# K974478: Immuno Concepts Anca Test Systems

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Feb 9, 1998 after 75 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961340 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961340: Nova Lite Anca, Inova Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
This is an in vitro diagnostic test system for the detection and semi-quantitation of antineutrophil cytoplasmic antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.

Source page: https://510kreport.com/device/K974478
Methodology: https://510kreport.com/methodology