# K222610: Elecsys Anti-Tg

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 15, 2023 after 382 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: 5 generations back to K950090 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053426: Roche Elecsys Anti-TG, Roche Diagnostics Corp. (2006) Summary page 4.

## Indications for use
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti‑Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzer.

Source page: https://510kreport.com/device/K222610
Methodology: https://510kreport.com/methodology