cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
FDA 510(k) K240867 · Roche Molecular Systems, Inc.
Submission
- Device name
- cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- March 29, 2024
- Decision date
- February 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
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…
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| K243396 | Aptima SARS-CoV-2 AssayQQX · Traditional | Hologic, Inc. | 02/13/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | Cepheid® | 01/15/2025SE |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional | Abbott Molecular | 12/06/2024SE |
| K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR KitQQX · Traditional | Life Technologies Corporation | 07/10/2024SE |
| K230440 | Xpert® Xpress CoV-2 plusQQX · Traditional | Cepheid® | 10/13/2023SE |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsQQX · Special | Roche Molecular Systems, Inc. | 06/01/2023SE |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQX · Traditional | Roche Molecular Systems, Inc. | 10/22/2022SE |
| K212147 | Simplexa COVID-19 DirectQQX · Traditional | Diasorin Molecular, LLC | 09/13/2022SE |
| K221460 | BioFire COVID-19 Test 2QQX · Special | Biofire Defense, LLC | 07/25/2022SE |
| K211079 | BioFire COVID-19 Test 2QQX · Traditional | Biofire Defense, LLC | 11/01/2021SE |
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Questions and answers
When was cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems cleared by the FDA?
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867) received a 510(k) decision of Substantially Equivalent on February 11, 2025, 319 days after the submission was received.
What is the product code of K240867?
The FDA product code is QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test, a Class II (moderate risk) device regulated under 21 CFR 866.3981.