# K981786: Iga Minineph Antiserum

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Nov 24, 1999 after 553 days
- Product code: CFQ (Radioimmunoassay, 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 assay is designed for the in vitro measurement of human IgA in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal IgA metabolism.

Source page: https://510kreport.com/device/K981786
Methodology: https://510kreport.com/methodology