510(k) · Cleared
Recalled · Class II · 2024Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on May 16, 2023 as substantially equivalent to DEN200031 (Biofire Diagnostics, LLC, 2021) after a 249-day review. Its family tree reaches back 1 generation to 2021. 6 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2023
- Review
- 249 days
- Class
- Class II
- Product code
- QOF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200031 (2021). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- This deviceK222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252387 Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™…Diasorin Molecular, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK243400 cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243406 cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K241240Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2024 · cites it directly4descendants
- K242465Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc. · 2024 · 2 generations on1descendant
- K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV…Diasorin Molecular, LLC · 2025 · 3 generations on0descendants
- K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc. · 2025 · 2 generations on0descendants
- K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc. · 2025 · 2 generations on0descendants
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) | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023 | — |
| +1 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024 | — |
| +2 | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. | 2024 | — |
| +3 | K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu… | Diasorin Molecular, LLC | 2025 | — |
| +2 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
| +2 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 4 | 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 QOF? 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 QOF device
- #1 K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assayscore 17.0 · 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…OOI III. PREDICATE DEVICE The predicate device for the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is the BioFire Respiratory Panel 2.1 (BioFire RP2.1) Assay (DEN200031; granted March 17, 2021, BioFire Diagnostics, LLC). 510(k) Summary… | 2021 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2024 | Class II | Z-0694-2025 | Unknown/Undetermined by firm | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QOF devicesQOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QOF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QOF
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QOF
10in 2025
MAUDE reports naming product code QOF, 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 | 0 | — | 0 | 0 |
| 2023 | 7 | 238 | 1 | 6 |
| 2024 | 9 | 147 | 1 | 30 |
| 2025 | 13 | 178 | 1 | 10 |
| 2026 | 8 | 128 | 2 | — |
What is it indicated for?
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B) and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) specimens obtained from…
Read the full statement (340 words)
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B) and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B and RSV infections in humans and is not intended to detect influenza C virus infections.
Nucleic acids from the viral organisms identified by this test are generally detectable in NP specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.
The Hologic® RespDirect™ Collection Kit can be used to collect NP specimens for testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay. Additionally, other NP swabs (not provided with the Hologic RespDirect Collection Kit) may be used to collect NP specimens in 3mL of VTM or UTM.
The Hologic® RespDirect™ Collection Kit is intended to be used for the collection of nasopharyngeal (NP) swab specimens (collected by a healthcare provider) for testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222736 · printed Nov 3, 2026
Cite this page
510(k) Report. “K222736: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K222736
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