Cleared Traditional

VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST

K070597 · Nanosphere, Inc. · Hematology

Oct 2007

Decision

223d

Days

Class 2

Risk

About This 510(k) Submission

K070597 is an FDA 510(k) clearance for the VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST, a Instrumentation For Clinical Multiplex Test Systems (Class II — Special Controls, product code NSU), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on October 11, 2007, 223 days after receiving the submission on March 2, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K070597 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2007
Decision Date	October 11, 2007
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Hematology (HE)
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