# K080643: Elecsys Anti-TSHR Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 22, 2008 after 169 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: 4 generations back to K001015 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040157: Elecsys C-Peptide Calcheck, Roche Diagnostics Corp. (2004) Summary page 1.

## Most influential descendants
- K152061: IMMULITE 2000 TSI Assay,  IMMULITE 2000 TSI Calibration Verification Material (2016), 0 descendants of its own

## Indications for use
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K080643
Methodology: https://510kreport.com/methodology