510(k) · Cleared
Recalled · 2008Light Diagnostics Simulfluor Flu a/Flu B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Diagnostics · GNW Antisera, Cf, Influenza Virus A, B, C
Cleared on Apr 8, 1998 after a 142-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Apr 8, 1998
- Review
- 142 days
- Class
- Class I
- Product code
- GNW
- Recalls
- 2
- 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 GNW? 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? (2)
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 Influenza A and B Reagents Named without a submission number | |
| * | — | DAKO IMAGEN™ Influenza Virus A and B 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2008 | Not classified | Z-0953-2009 | Pending | Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B. |
| Nov 24, 2008 | Not classified | Z-0954-2009 | Pending | Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GNW devicesGNW Antisera, Cf, Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GNW
2in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GNW
Too few GNW 510(k)s in any year since 2007 to give a median.
Recalls per year · GNW
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNW
No MAUDE report names GNW 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 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 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 Light Diagnostics SimulFluor™ Flu A/Flu B Immunofluorescence Assay is intended for the detection and identification of influenza A and influenza B in respiratory specimens such as throat, nasal and nasopharyngeal swabs, nasopharyngeal aspirates, broncho-alveolar lavages from patients with febrile respiratory illness and following amplification of virus in cell culture. Specimens found to be negative on direct specimen examination must be confirmed with culture.
For in vitro diagnostic use.
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/K974302 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974302: Light Diagnostics Simulfluor Flu a/Flu B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974302
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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