FDA Product Code QQX: Respiratory Specimen Nucleic Acid Sars-cov-2 Test
Under FDA product code QQX, respiratory specimen nucleic acid tests for SARS-CoV-2 are cleared for the molecular diagnosis of COVID-19.
These PCR-based or isothermal amplification assays detect SARS-CoV-2 RNA in nasopharyngeal, nasal, or saliva specimens with high sensitivity and specificity. They are used in clinical laboratories for COVID-19 diagnosis and surveillance.
QQX devices are Class II medical devices, regulated under 21 CFR 866.3981 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Biofire Defense, LLC and Cepheid.
11
Total
11
Cleared
212d
Avg days
2021
Since
Growing category -
4 submissions in the last 2 years
vs 3 in the prior period
Consistent review times:
198d avg (recent)
FDA 510(k) Cleared Respiratory Specimen Nucleic Acid Sars-cov-2 Test Devices (Product Code QQX)
11 devices
Cleared
Feb 13, 2025
Aptima SARS-CoV-2 Assay
Hologic, Inc.
Microbiology
105d
Cleared
Feb 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
Roche Molecular Systems, Inc.
Microbiology
319d
Cleared
Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
Cepheid
Microbiology
180d
Cleared
Dec 06, 2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
Abbott Molecular
Microbiology
186d
Cleared
Jul 10, 2024
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
Life Technologies Corporation
Microbiology
264d
Cleared
Oct 13, 2023
Xpert® Xpress CoV-2 plus
Cepheid
Microbiology
234d
Cleared
Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
Roche Molecular Systems, Inc.
Microbiology
27d
Cleared
Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
Roche Molecular Systems, Inc.
Microbiology
320d
Cleared
Sep 13, 2022
Simplexa COVID-19 Direct
Diasorin Molecular, LLC
Microbiology
431d
Cleared
Jul 25, 2022
BioFire COVID-19 Test 2
Biofire Defense, LLC
Microbiology
67d
Cleared
Nov 01, 2021
BioFire COVID-19 Test 2
Biofire Defense, LLC
Microbiology
203d
About Product Code QQX - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code QQX since 2021, with 11 receiving FDA clearance (average review time: 212 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QQX Product Code
FDA review times for QQX submissions have been consistent, averaging 198 days recently vs 221 days historically.
QQX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →