# K103221: Elecys HGH Calset, Elecsys HGH Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 23, 2010 after 52 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: 5 generations back to K001015 (2000). 9 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033873: Elecsys C-Peptide Calset, Roche Diagnostics Corp. (2004) Summary page 1.
- K100810: Elecsys  C-Peptide Calcheck 5, Roche Diagnostics (2010) Summary page 1.

## Most influential descendants
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), 4 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K210901: Elecsys Vitamin D total III (2021), 1 descendant of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own

## Indications for use
Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGH assay on the Elecsys and cobas e immunoassay analyzers. The Elecsys hGH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys hGH reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K103221
Methodology: https://510kreport.com/methodology