Cleared Special

K141220 - APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

K141220 is an FDA 510(k) clearance for APPLIED BIOSYSTEMS 7500 FAST DX REAL-TI..., manufactured by Thermo Fisher Scientific (Life Technologies Holdin. The device is a Class 2 Microbiology device with product code NSU cleared through the Special 510(k) pathway after a 10-day FDA review.

K141220 · Thermo Fisher Scientific (Life Technologies Holdin · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
10d
Days
Class 2
Risk

K141220 is an FDA 510(k) clearance for the APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE. Classified as Instrumentation For Clinical Multiplex Test Systems (product code NSU), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Life Technologies Holdin (Singapore, SG). The FDA issued a Cleared decision on May 22, 2014 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2570 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141220

510(k) Number K141220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

NSU Device Classification - Class 2, Special Controls

Product Code NSU Instrumentation For Clinical Multiplex Test Systems
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - NSU Instrumentation For Clinical Multiplex Test Systems

All 12
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K141220 · APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
Download PDF FDA Summary Thermo Fisher Scienti…