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. · GOG Antisera, Cf, Poliovirus 1-3
Cleared on Sep 13, 2002 as substantially equivalent to K981651 (Biostar, Inc., 1998) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Sep 13, 2002
- Review
- 154 days
- Class
- Class I
- Product code
- GOG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902609 (1990). 3 ancestors in all, the oldest K882629 (1988). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 1 generation backK981651 AB Flu OiaBiostar, Inc. · 1998
- This deviceK021172 RSV OiaThermo Biostar, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK023779 RSV OiaThermo Biostar, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK041445 Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK071101 Tru RSVMeridian Bioscience, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −1 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| 0 (this device) | K021172 | RSV Oia | Thermo Biostar, Inc. | 2002 | — |
| +1 | K023779 | RSV Oia | Thermo Biostar, Inc. | 2003 | — |
| +2 | K041445 | Immunocard Stat! RSV Model #750630 | Meridian Bioscience, Inc. | 2004 | — |
| +3 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K981651 | AB Flu OiaSummary page 1…I Manufacturer: Thermo BioStar 510(k) Number: K981651 Clinical application: Trade or Proprietary Name: Directigen Respiratory Syncytial… | 1998 |
| * | K882629 | Directigen Respiratory Syncytial Virus Test KitSummary page 1…I Manufacturer: Becton Dickinson 510(k) Number: K882629 Historical Reference Method: Viral Culture E. Intended use of device [$807,92(a)(5)]: The Thermo… | 1988 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023779 | RSV Oia | 2003 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K023779 (Thermo Biostar, Inc., 2003) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K981651.
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.
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?
The Thermo BioStarTMRSV OIAO assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of respiratory syncytial virus antigens (nucleoprotein and fusion protein) from nasal wash specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus 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/K021172 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021172: RSV Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021172
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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