Cleared Traditional

Xpert Xpress Strep A

K172126 · Cepheid · Microbiology

Sep 2017

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K172126 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 September 25, 2017, 73 days after receiving the submission on July 14, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K172126 FDA.gov
FDA Decision	Cleared 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

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.