(23 days)
The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin in fresh capillary or venous whole blood samples. The test is for prescription home use by people with diabetes to monitor glycemic control.
Not Found
This is a 510(k) premarket notification for the A1cNow™ device, a glycosylated hemoglobin assay for prescription home use. There is no information in the provided text that describes the acceptance criteria, or a study that proves the device meets the acceptance criteria. The document is primarily a letter from the FDA confirming the device's substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information in the format requested.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (1 see contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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_
§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).