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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262168

510(k) cleared

QIAstat-Dx BCID GN Plus AMR Panel

QIAGEN GmbH · Sep 24, 2026 · K262168

FDA cleared the QIAstat-Dx BCID GN Plus AMR Panel from QIAGEN GmbH on Sep 24, 2026 under K262168, a traditional 510(k). The device falls under product code PEN, Gram-Negative Bacteria And Associated 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 Jun 26, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

QIAGEN GmbH has 3 other decisions in the tracker over the last 12 months: K254194 (QIAstat-Dx BCID GPF Plus AMR Panel), 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 K262168?

K262168 is the FDA 510(k) for QIAstat-Dx BCID GN Plus AMR Panel, submitted by QIAGEN GmbH. FDA's decision date was Sep 24, 2026, under product code PEN (Gram-Negative Bacteria And Associated Resistance Markers).

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

QIAGEN GmbH, based in Hilden, is the applicant of record for K262168.

How long did the K262168 review take?

FDA received the submission on Jun 26, 2026 and issued its decision on Sep 24, 2026, 90 days later.

← All decisions in September 2026