# K111369: The Helena V8 Immunodisplacement Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories Uk, Ltd.
- Decided: Jun 26, 2012 after 407 days
- Product code: CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 6, 2022 · Class II · Z-1244-2022: Due to microbial growth causing interference with interpretation.

## Indications for use
The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's lgG, IgA, 1gM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera. are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K111369
Methodology: https://510kreport.com/methodology