# K142021: Elecsys Estradiol III CalSet

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 12, 2014 after 18 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 K965109 (1997). 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)
- K992981: Elecsys Estradiol Calset II, Roche Diagnostics Corp. (1999) Summary page 2.

## Most influential descendants
- K163053: Lumipulse G E2-III Calibrators (2016), 0 descendants of its own

## Indications for use
Estradiol III CalSet is used for calibrating the quantitative Elecsys Estradiol III assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K142021
Methodology: https://510kreport.com/methodology