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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
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeJHI
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
HANGZHOU ALLTEST BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 114 114
2021 158 158
2022 126 126
2023 148 148
2024 256 256
2025 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 547 547
False Negative Result 196 196
High Test Results 38 38
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Low Test Results 11 11
Unable to Obtain Readings 5 5
Non Reproducible Results 5 5
Product Quality Problem 4 4
No Apparent Adverse Event 4 4
Device Ingredient or Reagent Problem 1 1
High Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Packaging Problem 1 1
Use of Device Problem 1 1
No Flow 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 618 618
Insufficient Information 145 145
No Consequences Or Impact To Patient 38 38
No Known Impact Or Consequence To Patient 21 21
Nausea 4 4
No Information 4 4
Syncope/Fainting 4 4
Distress 3 3
Ectopic Pregnancy 3 3
Abdominal Pain 3 3
Cough 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Anxiety 2 2
Hormonal Imbalance 2 2
Spontaneous Abortion 2 2
Respiratory Tract Infection 2 2
Dizziness 1 1
Pregnancy 1 1
Fatigue 1 1
Cyst(s) 1 1
Miscarriage 1 1
Pregnancy with a Contraceptive Device 1 1
Intermenstrual Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Princeton Biomeditech Corp II Oct-30-2024
3 Universal Meditech Inc. II Oct-23-2023
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