510(k) · Cleared
Clearedcobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Jul 6, 2022 as substantially equivalent to K210234 (Roche Molecular Systems, Inc., 2021) after a 210-day review. Its family tree reaches back 9 generations to 2008.
- Decided
- Jul 6, 2022
- Review
- 210 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to DEN070013 (2008). 20 ancestors in all, the oldest DEN060008 (2006). No later device cites it as a predicate yet.
- Root · 9 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations between
- 3 generations backK153544 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas…Iquum, Inc. · 2016
- 2 generations backK200065 cobas Influenza A/B Nucleic acid test for use on the cobas Liat…Roche Molecular Systems, Inc. · 2020
- 1 generation backK210234 cobas Influenza A/B & RSV Nucleic acid test for use on the cobas…Roche Molecular Systems, Inc. · 2021
- This deviceK213822 cobas Influenza A/B & RSV nucleic acid test for use on the cobas…Roche Molecular Systems, Inc. · 2022
Show all 9 generations
- Root · 9 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 8 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 7 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 6 generations backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- 5 generations backK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- 4 generations backK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- 3 generations backK153544 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas…Iquum, Inc. · 2016
- 2 generations backK200065 cobas Influenza A/B Nucleic acid test for use on the cobas Liat…Roche Molecular Systems, Inc. · 2020
- 1 generation backK210234 cobas Influenza A/B & RSV Nucleic acid test for use on the cobas…Roche Molecular Systems, Inc. · 2021
- This deviceK213822 cobas Influenza A/B & RSV nucleic acid test for use on the cobas…Roche Molecular Systems, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −8 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −7 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −6 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| −5 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| −4 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| −3 | K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Iquum, Inc. | 2016 | — |
| −2 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas… | Roche Molecular Systems, Inc. | 2020 | — |
| −1 | K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021 | — |
| 0 (this device) | K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 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 OCC? 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 OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemSummary page 4…CFR 862.2570 cobas® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® Predicate Devices System (K210234) Roche Molecular Systems, Inc. Branchburg, NJ Establishment Number: 224… | 2021 |
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 14 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 4 of the 20 ancestors have a recall of any class.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, 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 | 0 | — | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
The cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (cobas Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk…
Read the full statement (258 words)
The cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (cobas Influenza A/B & RSV) is an
automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A
virus, Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with
signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is
intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended
to detect Influenza C.
Negative results do not preclude Influenza virus or RSV infection and should not be used as the sole basis for treatment or
other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with
other viruses. The agent detected may not be the definite cause of disease.
Performance characteristics for Influenza A were established during the 2013-2014 and the 2014-2015 Influenza seasons
when Influenza A/H3 and A/HIN1 pandemic were the predominant Influenza A viruses in circulation. When other
Influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria
recommended by public health authorities, specimens should be collected with appropriate infection control precautions
for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be
attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213822: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213822
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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