Acucy Influenza A&B Test with Acucy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182001 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 System is a rapid diagnostic device designed to detect influenza A and B antigens. It functions as an immunoassay for qualitative detection of viral antigens in nasal or nasopharyngeal swab samples, providing results within a short timeframe.
This device is intended for single-use in clinical settings, such as laboratories or point-of-care environments. Supplied as a test kit paired with a reader system, it requires no special storage conditions beyond standard laboratory practices. The device holds FDA 510(k) clearance under the classification of Class II medical devices, adhering to regulatory standards for diagnostic testing.
Frequently asked questions
What types of samples can the Acucy Influenza A&B Test detect, and how quickly are results available?
The Acucy Influenza A&B Test is designed to detect viral antigens in nasal or nasopharyngeal swab samples. It uses an immunoassay method to provide qualitative results, and the test is completed within a short timeframe, making it suitable for rapid diagnostic use in clinical settings like laboratories or point-of-care environments.
Is the Acucy Influenza A&B Test intended for single-use, and if so, what does this mean for clinical workflows?
Yes, the Acucy Influenza A&B Test is intended for single-use only. This means each test kit is designed to be used once per patient sample, ensuring sterility and reducing the risk of cross-contamination. Clinicians should plan their workflows accordingly, treating each test as disposable and discarding it after use.
What storage conditions are required for the Acucy Influenza A&B Test, and how should it be handled before use?
The Acucy Influenza A&B Test requires no special storage conditions beyond standard laboratory practices. This means it can be stored under typical environmental conditions (e.g., room temperature) until use, simplifying handling in clinical or point-of-care settings. Always follow manufacturer guidelines for proper storage and expiration checks.
How is the Acucy Influenza A&B Test supplied, and what components are included in the kit?
The Acucy Influenza A&B Test is supplied as a test kit paired with a reader system. The kit itself is designed for single-use testing, while the reader system is likely reusable for multiple tests. The exact contents of the kit (e.g., swabs, buffers, or test cartridges) are not detailed here, but the system is intended to be user-friendly for rapid, on-site diagnostic use.
What regulatory pathway was followed for FDA clearance of the Acucy Influenza A&B Test, and what does this mean for its use?
The Acucy Influenza A&B Test received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SESE) under the Dual Track process. This means the device was determined to be comparable to a legally marketed predicate device and adheres to Class II regulatory standards for diagnostic testing. Clinicians and buyers can rely on this clearance as evidence of the device’s compliance with U.S. safety and performance requirements.
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 Kit and System Reader - Vitality Medical, SEKISUI Diagnostics™ Acucy™ Influenza A and B Test Kit, INFLUENZA A&B TEST WITH THE ACUCY SYSTEM - Sekisui Diagnostics LLC ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182001 | Class II | Active |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA 510(k) K182001 24 fields · synced Sep 18, 2026