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TPLC - Total Product Life Cycle
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Device manual antimicrobial susceptibility test systems
Product CodeJWY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
AB BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX S.A.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 9
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIOFILCHEM S. R. 1.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. L.
  SUBSTANTIALLY EQUIVALENT 22
LIOFILCHEM S.R.L
  SUBSTANTIALLY EQUIVALENT 2
LIOFILCHEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 7
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 32
  1.  K133773  SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
  2.  K133847  SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE ...
  3.  K140985  SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP ...
  4.  K141000  SENSITITRE SUSCEPTIBILITY PLATES
  5.  K141651  SENSITITRE SUSCEPTIBILITY PLATES
  6.  K142151  SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
  7.  K142338  Sensititre HP MIC Susceptibility Plate with Tedizo ...
  8.  K143288  Sensititre Susceptibility plates
  9.  K143381  Sensititre Susceptibility Plates
  10.  K143526  The Sensititre HP MIC Susceptibility plate with Or ...
  11.  K150236  Sensititre 18 - 24 hour MIC or Breakpoint Suscepti ...
  12.  K150556  Sensititre 18-24 hours MIC or BP Susceptibility Sy ...
  13.  K152774  The Sensititre 18-24 hour MIC or Breakpoint Suscep ...
  14.  K171870  The Sensititre 18-24 hour MIC or Breakpoint Suscep ...
  15.  K172274  The Sensititre 20-24 hour Haemophilus influenzae/S ...
  16.  K172454  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  17.  K173209  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  18.  K181946  Sensititre 18-24 hour MIC Breakpoint Susceptibilit ...
  19.  K182797  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  20.  K183033  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  21.  K183324  Sensititre 20-24 hour Haemophilus influenzae/Strep ...
  22.  K192250  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  23.  K192729  Sensititre 18-24 Hour MIC or Breakpoint Susceptibi ...
  24.  K193024  Sensititre 20-24 hour Haemophilus influenzae/Strep ...
  25.  K193538  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  26.  K202612  Sensititre 20-24 hour Haemophilus influenzae /Stre ...
  27.  K203741  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  28.  K223844  Sensititre 20-24-hour Haemophilus influenzae/Strep ...
  29.  K230935  Sensititre 20-24 hour Haemophilus influenzae/Strep ...
  30.  K231988  Sensititre 20-24-hour Haemophilus influenzae/Strep ...
  31.  K231994  Sensititre 18-24 hour MIC or Breakpoint Susceptibi ...
  32.  K232310  Sensititre 20-24 hour Haemophilus influenzaelStrep ...
TREK DIAGNOSTIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TREK DIAGNOSTIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TREK DIAGNOSTIC SYSTEMS, LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 4 4
2015 11 11
2016 20 20
2017 9 9
2018 13 13
2019 10 10
2020 20 20
2021 41 41
2022 11 11
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 103 103
Incorrect Or Inadequate Test Results 17 17
Low Test Results 9 9
High Test Results 8 8
Low Readings 3 3
High Readings 2 2
Device Inoperable 2 2
Volume Accuracy Problem 1 1
False Positive Result 1 1
False Reading From Device Non-Compliance 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
No Known Impact Or Consequence To Patient 53 53
No Patient Involvement 19 19
No Consequences Or Impact To Patient 11 11
Not Applicable 3 3
Insufficient Information 2 2
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-02-2018
2 Beckman Coulter, Inc. II Apr-27-2015
3 Beckman Coulter, Inc. II Apr-27-2015
4 Beckman Coulter, Inc. II Apr-26-2015
5 Becton Dickinson & Co. II Dec-23-2015
6 Becton Dickinson & Co. II Sep-12-2014
7 Becton Dickinson & Co. II Jul-24-2013
8 BioMerieux SA II Dec-19-2017
9 BioMerieux SA II May-03-2017
10 BioMerieux SA II May-03-2017
11 BioMerieux SA II Mar-21-2017
12 BioMerieux SA II Feb-21-2017
13 BioMerieux SA II Jul-01-2015
14 Biomerieux I Dec-23-2015
15 Biomerieux III Nov-19-2014
16 Biomerieux Inc II Jan-04-2023
17 Biomerieux Inc II Aug-06-2021
18 Remel Inc I Dec-08-2022
19 Remel Inc II Mar-04-2022
20 Siemens Healthcare Diagnostics, Inc. II May-08-2012
21 Siemens Microscan II Feb-04-2009
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