# K082388: Minicap Immunotyping, Model: 2300

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Apr 14, 2009 after 238 days
- Product code: CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K143483: MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (2015), 0 descendants of its own

## Indications for use
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP System, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The MINICAP performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains, respectively. The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspected monoclonal proteins. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K082388
Methodology: https://510kreport.com/methodology