510(k) · Cleared
Clearedcobas SARS-CoV-2 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. · QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Cleared on Dec 4, 2023 as substantially equivalent to K221925 (Abbott Diagnostics Scarborough, Inc., 2023) after a 353-day review. Its family tree reaches back 2 generations to 2023. 1 later device descends from it.
- Decided
- Dec 4, 2023
- Review
- 353 days
- Class
- Class II
- Product code
- QWR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN220039 (2023). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- 1 generation backK221925 ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 2023 · Recalled
- This deviceK223783 cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243346 cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023 | — |
| −1 | K221925 | ID Now Covid-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2023 | 2 |
| 0 (this device) | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2023 | — |
| +1 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K221925 | ID Now Covid-19 2.0 Cleared while this submission was under review Summary page 4…Clinical Specimens in Near-Patient Settings Regulation Number 21 CFR 866.3982 Predicate Devices ID NOW COVID-19 2.0 (K221925) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION The cobas® SARS-CoV-… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | 2025 | 0 |
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 0 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K243346 (Roche Molecular Systems, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221925.
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. 2023, 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 SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) is an automated, real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the rapid in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection…
Read the full statement (246 words)
The cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) is an automated, real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the rapid in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals with 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 suspected of COVID-19 (i.e., asymptomatic).
The cobas SARS-CoV-2 performed on the cobas Liat System is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal 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.
A negative result from an asymptomatic individual is presumptive. Additionally, a negative result obtained with a nasal swab collected from an asymptomatic patient should be followed up by testing at least twice over three days with at least 48 hours between tests.
Negative results do not preclude SARS-CoV-2 infection.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
This test is intended for prescription use only and can be used in Point-of-Care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223783: cobas SARS-CoV-2 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 4, 2026. https://510kreport.com/device/K223783
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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