510(k) · Cleared
Clearedcobas liat SARS-CoV-2 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. · QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Cleared on Apr 11, 2025 as substantially equivalent to K223783 (Roche Molecular Systems, Inc., 2023) after a 165-day review. Its family tree reaches back 3 generations to 2023.
- Decided
- Apr 11, 2025
- Review
- 165 days
- Class
- Class II
- Product code
- QWR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN220039 (2023). No later device cites it as a predicate yet.
- Root · 3 generations backDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- 2 generations backK221925 ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 2023 · Recalled
- 1 generation backK223783 cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023
- This deviceK243346 cobas liat SARS-CoV-2 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 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023 | — |
| −2 | K221925 | ID Now Covid-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2023 | 2 |
| −1 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2023 | — |
| 0 (this device) | K243346 | cobas liat SARS-CoV-2 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 QWR? 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 QWR device
- #1 K221925 ID Now Covid-19 2.0score 9.8 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemSummary page 5…Clinical Specimens In Near-Patient Settings Product Codes QWR Predicate Devices cobas® SARS-CoV-2 for use on the cobas® Liat® System (K223783) Establishment Registration Roche Molecular Systems, Inc. (2243471)… | 2023 |
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 2 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All QWR devicesQWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QWR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWR
Too few QWR 510(k)s in any year since 2007 to give a median.
Recalls per year · QWR
No recall names QWR since 2007.
Adverse event reports per year · QWR
25in 2025
MAUDE reports naming product code QWR, 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 90 |
| 2025 | 1 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cobas liat SARS-CoV-2 v2 nucleic acid test is an automated real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals exhibiting signs and symptoms of respiratory tract infection (i.e., symptomatic). Additionally, this test is intended…
Read the full statement (236 words)
The cobas liat SARS-CoV-2 v2 nucleic acid test is an automated real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals exhibiting signs and symptoms of respiratory tract infection (i.e., symptomatic). Additionally, this test is intended to be used with nasal and nasopharyngeal swab specimens collected from individuals without signs and symptoms of COVID-19 (i.e., asymptomatic).
The cobas liat SARS-CoV-2 v2 nucleic acid test is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical and epidemiological information and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection.
Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out co-infection with other microorganisms. Negative results do not preclude SARS-CoV-2 infection. Negative results must be combined with clinical observations, patient history, and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
A negative result from an asymptomatic individual is presumptive. Additionally, a negative result obtained with a nasal or nasopharyngeal swab collected from an asymptomatic individual should be followed up by testing at least twice over three days with at least 48 hours between tests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243346: cobas liat SARS-CoV-2 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/K243346
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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