performance for Metrika A1cNow™ for Home Use

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (from predicate/comparison)	Reported Device Performance (A1cNow™ for Home Use)
Precision	Approximately 6.4 %CV (from A1cNow™ for Rx Home Use K020234)	Approximately 5.4 %CV
Accuracy (estimated bias)	Biases of 2-3% across the range of 6% A1C to 8 %A1C (from A1cNow™ for Rx Home Use K020234)	Biases of 1-2% (±0.1 %A1C) across the range of 6 %A1C to 8 %A1C. Average estimated bias less than 2% in clinical studies.
Accuracy (total error)	95% confidence limits of -0.8 %HbA1c to +1.2 %HbA1c (from A1cNow™ for Rx Home Use K020234)	95% confidence limits of -0.9 % HbA1c to +1.1 %HbAlc
Linearity	N/A (implied expectation based on previous submission)	Linear between 3% and 13% HbA1c
Hematocrit Tolerance	N/A (implied expectation based on previous submission)	Suitable results with sample hematocrits between 20% and 60% PCV
Specificity	N/A (implied expectation based on previous submission)	Assay not affected by high levels of various biological compounds, OTC therapeutics, and oral antihyperglycemic agents.
User Accuracy	N/A (no explicit criterion given, but clinical study addresses user performance)	98% accurate (in clinical studies with untrained subjects)

Note: The acceptance criteria for the A1cNow™ for Home Use are largely based on demonstrating substantial equivalence to its predicate device, A1cNow™ for Rx Home Use (K020234). Therefore, the "acceptance criteria" column reflects the performance characteristics reported for the predicate device, which the new device aims to meet or exceed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Approximately 300 subjects.
Data Provenance: Not explicitly stated, but the clinical studies involved "untrained subjects," suggesting real-world use or simulation. The document does not specify the country of origin, but it is a US 510(k) submission. It is a prospective study, as it involved untrained subjects using the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established by a "standard laboratory method."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the clinical study results. The comparison was made between the user's results and a "standard laboratory method."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study focused on the performance of the device when used by individual untrained subjects compared to a laboratory reference method, not on human readers interpreting results with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was conducted for the device. The nonclinical data (linearity, hematocrit tolerance, precision, specificity) directly address the device's inherent analytical performance independently of human interpretation of results. The device itself is designed for direct numeric output rather than human interpretation of an image or signal.

7. The Type of Ground Truth Used

The ground truth used was established by a standard laboratory method for measuring %HbA1c.

8. The Sample Size for the Training Set

The document does not explicitly state a separate training set sample size. This device is a measurement device with dry-reagent chemistry strips and a reflectance photometer, rather than a machine learning or AI-driven algorithm that typically requires a large training dataset. The "training" in this context would likely refer to the initial development and calibration data, which is not detailed as a distinct "training set" in the provided summary. Each unit is factory calibrated.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly describe how ground truth for a training set (if one existed in the typical machine learning sense) was established. Given it's a physical device with factory calibration, the "ground truth" for calibration would typically involve a series of known, precisely measured reference samples or calibrators, but the specifics are not provided.

Summary

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M = T R I K A

DEC 1 3 2002

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 K022661

807.92 (a)(1): Name:	Metrika, Inc.
Address:	510 Oakmead Parkway
	Sunnyvale, CA 94085
Phone:	(408) 524-2255
FAX:	(408) 524-2252
Contact:	Joel M. Blatt, Ph.D.

807.92 (a)(2): Device name- trade name and common name, and classification

Trade name: A1cNow™ for Home Use

Common Name: percent hemoglobin A1c (percent glycosylated hemoglobin)

Classification: assay, glycosylated hemoglobin 21 CFR 864.7470

807.92 (a)(3): Identification of the legally marketed predicate device

A1cNow™ for Home Use is substantially equivalent to A1cNow™ for Rx Home Use (K020234). The only difference between the two tests is in the intended use; A 1 Now TM for Home Use will be marketed directly to the diabetic consumer, while AlcNow™ for Rx Home Use requires a prescription. The device and procedural steps are identical.

807.92 (a)(4): Device Description

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807.92 (a)(4): Device Description (continued)

807.92 (a)(5): Intended use

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CHARACTERISTIC	A1cNow™ for Home Use	A1cNow™ for Rx Home UseK020234, K000885
Intended Use	Quantitative measurement of thepercent of glycated hemoglobin	Quantitative measurement of thepercent of glycated hemoglobin
Indications for Use	Used in the management andtreatment of diabetes, formonitoring long term glycemiccontrol	Used in the management andtreatment of diabetes, formonitoring long term glycemiccontrol
Risk to Patient	Not a critical analyte - reflectsglucose monitoring over time	Not a critical analyte - reflectsglucose monitoring over time
Sample	Whole blood	Whole blood
Visual Display	LCD readout	LCD readout
Hemolysate Preparation	Manual (Sample Dilution Kit)	Manual (Sample Dilution Kit)
Calibration	Not required by end-user; eachunit is factory calibrated	Not required by end-user; eachunit is factory calibrated
Methodology	Immunoassay	Immunoassay
Detection Method	Four-channel reflectancephotometer	Four-channel reflectancephotometer
Testing Environment	Home Use	Rx Home Use
Throughput	8 minutes per sample	8 minutes per sample
Precision	Percent coefficient of variation:approximately 5.4 %CV	Percent coefficient of variation:approximately 6.4 %CV
Accuracy (estimatedbias)	Biases of 1-2% (±0.1 %A1C)across the range of 6 %A1C to 8%A1C	Biases of 2-3% across the rangeof 6% A1C to 8 %A1C
Accuracy (total error)	Bias plot reveals 95% confidencelimits of -0.9 % HbA1c to +1.1%HbAlc	Bias plot reveals 95% confidencelimits of -0.8 %HbA1c to +1.2%HbAlc
NGSP CertificationStatus	A1cNow™ NGSP-certified as ofJune 1, 2002	Previous submissions predatedNGSP certification

	Comparisons Between A1cNow™ for Home Use and A1cNowTM for Rx Home Use

The differences in the two testing platforms do not raise new issues of safety and effectiveness.

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807.92 (b)(1): Brief Description of Nonclinical Data

Studies were performed that evaluated linearity, hematocrit tolerance, precision, and specificity. Results from these studies were presented in a previous submission, and were not repeated for this submission.

A1cNow™ is linear between 3% and 13% HbA1c. The test produces suitable results with sample hematocrits between 20% and 60% PCV (packed cell volume). The test's imprecision is approximately 5.4 %CV, and the assay is not affected by high levels of various biological compounds, various common overthe-counter therapeutics, and oral antihyperglycemic agents.

807.92 (b)(2): Brief Description of Clinical Data

In clinical studies with approximately 300 untrained subjects, A1cNow™ was 98% accurate. The average estimated bias between the consumer's results and results obtained by a standard laboratory method was less than 2%.

807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing

A 1 c NowTM was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrated that the test is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is a stylized image of three faces in profile, one behind the other. The faces are rendered in a simple, flowing line.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Erika Ammirati, R.A.C., MT (ASCP) Clinical/Regulatory Consultant to Metrika Metrika, Inc. - -510 Oakmead Parkway Sunnyvale, CA 94086

Re: K022661

Trade/Device Name: Metrika A1cNow® for Home Use Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: October 17, 2002 Received: October 18, 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 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 (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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Metrika, Inc. IcNow™ Home Use emarket Notification

STATEMENT OF INTEN

510(K) Number (if known

Device Name: A1cNow™

Indications for Use:

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

Souphine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices K122661

510k) Number

(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) ÖR

Over –the-Counter Use

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).