A1CNOW FOR RX HOME USE

K020234 · Metrika, Inc. · LCP · Feb 15, 2002 · Hematology

Device Facts

• Record ID: K020234
• Device Name: A1CNOW FOR RX HOME USE
• Applicant: Metrika, Inc.
• Product Code: LCP · Hematology
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

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

Device Story

A1cNow™ is a point-of-care diagnostic device for home use by patients with diabetes. It utilizes capillary whole blood samples to provide a quantitative measurement of glycated hemoglobin (HbA1c). The device enables patients to monitor their glycemic control independently, facilitating self-management of diabetes. Results are displayed directly to the user, allowing for informed adjustments to diabetes management in consultation with a healthcare provider.

Technological Characteristics

Quantitative assay for glycated hemoglobin; capillary whole blood sample; point-of-care diagnostic form factor; intended for home use.

Indications for Use

Indicated for people with diabetes for the quantitative measurement of glycated hemoglobin in capillary whole blood to monitor glycemic control. For prescription home use.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 5 2002

Re: k020234

Trade/Device Name: A1cNow™ Prescription Home 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 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 If your device to such additional controls. Existing major regulations affecting your device can may oe subject to back acated 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 rouse of acressed a determination that your device complies with other requirements of the Act that I Dr Has Intact 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 Part 801); good manufacturing practice requirements as set Orth 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 nouticate device results 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 If you dosire specific devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (1 see contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INTENDED USE

K02023 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: A1cNow™

## Indications for Use:

The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin The Archives - test provises qualifical whole blood samples. The test is for prescription home use by people with diabetes to monitor glycemic control.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over -the-Counter Use ________________________________________________________________________________________________________________________________________________________ OR Prescription Use له (Per 21 CFR 801.109)

Josephine Bautista

(Divisi Division of C 510(k) Number

Over-the-Counter Use_