# K964694: Elecsys LH Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 24, 1997 after 63 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 K900779 (1990). 1 ancestor in all.
14 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)
- K900779: Enzymun Test (R) LH, Boehringer Mannheim Corp. (1990) Summary page 2.

## Most influential descendants
- K031299: Elecsys LH Calset II (2003), 13 descendants of its own
- 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

## Indications for use
Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma.

Source page: https://510kreport.com/device/K964694
Methodology: https://510kreport.com/methodology