QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Class II
FDA product code QQX covers "Respiratory Specimen Nucleic Acid Sars-Cov-2 Test", a Class II medical device regulated under 21 CFR 866.3981. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
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 |