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The Tracker / September 2026 / P250046

PMA approved

OncoMate® MSI Dx Analysis System

Promega Corporation · Sep 15, 2026 · P250046

FDA approved the OncoMate® MSI Dx Analysis System from Promega Corporation on Sep 15, 2026 under P250046, an original premarket approval. The device falls under product code SFL, Nucleic Acid Based Assay, Microsatellite Instability as a Class 3 device. The review panel was Medical Genetics.

FDA logged the submission as received on Nov 14, 2025. The decision came 305 days later.

Promega Corporation has one other decision in the tracker over the last 12 months: P240026 (OncoMate® MSI Dx Analysis System).

Questions & Answers

What did FDA approve under P250046?

P250046 is the FDA PMA for OncoMate® MSI Dx Analysis System, submitted by Promega Corporation. FDA's decision date was Sep 15, 2026, under product code SFL (Nucleic Acid Based Assay, Microsatellite Instability).

Who makes the OncoMate® MSI Dx Analysis System?

Promega Corporation, based in Madison, WI, is the applicant of record for P250046.

How long did the P250046 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Sep 15, 2026, 305 days later.

← All decisions in September 2026