# K964841: Elecsys Progesterone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 24, 1997 after 111 days
- Product code: JLS (Radioimmunoassay, Progesterone)
- Device class: 1
- Regulation: 21 CFR 862.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K931117: Assess (TM) Low Abnormal Control, Instrumentation Laboratory CO (1994). Our OCR of the scanned summary read K931117, FDA’s number for Assess (TM) Low Abnormal Control (Instrumentation Laboratory CO). Its FDA name has none of the distinctive words the summary uses for the device it names, “Enzymun-Test® Progesterone Assay”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K152526: Elecsys Progesterone III CalSet (2015), 2 descendants of its own
- K163546: Lumipulse G Progesterone-N Calibrators (2017), 0 descendants of its own
- K160729: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K964841
Methodology: https://510kreport.com/methodology