(59 days)
The Diastat ™Anti-Thyroid Peroxidase (anti-TPO) test is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection the IgG class of autoantibodies specific for thyroid peroxidase in human serum or EDTA, heparin or citrated plasma. It is intended to aid in the diagnosis of autoimmune thyroid disorders and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.
quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection the IgG class of autoantibodies specific for thyroid peroxidase in human serum or EDTA, heparin or citrated plasma.
The provided document is a 510(k) clearance letter for an in vitro diagnostic device, specifically the Diastat™ Anti-Thyroid Peroxidase (anti-TPO) Elisa Test. This type of document typically focuses on establishing substantial equivalence to a predicate device and does not usually contain the detailed study information (like acceptance criteria, sample sizes, and expert qualifications) that would be found in a clinical study report or a more comprehensive technical document for an AI/ML medical device.
Therefore, the specific information requested in your prompt regarding acceptance criteria and performance studies, particularly in the context of AI/ML devices, cannot be extracted from the provided text because it is not present.
This document confirms the device's classification and lists its intended use, but it doesn't delve into the performance study details for demonstrating accuracy or other metrics in the way an AI/ML device submission would.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administratio 2098 Gaither Road · Rockville MD 20850
Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA SCOTLAND, UK
MAY 0 2 2002
Re: K020687
Kozoon
Trade/Device Name: Diastat™ Anti-Thyroid Peroxidase (anti-TPO) Elisa Test Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO Dated: February 15, 2002 Received: March 4, 2002
Dear Ms. McCafferty:
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 the Code of Federal 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 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 Part 801); good manufacturing practice requirements as set forth 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please 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 Butman
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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INDICATIONS FOR USE
510(k) number if known ... ...
Device Name...
Indications for Use The Diastat ™Anti-Thyroid Peroxidase (anti-TPO) test is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection the IgG class of autoantibodies specific for thyroid peroxidase in human serum or EDTA, heparin or citrated plasma.
It is intended to aid in the diagnosis of autoimmune thyroid disorders and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED ..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)
Radhe Menan
(Division Sign-Off) Division of Clinical Laboratory D 510(k) Number
Prescription Use ... ... Per 21 CFR 801. 109
OR
Over - the - Counter Use............
Optional format 1 - 2 - 96
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).