Cleared Traditional

K113731 - ESENSOR RESPIRATORY VIRAL PANEL (FDA 510(k) Clearance)

Class I Microbiology device.

K113731 · Clinical Micro Sensors, Inc. · Microbiology device
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Sep 2012
Decision
266d
Days
Class 1
Risk

K113731 is an FDA 510(k) clearance for the ESENSOR RESPIRATORY VIRAL PANEL. Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by Clinical Micro Sensors, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 10, 2012 after a review of 266 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2310 - 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 Clinical Micro Sensors, Inc. devices

Submission Details

510(k) Number K113731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date September 10, 2012
Days to Decision 266 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
164d slower than avg
Panel avg: 102d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJH Clinical Sample Concentrator
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2310
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.