# K140534: Elecsys Precicontrol TS

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 27, 2014 after 23 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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: 3 generations back to K915195 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962573: Elecsys Precicontrol TSH, Boehringer Mannheim Corp. (1996) Summary page 2.

## Indications for use
Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K140534
Methodology: https://510kreport.com/methodology