# K101075: Elecsys Insulin Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 11, 2010 after 53 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 K010237 (2001). 2 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092168: Elecsys HCG+B Calcheck 5, Roche Diagnostics (2009) Summary page 1.

## Most influential descendants
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 descendants of its own
- K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C (2014), 2 descendants of its own
- K142864: ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) (2014), 1 descendant of its own

## Indications for use
The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K101075
Methodology: https://510kreport.com/methodology