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K Number
K033454
Device Name
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
2004-03-22

(144 days)

Product Code
JZO
Regulation Number
866.5870
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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).

Device Description

Not Found

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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Information on experts used to establish ground truth or their qualifications.
  4. Adjudication methods.
  5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
  6. Results of a standalone algorithm performance study.
  7. The specific type of ground truth used (beyond implying a clinical diagnostic context for "TSH receptor autoantibodies").
  8. The sample size for the training set.
  9. 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.

§ 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).