DeviceClearance

Product code SCA— Microbiology

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

Classification name
Multi-Analyte Respiratory Virus Antigen Detection Test
Device class
Class 2
Regulation
21 CFR 866.3987
Advisory panel
Microbiology
Total cleared
12
First cleared
Most recent

FDA classification definition

“A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.”

— U.S. Food and Drug Administration, device classification record for product code SCA under 21 CFR 866.3987, via openFDA

Market context for product code SCA

FDA has cleared 12 devices under product code SCA between 2024 and 2026, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SCA

Recent clearances under product code SCA

Data sourced from openFDA. This site is unofficial and independent of the FDA.