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FDA product code · Microbiology · Class 2

PSZ: Devices Detecting Influenza A, B, And C Virus Antigens

PSZ is FDA's product code for "Devices Detecting Influenza A, B, And C Virus Antigens": a Class 2 device classified under 21 CFR 866.3328, reviewed by the Microbiology panel.

510(k) review time for PSZ

Across 13 510(k) clearances under PSZ decided from 2018-01-01 to 2026-10-06, the median was 141 days from FDA receipt to decision. Half took between 40 and 190 days, and 80% were decided within 225 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PSZ, decisions 2018-01-01 to 2026-10-06 (n = 13)
Fastest12
25th percentile40
Median141
75th percentile190
80th percentile225
90th percentile254
Slowest354

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.

PSZ in the public FDA record

Records naming PSZ, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years73
Establishment listings119

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

No FDA recognized consensus standard cites PSZ 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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