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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, cystatin c
Product CodeNDY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
KAMIYA BIOMEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 2 2
2019 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6 6
Low Test Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gentian AS II Oct-13-2020
2 Randox Laboratories Ltd. II Jul-24-2024
3 Randox Laboratories Ltd. II Mar-22-2024
4 Tosoh Bioscience Inc II Jun-05-2018
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