Class Class II
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (K251604)
Description
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test by Access Bio, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251604
Clearance Date2025-08-22
Clearance TypeTraditional
Product CodeSCA
Regulation Number866.3987
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251604
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/Flu A&B Antigen Combo Home Test (K251604) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COV... | Wondfo USA Co, Ltd. | 2025 |
Trace the full predicate network for K251604
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.