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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, test, pregnancy, hcg, over the counter
Product CodeLCX
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
ACESO LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ACRO BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASSURE TECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATLAS LINK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CO-INNOVATION BIOTECH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORETESTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU WONDFO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU CLONGENE BIOTECH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALSTONE BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIA DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO HIGHTOP BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RUNBIO BIOTECH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPD SWISS PRECISION DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 4
SUGENTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WHOLEPOWER BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 4 4
2017 1 1
2018 2 2
2019 3 3
2020 3 3
2021 4 4
2022 12 12
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 22 22
Incorrect, Inadequate or Imprecise Result or Readings 5 5
False Negative Result 3 3
Defective Device 2 2
Device Displays Incorrect Message 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Insufficient Information 1 1
Missing Test Results 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 16 16
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 7 7
No Information 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Miscarriage 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Church & Dwight Inc II Apr-07-2023
2 Family Dollar Stores, Llc. II Nov-07-2023
3 Family Dollar Stores, Llc. II Aug-17-2022
4 Universal Meditech Inc. II Oct-23-2023
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