# K081164: D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Jun 13, 2008 after 50 days
- Product code: LIN (Antisera, Conjugated Fluorescent, 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
Longest line of descent: 1 generation back to K904036 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951821: Cytomegalovirus Direct Immunofluorescence Assay, Light Diagnostics (1996) Summary page 1.
- K904036: Bartels Cytomegalovirus Immed. Early Antigen, Baxter Healthcare Corp (1990) Summary page 1.

## Indications for use
The Diagnostic Hybrids, Inc. device, D 3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.

Source page: https://510kreport.com/device/K081164
Methodology: https://510kreport.com/methodology