# K012399: Modification to Elecsys FSH II Calset

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 24, 2001 after 28 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 K003409 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003409: Elecsys FSH Calset II, Roche Diagnostics Corp. (2001) Summary page 1.

## Most influential descendants
- K163534: Lumipulse G FSH-N Calibrators (2017), 0 descendants of its own

## Indications for use
Elecsys FSH II CalSet is used for calibrating the quantitative Elecsys FSH assay on the Elecsys 1010 and 2010 immunoassay and Modular Analytics E170 systems.

Source page: https://510kreport.com/device/K012399
Methodology: https://510kreport.com/methodology