# K990843: Serum Crosslaps One Step Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Osteometer Biotech A/S
- Decided: Jul 9, 1999 after 116 days
- Product code: JMM (Column Chromatography & Color Development, Hydroxyproline)
- Device class: 1
- Regulation: 21 CFR 862.1400
- 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 K960171 (1996). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972788: Crosslaps Elisa, Devices and Diagnostics Consulting Group (1998) Summary page 2.

## Most influential descendants
- K993706: Elecsys Serum B-Crosslaps/Serum Immunoassay (2000), 5 descendants of its own
- K051543: Elecsys Precicontrol Bone (2005), 4 descendants of its own
- K111506: Elecsys Precicontrol Varia 3 (2011), 3 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own

## Indications for use
The Serum CrossLaps™ One Step ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in : A. Monitoring bone resorption changes of 1.) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies 2.) Anti-resorptive therapies in individuals diagnosed with osteopenia, a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies

Source page: https://510kreport.com/device/K990843
Methodology: https://510kreport.com/methodology