Cleared Dual Track

Xpert Xpress Strep A

K173398 · Cepheid · Microbiology

Apr 2018

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K173398 is an FDA 510(k) clearance for the Xpert Xpress Strep A, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 26, 2018, 177 days after receiving the submission on October 31, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K173398 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2017
Decision Date	April 26, 2018
Days to Decision	177 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PGX — Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class	Class II — 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.