• 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 enzymatic method, creatinine
Product CodeJFY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
HEALTHY.IO LTD
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TECO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
YD DIAGNOSTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 16 16
2018 34 34
2019 56 56
2020 34 34
2021 57 57
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 65 65
High Test Results 61 61
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Non Reproducible Results 21 21
Adverse Event Without Identified Device or Use Problem 16 16
High Readings 12 12
Insufficient Information 6 6
Appropriate Term/Code Not Available 6 6
Low Readings 2 2
Incorrect Or Inadequate Test Results 2 2
Imprecision 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 96 96
No Clinical Signs, Symptoms or Conditions 64 64
No Consequences Or Impact To Patient 34 34
Insufficient Information 5 5
No Patient Involvement 3 3
Test Result 3 3
Unspecified Kidney or Urinary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Beckman Coulter Inc. II May-12-2017
3 Ortho-Clinical Diagnostics II Aug-24-2020
4 Ortho-Clinical Diagnostics III Sep-19-2018
5 Sentinel CH SPA II Jun-27-2017
6 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
7 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
-
-