# K103757: Immunofixation Electrophoresis Test Using Interlab G26 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Grifols
- Decided: Oct 13, 2011 after 294 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
- K120169: Interlab Ife Test Using G 26 Ver. 2.0 Instrument (2012), 0 descendants of its own

## Indications for use
The Immunofixation Electrophoresis (IFE) Test using the Interlab 026 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings. The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab 026 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.

Source page: https://510kreport.com/device/K103757
Methodology: https://510kreport.com/methodology