A1CNOW FOR HOME AND PROFESSIONAL USE

K033847 · Metrika, Inc. · LCP · Dec 23, 2003 · Hematology

Device Facts

• Record ID: K033847
• Device Name: A1CNOW FOR HOME AND PROFESSIONAL USE
• Applicant: Metrika, Inc.
• Product Code: LCP · Hematology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The AlcNow® test provides quantitative measurement of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.

Device Story

Device modification involves formulation change in sample dilution buffer to improve room temperature stability. Device functions as in-vitro diagnostic tool; utilizes dilution buffer for sample preparation. Modification verified via design control activities, risk analysis, and performance testing to ensure fundamental scientific technology remains unchanged from previously cleared device.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Quantitative assay for glycated hemoglobin (%HbA1c) in whole blood. Designed for point-of-care and home use. Class II device, product code LCP.

Indications for Use

Indicated for quantitative measurement of %HbA1c in whole blood for monitoring glycemic control in patients with diabetes. Suitable for both professional and 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)

{0}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

9 2005 SEP

2005

Erika Ammirati Regulatory Consultant Metrika. Inc 510 Oakmead Parkway Sunnyvale, CA 94086

Re: k033847

Trade/Device Name: A1cNow® Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: December 10 2003 Received: December 11 2003

Dear Ms. Ammirati:

This letter corrects our substantially equivalent letter of December 23, 2003 regarding the Metrika, Inc AlcNow® for prescription and home use. The Indications for Use that accompanies the clearance letter was marked erroneously as "Prescription Use" only. A corrected Indication for Use form with both Prescription Use and Over the Counter use is included.

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 (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 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.

{1}------------------------------------------------

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 Part 801); good manufacturing practice requirements as set forth 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.

This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely vours.

Carol Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

{2}------------------------------------------------

## Indications for Use

## 510(K) Number (if known): K033847

Device Name: AlcNow®

## Indications for Use:

The AlcNow® test provides quantitative measurement of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OND)

Carol Benam
Division Sign-Off

**Office of In Vitro Diagnostic Device Evaluation and Safety**

Page 1 of 1

510(k) K033847