Class Class II
CareSuperb™ COVID-19 Antigen Home Test (K241915)
Description
CareSuperb™ COVID-19 Antigen Home Test by Access Bio, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241915
Clearance Date2025-01-29
Clearance TypeTraditional
Product CodeQYT
Regulation Number866.3984
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241915
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. CareSuperb™ COVID-19 Antigen Home Test (K241915) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230828 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 2023 |
Trace the full predicate network for K241915
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.