Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241240 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay is a Multi-Target Respiratory Specimen Nucleic Acid Test designed to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) from respiratory specimens. This fully automated, multiplex nucleic acid assay employs real-time reverse transcription polymerase chain reaction (RT-PCR) for nucleic acid extraction, amplification, and detection, enabling simultaneous identification of multiple respiratory pathogens in a single test.
The assay is intended for use in clinical microbiology laboratories and operates within a fully automated workflow, requiring only manual sample addition to the sample lysis tube (SLT). It is classified as a Class II device under FDA regulations (866.3981) and has received FDA 510(k) clearance as substantially equivalent. The system supports scalable, high-throughput testing and is designed for laboratory settings, with no specific sterility or single-use requirements noted beyond standard nucleic acid assay protocols.
Frequently asked questions
How many respiratory pathogens can the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay detect simultaneously, and what is the testing method used?
The Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay is designed to detect and differentiate four respiratory pathogens—SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV)—in a single test. It employs real-time reverse transcription polymerase chain reaction (RT-PCR) for nucleic acid extraction, amplification, and detection, enabling high-throughput, automated workflows in clinical microbiology laboratories.
Is this assay intended for use in point-of-care settings, or is it strictly for clinical microbiology laboratories?
The assay is explicitly intended for use in clinical microbiology laboratories only. It operates within a fully automated workflow requiring manual sample addition to a sample lysis tube (SLT), making it unsuitable for point-of-care or non-laboratory settings. The design emphasizes scalability and high-throughput capabilities for laboratory environments.
What is the regulatory pathway taken by the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, and what classification does it hold?
The assay received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). It is classified as a Class II device under FDA regulations (866.3981), reflecting its role as a Multi-Target Respiratory Specimen Nucleic Acid Test. The review was conducted by the Microbiology (MI) Advisory Committee.
Are there any specific sterility or single-use requirements for the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay components?
The device data does not specify sterility or single-use requirements beyond standard nucleic acid assay protocols. While the assay is fully automated and designed for laboratory use, the sample lysis tube (SLT) is the only manual component mentioned, implying typical laboratory handling practices apply. No explicit reuse or sterility claims are provided.
What types of respiratory specimens are compatible with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay?
The assay is designed for respiratory specimens, though the exact types (e.g., nasopharyngeal swabs, nasal swabs, oropharyngeal swabs, etc.) are not detailed in the provided data. It is intended for use in clinical microbiology laboratories to detect and differentiate SARS-CoV-2, influenza A/B, and RSV from such specimens via automated RT-PCR workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Panther Fusion SARS-CoV-2/Flu A/B/RSV | Hologic, Panther Fusion® SARS-CoV-2/Flu A/B/RSV | Hologic® Canada, PDF K222736 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241240 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K241240 24 fields · synced Oct 6, 2026