(119 days)
Teco Enzymatic Homocysteine Assay is in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.
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I am sorry, but the provided text does not contain the information required to answer your request. The document discusses regulatory approval for a medical device (Teco Enzymatic Homocysteine Assay) but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. It is a letter of substantial equivalence from the FDA, not a study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 1 2007
Teco Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807 ATTN: Jian Vaeches
Re: K063701 Trade/Device Name: Teco Enzymatic Homocysteine Assay Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system. Regulatory Class: Class II Product Codes: LPS Dated: February 21, 2007 Received: February 21, 2007
Dear Ms. Vaeches:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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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Indications for Use
K063701 510(k) Number (if known):
Device Name: Teco Enzymatic Homocysteine Assay
Indications for Use:
Teco Enzymatic Homocysteine Assay is in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.
Prescription Use V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.