# K984139: The Aptus (Automated) Application of the CMV Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jan 11, 1999 after 54 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
This test system is designed for the manual or automated (Aptus), qualitative determination of IgG antibody to CMV in human serum. The test system is intended to be used fo evaluate serologic evidence of previous infection with CMV and is for in vitro diagnostic use. The test is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Source page: https://510kreport.com/device/K984139
Methodology: https://510kreport.com/methodology