Cleared Traditional

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

K143651 · Focus Diagnostics, Inc. · Microbiology

Mar 2015

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K143651 is an FDA 510(k) clearance for the Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on March 18, 2015, 85 days after receiving the submission on December 23, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K143651 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2014
Decision Date	March 18, 2015
Days to Decision	85 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.