# K173792: EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Mar 13, 2018 after 89 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974169 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140225: Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM Positive Control 100, Elia Anca/GBM PO, Phadia US, Inc. (2014) Summary page 6.

## Recalls of this device
- May 24, 2023 · Class II · Z-0783-2024: Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen

## Indications for use
EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA, formerly called Wegener’s Granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 2500/5000. EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. EliA MPOs uses the EliA IgG method on the instrument Phadia 2500/5000. EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies to α3 chain of collagen IV in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 2500/5000.

Source page: https://510kreport.com/device/K173792
Methodology: https://510kreport.com/methodology