Cleared Dual Track

Nano-Check Influenza+COVID-19 Dual Test

K243561 · Nano-Ditech Corporation · Microbiology

Jun 2025

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K243561 is an FDA 510(k) clearance for the Nano-Check Influenza+COVID-19 Dual Test, a Multi-analyte Respiratory Virus Antigen Detection Test (Class II — Special Controls, product code SCA), submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on June 17, 2025, 211 days after receiving the submission on November 18, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3987.

Submission Details

510(k) Number	K243561 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	SCA — Multi-analyte Respiratory Virus Antigen Detection Test
Device Class	Class II — 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.