Cleared Special

APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

K141220 · Thermo Fisher Scientific (Life Technologies Holdin · Microbiology

May 2014

Decision

10d

Days

Class 2

Risk

About This 510(k) Submission

K141220 is an FDA 510(k) clearance for the APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE, a Instrumentation For Clinical Multiplex Test Systems (Class II — Special Controls, product code NSU), submitted by Thermo Fisher Scientific (Life Technologies Holdin (Singapore, SG). The FDA issued a Cleared decision on May 22, 2014, 10 days after receiving the submission on May 12, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K141220 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2014
Decision Date	May 22, 2014
Days to Decision	10 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NSU — Instrumentation For Clinical Multiplex Test Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.2570
Definition	Instrumentation For Clinical Multiplex Test Systems Is A Device That Is Intended To Measure And Sort Multiple Signals Generated By An Assay From A Clinical Sample. The Generated Signals From Multiple Probes Or Other Ligands May Be Measured By Fluorescence, Luminescence, Or Other Physical Or Chemical Properties. The Device May Integrate Scanning, Reagent Handling, Hybridization, Washing, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. This Instrumentation Is Used With Specific Assays To Comprise An Assay Test System To Measure Multiple Analytes Of A Similar Chemical Nature For De