# K990998: Polyslit Ife Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Jun 28, 1999 after 95 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.
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.

## Indications for use
This kit is intended for the separation of immunoglobulins using agarose gel electrophoresis. This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.

Source page: https://510kreport.com/device/K990998
Methodology: https://510kreport.com/methodology