Cleared Dual Track

LIAISON NES Group A Strep (K260333) - FDA 510(k) Clearance

Also marketed or referenced as:
LIAISON NES Group A Strep Control Swab Kit

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

K260333 · Diasorin Molecular, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
133d
Days
Class 2
Risk

K260333 is an FDA 510(k) clearance for the LIAISON NES Group A Strep. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on June 15, 2026 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2680 - 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 Diasorin Molecular, LLC devices

Submission Details

510(k) Number K260333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2026
Decision Date June 15, 2026
Days to Decision 133 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 102d · This submission: 133d
Pathway characteristics

Device Classification

Product Code PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2680
Definition An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.
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 - PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K260333.
Accula Strep A Test
K201269 · Mesa Biotech, Inc. · Nov 2020
GenePOC Strep A
K183366 · Genepoc, Inc. · Mar 2019
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · Alere Scarborough, Inc. · May 2018
Xpert Xpress Strep A
K173398 · Cepheid · Apr 2018