# K972274: SPIFE

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Oct 27, 1997 after 131 days
- Product code: CEF (Electrophoretic, Protein Fractionation)
- Device class: 1
- Regulation: 21 CFR 862.1630
- 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 separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis. these tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.

Source page: https://510kreport.com/device/K972274
Methodology: https://510kreport.com/methodology