Cleared Traditional

VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

K132843 · Nanosphere, Inc. · Microbiology

Jan 2014

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K132843 is an FDA 510(k) clearance for the VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN), a Gram-negative Bacteria And Associated Resistance Markers (Class II — Special Controls, product code PEN), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 8, 2014, 120 days after receiving the submission on September 10, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K132843 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2013
Decision Date	January 08, 2014
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PEN — Gram-negative Bacteria And Associated Resistance Markers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.