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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device visual, pregnancy hcg, prescription use
Product CodeJHI
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
ASSURE TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHEMTRON BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JAMES NGUYEN
  SUBSTANTIALLY EQUIVALENT 1
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
POLYMED THERAPEUTICS, INC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K112101  FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPST ...
  2.  K132834  FASTEP S10 HCG SERUM/URINE COMBO TEST
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUE DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 112 112
2015 134 134
2016 143 143
2017 113 113
2018 132 132
2019 571 571
2020 114 114
2021 158 158
2022 126 126
2023 148 148
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 794 794
False Negative Result 719 719
Incorrect, Inadequate or Imprecise Result or Readings 141 141
Incorrect Or Inadequate Test Results 65 65
High Test Results 42 42
Adverse Event Without Identified Device or Use Problem 37 37
No Apparent Adverse Event 22 22
Low Test Results 12 12
Non Reproducible Results 5 5
Product Quality Problem 4 4
Insufficient Information 4 4
Unable to Obtain Readings 4 4
False Reading From Device Non-Compliance 2 2
High Readings 2 2
No Display/Image 1 1
Use of Device Problem 1 1
No Flow 1 1
Device Operates Differently Than Expected 1 1
Device Ingredient or Reagent Problem 1 1
Display Difficult to Read 1 1
Cut In Material 1 1
Packaging Problem 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 791 791
No Clinical Signs, Symptoms or Conditions 390 390
No Known Impact Or Consequence To Patient 290 290
Insufficient Information 127 127
No Information 126 126
No Code Available 31 31
Pregnancy 20 20
Ectopic Pregnancy 12 12
Abdominal Pain 9 9
Miscarriage 7 7
Hemorrhage/Bleeding 6 6
Misdiagnosis 6 6
Patient Problem/Medical Problem 5 5
Radiation Exposure, Unintended 4 4
Test Result 3 3
Distress 3 3
Pain 2 2
Urinary Tract Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 2 2
Anxiety 2 2
Spontaneous Abortion 2 2
Menstrual Irregularities 2 2
Cyst(s) 2 2
Hormonal Imbalance 2 2
Nausea 1 1
Complaint, Ill-Defined 1 1
Mitral Insufficiency 1 1
Electrolyte Imbalance 1 1
Fall 1 1
Dyspnea 1 1
Dehydration 1 1
Weight Changes 1 1
Discomfort 1 1
Vomiting 1 1
Intermenstrual Bleeding 1 1
Unspecified Infection 1 1
Dizziness 1 1
Blood Loss 1 1
Rupture 1 1
Pyrosis/Heartburn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II May-25-2013
2 Alere San Diego, Inc. III May-21-2013
3 Beckman Coulter Inc. II Oct-17-2011
4 Beckman Coulter Inc. II Mar-21-2011
5 Ekla Corporation II Jul-09-2018
6 Mainline Technology, Inc. II Jan-15-2009
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Quidel Corporation II Mar-01-2011
9 Siemens Healthcare Diagnostics II Feb-07-2012
10 Tosoh Bioscience Inc II Jun-05-2018
11 Universal Meditech Inc. II Oct-23-2023
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