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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, blood glucose, over the counter
Regulation Description Glucose test system.
Product CodeNBW
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 6
ACON LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 3
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 6
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 7
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 25164
Failure to Power Up 21577
Incorrect Or Inadequate Test Results 13241
Incorrect, Inadequate or Imprecise Result or Readings 8483
High Test Results 5841
Loss of Power 5372
Device Alarm System 3380
Low Test Results 2783
Appropriate Term/Code Not Available 2132
No Display / Image 2109
Low Battery 1827
Battery Problem 1367
Device Operational Issue 1062
Device Damaged Prior to Use 1044
High Readings 933
Insufficient Information 857
Adverse Event Without Identified Device or Use Problem 847
Component Missing 762
Device Operates Differently Than Expected 624
Display 562
Output Problem 546
Image Resolution Poor 542
Sticking 480
Missing Test Results 423
Incorrect Software Programming Calculations 388
Device Inoperable 385
Display or Visual Feedback Problem 379
Electrical /Electronic Property Problem 357
Display Difficult to Read 305
No Device Output 292
Failure to Calibrate 286
Test Strip 278
Low Readings 264
Device Handling Problem 262
Unable to Obtain Readings 257
Gauges/Meters 248
Defective Component 247
Monitor 238
Off-Label Use 235
Crack 209
Image Display Error / Artifact 189
Application Program Problem: Dose Calculation Error 178
Bent 173
False Reading From Device Non-Compliance 171
Failure to Obtain Sample 163
Material Discolored 146
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 111
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
Unsealed Device Packaging 65
Use of Incorrect Control Settings 65
Charging Problem 48
Thermal Decomposition of Device 46
Erratic or Intermittent Display 44
Melted 43
Data Problem 42
Incomplete or Missing Packaging 41
Computer Software Problem 39
Incorrect Measurement 39
Switch, Push Button 38
Device Stops Intermittently 36
Inappropriate Audible Prompt / Feedback 34
Loss of Data 31
Device Ingredient or Reagent Problem 27
Packaging Problem 27
Computer Operating System Problem 26
Material Opacification 24
Operating System Becomes Nonfunctional 24
Housing 23
Device Markings / Labelling Problem 21
Application Program Problem 21
Product Quality Problem 21
Communication or Transmission Problem 19
Calibration Error 19
Peeled / Delaminated 17
Contamination During Use 17
Battery 16
Self-Activation or Keying 16
Screen 15
Smoking 14
Nonstandard device 14
Manufacturing, Packaging or Shipping Problem 13
Use of Device Problem 13
Label 12
Calibration Problem 12
Unexpected Therapeutic Results 11
Date/Time-Related Software Problem 11
Failure to Charge 10
Cut In Material 10
Imprecision 10
Device Issue 10
Physical Resistance / Sticking 9
Total Device Problems 109925

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. I Mar-18-2014
2 Cambridge Sensors Limited II Aug-22-2019
3 Livongo Health II Apr-29-2016
4 Nipro Diagnostics, Inc. II Feb-03-2014
5 Polymer Technology Systems, Inc. II Apr-28-2018
6 Roche Diagnostics Operations, Inc. II May-13-2014
7 Trividia Health II Sep-23-2016
8 Unistrip Technologies LLC II Dec-23-2014

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