Class Class II
Alinity m STI Assay (K222379)
Description
Alinity m STI Assay by Abbott Molecular, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222379
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeQEP
Regulation Number866.3393
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222379
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. Alinity m STI Assay (K222379) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 |
Trace the full predicate network for K222379
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.