# K091860: Aeskulisa Mpo, Model 30-7303US

- Pathway: 510(k) (Traditional)
- Applicant: Aesku Diagnostics
- Decided: Feb 23, 2010 after 249 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
AESKULISA MPO is a solid phase enzyme immunoassay employing purified native myeloperoxidase (MPO) from human peripheral blood polymorphonuclear cells for the semiquantitative and qualitative detection of antibodies against MPO in human serum. The assay is an aid in the diagnosis of autoimmune systemic vasculitis, such as microscopic polyangiitis, and glomerulonephritis and should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K091860
Methodology: https://510kreport.com/methodology