Cleared Traditional

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (K202215) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202215 · Roche Molecular Systems, Inc. · Microbiology device
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Sep 2020
Decision
27d
Days
Class 2
Risk

K202215 is an FDA 510(k) clearance for the cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit. Classified as Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna (product code QMI), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 2, 2020 after a review of 27 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K202215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2020
Decision Date September 02, 2020
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3183
Definition An In Vitro Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bkv) Dna In Human Samples Intended For Use As An Aid In The Management Of Bkv In Transplant Patients. In Patients Undergoing Monitoring Of Bkv, Serial Dna Measurements Can Be Used To Indicate The Need For Potential Treatment Changes And To Assess Viral Response To Treatment. Test Results Are Intended To Be Read And Analyzed By A Qualified Licensed Healthcare Professional In Conjunction With Clinical Signs And Symptoms And Relevant Laboratory Findings. Test Results Must Not Be The Sole Basis For Patient Management Decisions.
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.