cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306)
Description
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems by Roche Molecular Systems, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231306
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800... | Roche Molecular Systems, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/68... | Roche Molecular Systems, Inc. | 2025 |
Trace the full predicate network for K231306
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.