# K031299: Elecsys LH Calset II

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: May 12, 2003 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 K900779 (1990). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964694: Elecsys LH Assay, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- K033873: Elecsys C-Peptide Calset (2004), 12 descendants of its own
- K103221: Elecys HGH Calset, Elecsys HGH Calcheck 5 (2010), 10 descendants of its own
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), 4 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own

## Indications for use
The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K031299
Methodology: https://510kreport.com/methodology