Cleared Traditional

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

K122514 · Nanosphere, Inc. · Microbiology

Sep 2012

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K122514 is an FDA 510(k) clearance for the VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST, a Gram-positive Bacteria And Their Resistance Markers (Class II — Special Controls, product code PAM), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on September 19, 2012, 33 days after receiving the submission on August 17, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K122514 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2012
Decision Date	September 19, 2012
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PAM — Gram-positive Bacteria And Their Resistance Markers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.