510(k) · Cleared
Clearedcobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Apr 25, 2025 as substantially equivalent to K241240 (Hologic, Inc., 2024) after a 176-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Apr 25, 2025
- Review
- 176 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 2 generations backK222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2023 · Recalled
- 1 generation backK241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2024
- This deviceK243400 cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −2 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023 | 1 |
| −1 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024 | — |
| 0 (this device) | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
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 QOF? 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 QOF device
- #1 K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assayscore 17.0 · 2 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 |
|---|---|---|---|
| * | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV AssaySummary page 5…Other Microbial Agents When In A Multi-Target Test Product Codes QOF Predicate Devices HOLOGIC Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay (K241240) Establishment Registration Roche Molecular Systems, Inc. (2243471)… | 2024 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K241240.
How does its category compare?
All QOF devicesQOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QOF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QOF
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QOF
10in 2025
MAUDE reports naming product code QOF, 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 | 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 7 | 238 | 1 | 6 |
| 2024 | 9 | 147 | 1 | 30 |
| 2025 | 13 | 178 | 1 | 10 |
| 2026 | 8 | 128 | 2 | — |
What is it indicated for?
The cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens from individuals exhibiting signs and…
Read the full statement (251 words)
The cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens from individuals exhibiting signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A and influenza B infections in humans and is not intended to detect influenza C virus infections.
Nucleic acids from the viral organisms identified by this test are generally detectable in nasopharyngeal and nasal swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus, and aid in diagnosis if used in conjunction with other clinical and epidemiological information and laboratory findings.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Positive results do not rule out coinfection with other organisms. The organism(s) detected by the cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus or influenza B virus infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243400: cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243400
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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