# K080916: Capillarys Urine

- Pathway: 510(k) (Special)
- Applicant: Sebia
- Decided: Jul 1, 2008 after 90 days
- Product code: JKM (Immunochemical, Bence-Jones Protein)
- Device class: 2
- Regulation: 21 CFR 866.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.

Source page: https://510kreport.com/device/K080916
Methodology: https://510kreport.com/methodology