# K152526: Elecsys Progesterone III CalSet

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 2, 2015 after 29 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 K964841 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K964841: Elecsys Progesterone Assay, Boehringer Mannheim Corp. (1997) Summary page 6.

## Most influential descendants
- K163546: Lumipulse G Progesterone-N Calibrators (2017), 0 descendants of its own
- K160729: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (2016), 0 descendants of its own

## Indications for use
Progesterone 111 CalSet is used for calibrating the quantitative Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K152526
Methodology: https://510kreport.com/methodology