# K020672: Elecsys Anti-TG Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 5, 2002 after 157 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: 3 generations back to K950090 (1995). 3 ancestors in all.
2 later devices descend 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)
- K991094: Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6, Diagnostic Products Corp. (1999) Summary page 2.

## Most influential descendants
- K053426: Roche Elecsys Anti-TG (2006), 1 descendant of its own
- 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 disease. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche ElecsysB 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

Source page: https://510kreport.com/device/K020672
Methodology: https://510kreport.com/methodology