# K060754: Elecsys TSH Calset W/Models 04738551

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 18, 2006 after 28 days
- Product code: JIT (Calibrator, Secondary)
- 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 K915195 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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) Summary page 2.

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

## Indications for use
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.

Source page: https://510kreport.com/device/K060754
Methodology: https://510kreport.com/methodology