Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
FDA 510(k) K242465 · Hologic, Inc.
Submission
- Device name
- Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- August 20, 2024
- Decision date
- November 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from…
Other 510(k)s with product code QOF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261837 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Traditional | Baebies, Inc. | 09/11/2026SE |
| K252932 | Fast PCR Mini Respiratory PanelQOF · Dual Track | Autonomous Medical Devices Incorporated | 06/12/2026SE |
| K252269 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Dual Track | Baebies, Inc. | 03/30/2026SE |
| K251742 | VELO Respiratory TestQOF · Dual Track | Lex Diagnostics Limited | 02/13/2026SE |
| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | Diasorin Molecular, LLC | 12/23/2025SE |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional | Diasorin Molecular, LLC | 10/30/2025SE |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional | QIAGEN GmbH | 08/27/2025SE |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | Biofire Diagnostics, LLC | 08/14/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | Roche Molecular Systems, Inc. | 07/31/2025SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | Cepheid® | 05/01/2025SE |
More from Cepheid®
| 510(k) | Device | Decision |
|---|---|---|
| K254090 | I-View®MUE · Traditional | 09/02/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | 08/12/2026SE |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | 06/17/2026SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K243341 | Genius AI Detection 2.0QDQ · Traditional | 07/31/2025SE |
| K243396 | Aptima SARS-CoV-2 AssayQQX · Traditional | 02/13/2025SE |
| K243935 | Aptima CMV Quant AssayPAB · Special | 01/17/2025SE |
| K243345 | Aptima BV Assay; Aptima CV/TV AssayPQA · Special | 11/25/2024SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | 07/25/2024SE |
Questions and answers
When was Panther Fusion SARS-CoV-2/Flu A/B/RSV assay cleared by the FDA?
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) received a 510(k) decision of Substantially Equivalent on November 15, 2024, 87 days after the submission was received.
What is the product code of K242465?
The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.