# K960171: Active Crosslaps Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Mar 28, 1996 after 72 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
No predicates in its family tree.
8 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)
- None. The FDA summary names its predicate without a number.
- (no number) OSTEX OSTEOMARK assay: named in the summary without a submission number

## Most influential descendants
- K972788: Crosslaps Elisa (1998), 7 descendants of its own
- 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

## Indications for use
The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.

Source page: https://510kreport.com/device/K960171
Methodology: https://510kreport.com/methodology