# K071657: Tru Flu

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Nov 15, 2007 after 150 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902609 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041626: Immunocard Stat! Flu a & B, Meridian Bioscience, Inc. (2005) Summary page 1.
- K062109: Binaxnow Influenza a & B Test, Binax, Inc. (2006) Summary page 1.

## Indications for use
TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples in symptomatic patients. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other clinical management decisions.

Source page: https://510kreport.com/device/K071657
Methodology: https://510kreport.com/methodology