A1CNOW FOR PROFESSIONAL USE

K020235 · Metrika, Inc. · LCP · Feb 15, 2002 · Hematology

Device Facts

• Record ID: K020235
• Device Name: A1CNOW FOR PROFESSIONAL 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

Intended Use

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 Story

A1cNow™ is a point-of-care diagnostic device for quantitative measurement of glycated hemoglobin (% HbA1c) in whole blood. Operated by healthcare professionals in clinical settings; device processes capillary or venous blood samples to provide rapid HbA1c results. Output assists clinicians in monitoring glycemic control and adjusting diabetes management strategies. Benefits include immediate feedback for patient care decisions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

In vitro diagnostic assay for quantitative measurement of HbA1c in whole blood. Class II device, product code LCP. Operates under 21 CFR 864.7470.

Indications for Use

Indicated for professional use to monitor glycemic control in patients with diabetes using capillary (fingerstick) or venous whole blood samples.

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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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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## Page 2

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please 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/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:

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.

(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