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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / P200048

PMA approved

IsoPSA Assay

Cleveland Diagnostics, Inc. · Nov 28, 2025 · P200048 · In the directory

FDA approved the IsoPSA Assay from Cleveland Diagnostics, Inc. on Nov 28, 2025 under P200048, an original premarket approval. The device falls under product code QRF, Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer as a Class 3 device. The review panel was Immunology.

FDA logged the submission as received on Dec 28, 2020. The decision came 1796 days later.

This is the only decision on file for Cleveland Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P200048?

P200048 is the FDA PMA for IsoPSA Assay, submitted by Cleveland Diagnostics, Inc.. FDA's decision date was Nov 28, 2025, under product code QRF (Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer).

Who makes the IsoPSA Assay?

Cleveland Diagnostics, Inc., based in Cleveland, OH, is the applicant of record for P200048. The company is listed in the MedDevice Startups directory.

How long did the P200048 review take?

FDA received the submission on Dec 28, 2020 and issued its decision on Nov 28, 2025, 1796 days later.

← All decisions in November 2025