Cleared Traditional

Great Basin Staph ID/R Blood Culture Panel

K152470 · Great Basin Scientific, Inc. · Microbiology

Mar 2016

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K152470 is an FDA 510(k) clearance for the Great Basin Staph ID/R Blood Culture Panel, a Gram-positive Bacteria And Their Resistance Markers (Class II — Special Controls, product code PAM), submitted by Great Basin Scientific, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 25, 2016, 207 days after receiving the submission on August 31, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K152470 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2015
Decision Date	March 25, 2016
Days to Decision	207 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.