# K261466: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific
- Decided: Aug 21, 2026 after 109 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
Longest line of descent: 1 generation back to K040111 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040111: Zeus Scientific, Inc., Athena Multi-Lyte Mpo/PR3 Igg Test System, Zeus Scientific, Inc. (2004) Summary page 5.
- K071219: Athena Multi-Lyte GBM Test System, Zeus Scientific, Inc. (2007)

## Indications for use
Alegria FLASH MPO: The Alegria Flash MPO kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to MPO in human serum. It is intended for use as an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument. Alegria FLASH PR3: The Alegria Flash PR3 kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to PR3 in human serum. It is intended for use as an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument. Alegria FLASH GBM: The Alegria Flash GBM kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to GBM in human serum. It is intended for use as an aid in the diagnosis of Goodpasture’s Syndrome in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.

Source page: https://510kreport.com/device/K261466
Methodology: https://510kreport.com/methodology