Cleared Traditional

K113731 - ESENSOR RESPIRATORY VIRAL PANEL

K113731 is an FDA 510(k) clearance for ESENSOR RESPIRATORY VIRAL PANEL, manufactured by Clinical Micro Sensors, Inc.. The device is a Class 1 Microbiology device with product code JJH cleared through the Traditional 510(k) pathway after a 266-day FDA review.

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

FDA 510(k) Submission Details - K113731

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 102d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

JJH Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJH Clinical Sample Concentrator

All 9
Devices cleared under the same product code (JJH) and FDA review panel - the closest regulatory comparables to K113731.
VIVASPIN 4 10,000 MW
K960298 · Vivascience, Inc. · Mar 1996
ULTRAFREE-CL
K941326 · Millipore Corp. · May 1994
CENTRICON -50 CONCENTRATOR
K930168 · Amicon, Inc. · Aug 1993
CENTRICON CONCENTRATOR
K893733 · Amicon, Inc. · Jul 1989
CENTRIPREP CONCENTRATOR
K870690 · Amicon, Inc. · Mar 1987
DUPONT PREP FOUR-SOLVENT RETROFIT KIT
K851393 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1985