Cleared Traditional

Solana GBS Assay

K173250 · Quidel Corporation · Microbiology

Dec 2017

Decision

72d

Days

Class 1

Risk

About This 510(k) Submission

K173250 is an FDA 510(k) clearance for the Solana GBS Assay, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on December 21, 2017, 72 days after receiving the submission on October 10, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K173250 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2017
Decision Date	December 21, 2017
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3740
Definition	A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status.