FDA product code · Microbiology · Class 2
SCA: Multi-Analyte Respiratory Virus Antigen Detection Test
SCA is FDA's product code for "Multi-Analyte Respiratory Virus Antigen Detection Test": a Class 2 device classified under 21 CFR 866.3987, reviewed by the Microbiology panel.
510(k) review time for SCA
Across 11 510(k) clearances under SCA decided from 2018-01-01 to 2026-10-06, the median was 93 days from FDA receipt to decision. Half took between 90 and 195 days, and 80% were decided within 211 days. These are past clearances, not a forecast for a new submission.
| Fastest | 87 |
|---|---|
| 25th percentile | 90 |
| Median | 93 |
| 75th percentile | 195 |
| 80th percentile | 211 |
| 90th percentile | 246 |
| Slowest | 247 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite SCA
No FDA recognized consensus standard cites SCA by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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