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FDA product code · Microbiology · Class 2

OCC: Respiratory Virus Panel Nucleic Acid Assay System

OCC is FDA's product code for "Respiratory Virus Panel Nucleic Acid Assay System": a Class 2 device classified under 21 CFR 866.3980, reviewed by the Microbiology panel.

510(k) review time for OCC

Across 18 510(k) clearances under OCC decided from 2018-01-01 to 2026-10-06, the median was 31 days from FDA receipt to decision. Half took between 28 and 124 days, and 80% were decided within 141 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OCC, decisions 2018-01-01 to 2026-10-06 (n = 18)
Fastest19
25th percentile28
Median31
75th percentile124
80th percentile141
90th percentile177
Slowest210

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.

OCC in the public FDA record

Records naming OCC, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years80
Device recalls25

Counts of records, not of devices or events. Adverse event reports for OCC 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 OCC

No FDA recognized consensus standard cites OCC 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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