# K981226: Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Dako Diagnostics, Ltd.
- Decided: Sep 28, 1998 after 188 days
- Product code: GQP (Antisera, Neutralization, Parainfluenza Virus 1-4)
- Device class: 1
- Regulation: 21 CFR 866.3400
- 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) Bartels Viral Respiratory Screening and Identification kit: named in the summary without a submission number

## Indications for use
The IMAGEN™ Parainfluenza virus Group (Types 1, 2 and 3) is a qualitative direct immunofluorescence test for the presumptive detection and confirmation of parainfluenza virus type 1, 2 and 3 antigens in respiratory specimens (nasopharyngeal aspirates) from paediatric populations and in cell culture preparations. The IMAGEN™ Parainfluenza virus Types 1, 2 and 3 is a qualitative direct immunofluorescence test for the presumptive detection and differentiation of parainfluenza virus type 1, 2 and 3 antigens respectively in respiratory specimens (nasopharyngeal aspirates) from paediatric populations and in cell culture preparations. A negative result obtained following direct staining of nasopharyngeal aspirates should be considered presumptive until confirmed by culture.

Source page: https://510kreport.com/device/K981226
Methodology: https://510kreport.com/methodology