Cleared Traditional

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS (K122019) - FDA 510(k) Clearance

Class I Microbiology device.

K122019 · Meridian Bioscience, Inc. · Microbiology device
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Sep 2012
Decision
65d
Days
Class 1
Risk

K122019 is an FDA 510(k) clearance for the STREPTOCOCCUS APP. SEROLOGICAL REAGENTS. Classified as Group A Streptococcus Nucleic Acid Amplification Assay System (product code OYZ), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 65 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 K122019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2012
Decision Date September 13, 2012
Days to Decision 65 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
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OYZ Group A Streptococcus Nucleic Acid Amplification Assay System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
Definition An In Vitro Diagnostic Test For The Detection Of Streptococcuc Pyogenes (group A Beta Hemolytic Streptococcus) In Throat Swab Specimens From Symptomatic Patients.
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.