Trek Diagnostic Systems, Ltd.
Oakwood Village, OH, US
TREK DIAGNOSTIC SYSTEMS, LTD. appears in FDA device records in Oakwood Village, OH. FDA records list 68 510(k) clearances between and , 6 PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Trek Diagnostic Systems, Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Remel Cleveland, A Division of Remel Inc.registration
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Trek Diagnostic Systems, Ltd. between 1998 and 2014. The busiest year on record is 2001, with 14. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 14 |
| 2002 | 9 |
| 2003 | 5 |
| 2004 | 4 |
| 2005 | 1 |
| 2006 | 11 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 2 |
| 2011 | 7 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | |
| K112276 | VIZION | JWY | Substantially Equivalent | |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K110583 | SENSITITRE OPTIREAD | LRG | Substantially Equivalent | |
| K103532 | AUTOREADER 2 | LRG | Substantially Equivalent | |
| K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | JWY | Substantially Equivalent | |
| K103456 | THE SENSITITRE AIM | LIE | Substantially Equivalent | |
| K110331 | SENSITITRE AIM (TM) | LIE | Substantially Equivalent | |
| K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | |
| K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | NGZ | Substantially Equivalent | |
| K081520 | SENSITITRE VIZION | JWY | Substantially Equivalent | |
| K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent | |
| K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent | |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K062783 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K062722 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K062681 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K062022 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K062190 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | JWY | Substantially Equivalent | |
| K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL | JWY | Substantially Equivalent | |
| K053243 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | LRG | Substantially Equivalent | |
| K052323 | VERSATREK MYCO PZA KIT | MJA | Substantially Equivalent | |
| K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | JWY | Substantially Equivalent | |
| K041534 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL | JWY | Substantially Equivalent | |
| K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | JWY | Substantially Equivalent | |
| K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | JWY | Substantially Equivalent | |
| K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K032382 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | JWY | Substantially Equivalent | |
| K032306 | VERSATREK | MDB | Substantially Equivalent | |
| K031545 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent | |
| K024357 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | LTT | Substantially Equivalent | |
| K024353 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | LTT | Substantially Equivalent | |
| K022656 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K022775 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K021997 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K021627 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K020859 | CEFOTAXIME | JWY | Substantially Equivalent | |
| K021339 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE | JWY | Substantially Equivalent | |
| K020762 | GATIFLOXIN | JWY | Substantially Equivalent | |
| K014259 | SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K014258 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | |
| K013925 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K013580 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1530126 | 1000515493 | Remel Cleveland, A Division of Remel Inc. | 1 Thermo Fisher Way, Oakwood Village, OH 44146 US | 2026 | |
| 8021914 | 3002806332 | TREK DIAGNOSTIC SYSTEMS, LTD. | Units 17 - 19, East Grinstead West Sussex RH19 1XZ GB | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- LQMGram Negative Identification Panel
- LQLGram Positive Identification Panel
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- JWYManual Antimicrobial Susceptibility Test Systems
- JQXNephelometer, For Clinical Use
- LTTPanels, Test, Susceptibility, Antimicrobial
- LIEReagent/Device, Inoculum Calibration
- LTWSusceptibility Test Cards, Antimicrobial
- NGZSusceptibility Test Plate, Antifungal
- MJASusceptibility Test Powders, Antimycobacterial
- MDBSystem, Blood Culturing
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- JTWSystem, Transport, Aerobic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1939-2020 | SWIN 2017 database, Model YSW4000 | Potential for out of range microbial results | Class II | Terminated | |
| Z-2323-2012 | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids. | Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database. | Class III | Terminated | |
| Z-2324-2009 | Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results. | Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA. | Terminated | ||
| Z-0669-2009 | HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box | Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm. | Terminated | ||
| Z-1540-05 | VersaTREK Myco AS. | Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results. | Terminated | ||
| Z-0708-05 | Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. | Blood culture bottles with an error in the bar code on the labels, were shipped. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain