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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device method, nephelometric, immunoglobulins (g, a, m)
Product CodeCFN
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K183151  Optilite IgA CSF Kit
  2.  K190686  Optilite IgM CSF Kit
  3.  K191465  Human IgM Kit for use on SPAPlus
  4.  K191635  Optilite IgM Kit
  5.  K191985  Optilite IgA Kit
THE BINDING SITE GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K183151  Optilite IgA CSF Kit
  2.  K190686  Optilite IgM CSF Kit
  3.  K191465  Human IgM Kit for use on SPAPlus
  4.  K191635  Optilite IgM Kit
  5.  K191985  Optilite IgA Kit

MDR Year MDR Reports MDR Events
2019 8 8
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Low Test Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-31-2023
2 SIEMENS HEALTHCARE DIAGNOSTICS INC II Oct-14-2022
3 Siemens Healthcare Diagnostics, Inc. II Feb-07-2024
4 The Binding Site Group, Ltd. II Feb-19-2020
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