FDA product code · Microbiology

Multi-Analyte Respiratory Virus Antigen Detection Test

Name: FDA decisions, review times, recalls and adverse event reports for product code SCA
Creator: 510(k) Report

SCAClass II21 CFR 866.3987510(k) required13 decisions since 20240 recalls

13 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 116 days (half between 90 and 203). No recall names this code. The most-cited predicate is DEN240029, named by 4 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of SCA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SCA

10in 2025

2007high 10 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SCA

116in 2025

2007high 116 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · SCA

No recall names SCA since 2007.

Adverse event reports per year · SCA

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code SCA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	10	116	4
2026	2	—	—

FIG. 1 — SCA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SCA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Multi-Analyte Respiratory Virus Antigen Detection Test

Which predicates do SCA devices cite most?

Which SCA devices have the deepest lineage?

What has FDA decided in SCA lately?