510(k) Report

510(k) · Cleared

Cleared

Immunocard Stat! Flu a & B

K041626510(k) TraditionalCleared Mar 16, 2005273-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

Meridian Bioscience, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens

Cleared on Mar 16, 2005 as substantially equivalent to K021649 (Binax, Inc., 2002) and 6 other predicates after a 273-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.

Decided
Mar 16, 2005
Review
273 days
Class
Class II
Product code
PSZ
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K902609 (1990). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor1999: 1 other ancestor2007: 1 descendant clearedK902609 · Directigen Flu a · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1990K981651 · AB Flu Oia · Biostar, Inc. · 1998K023556 · Flu Oia a/B Test Kit · Thermo Biostar, Inc. · 2003 · recalledK031899 · Quickvue Influenza a+B Test · Quidel Corp. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K031899 · Quickvue Influenza a+B Test · Quidel Corp. · 2003K023556 · Flu Oia a/B Test Kit · Thermo Biostar, Inc. · 2003 · recalledK981651 · AB Flu Oia · Biostar, Inc. · 1998K902609 · Directigen Flu a · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19900
  1. Root · 4 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
  2. 3 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
  3. 2 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
  4. 1 generation backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
  5. This deviceK041626 Immunocard Stat! Flu a & BMeridian Bioscience, Inc. · 2005
  6. Descendant · cites it directly · 0 of its ownK071657 Tru FluMeridian Bioscience, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K071657Tru FluMeridian Bioscience, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K902609Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic1990—
−3K981651AB Flu OiaBiostar, Inc.1998—
−2K023556Flu Oia a/B Test KitThermo Biostar, Inc.20031
−1K031899Quickvue Influenza a+B TestQuidel Corp.2003—
0 (this device)K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc.2005—
+1K071657Tru FluMeridian Bioscience, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200010
200220
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K041626, 1990–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K021649Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack
Summary page 1
…s intended to detect the same analytes as other cleared devices including: • Binax NOW® Flu A + B [a rapid lateral-flow immunoassay cleared to market under 510(k)s K021649 and K0216461 (Binax, Inc. South Portland, ME) · BD Directigen® Flu A+B [a rapid enzyme immunoassay cleared to market under 510(k…
Binax, Inc.2002—
*K021646Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack
Summary page 1
…o detect the same analytes as other cleared devices including: • Binax NOW® Flu A + B [a rapid lateral-flow immunoassay cleared to market under 510(k)s K021649 and K0216461 (Binax, Inc. South Portland, ME) · BD Directigen® Flu A+B [a rapid enzyme immunoassay cleared to market under 510(k) K001364]…
Binax, Inc.2002—
*K001364BD Directigen Flu a+B
Summary page 1
…ed to market under 510(k)s K021649 and K0216461 (Binax, Inc. South Portland, ME) · BD Directigen® Flu A+B [a rapid enzyme immunoassay cleared to market under 510(k) K001364] (Becton Dickinson & Co., Sparks, MD) · FLU OIA [an optical immunoassay cleared to market under 510(k) K0235561 (Thermo-Bios…
Bd Becton Dickinson Vacutainer Systems Preanalytic2000—
*K023556Flu Oia a/B Test Kit
Summary page 1
…pid enzyme immunoassay cleared to market under 510(k) K001364] (Becton Dickinson & Co., Sparks, MD) · FLU OIA [an optical immunoassay cleared to market under 510(k) K0235561 (Thermo-Biostar Inc., Louisville, CO) · Quickvue® Influenza A+ B Test [a rapid lateral-flow immunoassay cleared to market u…
Thermo Biostar, Inc.20031
*K031899Quickvue Influenza a+B Test
Summary page 1
…et under 510(k) K0235561 (Thermo-Biostar Inc., Louisville, CO) · Quickvue® Influenza A+ B Test [a rapid lateral-flow immunoassay cleared to market under 510(k) K031899] (Quidel, Inc., San Diego, CA) · Xpext® Flu A/B [a rapid immunochromatographic assay cleared to market under 510(k) K031565]…
Quidel Corp.2003—
*K031565Xpect Influenza a/B
Summary page 1
…noassay cleared to market under 510(k) K031899] (Quidel, Inc., San Diego, CA) · Xpext® Flu A/B [a rapid immunochromatographic assay cleared to market under 510(k) K031565] (Remel, Inc., Lenexa, KS) Tab 6…
Remel, Inc.2003—
*K982429Zstatflu Test for Influenza Types a and B Viruses
Summary page 2
…=== Meridian Bioscience, Inc. Cincinnati, OH * Zstatflu®Test for Influenza types A & B Virus [an endogenous viral-encoded enzyme assay cleared to market under 510(k) K982429] (ZymeTx, Inc., Oklahoma City, OK) BACKGROUND: Influenza is a highly contagious, epidemic to pandemic acute viral respiratory d…
Zymetx, Inc.1998—

Also cleared against K021649: 4 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K071657Tru FluMeridian Bioscience, Inc.20070

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 15 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K071657 (Meridian Bioscience, Inc., 2007) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K021649.

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.

FDA decisions per year · PSZ

2in 2025

2007: 22008: 12009: 72010: 52011: 32012: 22013: 82014: 12015: 42016: 32017: 32018: 52020: 22023: 22025: 22026 (partial year): 2
2007high 8 (2013) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSZ

28in 2018

2009: 20 days median2010: 29 days median2011: 80 days median2013: 28 days median2015: 27 days median2016: 29 days median2017: 200 days median2018: 28 days median
2007high 200 (2017) · low 20 (2009)2026

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

Recalls per year · PSZ

1in 2022

2020: 12022: 1
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

2018: 12019: 12020: 52021: 422022: 102023: 122024: 162025: 60
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
200972000
201052900
201138000
20122—00
201382800
20141—00
201542700
201632900
2017320000
201852801
20190—01
20202—15
20210—042
20220—110
20232—012
20240—016
20252—060
20262—0—

What is it indicated for?

ImmunoCard STAT! Flu A&B PLUS is a rapid, qualitative, lateral-flow immunoassay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal aspirate, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test samples from symptomatic patients. It is recommended that all negative test results be confirmed by cell culture.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K021649

4 other devices cite the same predicate.

  • K053126Binaxnow Influenza a & B TestBinax, Inc. · 2005
  • K041049Binaxnow Influenza a & B TestBinax, Inc. · 2004
  • K041439Sas Influenza B TestSa Scientific, Inc. · 2004
  • K041441Sas Influenza a TestSa Scientific, Inc. · 2004

More from Meridian Bioscience, Inc.

53 FDA decisions under this applicant name. See the company

  • K243922RevogeneMeridian Bioscience, Inc. · 2025
  • K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
  • K222829Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023
  • K222779RevogeneMeridian Bioscience, Inc. · 2023
  • K220480RevogeneMeridian Bioscience, Inc. · 2022

Recent decisions in PSZ

The PSZ category page

  • K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026
  • K252283Nano-Check Influenza A+B TestNano-Ditech Corporation · 2026
  • K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025
  • K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC · 2025
  • K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd · 2023

https://510kreport.com/device/K041626 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041626: Immunocard Stat! 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/K041626

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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