MODIFICATION TO AVIE A1C TEST SYSTEM

K091400 · Mec Dynamics Corp · LCP · Jun 11, 2009 · Hematology

Device Facts

• Record ID: K091400
• Device Name: MODIFICATION TO AVIE A1C TEST SYSTEM
• Applicant: Mec Dynamics Corp
• Product Code: LCP · Hematology
• Decision Date: Jun 11, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Avie A1C test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

Device Story

Point-of-care system for quantitative measurement of % A1C (glycated hemoglobin) in capillary or venous whole blood; used for monitoring glycemic control in diabetic patients. Intended for prescription use and physician-directed home use. Device provides quantitative results to assist healthcare providers and patients in managing diabetes. Contraindicated for patients with specific hemoglobinopathies (HbF, HbC, HbD).

Clinical Evidence

No clinical data; bench testing and design verification/validation activities performed per 21 CFR 820.30.

Technological Characteristics

RFID technology for lot information scanning; increased cartridge capacity. Fundamental scientific technology unchanged from predicate. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative measurement of % A1C in capillary or venous whole blood to monitor glycemic control in patients with diabetes mellitus. Contraindicated for patients with hemoglobinopathies HbF, HbC, and HbD.

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MEC Dynamics Corporation C/o Mr. Emmanuel Mpock 2225 Martin Ave, Suite 1 Santa Clara, CA 95050

JUN 1 1 2009

Re: k091400

Trade/Device Name: Avie A1C Test System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 8, 2009 Received: May 12, 2009

Dear Mr. Mpock:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

G.C.H.

Courtney C. Harper. Ph.D. 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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# Indication for Use

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

K091400

Device Name: AvieTM A1C Test System

## Intended Use

See indications for use below

### Indications for Use

The Avie A1C test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091400

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