# K110613: Elecsys Prolactin II Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 12, 2011 after 70 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: 6 generations back to K001015 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103402: Elecsys Dhea-S Calcheck 5, Roche Diagnostics (2011) Summary page 1.

## Most influential descendants
- K143194: ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (2014), 0 descendants of its own

## Indications for use
The Eleesys Prolactin 11 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 Prolactin 11 reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K110613
Methodology: https://510kreport.com/methodology