Cleared Special

QIAstat-Dx GI Panel 2 Mini B&V

K243813 · QIAGEN GmbH · Microbiology

Jan 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K243813 is an FDA 510(k) clearance for the QIAstat-Dx GI Panel 2 Mini B&V, a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCH), submitted by QIAGEN GmbH (Hiden, DE). The FDA issued a Cleared decision on January 8, 2025, 28 days after receiving the submission on December 11, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K243813 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2024
Decision Date	January 08, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3990
Definition	A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.