# K992981: Elecsys Estradiol Calset II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 24, 1999 after 21 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: 1 generation back to K965109 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K965109: Elecsys Estradiol Assay, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- 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
For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.

Source page: https://510kreport.com/device/K992981
Methodology: https://510kreport.com/methodology