# K000155: Elecsys Anti-Thyroid Peroxidase Antibody Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 17, 2000 after 119 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051890: Roche Diagnostics Cobas Elecsys Anti-Tpo (2005), 1 descendant of its own
- K103171: Elecsys Anti-Tpo Calset (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K000155
Methodology: https://510kreport.com/methodology