# K092320: Elecsys Precicontrol Thyroab

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Nov 3, 2009 after 91 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K033454 (2004). 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)
- K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab, Roche Diagnostics Corp. (2008) Summary page 2.

## Indications for use
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K092320
Methodology: https://510kreport.com/methodology