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FDA product code · Microbiology · Class 2

PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

PCH is FDA's product code for "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System": a Class 2 device classified under 21 CFR 866.3990, reviewed by the Microbiology panel.

510(k) review time for PCH

Across 24 510(k) clearances under PCH decided from 2018-01-01 to 2026-10-06, the median was 104 days from FDA receipt to decision. Half took between 70 and 204 days, and 80% were decided within 215 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PCH, decisions 2018-01-01 to 2026-10-06 (n = 24)
Fastest23
25th percentile70
Median104
75th percentile204
80th percentile215
90th percentile266
Slowest872

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.

PCH in the public FDA record

Records naming PCH, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years38
Device recalls24

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

No FDA recognized consensus standard cites PCH 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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