# K042939: Capillary's Immunotyping (PN 2100)

- Pathway: 510(k) (Traditional)
- Applicant: Sebia, Inc.
- Decided: Jun 27, 2005 after 245 days
- Product code: DFH (Kappa, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument (2013), 2 descendants of its own
- K161928: Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control (2016), 1 descendant of its own
- K192095: CAPI 3 Immunotyping, Capillarys 3 Tera (2019), 0 descendants of its own

## Indications for use
The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 or CAPILLARYS 1,1-112 + kits designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAPILLARYS system performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each sample is mixed with individual antisera that are specific against gamma (IgG), alpha (IgA) and mu (IgM) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains. The proteins fractions, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually by comparing the profile of the untreated sample with the individual profiles treated with the respective antisera. Monoclonal immunoglobulins are thus detected and identified. Identification of Monoclonal immunoglobulins is essential for the classification of monoclonal gammopathies by the class and type of involved immunoglobulins. "For In Vitro Diagnostic Use."

Source page: https://510kreport.com/device/K042939
Methodology: https://510kreport.com/methodology