Cleared Traditional

ARIES GBS Assay

K162772 · Luminex Corporation · Microbiology

Dec 2016

Decision

81d

Days

Class 1

Risk

About This 510(k) Submission

K162772 is an FDA 510(k) clearance for the ARIES GBS Assay, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on December 23, 2016, 81 days after receiving the submission on October 3, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K162772 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 2016
Decision Date	December 23, 2016
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

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.