Cleared Traditional

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

K152679 · Bio-Rad Laboratories · Microbiology

May 2016

Decision

235d

Days

Class 2

Risk

About This 510(k) Submission

K152679 is an FDA 510(k) clearance for the Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak, a Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (Class II — Special Controls, product code PMN), submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on May 10, 2016, 235 days after receiving the submission on September 18, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K152679 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2015
Decision Date	May 10, 2016
Days to Decision	235 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.