Cleared Traditional

Cepheid Xpert CT/NG Control Panel

K190223 · Microbiologics, Inc. · Microbiology

May 2019

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K190223 is an FDA 510(k) clearance for the Cepheid Xpert CT/NG 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 May 8, 2019, 92 days after receiving the submission on February 5, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K190223 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2019
Decision Date	May 08, 2019
Days to Decision	92 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.