# K061376: EL-Anca: Anti-Mpo, Anti-PR3, Anti-Mpo and Anti-PR3

- Pathway: 510(k) (Traditional)
- Applicant: Theratest Laboratories, Inc.
- Decided: Jul 20, 2006 after 64 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
TheraTest EL- ANCATM: anti-MPO- and EL- ANCATM: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis. TheraTest EL-ANCA TM:anti-MPG is intended for use in clinical laboratories as in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase. Measurement of anti-MPG aids in the diagnosis of microscopic polyangiitis. TheraTest EL-ANCA TM : anti-PR3 is intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil proteinase 3. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.

Source page: https://510kreport.com/device/K061376
Methodology: https://510kreport.com/methodology