# K031698: Elecys SHBG Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 20, 2003 after 79 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 K001015 (2000). 2 ancestors in all.
44 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020883: Elecsys Probnp Calcheck, Roche Diagnostics Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K101365: Elecsys CA 19-9 Calcheck 5 (2010), 11 descendants of its own
- K122242: Elecsys CA 15-3 II Calcheck 5 (2012), 10 descendants of its own

## Indications for use
EIecsysB SHBG CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined SHBG concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The ElecsysB SHBG CalCheck is intended for use in the verification of the calibration established by the ElecsysB SHBG reagent on Elecsys@ 1010/2010/MODULARANALYTICS E170 immunoassay analyzers.

Source page: https://510kreport.com/device/K031698
Methodology: https://510kreport.com/methodology