# K193313: Elecsys Anti-TSHR

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 27, 2020 after 90 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033454 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab, Roche Diagnostics Corp. (2008) Summary page 5.

## Recalls of this device
- Nov 21, 2025 · Class II · Z-1009-2026: Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment

## Indications for use
Immunoassay for the in vitro quantitative determination of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti‑TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e 601 immunoassay analyzers.

Source page: https://510kreport.com/device/K193313
Methodology: https://510kreport.com/methodology