# K991650: CMV Brite Turbo Kit

- Pathway: 510(k) (Special)
- Applicant: Biotest Diagnostics Corp.
- Decided: Jul 12, 1999 after 60 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 K951550 (1996). 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)
- K951550: CMV Brite Antigenemia Test Kit, Biotest Diagnostics Corp. (1996) Summary page 1.

## Indications for use
The CMV Brite™ Turbo Kit is intended for use in the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence using microscopy in isolated peripheral blood leukocytes obtained from ethylenediaminetreaacetic acid (EDTA) or heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human peripheral blood cells aids in the diagnosis of acute or reactivated CMV infection. This product is not FDA cleared (approved) for use in testing (i.e., screening) of blood or plasma donors.

Source page: https://510kreport.com/device/K991650
Methodology: https://510kreport.com/methodology