(87 days)
The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroid-peroxidase (anti-TPO) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease.
Not Found
The provided document is a 510(k) cleared letter from the FDA for an in vitro diagnostic device, the Abbott AxSYM® anti-Thyroid peroxidase (anti-TPO) Microparticle Enzyme Immunoassay (MEIA). This document does not contain the detailed study information needed to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The letter explicitly states: "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...". This means the FDA found the device to be as safe and effective as a legally marketed predicate device, based on the information provided by the manufacturer in their 510(k) submission. However, the 510(k) clearance letter itself does not include the detailed study report or the data that led to this determination.
To answer your questions, one would need to access the full 510(k) submission (which often includes clinical study reports, analytical validation data, etc.). This information is typically proprietary and not publicly available in detail through the FDA's public database for 510(k) clearance letters.
Therefore, I cannot provide the requested information based on the document you provided.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA SCOTLAND, UK
FEB 1 3 2004
| Re: | K020348 |
|---|---|
| Trade/Device Name: | Abbott AxSYM® anti-Thyroid peroxidase(anti-TPO) Microparticle 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 Controls (JJX).
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 [{{or 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 (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 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.
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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 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.
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 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 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,
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........................................................................................................................................................
Device Name ...
...Abbott AxSYM® anti-Thyroid-peroxidase (anti-TPO) Microparticle Enzyme Immunoassay (MEIA)
Indications for Use
Indications for Use The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroid-peroxidase (anti-TPO) 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)
Radha Nevin
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ K Q2 C 3 4 8
Prescription Use ... ...... OR Per 21 CFR 801. 109
Over - the - Counter Use......................
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§ 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).