(61 days)
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No
The summary describes a laboratory assay kit for detecting antibodies, which is a chemical/biological test, and there is no mention of AI, ML, image processing, or any computational analysis that would typically involve these technologies.
No
The device is an assay kit for the quantitative or qualitative determination of thyroid stimulating hormone receptor antibody and is useful as an aid in differential diagnosis, not for treatment.
Yes
The device is used to aid in the differential diagnosis of Graves' disease.
No
The device is described as a "TRab CT Assay Kit," which strongly suggests a physical kit containing reagents and potentially other hardware components for performing a laboratory assay. The description does not mention any software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to gain information about a physiological state (presence and level of the antibody).
- Sample Type: The kit uses "human serum," which is a biological sample taken from a patient.
- Purpose: The purpose is to aid in the "differential diagnosis of Graves' disease," which is a medical condition.
These characteristics are the defining features of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TRab CT Assay Kit is for the quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum.
The TRab CT Assay kit is useful as an aid in differential diagnosis of Graves' disease.
Product codes
JZO
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 0 2003 Ms. Heather Viele Director, Technical Affairs KRONUS Market Development Associates, Inc. Boise Research Center 12554 West Bridger Street, Suite 108 Boise. Idaho 83713
Re: K032134
Trade/Device Name: KRONUS TSH Receptor Antibody (TRAb) Coated Tube (CT) Assay Kit Regulation Number: 21 CFR § 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: II Product Code: JZO Dated: July 2, 2003 Received: July 11, 2003
Dear Ms. Viele:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): To be assigned by FDA KO32134
Device Name:
TSH Receptor Antibody (TRab) Coated Tube (CT) Assay Kit
Indications for Use Statement:
The TRab CT Assay Kit is for the quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum.
The TRab CT Assay kit is useful as an aid in differential diagnosis of Graves' disease.
(Please Do Not Write Below This Line - Continue On another Page If Needed)
J. Reeves for T.J. O'Leary
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032134
Prescription Use √