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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 / August 2026 / K254194

510(k) cleared

QIAstat-Dx BCID GPF Plus AMR Panel

QIAGEN GmbH · Aug 6, 2026 · K254194

FDA cleared the QIAstat-Dx BCID GPF Plus AMR Panel from QIAGEN GmbH on Aug 6, 2026 under K254194, a traditional 510(k). The device falls under product code PAM, Gram-Positive Bacteria And Their Resistance Markers, regulated at 21 CFR 866.3365 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 23, 2025. The decision came 226 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

QIAGEN GmbH has 2 other decisions in the tracker over the last 12 months: K254032 (QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B), K252329 (QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B).

Questions & Answers

What did FDA clear under K254194?

K254194 is the FDA 510(k) for QIAstat-Dx BCID GPF Plus AMR Panel, submitted by QIAGEN GmbH. FDA's decision date was Aug 6, 2026, under product code PAM (Gram-Positive Bacteria And Their Resistance Markers).

Who makes the QIAstat-Dx BCID GPF Plus AMR Panel?

QIAGEN GmbH, based in Hilden, is the applicant of record for K254194.

How long did the K254194 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Aug 6, 2026, 226 days later.

← All decisions in August 2026

Sources