510(k) · Cleared
ClearedTru Flu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Nov 15, 2007 as substantially equivalent to K041626 (Meridian Bioscience, Inc., 2005) and 1 other predicate after a 150-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Nov 15, 2007
- Review
- 150 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902609 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 4 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 3 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 2 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 1 generation backK041626 Immunocard Stat! Flu a & BMeridian Bioscience, Inc. · 2005
- This deviceK071657 Tru FluMeridian Bioscience, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −4 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −3 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −2 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −1 | K041626 | Immunocard Stat! Flu a & B | Meridian Bioscience, Inc. | 2005 | — |
| 0 (this device) | K071657 | Tru Flu | Meridian Bioscience, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
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 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
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 |
|---|---|---|---|
| * | K041626 | Immunocard Stat! Flu a & BSummary page 1…er clinical management decisions. PREDICATE DEVICES: TRU FLU is a modification of, and is intended to detect the same analytes as, ImmunoCard STAT! Flu A&B PLUS (K041626), Meridian Bioscience, Inc. Binax NOW Influenza A&B, Inverness Medical (K062109) BACKGROUND: Influenza is a highly contagious, e… | 2005 |
| * | K062109 | Binaxnow Influenza a & B TestSummary page 1…of, and is intended to detect the same analytes as, ImmunoCard STAT! Flu A&B PLUS (K041626), Meridian Bioscience, Inc. Binax NOW Influenza A&B, Inverness Medical (K062109) BACKGROUND: Influenza is a highly contagious, epidemic to pandemnic acute viral respiratory disease caused by several genera of… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 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?
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.
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/K071657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071657: Tru Flu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071657
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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