# K972788: Crosslaps Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Devices and Diagnostics Consulting Group
- Decided: Dec 22, 1998 after 512 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: 1 generation back to K960171 (1996). 1 ancestor in all.
7 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)
- K960171: Active Crosslaps Elisa, Diagnostic Systems Laboratories, Inc. (1996) Summary page 1.

## Most influential descendants
- K990843: Serum Crosslaps One Step Elisa (1999), 6 descendants of its own
- 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

## Indications for use
The CrossLaps™ 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 3.) Anti-resorptive therapies in individuals diagnosed with Paget’s disease of bone 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/K972788
Methodology: https://510kreport.com/methodology