Cleared Traditional

K172126 - Xpert Xpress Strep A

K172126 is an FDA 510(k) clearance for Xpert Xpress Strep A, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code PGX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K172126 · Cepheid · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
73d
Days
Class 2
Risk

K172126 is an FDA 510(k) clearance for the Xpert Xpress Strep A. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 25, 2017 after a review of 73 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 Cepheid devices

FDA 510(k) Submission Details - K172126

510(k) Number K172126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2017
Decision Date September 25, 2017
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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

All 8
Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K172126.
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
Solana Strep Complete Assay
K162274 · Quidel Corporation · Oct 2016
Solana GAS Assay, Solana instrument
K150868 · Quidel Corporation · Jun 2015
AMPLIVUE GAS ASSAY
K141173 · Quidel Corporation · Jul 2014