# K993706: Elecsys Serum B-Crosslaps/Serum Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 24, 2000 after 265 days
- Product code: JMM (Column Chromatography & Color Development, Hydroxyproline)
- Device class: 1
- Regulation: 21 CFR 862.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960171 (1996). 3 ancestors in all.
5 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)
- K990843: Serum Crosslaps One Step Elisa, Osteometer Biotech A/S (1999) Summary page 1.

## Most influential descendants
- 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
- K182012: ADVIA Centaur Calcitonin (CALCT) assay (2018), 0 descendants of its own

## Recalls of this device
- Apr 25, 2013 · Class II · Z-1727-2013: Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ¿-CrossLaps (¿-CL) assay package insert version 5, cou

## Indications for use
For the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma, for assessing individual bone resorption. The test may be used as an aid in monitoring anti-resorptive therapies (e.g. bisphosphonates, hormone replacement therapy — HRT) in postmenopausal women and individuals diagnosed with osteopenia. The elecrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche ELECSYS 1010 and 2010 immunoassay analyzers.

Source page: https://510kreport.com/device/K993706
Methodology: https://510kreport.com/methodology