# K132465: Biosign Flu a + B, Status Flu a & B

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Sep 9, 2013 after 33 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133474: Biosign Flu a + B, Status Flu a & B (2013), 0 descendants of its own

## Indications for use
The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonla/20/99 (Hi NI. A/Solomon Islands/3/2006 (H1iNi), AlBrisbane/59/2007 (H1iN1), AlCalifornia/07/2009 (H-11M), AiWisconsin/67/2005 (H3N2), A/Brisbane/i 0/2007 (I-3N2), and influenza B viruses B/Ohio/01 12005, B/FloridaI4I2006, B/BrisbaneI6OI2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel Influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K132465
Methodology: https://510kreport.com/methodology