Cleared Traditional

Cepheid Xpert C. difficile/Epi Control Panel

K190463 · Microbiologics, Inc. · Microbiology

Apr 2019

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K190463 is an FDA 510(k) clearance for the Cepheid Xpert C. difficile/Epi Control Panel, a Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (Class II — Special Controls, product code PMN), submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on April 19, 2019, 52 days after receiving the submission on February 26, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K190463 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2019
Decision Date	April 19, 2019
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3920
Definition	Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.