# K143284: Elecsys Estradiol III Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 16, 2014 after 29 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K970148 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970148: Elecsys Calcheck Estradiol, Boehringer Mannheim Corp. (1997) Summary page 5.

## Indications for use
For use in the verification of the calibration established by the Elecsys Estradiol III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K143284
Methodology: https://510kreport.com/methodology