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FDA product code · Microbiology · Class 2

QOF: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

QOF is FDA's product code for "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents": a Class 2 device classified under 21 CFR 866.3981, reviewed by the Microbiology panel.

510(k) review time for QOF

Across 35 510(k) clearances under QOF decided from 2018-01-01 to 2026-10-06, the median was 178 days from FDA receipt to decision. Half took between 89 and 251 days, and 80% were decided within 253 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QOF, decisions 2018-01-01 to 2026-10-06 (n = 35)
Fastest21
25th percentile89
Median178
75th percentile251
80th percentile253
90th percentile270
Slowest413
Median days by decision year, QOF (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20232387
20241479
202517813
2026 (to 10-06, partial)2046

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.

QOF in the public FDA record

Records naming QOF, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years33
Device recalls9

Counts of records, not of devices or events. Adverse event reports for QOF are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite QOF

No FDA recognized consensus standard cites QOF 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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