Not Cleared Direct

DEN160003 - Quantidex qPCR BCR-ABL IS Kit (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160003 · Asuragen, Inc. · Medical Genetics device
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Jul 2016
Decision
185d
Days
Class 2
Risk

DEN160003 is an FDA 510(k) submission (not cleared) for the Quantidex qPCR BCR-ABL IS Kit. Classified as Bcr/abl1 Monitoring Test (product code OYX), Class II - Special Controls.

Submitted by Asuragen, Inc. (Austin, US). The FDA issued a Not Cleared (DENG) decision on July 22, 2016 after a review of 185 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6060 - the FDA medical genetics 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 Medical Genetics review framework.

View all Asuragen, Inc. devices

Submission Details

510(k) Number DEN160003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 19, 2016
Decision Date July 22, 2016
Days to Decision 185 days
Submission Type Direct
Review Panel Medical Genetics (MG)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d faster than avg
Panel avg: 399d · This submission: 185d
Pathway characteristics

Device Classification

Product Code OYX Bcr/abl1 Monitoring Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6060
Definition A Bcr/abl1 Monitoring Test Is A Quantitative In Vitro Diagnostic Device Used To Monitor The Bcr/abl1 To Abl1 Ratio By Reverse-transcriptase Quantitative Polymerase Chain Reaction (rq-pcr) On Whole Blood Or Bone Marrow Of Diagnosed Philadelphia Chromosome Positive (ph+) Chronic Myeloid Leukemia (cml) Patients Expressing Bcr-abl1 Fusion Transcripts Such As E13a2 And/or E14a2. It Is Intended For Use During Monitoring Of Treatment Response By Reporting Results On The International Scale (%is) And As Log Molecular Reduction (mr) Value.
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 Medical Genetics devices follow this clearance model.