K221925 is an FDA 510(k) clearance for the ID NOW COVID-19 2.0. 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 Abbott Diagnostics Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on August 10, 2023, 405 days after receiving the submission on July 1, 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 | K221925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2022 |
| Decision Date | August 10, 2023 |
| Days to Decision | 405 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. |