FDA.reportPublic FDA data

510(k) K243759

Device
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Applicant
Biofire Diagnostics, LLC
510(k) number
K243759
Product code
PEN
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-20
Date received
2024-12-06
Regulation
866.3365
Classification name
Gram-Negative Bacteria And Associated Resistance Markers
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karli Plenert
Address
515 Colorow Dr. Salt Lake City UT US 84108 84108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PEN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation2025-04-18
K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated2022-04-27
K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC2020-03-18
K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.2019-06-28
K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated2019-04-12
K181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC2018-07-05
K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchBiofire Diagnostics, LLC2016-03-15
K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC2015-01-30
K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)Nanosphere, Inc.2014-01-08
K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc.2013-06-21