510(k) · Cleared
Clearedcobas SARS-CoV-2 Qualitative for use on the cobas 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 Oct 22, 2022 as substantially equivalent to K211079 (Biofire Defense, LLC, 2021) after a 320-day review. Its family tree reaches back 2 generations to 2021. 3 later devices descend from it.
- Decided
- Oct 22, 2022
- Review
- 320 days
- Class
- Class II
- Product code
- QQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200031 (2021). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 1 generation backK211079 BioFire COVID-19 Test 2Biofire Defense, LLC · 2021
- This deviceK213804 cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231306 cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800…Roche Molecular Systems, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK240867 cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800…Roche Molecular Systems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241580 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL…Abbott Molecular · 2024
Most influential descendants
Showing 3 of 3 · See all- K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc. · 2023 · cites it directly1descendant
- K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc. · 2025 · 2 generations on0descendants
- K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −1 | K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 | — |
| 0 (this device) | 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 | — |
| +2 | K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025 | — |
| +1 | K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit… | Abbott Molecular | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K211079 | BioFire COVID-19 Test 2Summary page 4…microbial agents when in a multi-target test Product Codes 21 CFR 866.3981 Predicate Devices BioFire COVID-19 Test 2 (K211079) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION cobas SARS-CoV-2 Qualitat… | 2021 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 year and passes through 3 companies; a new generation was cleared every 12 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231306 (Roche Molecular Systems, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K211079.
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. 2022, 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 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider. Results are for the detection of SARS-CoV-2 RNA. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and…
Read the full statement (171 words)
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider.
Results are for the detection of SARS-CoV-2 RNA. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. 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 and epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. cobas SARS-CoV-2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas 6800/8800 Systems.
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/K213804 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213804: cobas SARS-CoV-2 Qualitative for use on the cobas 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/K213804
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