510(k) · Cleared
Clearedcobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Cleared on Feb 11, 2025 as substantially equivalent to K231306 (Roche Molecular Systems, Inc., 2023) after a 319-day review. Its family tree reaches back 4 generations to 2021.
- Decided
- Feb 11, 2025
- Review
- 319 days
- Class
- Class II
- Product code
- QQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 4 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 3 generations backK211079 BioFire COVID-19 Test 2Biofire Defense, LLC · 2021
- 2 generations backK213804 cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. · 2022
- 1 generation backK231306 cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800…Roche Molecular Systems, Inc. · 2023
- This deviceK240867 cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800…Roche Molecular Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −3 | K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 | — |
| −2 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2022 | — |
| −1 | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2023 | — |
| 0 (this device) | K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | 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 QQX? 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 QQX device
- #1 K211079 BioFire COVID-19 Test 2score 23.3 · 1 generation · 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 |
|---|---|---|---|
| * | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsSummary page 5…21 CFR 866.3981 cobas® SARS-CoV-2 Qualitative for use on cobas® 5800/6800/8800 Systems Predicate Devices (K231306) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION cobas® SARS-CoV-2 Qual… | 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 4 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QQX devicesQQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QQX
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQX
180in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QQX
No recall names QQX since 2007.
Adverse event reports per year · QQX
1in 2022
MAUDE reports naming product code QQX, 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 | 3 | 320 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 180 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
cobas® SARS-CoV-2 Qualitative for use on the cobas®5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals with signs and symptoms of COVID-19 and in anterior nasal swab specimens collected from any individuals with or without signs and symptoms of COVID-19. Positive results are indicative of the presence of SARS-CoV-2 RNA.…
Read the full statement (130 words)
cobas® SARS-CoV-2 Qualitative for use on the cobas®5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals with signs and symptoms of COVID-19 and in anterior nasal swab specimens collected from any individuals with or without signs and symptoms of COVID-19.
Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other pathogens.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures, epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240867: cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240867
Report an extraction error
Are you the manufacturer?
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