Trek Diagnostic Systems, Inc.
Medical device manufacturer in Oakwood Village, OH.
68510(k) clearances
0PMA approvals
3recalls
Device types
- JWY Manual Antimicrobial Susceptibility Test… 51
- NGZ Susceptibility Test Plate, Antifungal 4
- LTT Panels, Test, Susceptibility, Antimicrobial 4
- LRG Instrument For Auto Reader & Interpretation… 3
- MJA Susceptibility Test Powders… 2
- LIE Reagent/Device, Inoculum Calibration 2
- JTW System, Transport, Aerobic 1
- MDB System, Blood Culturing 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K133038 | Sensititre Yeastone Susceptibility PlatesNGZ · Traditional | 01/31/2014SE |
| K112276 | VizionJWY · Traditional | 11/16/2011SE |
| K111615 | Sensititre 18-24 HR Susceptibility PlatesJWY · Traditional | 11/08/2011SE |
| K110583 | Sensititre OptireadLRG · Traditional | 09/22/2011SE |
| K103532 | Autoreader 2LRG · Traditional | 08/26/2011SE |
| K111429 | Sensititre (R) HP Mic Susceptibility Plate with Cefaroline (0.004-8UG/ML) and the…JWY · Traditional | 08/18/2011SE |
| K103456 | The Sensititre AimLIE · Traditional | 06/22/2011SE |
| K110331 | Sensititre Aim (TM)LIE · Traditional | 04/27/2011SE |
| K093741 | Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (HP) Mic Susceptibility PlatesJWY · Traditional | 02/25/2010SE |
| K093865 | Sensititre 18-24HR Susceptibility PlatesJWY · Traditional | 02/17/2010SE |
| K092445 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 12/16/2009SE |
| K090968 | Sensititre Yeastone Susceptibility PlatesNGZ · Traditional | 06/04/2009SE |
| K083606 | Sensititre 18-24 Hour Suseceptibility PlatesJWY · Traditional | 03/24/2009SE |
| K081063 | Sensititre Yeastone Susceptibility Plates- Additional AntimicrobicsNGZ · Traditional | 03/06/2009SE |
| K081520 | Sensititre VizionJWY · Special | 10/24/2008SE |
| K073653 | Sensititre 18 - 24 Hour Susceptibility PlateJWY · Traditional | 03/20/2008SE |
| K073558 | Sensititre 18-24 Susceptibility PlateJWY · Traditional | 03/13/2008SE |
| K073424 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 01/22/2008SE |
| K062841 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic and Susceptibility PlatesJWY · Traditional | 12/20/2006SE |
| K062839 | Modification to Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 11/09/2006SE |
| K062816 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 11/01/2006SE |
| K062783 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 10/26/2006SE |
| K062722 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 10/20/2006SE |
| K062681 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 10/13/2006SE |
| K062022 | Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 09/11/2006SE |
| K062190 | Sensititre Haemophilus / Streptococcus Pneumoniae (HP) Mic PlatesJWY · Traditional | 08/31/2006SE |
| K060783 | Susceptibility Test Plate for Vancomycin Vrsa Limitation RemovalJWY · Traditional | 05/16/2006SE |
| K053243 | Sensititre 18-24 Hours Susceptibility PlatesLRG · Traditional | 01/20/2006SE |
| K052323 | Versatrek Myco Pza KitMJA · Traditional | 01/19/2006SE |
| K052091 | Sensitire Susceptibility Plates- Additional AntimicrobicsJWY · Traditional | 09/21/2005SE |
| K041534 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Susceptibility Plate and…JWY · Traditional | 07/27/2004SE |
| K040846 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlatesJWY · Traditional | 04/26/2004SE |
| K040619 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlatesJWY · Traditional | 04/07/2004SE |
| K033522 | Sensititre 18-24 Hours Susceptibility PlatesJWY · Traditional | 02/03/2004SE |
| K032382 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlatesJWY · Traditional | 08/29/2003SE |
| K032306 | VersatrekMDB · Special | 08/22/2003SE |
| K031545 | Sensititre 18-24 Hour Susceptibility PlateJWY · Traditional | 07/16/2003SE |
| K024357 | Sensititre 18-24 Hour Susceptibility PlatesLTT · Traditional | 03/17/2003SE |
| K024353 | Sensititre 18-24 Hours Susceptibility PlatesLTT · Traditional | 03/06/2003SE |
| K022656 | Sensititre 18-24 Hours Susceptibility PlatesJWY · Traditional | 10/08/2002SE |
| K022775 | Sensititre 18-24 Hours Susceptibility PlatesJWY · Traditional | 09/25/2002SE |
| K021997 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 09/25/2002SE |
| K021627 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 06/20/2002SE |
| K020859 | CefotaximeJWY · Traditional | 05/15/2002SE |
| K021339 | Haemophilus/Streptococcus PneumoniaeJWY · Traditional | 05/09/2002SE |
| K020762 | GatifloxinJWY · Traditional | 05/09/2002SE |
| K014259 | Sensititre Heamophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 03/26/2002SE |
| K014258 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 02/19/2002SE |
| K013925 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Susceptibility PlatesJWY · Traditional | 12/21/2001SE |
| K013580 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Susceptibility PlateJWY · Traditional | 12/12/2001SE |
| K013075 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 11/26/2001SE |
| K013368 | Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateLTT · Traditional | 11/20/2001SE |
| K013195 | Haemophilus/Streptococcus Pneumoniae (Hp)Mic Susceptibility PlatesLTT · Traditional | 11/07/2001SE |
| K012921 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 11/02/2001SE |
| K012895 | Heamophilus/Streptococcus PneumoniaeJWY · Traditional | 10/30/2001SE |
| K991810 | Modification to Sensititre Yeastone Mic Susceptibility TestNGZ · Traditional | 10/09/2001SE |
| K012565 | Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 09/12/2001SE |
| K012151 | Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateJWY · Traditional | 08/29/2001SE |
| K011803 | Sensititre 18 - 24 Hours Susceptibility PlatesJWY · Traditional | 08/15/2001SE |
| K004045 | Susceptibility Test PanelJWY · Traditional | 03/06/2001SE |
| K003868 | Sensititre Susceptibility Plates-Additional AntimicrobicsJWY · Traditional | 02/27/2001SE |
| K003834 | Sensititre Susceptibility Plates-Additional AntimicrobicsJWY · Traditional | 02/23/2001SE |
| K001558 | Sensititre 18-24 Hours Susceptibility Plates (Quinupristin/Dalfopristin)JWY · Traditional | 07/24/2000SE |
| K001573 | Sensititre 18-24 Hours Susceptibility PlatesJWY · Traditional | 07/18/2000SE |
| K001036 | Sensititre 18-24 Hours Susceptibility Plates (Moxifloxacin)JWY · Traditional | 06/06/2000SE |
| K001035 | Sensititre 18-24 Hours Susceptibility Plates (Gatifloxacin)JWY · Traditional | 05/23/2000SE |
| K972772 | Esp Culture System II - Myco Susceptibility TestingMJA · Traditional | 07/13/1999SE |
| K983244 | Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)JTW · Traditional | 11/30/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2323-2012 Class III | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The…Review of instrument software databases and investigation of two customer reports determined that on rare… | 07/23/2012Terminated |
| Z-2324-2009 | Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10…Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently… | 06/04/2009Terminated |
| Z-0669-2009 | HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per boxIncorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become… | 09/22/2008Terminated |