Not Cleared Post-NSE

DEN080007 - ALLOMAP MOLECULAR EXPRESSION TESTING (FDA 510(k) Clearance)

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

DEN080007 · Xdx · Chemistry device
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Aug 2008
Decision
11d
Days
Class 2
Risk

DEN080007 is an FDA 510(k) submission (not cleared) for the ALLOMAP MOLECULAR EXPRESSION TESTING. Classified as Cardiac Allograft Gene Expression Profiling Test System (product code OJQ), Class II - Special Controls.

Submitted by Xdx (Brisbane, US). The FDA issued a Not Cleared (DENG) decision on August 26, 2008 after a review of 11 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1163 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework.

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Submission Details

510(k) Number DEN080007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 15, 2008
Decision Date August 26, 2008
Days to Decision 11 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics

Device Classification

Product Code OJQ Cardiac Allograft Gene Expression Profiling Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1163
Definition In Vitro Diagnostic Multivariate Index Assay (ivdmia) Test Service, Performed In A Single Laboratory, For Assessing The Gene Expression Profile Of Rna Isolated From Peripheral Blood Mononuclear Cells (pbmc) And Indicated For Use To Aid In The Identification Of Heart Transplant Recipients With Stable Allograft Function Who Have A Low Probability Of Moderate/severe Acute Cellular Rejection (acr) At The Time Of Testing In Conjunction With Standard Clinical Assessment.
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 Chemistry devices follow this clearance model.