Class Class II
Aptima SARS-CoV-2 Assay (K243396)
Description
Aptima SARS-CoV-2 Assay by Hologic, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243396
Clearance Date2025-02-13
Clearance TypeTraditional
Product CodeQQX
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243396
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. Aptima SARS-CoV-2 Assay (K243396) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 |
Trace the full predicate network for K243396
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.