Cleared Traditional

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

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

About This 510(k) Submission

K202215 is an FDA 510(k) clearance for the cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit, a Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna (Class II — Special Controls, product code QMI), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 2, 2020, 27 days after receiving the submission on August 6, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3183.

Submission Details

510(k) Number K202215 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code QMI — Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna
Device Class Class II — 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.