# K091859: Aesku PR3

- Pathway: 510(k) (Traditional)
- Applicant: Aesku Diagnostics
- Decided: Jun 3, 2010 after 349 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. The FDA summary names no predicate by number.

## Indications for use
AESKLISAPR3 is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the semniquantitative and qualitative detection of antibodies against proteinase 3 in human serum. The assay is an aid in the diagnosis of Wegener's granulomnatosis and should be used in conjunction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K091859
Methodology: https://510kreport.com/methodology