Cleared Traditional

K132843 - VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

K132843 is an FDA 510(k) clearance for VERIGENE GRAM NEGATIVE BLOOD CULTURE NU..., manufactured by Nanosphere, Inc.. The device is a Class 2 Microbiology device with product code PEN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K132843 · Nanosphere, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
120d
Days
Class 2
Risk

K132843 is an FDA 510(k) clearance for the VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN). Classified as Gram-negative Bacteria And Associated Resistance Markers (product code PEN), Class II - Special Controls.

Submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 8, 2014 after a review of 120 days - within the typical 510(k) review window.

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 Nanosphere, Inc. devices

FDA 510(k) Submission Details - K132843

510(k) Number K132843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 102d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEN Device Classification - Class 2, Special Controls

Product Code PEN Gram-negative Bacteria And Associated Resistance Markers
Device Class Class 2 - 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.
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 - PEN Gram-negative Bacteria And Associated Resistance Markers

All 10
Devices cleared under the same product code (PEN) and FDA review panel - the closest regulatory comparables to K132843.
FilmArray Blood Culture Identification (BCID) Panel
K181493 · Biofire Diagnostics, LLC · Jul 2018
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · Biofire Diagnostics, LLC · Mar 2016
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
K143171 · Biofire Diagnostics, LLC · Jan 2015
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914 · Biofire Diagnostics, Inc. · Jun 2013