510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SCAClass II

Multi-Analyte Respiratory Virus Antigen Detection Test

21 CFR 866.3987 / Microbiology
FDA source (opens on fda.gov)

SCA is the FDA product code for Multi-Analyte Respiratory Virus Antigen Detection Test, a class II device type, regulated under 21 CFR 866.3987. FDA's definition for this code reads: "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...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SCA
Device name
Multi-Analyte Respiratory Virus Antigen Detection Test
FDA 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.
Regulation
21 CFR 866.3987
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code SCA

By decision year
12 clearances under product code SCA with a decision year between 2024 and 2026, 2025 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code SCA by decision year
YearClearances
20241
202510
20261

Applicants with the most clearances

Product code SCA
Applicants holding the most 510(k) clearances under product code SCA
ApplicantClearances
Acon Laboratories, Inc.3
iHealth Labs, Inc.2
Wondfo USA Co., Ltd.2
Access Bio, Inc.1
Healgen1
Nano-Ditech Corporation1
Osang, LLC1
Princeton BioMeditech Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order