510(k) K243396
K243396 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima SARS-CoV-2 Assay". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test), a Class II device regulated under 21 CFR 866.3981. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2025
- Date Received
- October 31, 2024
- 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.