# K982639: Spife Urine Ife

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Nov 4, 1998 after 98 days
- Product code: DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- 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 qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation. This kit could be a useful aid, in conjunction with other medical diagnostic tests, 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/K982639
Methodology: https://510kreport.com/methodology