Cleared Dual Track

K240280 - Nano-Check RSV Test

K240280 is an FDA 510(k) clearance for Nano-Check RSV Test, manufactured by Nano-Ditech Corporation. The device is a Class 1 Microbiology device with product code GQG cleared through the Dual Track 510(k) pathway after a 180-day FDA review.

K240280 · Nano-Ditech Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
180d
Days
Class 1
Risk

K240280 is an FDA 510(k) clearance for the Nano-Check™ RSV Test. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on July 30, 2024 after a review of 180 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - 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

FDA 510(k) Submission Details - K240280

510(k) Number K240280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date July 30, 2024
Days to Decision 180 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
78d slower than avg
Panel avg: 102d · This submission: 180d
Pathway characteristics

GQG Device Classification - Class 1, General Controls

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 25
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K240280.
Clungene RSV Antigen Rapid Test
K253318 · Hangzhou Clongene Biotech Co., Ltd. · Jan 2026
Sofia RSV FIA on Sofia 2 analyzer
K162911 · Quidel Corporation · Feb 2017
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · Becton, Dickinson & CO · Nov 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · Becton, Dickinson and Company · Nov 2013
SOFIA(R) RSV FIA
K130398 · Quidel Corp. · Aug 2013
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · Becton, Dickinson and Company · Sep 2012