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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 / October 2025 / K250249

510(k) cleared

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Gold Standard Diagnostics, LLC · Oct 10, 2025 · K250249

FDA cleared the Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System from Gold Standard Diagnostics, LLC on Oct 10, 2025 under K250249, a traditional 510(k). The device falls under product code GMQ, Antigens, Nontreponemal, All, regulated at 21 CFR 866.3820 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 27, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gold Standard Diagnostics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250249?

K250249 is the FDA 510(k) for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, submitted by Gold Standard Diagnostics, LLC. FDA's decision date was Oct 10, 2025, under product code GMQ (Antigens, Nontreponemal, All).

Who makes the Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System?

Gold Standard Diagnostics, LLC, based in Davis, CA, is the applicant of record for K250249.

How long did the K250249 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Oct 10, 2025, 256 days later.

← All decisions in October 2025