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FDA product code · Microbiology · Class 2

QYT: Over-The-Counter Covid-19 Antigen Test

QYT is FDA's product code for "Over-The-Counter Covid-19 Antigen Test": a Class 2 device classified under 21 CFR 866.3984, reviewed by the Microbiology panel.

510(k) review time for QYT

Across 14 510(k) clearances under QYT decided from 2018-01-01 to 2026-10-06, the median was 161 days from FDA receipt to decision. Half took between 91 and 223 days, and 80% were decided within 241 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QYT, decisions 2018-01-01 to 2026-10-06 (n = 14)
Fastest88
25th percentile91
Median161
75th percentile223
80th percentile241
90th percentile272
Slowest386
Median days by decision year, QYT (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20241795
20251385

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 QYT

No FDA recognized consensus standard cites QYT 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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