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FDA product code · Microbiology · Class 2

QEP: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

QEP is FDA's product code for "Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections": a Class 2 device classified under 21 CFR 866.3393, reviewed by the Microbiology panel.

510(k) review time for QEP

Across 23 510(k) clearances under QEP decided from 2018-01-01 to 2026-10-06, the median was 171 days from FDA receipt to decision. Half took between 88 and 357 days, and 80% were decided within 374 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QEP, decisions 2018-01-01 to 2026-10-06 (n = 23)
Fastest28
25th percentile88
Median171
75th percentile357
80th percentile374
90th percentile504
Slowest773

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 QEP

No FDA recognized consensus standard cites QEP 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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