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THE TAPE

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 / March 2026 / K254032

510(k) cleared

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

QIAGEN GmbH · Mar 9, 2026 · K254032

FDA cleared the QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B from QIAGEN GmbH on Mar 9, 2026 under K254032, a traditional 510(k). The device falls under product code PCH, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, regulated at 21 CFR 866.3990 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 16, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

QIAGEN GmbH has 2 other decisions in the tracker over the last 12 months: K254194 (QIAstat-Dx BCID GPF Plus AMR Panel), 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 K254032?

K254032 is the FDA 510(k) for QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B, submitted by QIAGEN GmbH. FDA's decision date was Mar 9, 2026, under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System).

Who makes the QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B?

QIAGEN GmbH, based in Hilden, is the applicant of record for K254032.

How long did the K254032 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Mar 9, 2026, 83 days later.

← All decisions in March 2026

Sources