# K974302: Light Diagnostics Simulfluor Flu a/Flu B

- Pathway: 510(k) (Traditional)
- Applicant: Light Diagnostics
- Decided: Apr 8, 1998 after 142 days
- Product code: GNW (Antisera, Cf, Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- Recalls of this device: 2 (0 Class I)
- 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 Influenza A and B Reagents: named in the summary without a submission number
- (no number) DAKO IMAGEN™ Influenza Virus A and B: named in the summary without a submission number

## Recalls of this device
- Nov 24, 2008 · Not classified · Z-0953-2009: 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 misdiagnos
- Nov 24, 2008 · Not classified · Z-0954-2009: 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 misdiagnos

## Indications for use
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.

Source page: https://510kreport.com/device/K974302
Methodology: https://510kreport.com/methodology