Cleared Traditional

K121044 - ILLUMIGENE GROUP B STREPTOCOCCUS CARROT...

K121044 is the FDA 510(k) clearance for ILLUMIGENE GROUP B STREPTOCOCCUS CARROT... by Meridian Bioscience, Inc.. It is a Class 1 Microbiology device (product code NJR) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K121044 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
25d
Days
Class 1
Risk

K121044 is an FDA 510(k) clearance for the ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K121044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

All 9
Devices cleared under the same product code (NJR) and FDA review panel - the closest regulatory comparables to K121044.
Panther Fusion GBS Assay
K181156 · Diagenode · Jul 2018
NeuMoDx GBS Assay
K173725 · Neumodx Molecular, Inc. · Jun 2018
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
K121539 · Cepheid · Nov 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · Becton, Dickinson & CO · Feb 2012
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
K062948 · Cepheid · Dec 2006
XPERT, GENEXPERT DX SYSTEM
K060540 · Cepheid · Jul 2006