Method, Enzymatic, Glucose (urinary, Non-quantitative)

Device Code: 438

Product Code(s): JIL

Device Type ID	438
Device Name	Method, Enzymatic, Glucose (urinary, Non-quantitative)
Regulation Description	Urinary Glucose (nonquantitative) Test System.
Regulation Medical Specialty	Clinical Chemistry
Review Panel	Clinical Chemistry
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(k)
CFR Regulation Number	862.1340 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	JIL
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Device Type ID	438
Device	Method, Enzymatic, Glucose (urinary, Non-quantitative)
Product Code	JIL
FDA Device Classification	Class 2 Medical Device
Regulation Description	Urinary Glucose (nonquantitative) Test System.
CFR Regulation Number	862.1340 [🔎]

Device Problems
False Negative Result	49
Low Test Results	25
Test Strip	19
High Test Results	17
Electrical /Electronic Property Problem	16
Use Of Device Problem	6
Non Reproducible Results	5
Smoking	3
Patient Data Problem	3
Failure To Run On AC/DC	3
Incorrect Or Inadequate Test Results	3
Mechanical Problem	2
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Device Markings / Labelling Problem	2
Transport	2
Computer Operating System Problem	2
Power Problem	2
False Positive Result	2
Fire	1
Sparking	1
Device Operates Differently Than Expected	1
Programming Issue	1
Nozzle	1
Data Problem	1
Missing Information	1
Device Displays Incorrect Message	1
Device Handling Problem	1
Failure To Power Up	1
Leak / Splash	1
Computer Software Problem	1
Total Device Problems	175

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Jan-13-2016
2	Roche Diagnostics Operations, Inc.	II	Oct-25-2016
3	Siemens Healthcare Diagnostics, Inc	II	Oct-17-2014

TPLC Last Update: 2019-04-02 19:34:39