# K982311: Bartels Cinakit CMV Antigenemia

- Pathway: 510(k) (Traditional)
- Applicant: Intracel Corp.
- Decided: Dec 14, 1998 after 166 days
- Product code: GQH (Antigen, Cf (Including Cf Control), 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 Bartels CINAkit™ CMV Antigenemia Test is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the rapid direct qualitative detection of CMV pp65 antigen in human blood leukocytes by indirect immunofluorescence (IF). This product is not intended to be used for testing (i.e. screening) blood or plasma donors.

Source page: https://510kreport.com/device/K982311
Methodology: https://510kreport.com/methodology