Not Cleared Direct

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (DEN200015) - FDA 510(k) Clearance

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

DEN200015 · Roche Molecular Systems, Inc. · Microbiology device
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Jul 2020
Decision
150d
Days
Class 2
Risk

DEN200015 is an FDA 510(k) submission (not cleared) for the cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit. Classified as Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna (product code QLX), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on July 30, 2020 after a review of 150 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3183 - 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 Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number DEN200015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 02, 2020
Decision Date July 30, 2020
Days to Decision 150 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 102d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3183
Definition A Quantitative Viral Nucleic Acid Test For Transplant Patient Management Is Identified As A Device Intended For Prescription Use In The Detection Of Viral Pathogens By Measurement Of Viral Deoxyribonucleic Acid (dna) Or Ribonucleic Acid (rna) Using Specified Specimen Processing, Amplification, And Detection Instrumentation. The Test Is Intended For Use As An Aid In The Management Of Transplant Patients With Active Viral Infection Or At Risk For Developing Viral Infections. The Test Results Are Intended To Be Interpreted By Qualified Healthcare Professionals In Conjunction With Other Relevant Clinical And Laboratory Findings.
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.

Regulatory Peers - QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna

Devices cleared under the same product code (QLX) and FDA review panel - the closest regulatory comparables to DEN200015.
Alinity m EBV (09N43-095)
K243489 · Abbott Molecular, Inc. · Jul 2025
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
K212778 · Abbott Molecular, Inc. · Jul 2022
cobas BKV
K203220 · Roche Molecular Systems, Inc. · Jan 2021