Cleared Traditional

Solana Strep Complete Assay

K162274 · Quidel Corporation · Microbiology

Oct 2016

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K162274 is an FDA 510(k) clearance for the Solana Strep Complete Assay, 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 October 25, 2016, 74 days after receiving the submission on August 12, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K162274 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2016
Decision Date	October 25, 2016
Days to Decision	74 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.