Cleared Traditional

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT

K112125 · Meridian Bioscience, Inc. · Microbiology

Dec 2011

Decision

133d

Days

Class 1

Risk

About This 510(k) Submission

K112125 is an FDA 510(k) clearance for the ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 5, 2011, 133 days after receiving the submission on July 25, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K112125 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2011
Decision Date	December 05, 2011
Days to Decision	133 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.