Cleared Traditional

Panther Fusion GBS Assay

K181156 · Diagenode · Microbiology

Jul 2018

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K181156 is an FDA 510(k) clearance for the Panther Fusion GBS Assay, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Diagenode (Seraing, BE). The FDA issued a Cleared decision on July 27, 2018, 87 days after receiving the submission on May 1, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K181156 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2018
Decision Date	July 27, 2018
Days to Decision	87 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.