510(k) · Cleared
ClearedRSV Oia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Biostar, Inc. · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Jan 14, 2003 as substantially equivalent to K021172 (Thermo Biostar, Inc., 2002) after a 63-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 14, 2003
- Review
- 63 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902609 (1990). 4 ancestors in all, the oldest K882629 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 2 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 1 generation backK021172 RSV OiaThermo Biostar, Inc. · 2002
- This deviceK023779 RSV OiaThermo Biostar, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK041445 Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK071101 Tru RSVMeridian Bioscience, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −2 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −1 | K021172 | RSV Oia | Thermo Biostar, Inc. | 2002 | — |
| 0 (this device) | K023779 | RSV Oia | Thermo Biostar, Inc. | 2003 | — |
| +1 | K041445 | Immunocard Stat! RSV Model #750630 | Meridian Bioscience, Inc. | 2004 | — |
| +2 | K071101 | Tru RSV | Meridian Bioscience, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K021172 | RSV Oia | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041445 | Immunocard Stat! RSV Model #750630 | 2004 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K041445 (Meridian Bioscience, Inc., 2004) has gone furthest, with 1 descendant of its own.
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?
The Thermo BioStar RSV OIA assay is an Optical ImmunoAssay test for the rapid and qualitative detection of respiratory syncytial virus (RSV) antigens (nucleoproteins and fusion proteins) from nasal wash and nasopharyngeal swab specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in symptomatic neonatal and pediatric patients under the age of five. 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/K023779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023779: RSV Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023779
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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