Cleared Dual Track

Nano-Check Influenza A+B Test

K252283 · Nano-Ditech Corporation · Microbiology

Jan 2026

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K252283 is an FDA 510(k) clearance for the Nano-Check Influenza A+B Test, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on January 15, 2026, 177 days after receiving the submission on July 22, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K252283 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2025
Decision Date	January 15, 2026
Days to Decision	177 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3328
Definition	An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.