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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device visual, pregnancy hcg, prescription use
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeJHI
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
ASSURE TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUE DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 143 143
2017 113 113
2018 132 132
2019 571 571
2020 114 114
2021 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 563 563
False Negative Result 472 472
Incorrect, Inadequate or Imprecise Resultor Readings 83 83
Adverse Event Without Identified Device or Use Problem 36 36
Incorrect Or Inadequate Test Results 34 34
No Apparent Adverse Event 22 22
High Test Results 10 10
Insufficient Information 4 4
Non Reproducible Results 4 4
Low Test Results 2 2
Device Ingredient or Reagent Problem 1 1
Device Operates Differently Than Expected 1 1
Use of Device Problem 1 1
Device Issue 1 1
Output Problem 1 1
Display Difficult to Read 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 707 707
No Known Impact Or Consequence To Patient 165 165
No Information 116 116
No Clinical Signs, Symptoms or Conditions 100 100
Insufficient Information 77 77
No Code Available 27 27
Ectopic Pregnancy 7 7
Pregnancy 6 6
Miscarriage 5 5
Patient Problem/Medical Problem 5 5
Abdominal Pain 4 4
Misdiagnosis 3 3
Test Result 3 3
Radiation Exposure, Unintended 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 2 2
Distress 2 2
Cyst(s) 2 2
Menstrual Irregularities 2 2
Dyspnea 1 1
Nausea 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Weight Changes 1 1
Rupture 1 1
Anxiety 1 1
Intermenstrual Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ekla Corporation II Jul-09-2018
2 Tosoh Bioscience Inc II Jun-05-2018
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