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 Jul 25, 2022 as substantially equivalent to K211079 (Biofire Defense, LLC, 2021) after a 67-day review. Its family tree reaches back 2 generations to 2021. 1 later device descends from it.
- Decided
- Jul 25, 2022
- Review
- 67 days
- Class
- Class II
- Product code
- QQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200031 (2021). 1 later device descends from it, 1 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 deviceK221460 BioFire COVID-19 Test 2Biofire Defense, LLC · 2022
- Descendant · cites it directly · 0 of its ownK230956 BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral…Bd Integrated Diagnostic Solutions / · 2023
Most influential descendants
Showing 1 of 1 · See all- K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD…Bd Integrated Diagnostic Solutions / · 2023 · 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) | K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022 | — |
| +1 | K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2… | Bd Integrated Diagnostic Solutions / | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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…-CoV-2 Test Product Code: QQX Regulatory Class: Class II (Special Controls) Panel: Microbiology III. Predicate Device BioFire® COVID-19 Test 2 (BioFire Defense, LLC) (K211079) This predicate has not been subject to a design-related recall. IV. Device Description The BioFire COVID-19 Test 2 is a mult… | 2021 |
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 |
|---|---|---|---|
| K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD… | 2023 | 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 1 year and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230956 (Bd Integrated Diagnostic Solutions /, 2023) has gone furthest, with 0 descendants 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?
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 (177 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.
For In Vitro Diagnostic Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221460: 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/K221460
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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