# K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 28, 2008 after 196 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
Longest line of descent: 1 generation back to K033454 (2004). 1 ancestor in all.
3 later devices descend from it; 3 cite 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)
- K033454: Brahms Diagnostica Lumitest Trak Human, Brahms Diagnostica, LLC (2004) Summary page 2.

## Most influential descendants
- 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
Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism). The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immuinoassay analyzers.

Source page: https://510kreport.com/device/K080092
Methodology: https://510kreport.com/methodology