Cleared Traditional

cobas BKV

K203220 · Roche Molecular Systems, Inc. · Microbiology
Jan 2021
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K203220 is an FDA 510(k) clearance for the cobas BKV, a Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna (Class II — Special Controls, product code QLX), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 29, 2021, 88 days after receiving the submission on November 2, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3183.

Submission Details

510(k) Number K203220 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2020
Decision Date January 29, 2021
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QLX — Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Device Class Class II — 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.