Cleared Dual Track

K243561 - Nano-Check Influenza+COVID-19 Dual Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K243561 · Nano-Ditech Corporation · Microbiology device
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Jun 2025
Decision
211d
Days
Class 2
Risk

K243561 is an FDA 510(k) clearance for the Nano-Check Influenza+COVID-19 Dual Test. Classified as Multi-analyte Respiratory Virus Antigen Detection Test (product code SCA), Class II - Special Controls.

Submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on June 17, 2025 after a review of 211 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3987 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nano-Ditech Corporation devices

Submission Details

510(k) Number K243561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2024
Decision Date June 17, 2025
Days to Decision 211 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 102d · This submission: 211d
Pathway characteristics

Device Classification

Product Code SCA Multi-analyte Respiratory Virus Antigen Detection Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3987
Definition A Multi-analyte Respiratory Virus Antigen Detection Test Is An In Vitro Diagnostic Device Intended For The Detection And/or Differentiation Of Respiratory Viruses Directly From Respiratory Clinical Specimens. The Device Is Intended To Be Performed At The Site Of Sample Collection, Does Not Involve Sample Storage And/or Transport.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - SCA Multi-analyte Respiratory Virus Antigen Detection Test

All 10
Devices cleared under the same product code (SCA) and FDA review panel - the closest regulatory comparables to K243561.
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