# K981330: Quanta Lite Mpo Igg (Myeloperoxidase) 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 myeloperoxidase (MPO). This test is to be used in conjunction with other clinical findings to aid in assessment of certain autoimmune vasculitides such as microscopic polyarteritis, and crescentic glomerulonephritis.

Source page: https://510kreport.com/device/K981330
Methodology: https://510kreport.com/methodology