System, Test, Blood Glucose, Over The Counter

Device Code: 630

Product Code(s): NBW

Device Classification Information

Device Type ID	630
Device Name	System, Test, Blood Glucose, Over The Counter
Regulation Description	Glucose 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	862.1345 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	NBW
GMP Exempt	No
Summary MR	Ineligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

7-203 CLSI GP42-A6 (Formerly H04-A6)
Procedures And Devices For The Collection Of Diagnostic Capillary Blood Specimens; Approved Standard -- Sixth Edition
13-88 IEEE ISO 11073-10417 Third Edition 2017-04
Health Informatics - Personal Health Device Communication - Part 10417: Device Specialization - Glucose Meter
13-90 IEEE Std 11073-10417-2015
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter

Total Product Life Cycle

Device Type ID	630
Device	System, Test, Blood Glucose, Over The Counter
Product Code	NBW
FDA Device Classification	Class 2 Medical Device
Regulation Description	Glucose Test System.
CFR Regulation Number	862.1345 [🔎]

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	6
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	6
ACON LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
ACON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
AGAMATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALL MEDICUS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ALLIANCE INTERNATIONAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANDON HEALTH CO.,LTD
	SUBSTANTIALLY EQUIVALENT	7
APEX BIOTECHNOLOGY CORP.
	SUBSTANTIALLY EQUIVALENT	4
APPLIED BIOMEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ARKRAY, INC.
	SUBSTANTIALLY EQUIVALENT	2
ASCENSIA DIABETES CARE
	SUBSTANTIALLY EQUIVALENT	1
ASCENSIA DIABETES CARE HOLDINGS AG
	SUBSTANTIALLY EQUIVALENT	2
BAYER
	SUBSTANTIALLY EQUIVALENT	2
BAYER HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
BAYER PHARMA, AG
	SUBSTANTIALLY EQUIVALENT	1
BIONIME COPORATION
	SUBSTANTIALLY EQUIVALENT	3
BIONIME CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
BIOTEST MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
BIOTEST MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CERAGEM MEDISYS INC.
	SUBSTANTIALLY EQUIVALENT	2
ENTRA HEALTH SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
EPS BIO TECHNOLOGY CORP.
	SUBSTANTIALLY EQUIVALENT	3
H2 INC.
	SUBSTANTIALLY EQUIVALENT	1
HMD BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
IDEAL LIFE INC.
	SUBSTANTIALLY EQUIVALENT	1
INTUITY MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
I-SENS, INC.
	SUBSTANTIALLY EQUIVALENT	6
JOINSOON MEDICAL TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LABSTYLE INNOVATIONS LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIFESCAN EUROPE
	SUBSTANTIALLY EQUIVALENT	2
NIPRO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVA
	SUBSTANTIALLY EQUIVALENT	2
NOVA BIOMEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
OK BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
OSANG HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
PHILOSYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLYMER TECHNOLOGY SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIABETES CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
ROCHE DIAGNOSTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS OPERATIONS, INC
	SUBSTANTIALLY EQUIVALENT	2
SD BIOSENSOR, INC.
	SUBSTANTIALLY EQUIVALENT	5
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TRIVIDIA HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
TYSON BIORESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Device Displays Incorrect Message	25056
Failure To Power Up	18492
Incorrect Or Inadequate Test Results	13241
High Test Results	5435
Loss Of Power	5316
Incorrect, Inadequate Or Imprecise Result Or Readings	4864
Device Alarm System	3364
Low Test Results	2659
No Display / Image	2103
Appropriate Term/Code Not Available	2101
Low Battery	1827
Battery Problem	1335
Device Operational Issue	1062
Device Damaged Prior To Use	1044
Insufficient Information	854
High Readings	819
Adverse Event Without Identified Device Or Use Problem	798
Component Missing	762
Device Operates Differently Than Expected	624
Display	562
Output Problem	545
Image Resolution Poor	542
Sticking	480
Incorrect Software Programming Calculations	388
Device Inoperable	385
Display Or Visual Feedback Problem	367
Missing Test Results	359
Electrical /Electronic Property Problem	357
Failure To Calibrate	280
Test Strip	278
No Device Output	264
Gauges/Meters	248
Defective Component	247
Monitor	238
Device Handling Problem	237
Off-Label Use	235
Low Readings	234
Crack	209
Image Display Error / Artifact	176
Bent	173
False Reading From Device Non-Compliance	171
Display Difficult To Read	164
Failure To Obtain Sample	162
Unable To Obtain Readings	160
Application Program Problem: Dose Calculation Error	150
Material Discolored	145
Break	141
Physical Property Issue	137
Material Integrity Problem	135
Poor Quality Image	133
Failure To Back-Up	122
Labelling, Instructions For Use Or Training Problem	110
Inadequate Instructions For Healthcare Professional	101
Device Difficult To Setup Or Prepare	99
Improper Device Output	86
Improper Or Incorrect Procedure Or Method	81
Defective Device	78
Use Of Incorrect Control Settings	65
Unsealed Device Packaging	58
Charging Problem	48
Thermal Decomposition Of Device	46
Erratic Or Intermittent Display	42
Data Problem	42
Incomplete Or Missing Packaging	41
Computer Software Problem	39
Melted	39
Switch, Push Button	38
Incorrect Measurement	36
Device Stops Intermittently	36
Inappropriate Audible Prompt / Feedback	34
Loss Of Data	31
Device Ingredient Or Reagent Problem	27
Computer Operating System Problem	26
Packaging Problem	25
Operating System Becomes Nonfunctional	24
Housing	23
Material Opacification	23
Application Program Problem	21
Device Markings / Labelling Problem	21
Calibration Error	19
Product Quality Problem	19
Communication Or Transmission Problem	18
Contamination During Use	17
Peeled / Delaminated	17
Battery	16
Self-Activation Or Keying	16
Screen	15
Smoking	14
Label	12
Manufacturing, Packaging Or Shipping Problem	12
Calibration Problem	12
Use Of Device Problem	11
Unexpected Therapeutic Results	11
Date/Time-Related Software Problem	11
Failure To Charge	10
Cut In Material	10
Device Issue	10
Nonstandard Device	9
Device Expiration Issue	9
Inappropriate Or Unexpected Reset	9
Total Device Problems	101797

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Diabetes Care, Inc.	I	Mar-18-2014
2	Livongo Health	II	Apr-29-2016
3	Nipro Diagnostics, Inc.	II	Feb-03-2014
4	Polymer Technology Systems, Inc.	II	Apr-28-2018
5	Roche Diagnostics Operations, Inc.	II	May-13-2014
6	Trividia Health	II	Sep-23-2016
7	Unistrip Technologies LLC	II	Dec-23-2014

TPLC Last Update: 2019-04-02 19:37:51