FDA product code SCA: Multi-Analyte Respiratory Virus Antigen Detection Test
SCA is the FDA product code for multi-analyte respiratory virus antigen detection test. It is a Class II device, regulated under 21 CFR 866.3987 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under SCA, 11 in the last five years, from 7 different applicants. The average 510(k) review took 142 days (median 93); 117 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3987 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for SCA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 10 | 147 |
| 2026 | 1 | 87 |
Compare with all 510(k) review times · Search every SCA clearance
Top SCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ACON Laboratories, Inc. | 3 | 2026-07-10 |
| Ihealth Labs, Inc. | 2 | 2025-12-12 |
| Wondfo USA Co, Ltd. | 2 | 2025-08-20 |
| Princeton BioMeditech Corp. | 1 | 2025-11-14 |
| Access Bio, Inc. | 1 | 2025-08-22 |
2 more applicants have SCA clearances. See the full list in Caduvo.
Most recent SCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261212 | ACON Laboratories, Inc. | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | 2026-07-10 | 87 |
| K251085 | Ihealth Labs, Inc. | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | 2025-12-12 | 247 |
| K251092 | Ihealth Labs, Inc. | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | 2025-12-12 | 246 |
| K251538 | Princeton BioMeditech Corp. | Status COVID-19/Flu A&B | 2025-11-14 | 179 |
| K251749 | ACON Laboratories, Inc. | Flowflex Plus RSV + Flu A/B + COVID Home Test | 2025-10-22 | 138 |
Recalls for SCA devices
openFDA lists no recalls for product code SCA.
Frequently asked questions
What is FDA product code SCA?
SCA is the FDA product code for multi-analyte respiratory virus antigen detection test. It is a Class II device, regulated under 21 CFR 866.3987 and reviewed by the Microbiology panel.
What device class is SCA?
Class II, regulation 21 CFR 866.3987. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCA?
Across 11 cleared submissions the average was 142 days from receipt to decision (median 93).
Which companies have the most SCA clearances?
ACON Laboratories, Inc. (3); Ihealth Labs, Inc. (2); Wondfo USA Co, Ltd. (2); Princeton BioMeditech Corp. (1); Access Bio, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCA
- Run a recall and safety report across every SCA manufacturer
- Watch product code SCA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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