Cleared Traditional

Xpert C. difficile/Epi

K243730 · Cepheid · Microbiology

Feb 2025

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K243730 is an FDA 510(k) clearance for the Xpert C. difficile/Epi, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 28, 2025, 87 days after receiving the submission on December 3, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K243730 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2024
Decision Date	February 28, 2025
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3130
Definition	Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.