Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
The Respiratory Specimen Nucleic Acid SARS-CoV-2 Test is an in vitro diagnostic device intended to detect and identify SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infection. It is used to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data. Classified as FDA Class 2 under regulation 866.3981, it requires 510(k) premarket notification to demonstrate substantial equivalence before marketing. The device falls under the Microbiology specialty and is neither an implant nor life-sustaining.
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Basic Information
- Product Code
- QQX
- Device Class
- FDA class 2
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243396 | Aptima SARS-CoV-2 Assay | Feb 13, 2025 | Substantially Equivalent | Hologic, Inc. |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Feb 11, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Jan 15, 2025 | Substantially Equivalent | Cepheid® |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Dec 06, 2024 | Substantially Equivalent | Abbott Molecular |
| K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | Jul 10, 2024 | Substantially Equivalent | Life Technologies Corporation |
| K230440 | Xpert® Xpress CoV-2 plus | Oct 13, 2023 | Substantially Equivalent | Cepheid® |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Jun 01, 2023 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | Oct 22, 2022 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K212147 | Simplexa COVID-19 Direct | Sep 13, 2022 | Substantially Equivalent | Diasorin Molecular, LLC |
| K221460 | BioFire COVID-19 Test 2 | Jul 25, 2022 | Substantially Equivalent | Biofire Defense, LLC |
| K211079 | BioFire COVID-19 Test 2 | Nov 01, 2021 | Substantially Equivalent | Biofire Defense, LLC |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.