# K120169: Interlab Ife Test Using G 26 Ver. 2.0 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Grifols USA, LLC
- Decided: Aug 24, 2012 after 218 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
Longest line of descent: 1 generation back to K103757 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103757: Immunofixation Electrophoresis Test Using Interlab G26 Instrument, Grifols (2011) Summary page 3.

## Indications for use
The Immunofixation Electrophoresis (IFE) Test using Interlab G 26 v2.0 instrument is for the qualitative in vitro.diagnostic separation and identification of immunoglobulins (lgG, IgA and 1gM), and kappa and lambda 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, and 6 samples per gel, are intended to be used with the automated Interlab G26 vi1.0 and v2.0 electrophoresis analyzers in conjunction with the Easy Mask antisera application device.

Source page: https://510kreport.com/device/K120169
Methodology: https://510kreport.com/methodology