(87 days)
The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroglobulin (anti-Tg) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease
Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Immunoassay (MEIA)
This document is a 510(k) premarket notification letter from the FDA to Axis-Shield Diagnostics Ltd. regarding the Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Immunoassay (MEIA). It largely focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of detailed performance data and study design information is typically found in the 510(k) summary or full submission, which is not provided in these pages.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 3 2004
Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA SCOTLAND, UK
Re: K020349
| Trade/Device Name: | Abbott AxSYM® anti-Thyroglobulin (anti-TgMicroparticle Enzyme Immunoassay (MEIA) |
|---|---|
| Regulation Number: | 21 C.F.R. 866.5870 |
| Regulation Name: | Thyroid antibody immunological test system |
| Product Codes: | JZO, JIT, JJX |
| Dated: | January 31, 2002 |
| Received: | February 4, 2002 |
Dear Ms. McCafferty:
This letter corrects our substantially equivalent letter of May 2, 2002, regarding omission of the product codes for both the AxSYM Calibrator (JIT) and Controle garan.
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 prodicated devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Macical 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actives of the Activals 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 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, This 21, and 600 to 698. In
Register Register.
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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 ther 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your School to a legally marketed predicate device results ing classification for your device on 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 Part 809.10) for in vitro diagnostic devices, please contact the Office of Compliance at (301) 594-3084 x177. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet Address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Freen Autman, m.D.
Steven I. Gutman, M.D., M.B.A. Office Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosures
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INDICATIONS FOR USE
· 510(k) number if known.............. | 020349
... Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Device Name ... . Immunoassay (MEIA)
Indications for Use The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroglobulin (anti-Tg) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Rostin Menon
(Division Sign-Off) Division of Clinical Laboratory Devices 51JK) Nuniber _ KO20349
Prescription Use ... ... ... OR Per 21 CFR 801. 109
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).