K223783 is an FDA 510(k) clearance for the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System. This device is classified as a Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings (Class II - Special Controls, product code QWR).
Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 4, 2023, 353 days after receiving the submission on December 16, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3982. A Simple Point-of-care Device To Detect Sars-cov-2 Nucleic Acid Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections (covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory..
| 510(k) Number | K223783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2022 |
| Decision Date | December 04, 2023 |
| Days to Decision | 353 days |
| Submission Type | Dual Track |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QWR — Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3982 |
| Definition | A Simple Point-of-care Device To Detect Sars-cov-2 Nucleic Acid Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections (covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory. |