(87 days)
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Not Found
No
The summary describes a laboratory test for auto-antibodies and contains no mention of AI, ML, or related concepts.
No.
The device is intended for diagnostic purposes (quantitative measurement of auto-antibodies to aid in the diagnosis of thyroid disease), not for treating or preventing a disease.
Yes
The 'Intended Use / Indications for Use' states that the test is "to aid in the diagnosis of thyroid disease," which directly indicates its function as a diagnostic device.
No
The 510(k) summary describes a test for measuring antibodies in human serum or plasma, which implies a laboratory-based assay requiring physical reagents and equipment, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that 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... to aid in the diagnosis of thyroid disease." This describes a test performed in vitro (outside the body) on a biological sample (serum or plasma) to provide information for diagnostic purposes.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The intended use perfectly aligns with this definition.
N/A
Intended 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.
Product codes
JZO, JIT, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, with flowing lines beneath them. The profiles and lines are black, and the background is white.
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
..............................................................................................................................................................................
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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