Cleared Traditional

K152470 - Great Basin Staph ID/R Blood Culture Panel

K152470 is an FDA 510(k) clearance for Great Basin Staph ID/R Blood Culture Panel, manufactured by Great Basin Scientific, Inc.. The device is a Class 2 Microbiology device with product code PAM cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K152470 · Great Basin Scientific, Inc. · Microbiology device
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Mar 2016
Decision
207d
Days
Class 2
Risk

K152470 is an FDA 510(k) clearance for the Great Basin Staph ID/R Blood Culture Panel. Classified as Gram-positive Bacteria And Their Resistance Markers (product code PAM), Class II - Special Controls.

Submitted by Great Basin Scientific, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 25, 2016 after a review of 207 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3365 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Great Basin Scientific, Inc. devices

FDA 510(k) Submission Details - K152470

510(k) Number K152470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 102d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PAM Device Classification - Class 2, Special Controls

Product Code PAM Gram-positive Bacteria And Their Resistance Markers
Device Class Class 2 - 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.
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 - PAM Gram-positive Bacteria And Their Resistance Markers

Devices cleared under the same product code (PAM) and FDA review panel - the closest regulatory comparables to K152470.
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490 · Luminex Corporation · Jun 2025
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663 · Genmark Diagnostics, Incorporated · Dec 2018
iC-GPC Assay TM for use on the iC-SystemTM
K163390 · Icubate, Inc. · Aug 2017
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
K122514 · Nanosphere, Inc. · Sep 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014 · Nanosphere, Inc. · Jun 2012