510(k) K230440
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2023
- Date Received
- February 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Device Class
- Class II
- Regulation Number
- 866.3981
- Review Panel
- MI
- Submission Type
A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.