# K984516: The Aptus (Automated) Application of the Mpo Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the Det

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jan 11, 1999 after 24 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. MPO ELISA test system is intended for the semi-quaniitative detection of IgG-class antibody to myeloperoxidase in human serum. The test systemis intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculiic disorders characterized by elevated levels of antibodies to MPO. Elevated antibody levels to MPO may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This testis for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984516
Methodology: https://510kreport.com/methodology