Cleared Traditional

ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM

K121044 · Meridian Bioscience, Inc. · Microbiology

May 2012

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K121044 is an FDA 510(k) clearance for the ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM, 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 May 1, 2012, 25 days after receiving the submission on April 6, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K121044 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2012
Decision Date	May 01, 2012
Days to Decision	25 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.