510(k) · Cleared
ClearedTru RSV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · GOG Antisera, Cf, Poliovirus 1-3
Cleared on Oct 18, 2007 as substantially equivalent to K041445 (Meridian Bioscience, Inc., 2004) after a 182-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Oct 18, 2007
- Review
- 182 days
- Class
- Class I
- Product code
- GOG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902609 (1990). 8 ancestors in all, the oldest K882629 (1988). 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 backK021172 RSV OiaThermo Biostar, Inc. · 2002
- 2 generations backK023779 RSV OiaThermo Biostar, Inc. · 2003
- 1 generation backK041445 Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc. · 2004
- This deviceK071101 Tru RSVMeridian 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 | K021172 | RSV Oia | Thermo Biostar, Inc. | 2002 | — |
| −2 | K023779 | RSV Oia | Thermo Biostar, Inc. | 2003 | — |
| −1 | K041445 | Immunocard Stat! RSV Model #750630 | Meridian Bioscience, Inc. | 2004 | — |
| 0 (this device) | 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 |
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 GOG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K041445 | Immunocard Stat! RSV Model #750630Summary page 1…ve test results be confirmed by cell culture. PREDICATE DEVICE: TRU RSV is a modification of, and is intended to detect the same analytes as, ImmunoCard STAT! RSV PLUS (K041445), manufactured by Meridian Bioscience, Inc. BACKGROUND: Respiratory Syncytial Virus (RSV) is the most important cause of pneum… | 2004 |
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 4 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All GOG devicesGOG Antisera, Cf, Poliovirus 1-3: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GOG
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GOG
Too few GOG 510(k)s in any year since 2007 to give a median.
Recalls per year · GOG
No recall names GOG since 2007.
Adverse event reports per year · GOG
No MAUDE report names GOG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. 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/K071101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071101: Tru RSV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071101
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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