(184 days)
The Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma. The measurement of glycated serum proteins (Fructosamine) is useful for monitoring long-term control of diabetes. This application was developed for the Polymedco Poly-Chem analyzer.
The Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma.
This document is an FDA 510(k) clearance letter for "The Polymedco Glyca-Direct™ Fructosamine Test". It confirms the device's substantial equivalence to a predicate device but does not contain detailed information about acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information based solely on the provided text. The document primarily focuses on regulatory approval rather than technical performance data.
To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents, which would typically include the study design, acceptance criteria, and performance data.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 2 2003
Ms. Helen Landicho Directory of Regulatory Affairs Polymedco Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567
Re: K023654
Trade/Device Name: The Polymedco Glyca-Direct™ Fructosamine Test Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: January 31, 2003 Received: February 4, 2003
Dear Ms. Landicho:
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 (301) 594-3084. 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 (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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: The Polymedco Glyca-Direct™ Fructosamine Test
Indications For Use:
The Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma. The Polymedco Glyca-Direct™ Fructosamine Test is use for the quantitative determination of glycated proteins in serum and plasma. The measurement of glycated serum proteins (Fructosamine) is useful for monitoring long-term control of diabetes.
This application was developed for the Polymedco Poly-Chem analyzer.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Jam Cooper
Division Sign-Off) ision of Clinical Laboratory Devices 510(k) Number
V Prescription Use (Per 21 CFR 801.109) OR
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).