Cleared Traditional

K172402 - ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

K172402 is an FDA 510(k) clearance for ARIES Group A Strep Assay, manufactured by Luminex Corporation. The device is a Class 2 Microbiology device with product code PGX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K172402 · Luminex Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
82d
Days
Class 2
Risk

K172402 is an FDA 510(k) clearance for the ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on October 30, 2017 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Luminex Corporation devices

FDA 510(k) Submission Details - K172402

510(k) Number K172402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2017
Decision Date October 30, 2017
Days to Decision 82 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 102d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

PGX Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03037957 Completed Observational Industry-sponsored

A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

704
Patients (actual)
5
Sites
Condition studied Pharyngitis Bacterial
Eligibility All sexes
Principal investigator Ronald Dunn
Sponsor Luminex Corporation (industry)
Started 2017-01-09 → Primary completion 2017-06-02
Primary outcome
Clinical performance (sensitivity/specificity) for Group A Strep Assay
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

All 14
Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K172402.
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
Xpert Xpress Strep A
K172126 · Cepheid · Sep 2017
Solana Strep Complete Assay
K162274 · Quidel Corporation · Oct 2016
Solana GAS Assay, Solana instrument
K150868 · Quidel Corporation · Jun 2015