Enzyme Immunoassay, Amphetamine

Device Code: 6069

Product Code(s): DKZ

Device Type ID	6069
Device Name	Enzyme Immunoassay, Amphetamine
Regulation Description	Amphetamine 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	862.3100 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	DKZ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Device Type ID	6069
Device	Enzyme Immunoassay, Amphetamine
Product Code	DKZ
FDA Device Classification	Class 2 Medical Device
Regulation Description	Amphetamine Test System.
CFR Regulation Number	862.3100 [🔎]

Premarket Reviews
Manufacturer	Decision
ALFA SCIENTIFIC DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOPHOR DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CO-INNOVATION BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEALGEN SCIENTIFIC LLC
	SUBSTANTIALLY EQUIVALENT	1
IMMUNALYSIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LIN-ZHI INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
OMEGA LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHAMATECH INC.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI CHEMTRON BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UCP BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	9
False Positive Result	3
Incorrect Or Inadequate Test Results	2
False Negative Result	1
Human Factors Issue	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	17

TPLC Last Update: 2019-04-02 21:16:48