Cleared Traditional

K071101 - TRU RSV

K071101 is an FDA 510(k) clearance for TRU RSV, manufactured by Meridian Bioscience, Inc.. The device is a Class 1 Microbiology device with product code GOG cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K071101 · Meridian Bioscience, Inc. · Microbiology device
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Oct 2007
Decision
182d
Days
Class 1
Risk

K071101 is an FDA 510(k) clearance for the TRU RSV. Classified as Antisera, Cf, Poliovirus 1-3 (product code GOG), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 18, 2007 after a review of 182 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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

FDA 510(k) Submission Details - K071101

510(k) Number K071101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2007
Decision Date October 18, 2007
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

GOG Device Classification - Class 1, General Controls

Product Code GOG Antisera, Cf, Poliovirus 1-3
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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.