BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k) clearance K243759 · decided 2024-12-20

Clearance details

K-number: K243759
Device name: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Applicant: Biofire Diagnostics, LLC
Decision: Substantially Equivalent
Date received: 2024-12-06
Decision date: 2024-12-20
Days to decision: 14 days
Clearance type: Special
Product code: PEN
Device class: 2
Regulation number: 866.3365
Medical specialty: Microbiology
Advisory committee: Microbiology
Location: Salt Lake City, UT, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
LIAISON PLEX Gram-Negative Blood Culture Assay (K243013)	Luminex Corporation	2025-04-18
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236)	Genmark Diagnostics, Incorporated	2022-04-27
BioFire Blood Culture Identification 2 (BCID2) Panel (K193519)	Biofire Diagnostics, LLC	2020-03-18
iC-GN iC-Cassette for use on the iC-System (K190341)	Icubate, Inc.	2019-06-28
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K182619)	Genmark Diagnostics, Incorporated	2019-04-12
FilmArray Blood Culture Identification (BCID) Panel (K181493)	Biofire Diagnostics, LLC	2018-07-05
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (K160457)	Biofire Diagnostics, LLC	2016-03-15
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (K143171)	Biofire Diagnostics, LLC	2015-01-30
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (K132843)	Nanosphere, Inc.	2014-01-08
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (K130914)	Biofire Diagnostics, Inc.	2013-06-21

No recalls on record reference this clearance.