# K974901: Hybrid Capture System CMV Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Digene Corp.
- Decided: Sep 29, 1998 after 272 days
- Product code: LJO (Antigen, Iha, 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 K921616 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921616: CMV-Vue (TM) CMV Antigen Detection Kit, Incstar Corp. (1992) Summary page 2.
- (no number) CMV Cell Culture (in use prior to May 28, 1976): named in the summary without a submission number

## Indications for use
The Digene Hybrid Capture® CMV DNA Assay is a qualitative, in vitro, diagnostic assay intended for the detection of human cytomegalovirus (CMV) DNA in human peripheral white blood cells isolated from whole blood specimens collected in EDTA. It is indicated for use as an aid in diagnosing CMV infection in solid organ transplant, bone marrow transplant and HIV/AIDS patients. This assay has not been cleared by the FDA for blood/plasma donor screening.

Source page: https://510kreport.com/device/K974901
Methodology: https://510kreport.com/methodology