# K964748: Elecsys Prolactin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 21, 1997 after 56 days
- Product code: CFT (Radioimmunoassay, Prolactin (Lactogen))
- Device class: 1
- Regulation: 21 CFR 862.1625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900695 (1990). 1 ancestor in all.
2 later devices descend 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)
- K900695: Enzymun Test (R) Prolactin, Boehringer Mannheim Corp. (1990) Summary page 1.

## Most influential descendants
- K052982: Roche Diagnostics Cobas Elecsys Prolactin II Calset (2005), 1 descendant of its own
- K163544: Lumipulse G Prolactin (2017), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of human prolactin in human serum and plasma.

Source page: https://510kreport.com/device/K964748
Methodology: https://510kreport.com/methodology