# K033454: Brahms Diagnostica Lumitest Trak Human

- Pathway: 510(k) (Traditional)
- Applicant: Brahms Diagnostica, LLC
- Decided: Mar 22, 2004 after 144 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab (2008), 3 descendants of its own
- K193313: Elecsys Anti-TSHR (2020), 0 descendants of its own
- K152061: IMMULITE 2000 TSI Assay,  IMMULITE 2000 TSI Calibration Verification Material (2016), 0 descendants of its own
- K092320: Elecsys Precicontrol Thyroab (2009), 0 descendants of its own

## 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).

Source page: https://510kreport.com/device/K033454
Methodology: https://510kreport.com/methodology