Not Cleared Post-NSE

DEN120012 - CDC DENV-1-4 REAL TIME RT-PCT ASSAY (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN120012 · Centers For Disease Control and Prevention · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
73d
Days
Class 2
Risk

DEN120012 is an FDA 510(k) submission (not cleared) for the CDC DENV-1-4 REAL TIME RT-PCT ASSAY. Classified as Dengue Nucleic Acid Amplification Assay (naat) (product code OZB), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on May 24, 2012 after a review of 73 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3946 - 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.

View all Centers For Disease Control and Prevention devices

Submission Details

510(k) Number DEN120012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 12, 2012
Decision Date May 24, 2012
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics

Device Classification

Product Code OZB Dengue Nucleic Acid Amplification Assay (naat)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3946
Definition A Qualitative In Vitro Diagnostic Assay For The Detection Of Dengue Virus Serotypes 1, 2, 3 Or 4 In Serum Or Plasma Specimens Collected From Human Patients With Signs And Symptoms Consistent With Dengue (mild Or Severe).
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.