# K971335: Quanta Lite CMV Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Dec 1, 1997 after 235 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 QUANTA Lite™ CMV IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quanitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Source page: https://510kreport.com/device/K971335
Methodology: https://510kreport.com/methodology