# K983803: The Aptus (Automated) Application of the CMV Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Dec 14, 1998 after 47 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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 CMV IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus) qualitative determination of IgM antibodies to cytomegalovirus in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for in vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Source page: https://510kreport.com/device/K983803
Methodology: https://510kreport.com/methodology