# K983740: IS-Anti-PR3 Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Bioscience, Inc.
- Decided: Nov 18, 1998 after 27 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) ELIAS PR-3 Kit: named in the summary without a submission number

## Indications for use
The & PR-3 IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and semi-quantitation of antibodies against the Proteinase-3 (PR-3) antigen in serum as an aid in the diagnosis of Wegener’s granulomatosis. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.

Source page: https://510kreport.com/device/K983740
Methodology: https://510kreport.com/methodology