Cleared Traditional

Cepheid Xpert Respiratory Control Panel

K190086 · Microbiologics, Inc. · Microbiology

Oct 2019

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K190086 is an FDA 510(k) clearance for the Cepheid Xpert Respiratory 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 October 7, 2019, 263 days after receiving the submission on January 17, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K190086 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2019
Decision Date	October 07, 2019
Days to Decision	263 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.