Cleared Traditional

Cepheid Xpert GBS LB Control Panel

K182472 · Microbiologics, Inc. · Microbiology

Nov 2018

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K182472 is an FDA 510(k) clearance for the Cepheid Xpert GBS LB 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 November 8, 2018, 59 days after receiving the submission on September 10, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K182472 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2018
Decision Date	November 08, 2018
Days to Decision	59 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.