# K984034: The Aptus (Automated) Application of the Anca Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Nov 30, 1998 after 18 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
The Zeus Scientific, Inc. ANCA Screen ELISA test system is intended for the qualitative detection of igG-class antibody to myeloperoxidase and/or proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA) to MPO and/or PR-3 ANCA may be associated with autoimmune disorders such as Wegener’s Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Puimonary Renal Syndrome. This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984034
Methodology: https://510kreport.com/methodology