# K150955: Elecsys Progesterone III Cal Check 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 1, 2015 after 22 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: 3 generations back to K093582 (2010). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142127: Elecsys Estradiol Iii Calcheck 5, Roche Diagnostics (2014). Our reading of the summary gave K142147, FDA’s number for Eeva System (Auxogyn, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Elecsys Estradiol III CalCheck 5”.

## Most influential descendants
- K162173: Elecsys CYFRA 21-1 CalCheck 5 (2017), 0 descendants of its own
- K160729: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (2016), 0 descendants of its own

## Indications for use
The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K150955
Methodology: https://510kreport.com/methodology