Class Class II
cobas® liat CT/NG/MG nucleic acid test (K240197)
Description
cobas® liat CT/NG/MG nucleic acid test by Roche Molecular Systems, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240197
Clearance Date2025-01-16
Clearance TypeDual Track
Product CodeQEP
Regulation Number866.3393
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240197
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® liat CT/NG/MG nucleic acid test (K240197) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG... | Roche Molecular Systems, Inc. | 2019 |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018 |
Trace the full predicate network for K240197
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.