K202215 is an FDA 510(k) clearance for the cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3183. 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..
| 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 |
| 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. |