# K973040: Spife Ife-6

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Jan 2, 1998 after 141 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
- Jul 21, 2017 · Class II · Z-0045-2020: The plates do not have wells punched for the controls in the patient 1 area.

## Indications for use
This kit is intended for the separation of immunoglobulins in serum 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/K973040
Methodology: https://510kreport.com/methodology