510(k) · Cleared
ClearedImmunocard Stat! RSV Model #750630
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Aug 13, 2004 as substantially equivalent to K032166 (Binax, Inc., 2003) and 2 other predicates after a 73-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Aug 13, 2004
- Review
- 73 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902609 (1990). 7 ancestors in all, the oldest K882629 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 3 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 2 generations backK021172 RSV OiaThermo Biostar, Inc. · 2002
- 1 generation backK023779 RSV OiaThermo Biostar, Inc. · 2003
- This deviceK041445 Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK071101 Tru RSVMeridian Bioscience, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071101Tru RSVMeridian Bioscience, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −3 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −2 | K021172 | RSV Oia | Thermo Biostar, Inc. | 2002 | — |
| −1 | K023779 | RSV Oia | Thermo Biostar, Inc. | 2003 | — |
| 0 (this device) | K041445 | Immunocard Stat! RSV Model #750630 | Meridian Bioscience, Inc. | 2004 | — |
| +1 | K071101 | Tru RSV | Meridian Bioscience, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 GQG? 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 GQG device
- #1 K253318 Clungene RSV Antigen Rapid Testscore 10.8 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…Summary page 1…rd STAT! RSV is intended to detect the same analyte as other cleared devices including: * Binax NOW® RSV [a rapid lateral-flow immunoassay cleared to market under 510(k) K032166] (Binax, Inc. South Portland, ME) * BD Directigen® EZ RSV [a rapid enzyme immunoassay cleared to market under 510(k) K022133]… | 2003 |
| * | K022133 | BD Directigen EZ RSV KitSummary page 1…immunoassay cleared to market under 510(k) K032166] (Binax, Inc. South Portland, ME) * BD Directigen® EZ RSV [a rapid enzyme immunoassay cleared to market under 510(k) K022133] (Becton Dickinson & Co., Sparks, MD) * RSV OIA® [an optical immunoassay cleared to market under 510(k) K023779] (Thermo-Biosta… | 2002 |
| * | K023779 | RSV OiaSummary page 1…rapid enzyme immunoassay cleared to market under 510(k) K022133] (Becton Dickinson & Co., Sparks, MD) * RSV OIA® [an optical immunoassay cleared to market under 510(k) K023779] (Thermo-Biostar Inc., Louisville, CO) BACKGROUND: Respiratory Syncytial Virus (RSV) is the most important cause of pneumonia and… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071101 | Tru RSV | 2007 | 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K071101 (Meridian Bioscience, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032166.
How does its category compare?
All GQG devicesGQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GQG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GQG
93in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GQG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GQG
2in 2025
MAUDE reports naming product code GQG, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 93 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ImmunoCard STAT! RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or internal protein) in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic neonatal and pediatric patients. It is recommended that all negative test results be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041445: Immunocard Stat! RSV Model #750630.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041445
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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