# K982898: Immuglo Anti-Neutrophil Cytoplasmic Antibody (Anca) Test Sytem

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Nov 30, 1998 after 105 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
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. The FDA summary names its predicate without a number.
- (no number) Anti-neutrophil Cytoplasmic Antibody (ANCA) Test System from Scimedx Corporation: named in the summary without a submission number
- (no number) NOVA Lite™ ANCA System by INOVA Diagnostics: named in the summary without a submission number

## Indications for use
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum to aid in the diagnosis of patients with necrotizing vasculitides.

Source page: https://510kreport.com/device/K982898
Methodology: https://510kreport.com/methodology