# K990796: Autostat II Anti-PR 3 (C-Anca)Elisa, HY*Tec Anti-PR 3 (C-Anca)Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Diagnotics, Ltd.
- Decided: Apr 28, 1999 after 49 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Indications for Use - Autostat™TI] Kit. Enzyme linked immunosorbent assay method for the semi—quanfitafivc determination of specific IgG autoantibodies to Pr 3 in human serum. Uses: The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener’s granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA). For in vilro diagnostic use only. Indications for Use - HyeTec Kit. Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific 1¢G autoantibodies to Pr 3 in buman serum. This device is designed for use with the Hycor Hy*Tec Automated EIA instrument. Uses: The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of auto-irumune vasculitides including Wegener’s granulomatosis and other conditions associated with elevated znti-neutrophil cytoplasmic antibodies (c-ANCA). For in virro diagnostic use only.

Source page: https://510kreport.com/device/K990796
Methodology: https://510kreport.com/methodology