Device Information
Device Specifications
The Nano-Check COVID-19 Antigen Test uses lateral flow immunochromatography to detect SARS-CoV-2 nucleoproteins in nasal swab samples. It comes with cassettes, reagent tubes, swabs, and control swabs. After collecting a sample, users add two drops to the cassette, showing positive or negative results within 15 minutes. It is easy to use and ideal for point-of-care testing.
Indications
The Nano-Check COVID-19 Antigen Test aids in diagnosing symptomatic COVID-19. It should be used within four days of symptom onset. A molecular follow-up test is required for a confirmed negative result.
Intended Use
This test is intended for symptomatic patients as a rapid diagnostic tool. It is recommended for prescription use only. Health professionals or trained individuals can administer it.
Availability
- Prescription Use Only (Rx)
Limitations
- Specific Limitations:
- A negative result is presumptive and requires molecular confirmation.
- Positive results do not exclude other infections.
- Performance may vary with emerging SARS-CoV-2 variants.
Study Results
The Nano-Check™ COVID-19 Antigen Test was evaluated in a U.S. clinical study across four sites, involving 670 symptomatic subjects. The test achieved a Positive Percent Agreement (PPA) of 83.67% and a Negative Percent Agreement (NPA) of 99.62% compared to RT-PCR results.
Nonclinical and Safety Testing:
- High precision with 100% agreement for positive and negative samples.
- No cross-reactivity with common respiratory pathogens.
- Stability testing confirmed the reliability for all test components.
Regulatory Information
- Regulation Number: 21 CFR 866.3982
- Regulatory Class: Class II
- Product Code: QVF
- Applicable Regulations: The device must follow labeling, registration, and reporting guidelines under 21 CFR 801, 820, and 807.
Manufacturer Information
- Name: Nano-Ditech Corporation
- Address: 259 Prospect Plains Rd, Bldg K, Cranbury, NJ 08512, USA
- Contact Person: James Chang
Predicate Device Information
- Primary Predicate Device: Sofia 2 SARS Antigen+ FIA (DEN220039)
- Comparison: Both tests detect SARS-CoV-2 nucleoproteins using lateral flow immunoassays. The Nano-Check test requires visual interpretation, whereas Sofia 2 provides automated readings via an instrument.
Implications
This device enhances point-of-care COVID-19 testing by providing quick results. It can complement molecular tests for better patient management. Its usability in symptomatic settings aligns with the need for rapid diagnosis during pandemics.
References
- Nano-Check COVID-19 Antigen Test. K231187. Nano-Ditech Corporation. FDA Summary Link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231187
- https://www.nanoditech.com/
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