510(k) · Cleared
ClearedBioFire COVID-19 Test 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Defense, LLC · QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Cleared on Nov 1, 2021 as substantially equivalent to DEN200031 (Biofire Diagnostics, LLC, 2021) after a 203-day review. Its family tree reaches back 1 generation to 2021. 11 later devices descend from it.
- Decided
- Nov 1, 2021
- Review
- 203 days
- Class
- Class II
- Product code
- QQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200031 (2021). 11 later devices descend from it, 7 citing it directly.
- Root · 1 generation backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- This deviceK211079 BioFire COVID-19 Test 2Biofire Defense, LLC · 2021
- Descendant · cites it directly · 3 of its ownK213804 cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK230440 Xpert® Xpress CoV-2 plusCepheid® · 2023
- Descendant · 2 generations on · 1 of its ownK231306 cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800…Roche Molecular Systems, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK221460 BioFire COVID-19 Test 2Biofire Defense, LLC · 2022
- Descendant · cites it directly · 0 of its ownK243396 Aptima SARS-CoV-2 AssayHologic, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. · 2022 · cites it directly3descendants
- K230440Xpert® Xpress CoV-2 plusCepheid® · 2023 · cites it directly1descendant
- K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc. · 2023 · 2 generations on1descendant
- K221460BioFire COVID-19 Test 2Biofire Defense, LLC · 2022 · cites it directly1descendant
- K243396Aptima SARS-CoV-2 AssayHologic, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| 0 (this device) | K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 | — |
| +1 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2022 | — |
| +1 | K230440 | Xpert® Xpress CoV-2 plus | Cepheid® | 2023 | — |
| +2 | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2023 | — |
| +1 | K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022 | — |
| +1 | K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 K213804 cobas SARS-CoV-2 Qualitative for use on the…score 10.5 · 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 |
|---|---|---|---|
| * | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1)Summary page 4…gulation: 21 CFR 866.3981 Panel: Microbiology – 83 Product Code: QQX III. Predicate Device BioFire® Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC) [DEN200031] This predicate has not been subject to a design-related recall. IV. Device Description Severe acute respiratory syndro… | 2021 |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | 2022 | 3 |
| K230440 | Xpert® Xpress CoV-2 plus | 2023 | 1 |
| K221460 | BioFire COVID-19 Test 2 | 2022 | 1 |
| K243396 | Aptima SARS-CoV-2 Assay | 2025 | 0 |
| K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | 2024 | 0 |
| K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD… | 2023 | 0 |
| K212147 | Simplexa COVID-19 Direct | 2022 | 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?
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. 2021, 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?
The BioFire COVID-19 Test 2 is a qualitative nested multiplexed RT-PCR in vitro diagnostic test intended for use with the BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems. The BioFire COVID-19 Test 2 detects nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from symptomatic individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2…
Read the full statement (172 words)
The BioFire COVID-19 Test 2 is a qualitative nested multiplexed RT-PCR in vitro diagnostic test intended for use with the BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems. The BioFire COVID-19 Test 2 detects nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from symptomatic individuals suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in NPS specimens during the acute phase of infection. 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 co-infection with other pathogens.
Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. The BioFire COVID-19 Test 2 is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.
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/K211079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211079: BioFire COVID-19 Test 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211079
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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