Cleared Traditional

Solana GAS Assay, Solana instrument

K150868 · Quidel Corporation · Microbiology

Jun 2015

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K150868 is an FDA 510(k) clearance for the Solana GAS Assay, Solana instrument, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on June 23, 2015, 83 days after receiving the submission on April 1, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K150868 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2015
Decision Date	June 23, 2015
Days to Decision	83 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.