FDA product code · Microbiology · Class 2
QQX: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
QQX is FDA's product code for "Respiratory Specimen Nucleic Acid Sars-Cov-2 Test": a Class 2 device classified under 21 CFR 866.3981, reviewed by the Microbiology panel.
510(k) review time for QQX
Across 11 510(k) clearances under QQX decided from 2018-01-01 to 2026-10-06, the median was 203 days from FDA receipt to decision. Half took between 143 and 292 days, and 80% were decided within 319 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 143 |
| Median | 203 |
| 75th percentile | 292 |
| 80th percentile | 319 |
| 90th percentile | 320 |
| Slowest | 431 |
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 QQX
No FDA recognized consensus standard cites QQX 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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