BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN by BRAHMS DIAGNOSTICA, LLC.

LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).

Device Description

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AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to BRAHMS Diagnostica, LLC., concerning the device "LUMItest TRAK human". This document primarily focuses on regulatory approval and does not contain the detailed study information required to fully answer your request.

Specifically, the document states:

Device Name: LUMItest TRAK human
Regulation Number: 21 CFR 866.5870
Regulation Name: Thyroid autoantibody immunological test system
Indications for Use: LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).

However, it does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Information on experts used to establish ground truth or their qualifications.
Adjudication methods.
Details of a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
Results of a standalone algorithm performance study.
The specific type of ground truth used (beyond implying a clinical diagnostic context for "TSH receptor autoantibodies").
The sample size for the training set.
How ground truth for the training set was established.

Without access to the full 510(k) submission or associated study reports, it's impossible to provide the requested information. The letter merely confirms that the FDA reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. William G. Frank BRAHMS Diagnostica, LLC. 35-B South Peachtree Street Norcross, GA 30071

Re: K033454 Trade/Device Name: LUMItest TRAK human Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO Dated: January 19, 2004 Received: January 21, 2004

Dear Mr. Frank:

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.

MAR 2 2 2004

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).

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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.

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.

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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1. Indications for Use Statement

510(k) Number (if known): Northown Ko3 3454 Device Name: LUMItest TRAK human

Indications For Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

P. Reeves for M. Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)K033454

Regulation Number and Section

§ 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).