TPLC - Total Product Life Cycle

• Device: enzymatic method, creatinine
• Regulation Description: Creatinine test system.
• Product Code: JFY
• Regulation Number: 862.1225
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BAYER
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	2
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	4
DADE BEHRING
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
Diagnostic Chemicals Ltd.
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
EASTMAN KODAK
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL SPECIALTIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO-CLINICAL
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
POLYMEDCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
SIEMENS
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
THERMO ELECTRON
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1

Device Problems
High test results	21
Low test results	16
Incorrect or inadequate test results	4
Hole in material	1
Incorrect or inadequate result	1
Total Device Problems	43

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Abaxis Inc	II	Mar-16-2010
2	Dade Behring, Inc.	II	Dec-13-2008
3	Diagnostic Chemicals, Ltd.	II	Sep-30-2009
4	Polymer Technology Systems, Inc.	II	Jun-28-2012
5	Roche Diagnostics Corp.	II	Oct-09-2008
6	Siemens Healthcare Diagnostics, Inc.	II	May-10-2011
7	Siemens Healthcare Diagnostics, Inc.	II	May-09-2011
8	Siemens Healthcare Diagnostics, Inc.	II	Sep-16-2010