# K954105: Eia Kit for the Detction of Anti-PR3 Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Scimedx Corp.
- Decided: Mar 19, 1996 after 201 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973822: Virgo Anca Screen Kit (1997), 0 descendants of its own
- K973823: PR 3 Antibody Kit (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K954105
Methodology: https://510kreport.com/methodology