Cleared Traditional

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT (K112125) - FDA 510(k) Clearance

Class I Microbiology device.

K112125 · Meridian Bioscience, Inc. · Microbiology device
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Dec 2011
Decision
133d
Days
Class 1
Risk

K112125 is an FDA 510(k) clearance for the ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT. 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 December 5, 2011 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K112125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 102d · This submission: 133d
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

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