# K051890: Roche Diagnostics Cobas Elecsys Anti-Tpo

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 4, 2005 after 23 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: 1 generation back to K000155 (2000). 1 ancestor in all.
1 later device descends 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)
- K000155: Elecsys Anti-Thyroid Peroxidase Antibody Test System, Roche Diagnostics Corp. (2000) Summary page 2.

## Most influential descendants
- K103171: Elecsys Anti-Tpo Calset (2011), 0 descendants of its own

## Recalls of this device
- Aug 20, 2020 · Class II · Z-2981-2020: Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.

## Indications for use
The Elecsys Anti-TPO immunoassay is for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis of autoimmune thyroid diseases. The electrochemiluminescence immunoassay "ECLIA' is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Source page: https://510kreport.com/device/K051890
Methodology: https://510kreport.com/methodology