Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162642 FDA 510(k)
- FDA Product Code
- PSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3328 FDA 510(k)
- Regulation Number
- 866.3328 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay designed for the qualitative detection of influenza A and B nucleoprotein antigens. This rapid diagnostic test is intended for use with nasopharyngeal swab, nasal swab, or nasal wash/aspirate specimens to differentiate between influenza A and B infections. The device provides a visual result within minutes, aiding in the rapid diagnosis of influenza virus infections. It operates as a point-of-care diagnostic tool, suitable for clinical settings requiring immediate patient assessment.
The Alere BinaxNOW Influenza A & B Card 2 is supplied as a single-use, non-sterile device intended for use in laboratory or point-of-care settings. It requires the Alere Reader for result interpretation and is accompanied by a control swab kit for quality assurance. The device is classified under FDA 510(k) clearance (K162642) and falls under the regulatory category of Devices Detecting Influenza A, B, and C Virus Antigens (PSZ). Storage and handling follow standard point-of-care diagnostic protocols, ensuring proper chain of custody and test validity.
Frequently asked questions
What is the Alere BinaxNOW Influenza A & B Card 2 used for?
The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay designed for the qualitative detection of influenza A and B nucleoprotein antigens. It is intended for use with nasopharyngeal swab, nasal swab, or nasal wash/aspirate specimens to differentiate between influenza A and B infections. This rapid diagnostic test provides a visual result within minutes, making it ideal for point-of-care settings where immediate patient assessment is required.
How is the Alere BinaxNOW Influenza A & B Card 2 supplied and what does the package include?
The Alere BinaxNOW Influenza A & B Card 2 is supplied as a single-use, non-sterile device. Each package includes the test card itself and is intended to be used alongside the Alere Reader for accurate result interpretation. Additionally, the Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit is provided for quality assurance, ensuring the reliability of the test results.
Is the Alere BinaxNOW Influenza A & B Card 2 sterile?
No, the Alere BinaxNOW Influenza A & B Card 2 is explicitly labeled as a non-sterile device. This classification is standard for many point-of-care diagnostic tests, as sterility is not required for single-use devices intended for immediate use in controlled clinical settings. Proper handling and adherence to standard point-of-care diagnostic protocols are recommended to maintain test validity.
Can the Alere BinaxNOW Influenza A & B Card 2 be reused?
No, the Alere BinaxNOW Influenza A & B Card 2 is designed for single-use only. Each card is intended for one test procedure, after which it should be discarded. Reusing the device could compromise test accuracy and introduce contamination risks, which is why it is explicitly labeled as a single-use item.
What regulatory pathway does the Alere BinaxNOW Influenza A & B Card 2 follow?
The Alere BinaxNOW Influenza A & B Card 2 has received FDA 510(k) clearance under the classification of Devices Detecting Influenza A, B, and C Virus Antigens (PSZ). The device was determined to be substantially equivalent to a predicate device through a traditional review process by the FDA’s Microbiology Advisory Committee. This clearance ensures the device meets regulatory standards for safety and effectiveness.
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: BinaxNOW Influenza A&B Card 2 | Abbott Point of Care, Alere BinaxNOW® Influenza A & B Cards - CLIAwaived Inc., BinaxNOW™ Influenza A&B Card - Abbott Point of Care
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162642 | Class II | Active |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA 510(k) K162642 24 fields · synced Oct 5, 2026