Acucy Influenza A&B Test with Acucy 2 System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241188 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 Acucy Influenza A&B Test with Acucy 2 System is a rapid chromatographic immunoassay designed for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens. It operates as a point-of-care diagnostic tool to assist in identifying respiratory infections caused by these viruses.
This device is intended for use with anterior nasal or nasopharyngeal swabs collected from symptomatic patients. Supplied as a single-use cassette, it requires the Acucy 2 Reader for result interpretation and is classified as a Class II medical device under FDA regulations (K241188, 510(k) clearance). No MRI safety or sterility specifications are noted in the provided data.
Frequently asked questions
What types of samples can be tested with the Acucy® Influenza A&B Test, and how should they be collected?
The Acucy® Influenza A&B Test is designed to detect influenza A and B viral antigens using anterior nasal or nasopharyngeal swabs collected from symptomatic patients. These swabs are the only specified sample types for this test, ensuring compatibility with the rapid chromatographic immunoassay format.
Is the Acucy® Influenza A&B Test intended for single-use, and what does that mean for clinical workflows?
Yes, the Acucy® Influenza A&B Test is supplied as a single-use cassette, meaning each test is intended for one patient sample only. This design ensures sterility and accuracy per use, requiring clinicians to use a new cassette for each patient swab. The Acucy 2 Reader is reusable and required for result interpretation.
How does the Acucy® Influenza A&B Test differ from other rapid influenza tests in terms of its regulatory pathway?
The Acucy® Influenza A&B Test follows a dual-track 510(k) clearance pathway under the FDA, classified as a Class II medical device (product code PSZ) for detecting influenza A and B antigens. It was determined substantially equivalent to predicate devices in the same category, streamlining its regulatory approval process.
What is the role of the Acucy® 2 System in this diagnostic workflow, and is it included in the test kit?
The Acucy® 2 System includes the Acucy 2 Reader, which is not part of the single-use cassette but is required to interpret test results. The reader processes the cassette’s chromatographic output to provide a definitive qualitative readout for influenza A or B detection, ensuring accurate point-of-care diagnosis.
Are there any special storage requirements for the Acucy® Influenza A&B Test cassettes before use?
While the provided data does not specify exact storage conditions (e.g., temperature or humidity), the test is designed as a single-use cassette, implying it should be stored according to standard rapid diagnostic assay guidelines—typically at room temperature (15–30°C) and protected from moisture or extreme conditions until use. Always refer to the included instructions for use for precise storage instructions.
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: Acucy® Influenza A&B Test with the Acucy® 2 System (K241188) — FDA 510 ..., INFLUENZA A&B TEST WITH THE ACUCY SYSTEM - Sekisui Diagnostics LLC ..., SEKISUI Diagnostics™ Acucy™ Influenza A and B Test Kit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241188 | Class II | Active |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA 510(k) K241188 24 fields · synced Oct 6, 2026