Not Cleared Post-NSE

DEN120013 - PORTRAIT ANALYZER

DEN120013 is an FDA 510(k) submission for PORTRAIT ANALYZER, manufactured by Great Basin Scientific. The device is a Class 1 Microbiology device with product code OMN cleared through the Post-NSE 510(k) pathway after a 59-day FDA review.

DEN120013 · Great Basin Scientific · Microbiology device
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Apr 2012
Decision
59d
Days
Class 1
Risk

DEN120013 is an FDA 510(k) submission (not cleared) for the PORTRAIT ANALYZER. Classified as C. Difficile Nucleic Acid Amplification Test Assay (product code OMN), Class I - General Controls.

Submitted by Great Basin Scientific (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on April 30, 2012 after a review of 59 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

FDA 510(k) Submission Details - DEN120013

510(k) Number DEN120013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 02, 2012
Decision Date April 30, 2012
Days to Decision 59 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 102d · This submission: 59d
Pathway characteristics

OMN Device Classification - Class 1, General Controls

Product Code OMN C. Difficile Nucleic Acid Amplification Test Assay
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
Definition In Vitro Diagnostic Test For The Qualitative Detection Of Toxigenic Clostridium Difficile Nucleic Acids Isolated And Purified From Stool Specimens Obtained 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.

Regulatory Peers - OMN C. Difficile Nucleic Acid Amplification Test Assay

Devices cleared under the same product code (OMN) and FDA review panel - the closest regulatory comparables to DEN120013.
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433 · Focus Diagnostics, Inc. · Apr 2012
XPERT C. DIFFICLE/EPI ASSAY
K110203 · Cepheid · Apr 2011
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K110012 · Meridian Bioscience, Inc. · Feb 2011
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
K100818 · Meridian Bioscience, Inc. · Jul 2010
DEN120013 · PORTRAIT ANALYZER
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