QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Class II
Classification Details
- Product Code
- QQX
- Device Class
- Class II
- Regulation Number
- 866.3981
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243396 | hologic | Aptima SARS-CoV-2 Assay | February 13, 2025 |
| K240867 | roche molecular systems | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | February 11, 2025 |
| K242109 | cepheid® | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | January 15, 2025 |
| K241580 | abbott molecular | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 | December 6, 2024 |
| K233453 | life technologies corporation | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | July 10, 2024 |
| K230440 | cepheid® | Xpert® Xpress CoV-2 plus | October 13, 2023 |
| K231306 | roche molecular systems | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | June 1, 2023 |
| K213804 | roche molecular systems | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | October 22, 2022 |
| K212147 | diasorin molecular | Simplexa COVID-19 Direct | September 13, 2022 |
| K221460 | biofire defense | BioFire COVID-19 Test 2 | July 25, 2022 |
| K211079 | biofire defense | BioFire COVID-19 Test 2 | November 1, 2021 |