# K965109: Elecsys Estradiol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 18, 1997 after 60 days
- Product code: CHP (Radioimmunoassay, Estradiol)
- Device class: 1
- Regulation: 21 CFR 862.1260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K916132: Enzymun-Test® Estradiol Assay. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K992981: Elecsys Estradiol Calset II (1999), 3 descendants of its own
- K142021: Elecsys Estradiol III CalSet (2014), 1 descendant of its own
- K163053: Lumipulse G E2-III Calibrators (2016), 0 descendants of its own
- K101460: Loci 8 Calibrator, Model KC 646 (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K965109
Methodology: https://510kreport.com/methodology