510(k) · Cleared
ClearedImagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako Diagnostics, Ltd. · GQP Antisera, Neutralization, Parainfluenza Virus 1-4
Cleared on Sep 28, 1998 after a 188-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 28, 1998
- Review
- 188 days
- Class
- Class I
- Product code
- GQP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bartels Viral Respiratory Screening and Identification kit Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GQP devicesGQP Antisera, Neutralization, Parainfluenza Virus 1-4: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GQP
FDA has decided no GQP device since 2007.
Median 510(k) review, days · GQP
Too few GQP 510(k)s in any year since 2007 to give a median.
Recalls per year · GQP
No recall names GQP since 2007.
Adverse event reports per year · GQP
No MAUDE report names GQP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (106 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981226: Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981226
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026