(55 days)
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serve or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
Homogeneous Enzymic Homocysteine Reagent
The provided text is a 510(k) clearance letter from the FDA for a Homogeneous Enzymic Homocysteine Reagent. It confirms that the device is substantially equivalent to previously marketed devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The letter is a regulatory approval document and focuses on the administrative aspects of device clearance, such as classification, regulation, and marketing permission, rather than the detailed technical study results that would typically include acceptance criteria and performance data.
Therefore, I cannot provide the requested table and study details based solely on the input document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 5 2001
Catch Inc. c/o Ms. Joan Cathey Consultant 2203 Airport Way So., Suite 400 Seattle, WA 98134
510(k) Number: K011689 Re: 510(K) Namber. Not Froo>
Trade/Device Name: Homogeneous Enzymic Homocysteine Reagent Regulation Number: 862.1377 Regulatory Class: II Product Code: LPS Dated: May 25, 2001 Received: May 31, 2001
Dear Ms. Cathey:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomor by t(x) is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce pror to May 20, 1978, the same with the provisions of the provisions of the Amendments, or to devices man have bool receitation in the the device, subject to Federal Food, Drug, and Cosment Proc (100) - Porceral controls provisions of the Act include the general controls provisions of the Fiction, Institutions, 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 II your device is classified (see above) anto such additional controls. Existing major regulations (Premarket Approval), it may of subject to ade of Federal Regulations, Title 21, Parts 800 to 895. allecting your device can or round in an assumes compliance with the Cood Manufacturing in A substantially equivalent decommisments (GMP) regulation (21 CFR Part 820) and that, through Fractive for Mcalcal Devrocer Contract Contrastration (FDA) will verify such periodic offir inspections, the I ood and Drog regulation may result in regulatory action. In assumptions. Transmission of compry was no meeting your device in the Federal addition, FDA may publish furniti allife and our premarket notification submission does not affect Register. Flease note: this response to your p531 through 542 of the Act for devices under the ally obligation you might have andel provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device of your device to a legally marketed notification. The IDA inding of succeantar vqur 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 II you desire specific advice for your actic devices), please contact the Office of Compliance at additionally 809.10 for m This diagliestions on the promotion and advertising of your device, (301) 594-4568. Additionally, Ior quisition at (301) 594-4639. Also, please note the regulation prease comact the Ornoo or Complants (21CFR 807.97). Other general entitled, Missurantuing by releveles to persons of the Act may be obtained from the Division of Small miorination on your responsionities are number (800) 638-2041 or (301) 443-6597 or at its Manufacturers "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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Indication for Use
Trade Name of the Device: Homogeneous Enzymic Homocysteine Reagent
510(k) Number: Koll68
Classification Name; Number:
Urinary Homocystine (Nonquantitative) Test System; 21 CFR §862.1377
Indications for Use
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serve or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
prescription use L
Fred Lacy
(Division Sign-Off) (Division of Clinical Laboratory Devices K811689 510(k) Number.
§ 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.