Not Cleared Post-NSE

DEN120014 - VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

DEN120014 is an FDA 510(k) submission for VERIGENE GRAM POSITIVE BLOOD CULTURE ..., manufactured by Nanosphere, Inc.. The device is a Class 2 Microbiology device with product code PAM cleared through the Post-NSE 510(k) pathway after a 11-day FDA review.

DEN120014 · Nanosphere, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
11d
Days
Class 2
Risk

DEN120014 is an FDA 510(k) submission (not cleared) for the VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP). Classified as Gram-positive Bacteria And Their Resistance Markers (product code PAM), Class II - Special Controls.

Submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Not Cleared (DENG) decision on June 26, 2012 after a review of 11 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3365 - 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 - DEN120014

510(k) Number DEN120014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 15, 2012
Decision Date June 26, 2012
Days to Decision 11 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
91d faster than avg
Panel avg: 102d · This submission: 11d
Pathway characteristics

PAM Device Classification - Class 2, Special Controls

Product Code PAM Gram-positive Bacteria And Their Resistance Markers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3365
Definition A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

DEN120014 · VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
Download PDF Nanosphere, Inc.