Cleared Traditional

GenePOC GBS LB

K170557 · Genepoc, Inc. · Microbiology

May 2017

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K170557 is an FDA 510(k) clearance for the GenePOC GBS LB, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on May 25, 2017, 90 days after receiving the submission on February 24, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K170557 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2017
Decision Date	May 25, 2017
Days to Decision	90 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.