Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Code: 6028

Product Code(s): DIO

Device Type ID	6028
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation Description	Cocaine And Cocaine Metabolite Test System.
Regulation Medical Specialty	Toxicology
Review Panel	Toxicology
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(k)
CFR Regulation Number	862.3250 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	DIO
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Device Type ID	6028
Device	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Product Code	DIO
FDA Device Classification	Class 2 Medical Device
Regulation Description	Cocaine And Cocaine Metabolite Test System.
CFR Regulation Number	862.3250 [🔎]

Premarket Reviews
Manufacturer	Decision
BIOPHOR DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANMEDICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALGEN SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMMUNALYSIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MP BIOMEDICALS, LLC
	SUBSTANTIALLY EQUIVALENT	1
QUEST DIAGNOSTICS INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
THERMO FISHER SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
False Positive Result	30
Incorrect Or Inadequate Test Results	9
False Negative Result	4
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	44

TPLC Last Update: 2019-04-02 21:16:15