Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
The simple point-of-care device to detect SARS-CoV-2 nucleic acid targets from clinical specimens in near-patient settings (product code QWR) is a Class 2 in vitro diagnostic device in the Microbiology specialty (regulation 866.3982) designed for direct detection of SARS-CoV-2 and intended as an aid in diagnosing COVID-19 infections. Requiring 510(k) clearance, the device is simple to use without sample manipulation or laboratory transport and is appropriate for healthcare professionals in near-patient settings outside centralized laboratories. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWR
- Device Class
- FDA class 2
- Regulation Number
- 866.3982
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Apr 11, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Dec 04, 2023 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K221925 | ID NOW COVID-19 2.0 | Aug 10, 2023 | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.