# K001015: Elecsys Thyroglobulin Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 27, 2000 after 29 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
No predicates in its family tree.
48 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020883: Elecsys Probnp Calcheck (2002), 47 descendants of its own
- K031698: Elecys SHBG Calcheck (2003), 44 descendants of its own
- K040157: Elecsys C-Peptide Calcheck (2004), 42 descendants of its own
- K100810: Elecsys  C-Peptide Calcheck 5 (2010), 32 descendants of its own
- K051185: Elecsys CA 19-9 Calcheck (2005), 12 descendants of its own

Source page: https://510kreport.com/device/K001015
Methodology: https://510kreport.com/methodology