Cleared Traditional

Cepheid Xpert SA Nasal Complete Control Panel

K191168 · Microbiologics, Inc. · Microbiology

Jun 2019

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K191168 is an FDA 510(k) clearance for the Cepheid Xpert SA Nasal Complete 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 June 25, 2019, 55 days after receiving the submission on May 1, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K191168 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2019
Decision Date	June 25, 2019
Days to Decision	55 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.