# K962573: Elecsys Precicontrol TSH

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 22, 1996 after 21 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: 2 generations back to K915195 (1992). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961491: Elecsys TSH Assay, Boehringer Mannheim Corp. (1996). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K140534: Elecsys Precicontrol TS (2014), 0 descendants of its own
- K062581: Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay System (2006), 0 descendants of its own

## Indications for use
Control for Thyroid Stimulating Hormone assays.

Source page: https://510kreport.com/device/K962573
Methodology: https://510kreport.com/methodology