# K052982: Roche Diagnostics Cobas Elecsys Prolactin II Calset

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Oct 28, 2005 after 4 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: 2 generations back to K900695 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964748: Elecsys Prolactin Assay, Boehringer Mannheim Corp. (1997) Summary page 2.

## Most influential descendants
- K163544: Lumipulse G Prolactin (2017), 0 descendants of its own

## Indications for use
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K052982
Methodology: https://510kreport.com/methodology