# K053426: Roche Elecsys Anti-TG

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 7, 2006 after 61 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: 4 generations back to K950090 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020672: Elecsys Anti-TG Test System, Roche Diagnostics Corp. (2002) Summary page 2.

## Most influential descendants
- K222610: Elecsys Anti-Tg (2023), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers.

Source page: https://510kreport.com/device/K053426
Methodology: https://510kreport.com/methodology