510(k) · Cleared

Cleared

Biosign Flu a + B, Status Flu a & B

K132465510(k) SpecialCleared Sep 9, 201333-day reviewClass II21 CFR 866.3328

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Princeton BioMeditech Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens

Cleared on Sep 9, 2013 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Sep 9, 2013
Review: 33 days
Class: Class II
Product code: PSZ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK132465 Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013
Descendant · cites it directly · 0 of its ownK133474 Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013

Most influential descendants

Showing 1 of 1 · See all

K133474Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K132465	Biosign Flu a + B, Status Flu a & B	Princeton BioMeditech Corp.	2013	—
+1	K133474	Biosign Flu a + B, Status Flu a & B	Princeton BioMeditech Corp.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K132465, 2013–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PSZ device

#1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133474	Biosign Flu a + B, Status Flu a & B	Princeton BioMeditech Corp.	2013	0

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.

What does this lineage say?

Of its descendants, K133474 (Princeton BioMeditech Corp., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PSZ devices

PSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PSZ

2in 2025

2007high 8 (2013) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSZ

28in 2018

2007high 200 (2017) · low 20 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PSZ

1in 2022

2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PSZ

60in 2025

2007high 60 (2025) · low 0 (2007)2025

MAUDE reports naming product code PSZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	1	—	0	0
2009	7	20	0	0
2010	5	29	0	0
2011	3	80	0	0
2012	2	—	0	0
2013	8	28	0	0
2014	1	—	0	0
2015	4	27	0	0
2016	3	29	0	0
2017	3	200	0	0
2018	5	28	0	1
2019	0	—	0	1
2020	2	—	1	5
2021	0	—	0	42
2022	0	—	1	10
2023	2	—	0	12
2024	0	—	0	16
2025	2	—	0	60
2026	2	—	0	—

What is it indicated for?

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…

Read the full statement (239 words)

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K132465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132465: Biosign Flu a + B, Status Flu a & B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132465

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026