• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
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 6
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 2
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 4
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 25209
Failure to Power Up 22453
Incorrect Or Inadequate Test Results 13241
Incorrect, Inadequate or Imprecise Result or Readings 9112
High Test Results 6026
Loss of Power 5376
Device Alarm System 3380
Low Test Results 2843
Appropriate Term/Code Not Available 2134
No Display / Image 2110
Low Battery 1827
Battery Problem 1373
Device Operational Issue 1062
Device Damaged Prior to Use 1044
High Readings 1001
Insufficient Information 859
Adverse Event Without Identified Device or Use Problem 859
Component Missing 762
Device Operates Differently Than Expected 624
Display 568
Output Problem 547
Image Resolution Poor 542
Sticking 480
Missing Test Results 463
Incorrect Software Programming Calculations 388
Device Inoperable 385
Display or Visual Feedback Problem 383
Display Difficult to Read 377
Electrical /Electronic Property Problem 357
No Device Output 305
Unable to Obtain Readings 295
Failure to Calibrate 288
Low Readings 284
Device Handling Problem 279
Test Strip 278
Gauges/Meters 248
Defective Component 247
Monitor 238
Off-Label Use 235
Image Display Error / Artifact 218
Crack 210
Application Program Problem: Dose Calculation Error 192
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 136
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 67
Use of Incorrect Control Settings 65
Incomplete or Missing Packaging 55
Charging Problem 48
Thermal Decomposition of Device 46
Incorrect Measurement 45
Erratic or Intermittent Display 44
Data Problem 43
Melted 43
Computer Software Problem 39
Switch, Push Button 38
Device Stops Intermittently 36
Inappropriate Audible Prompt / Feedback 34
Loss of Data 31
Packaging Problem 28
Device Ingredient or Reagent Problem 27
Computer Operating System Problem 26
Operating System Becomes Nonfunctional 24
Material Opacification 24
Product Quality Problem 23
Housing 23
Application Program Problem 21
Device Markings / Labelling Problem 21
Calibration Error 19
Communication or Transmission Problem 19
Peeled / Delaminated 17
Contamination During Use 17
Battery 16
Self-Activation or Keying 16
Screen 15
Manufacturing, Packaging or Shipping Problem 15
Nonstandard device 15
Smoking 14
Use of Device Problem 13
Label 12
Calibration Problem 12
Date/Time-Related Software Problem 11
Unexpected Therapeutic Results 11
Device Issue 10
Cut In Material 10
Imprecision 10
Failure to Charge 10
Physical Resistance / Sticking 9
Total Device Problems 112102

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. I Mar-18-2014
2 Cambridge Sensors Limited II Aug-22-2019
3 LABSTYLE INNOVATIONS II Oct-31-2019
4 Livongo Health II Apr-29-2016
5 Nipro Diagnostics, Inc. II Feb-03-2014
6 Polymer Technology Systems, Inc. II Apr-28-2018
7 Roche Diabetes Care, Inc. II Sep-30-2019
8 Roche Diagnostics Operations, Inc. II May-13-2014
9 Trividia Health II Sep-23-2016
10 Unistrip Technologies LLC II Dec-23-2014

-
-