Cleared Dual Track

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

K173653 · Alere Scarborough, Inc. · Microbiology

May 2018

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K173653 is an FDA 510(k) clearance for the Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on May 2, 2018, 155 days after receiving the submission on November 28, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K173653 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2017
Decision Date	May 02, 2018
Days to Decision	155 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.