# K103171: Elecsys Anti-Tpo Calset

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 11, 2011 after 107 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000155 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051890: Roche Diagnostics Cobas Elecsys Anti-Tpo, Roche Diagnostics Corp. (2005) Summary page 1.

## Indications for use
Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K103171
Methodology: https://510kreport.com/methodology