Cleared Traditional

NeuMoDx GBS Assay

K173725 · Neumodx Molecular, Inc. · Microbiology

Jun 2018

Decision

203d

Days

Class 1

Risk

About This 510(k) Submission

K173725 is an FDA 510(k) clearance for the NeuMoDx GBS Assay, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Neumodx Molecular, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 26, 2018, 203 days after receiving the submission on December 5, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K173725 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2017
Decision Date	June 26, 2018
Days to Decision	203 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.