# K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Jul 26, 2013 after 150 days
- Product code: CEF (Electrophoretic, Protein Fractionation)
- Device class: 1
- Regulation: 21 CFR 862.1630
- 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 K960669 (1996). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960669: Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits, Morax (1996) Summary page 3.
- K042939: Capillary's Immunotyping (PN 2100), Sebia, Inc. (2005) Summary page 2.
- K082085: Capillarys Immunotyping, Model 2100, Sebia (2009) Summary page 2.
- K101863: IT/IF Control, Sebia (2011) Summary page 2.
- K002799: Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100, Beckman Coulter, Inc. (2000) Summary page 2.

## Most influential descendants
- 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 far the detection and the characterization of monoclonal proteins (immunotyping) in human wine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAI'ILLARYS, CAIPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig 0), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.. The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 n. The electruphoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods: -Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAFILLARYS 2 FLEX PIERCING instruments and on SEBIA MINCAP instrument. - Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K(20 electrophoresis chamber. The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/If control.

Source page: https://510kreport.com/device/K130500
Methodology: https://510kreport.com/methodology