Nano-Check Influenza A+B Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252283 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 Nano-Check Influenza A+B Test is a rapid immuno-diagnostic device designed for the qualitative detection of influenza A and B nucleoprotein antigens. It functions as a lateral flow immuno-chromatographic assay, enabling point-of-care testing to identify viral antigens directly from anterior nasal swabs.
This device is intended for use in CLIA-waived or point-of-care testing sites and provides results within 15 minutes. Supplied as a single-use test, it requires no special storage conditions beyond those specified in the package insert. The Nano-Check Influenza A+B Test holds FDA 510(k) clearance (K252283) and CLIA waiver (CW250012), ensuring compliance with regulatory requirements for in vitro diagnostic use.
Frequently asked questions
What types of samples can the Nano-Check Influenza A+B Test detect, and how quickly can results be obtained?
The Nano-Check Influenza A+B Test is designed to detect influenza A and B nucleoprotein antigens directly from anterior nasal swabs. Results are available within 15 minutes, making it ideal for point-of-care or CLIA-waived settings where rapid diagnosis is critical.
Is the Nano-Check Influenza A+B Test intended for single-use, and if so, are there any special storage requirements?
Yes, the Nano-Check Influenza A+B Test is a single-use device, meaning each test cassette is meant for one use only. Storage does not require special conditions beyond those outlined in the package insert, ensuring convenience for healthcare providers.
How does the regulatory pathway for this device ensure its reliability and compliance for clinical use?
The Nano-Check Influenza A+B Test holds FDA 510(k) clearance (K252283) and a CLIA waiver (CW250012), confirming it meets regulatory standards for in vitro diagnostic use. The clearance was granted under the Microbiology advisory committee and classified as substantially equivalent, ensuring its safety, effectiveness, and compliance for point-of-care influenza testing.
What is the primary use case for the Nano-Check Influenza A+B Test in clinical settings?
The device is intended for qualitative detection of influenza A and B antigens in CLIA-waived or point-of-care testing environments, such as urgent care clinics, physician offices, or emergency departments. Its rapid lateral flow immuno-chromatographic assay design enables quick, on-site diagnosis without requiring specialized laboratory infrastructure.
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: Nano-CheckTM Influenza A+B Test - Nano-Ditech Corporation, Nano-CheckTM Influenza A+B Test - Nano-Ditech Corporation, Nano-Check Influenza A+B Test - BioCosm, Nano-Check Influenza A+B Test (K252283) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252283 | Class II | Active |
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Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA 510(k) K252283 24 fields · synced Sep 18, 2026