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FDA product code · Microbiology · Class 2

QBD: Microbial Nucleic Acid Storage And Stabilization Device

QBD is FDA's product code for "Microbial Nucleic Acid Storage And Stabilization Device": a Class 2 device classified under 21 CFR 866.2950, reviewed by the Microbiology panel.

510(k) review time for QBD

Across 16 510(k) clearances under QBD decided from 2018-01-01 to 2026-10-06, the median was 274 days from FDA receipt to decision. Half took between 195 and 401 days, and 80% were decided within 433 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QBD, decisions 2018-01-01 to 2026-10-06 (n = 16)
Fastest73
25th percentile195
Median274
75th percentile401
80th percentile433
90th percentile699
Slowest942
Median days by decision year, QBD (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20232865
20246515

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 QBD

No FDA recognized consensus standard cites QBD 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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