# K944438: Hemagen CMV Igg Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Feb 20, 1997 after 892 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. The FDA summary names its predicate without a number.
- (no number) Gull Laboratories, Inc. CMV IgG ELISA Test: named in the summary without a submission number

## Indications for use
This enzyme-linked immunosorbent assay (ELISA) is intended to determine an individual’s serologic status with respect to IgG antibodies to CMV. When the assay is used in the qualitative mode, a reactive result indicates current or past infection with CMV. When used in the semi-quantitative mode, this test can detect significant antibody rises associated with seroconversion, reinfection, or reactivation of latent disease. This product is not FDA-cleared for use in screening blood or plasma donors. The performance of this assay has not been established for neonates and pregnant women. Results from immunocompromised patients should be interpreted with caution.

Source page: https://510kreport.com/device/K944438
Methodology: https://510kreport.com/methodology