INVIEW

K051321 · Metrika, Inc. · LCP · Jun 13, 2005 · Hematology

Device Facts

• Record ID: K051321
• Device Name: INVIEW
• Applicant: Metrika, Inc.
• Product Code: LCP · Hematology
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The InView™ multi-use test provides quantitative measurement of the percent 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

Modified blood glucose/A1C monitor; enables multiple A1C determinations from single monitor; utilizes single-use reagent strip cartridges. Device modification maintains fundamental scientific technology of previously cleared predicate. Intended for clinical use to monitor A1C levels.

Clinical Evidence

No clinical data provided; device is a modification of a previously cleared predicate (K033847).

Technological Characteristics

Monitor modified for multiple A1C determinations; utilizes single-use reagent strip cartridges. Fundamental scientific technology unchanged from predicate.

Indications for Use

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

Predicate Devices

• K033847

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JUN 1 3 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Erika B. Ammirati, RAC, MT (ASCP) Regulatory Consultant Metrika, Inc. 510 Oakmead Parkway Sunnyvale CA 94085

Re: k051321 Trade/Device Name: InView™M Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 19, 2005 Received: May 20, 2005

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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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 [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 yours,

Carol C. Benson

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

Enclosure

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May 19, 2005

AlcNow® Multi-Use for Home and Professional Use (InView™) Special 510(k)- Device Modification for K033847

## STATEMENT OF INTENDED USE

510(K) Number (if known): K051321

Device Name: InView™

## Indications for Use:

The InView™ multi-use test provides quantitative measurement of the percent 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 _ >> (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 Device Evaluation (ODE)

Rute Chealer

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051321