Nano-Check COVID-19 Antigen Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231187 FDA 510(k)
- FDA Product Code
- QVF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3982 FDA 510(k)
- Regulation Number
- 866.3982 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nano-Check COVID-19 Antigen Test is a simple point-of-care device designed for the direct detection of SARS-CoV-2 viral targets from clinical specimens in near-patient settings. It employs a lateral flow immunochromatographic assay to rapidly and qualitatively identify SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens.
This test is intended for use by medical professionals or operators and is CLIA-waived, enabling rapid results within 15 minutes. Supplied as 20 test cassettes per box (Catalog No.: ND-MD8147CW), it is intended for symptomatic individuals when testing begins within four days of symptom onset. The device is regulated under FDA 510(k) clearance (K231187) and falls under product code QVF, adhering to regulation 866.3982.
Frequently asked questions
What types of clinical specimens can the Nano-Check COVID-19 Antigen Test detect, and how quickly can results be obtained?
The Nano-Check COVID-19 Antigen Test is designed to detect SARS-CoV-2 nucleocapsid protein antigens specifically in anterior nasal swab specimens. Results are delivered within 15 minutes, making it ideal for rapid point-of-care testing in near-patient settings like clinics or emergency rooms.
Is this test suitable for use by non-laboratory personnel, and what are the recommended testing conditions?
Yes, the Nano-Check COVID-19 Antigen Test is CLIA-waived, meaning it can be performed by medical professionals or trained operators without needing a full clinical laboratory setting. It is intended for use with symptomatic individuals when testing begins within four days of symptom onset, ensuring timely detection of active infections.
How is the Nano-Check COVID-19 Antigen Test supplied, and what should I expect in a single box?
The test is supplied as 20 individual test cassettes per box, packaged under the catalog number ND-MD8147CW. Each cassette is designed for a single-use, one-step lateral flow assay, ensuring no cross-contamination between tests.
What regulatory pathway does the Nano-Check COVID-19 Antigen Test follow, and how does this affect its use?
The Nano-Check COVID-19 Antigen Test received FDA 510(k) clearance (K231187) under the Traditional review pathway, classified as a Class II device (device class 2) and regulated under 21 CFR 866.3982. This clearance confirms its compliance with U.S. safety and performance standards, allowing authorized use in clinical settings as described in the labeling.
Are there any specific storage requirements for the Nano-Check COVID-19 Antigen Test?
While the exact storage conditions are not detailed in the provided data, lateral flow antigen tests like this typically require protection from extreme temperatures, humidity, and direct sunlight. The manufacturer’s instructions (not provided here) should specify optimal storage, such as refrigeration or room temperature, to maintain test validity until the expiration date.
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 COVID-19 Antigen Test - Nano-Ditech Corporation, PDF Nano-Check COVID-19 Antigen Test, Nano-Check COVID-19 Antigen Test - Instructions for Use
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231187 | Class II | Active |
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Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA 510(k) K231187 24 fields · synced Sep 20, 2026