# K981328: Quanta Lite PR3 Igg (Serine Protease) Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 19, 1998 after 67 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K140225: Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM Positive Control 100, Elia Anca/GBM PO (2014), 1 descendant of its own
- K173792: EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (2018), 0 descendants of its own

## Indications for use
An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3). This test is to be used in conjunction with other clinical findings to aid in assessment of certain autoimmune vasculitides such as Wegener's granulomatosis.

Source page: https://510kreport.com/device/K981328
Methodology: https://510kreport.com/methodology