TPLC - Total Product Life Cycle

• Device: hexokinase, glucose
• Regulation Description: Glucose test system.
• Product Code: CFR
• Regulation Number: 862.1345
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	4
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BAYER
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	1
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	1
DADE BEHRING
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
Diagnostic Chemicals Ltd.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
EMD
	SUBSTANTIALLY EQUIVALENT	3
HITACHI MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	3
KULZER
	SUBSTANTIALLY EQUIVALENT	6
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	1
ORASURE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLYMEDCO, INC.
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
TRACE SCIENTIFIC LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
High test results	15
Low test results	15
Incorrect or inadequate test results	2
Total Device Problems	32

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	1	0	0	0	0
Class II	0	2	0	0	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc	II	Sep-21-2008
2	Pointe Scientific, Inc.	I	Nov-04-2009
3	Pointe Scientific, Inc.	II	Oct-31-2008