International Technidyne Corp.
Medical device manufacturer in Edison, NJ.
48510(k) clearances
0PMA approvals
20recalls
Device types
- JPA System, Multipurpose For In Vitro… 9
- GJS Test, Time, Prothrombin 8
- GFO Activated Partial Thromboplastin 5
- JBP Activated Whole Blood Clotting Time 4
- GGN Plasma, Coagulation Control 4
- FMK Single Use Only Blood Lancet With An… 3
- JKA Tubes, Vials, Systems, Serum Separators… 3
- JCA Device, Bleeding Time 2
- KFF Assay, Heparin 2
- GFT Protamine Sulphate 1
- GJA Test, Thrombin Time 1
- GIM Tubes, Vacuum Sample, With Anticoagulant 1
- KQJ System, Fibrinogen Determination 1
- GKP Instrument, Coagulation, Automated 1
- KQG Instrument, Coagulation 1
- GKR System, Hemoglobin, Automated 1
- JJX Single (Specified) Analyte Controls… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K120977 | Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional | 07/03/2013SE |
| K050983 | Irma Trupoint Creatinine Control KitJJX · Traditional | 05/16/2005SE |
| K050016 | Hemochron Signature EliteJPA · Traditional | 02/10/2005SE |
| K030818 | Hemochron Response/SystemJPA · Special | 04/02/2003SE |
| K023561 | Itc HGB Pro Professional Hemoglobin Testing SystemGKR · Traditional | 01/31/2003SE |
| K020798 | Hemochron Jr. Signature +JPA · Special | 03/28/2002SE |
| K010599 | Protime Microcoagulation System / Protime 3 CuvetteGJS · Special | 07/02/2001SE |
| K010193 | Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional | 06/06/2001SE |
| K983475 | Hemochron ResponseKQG · Traditional | 05/03/1999SE |
| K990449 | Hemochron Electronic System Verification TubeJPA · Traditional | 04/13/1999SE |
| K972866 | Hemochron Jr. Miocrocoagulation Citrated PTGJS · Traditional | 09/30/1998SE |
| K974799 | Hemochron JR Generation II, Hemochron JR SignatureJPA · Traditional | 07/07/1998SE |
| K972831 | Hemochron Citrate ApttGFO · Traditional | 11/20/1997SE |
| K961835 | Protime Microcoagulation SystemGJS · Traditional | 03/12/1997SE |
| K960749 | Hemochron Jr. Microcoagulation Low Range ActJBP · Traditional | 08/12/1996SE |
| K951072 | Protime Microcoagulation SystemGKP · Traditional | 10/27/1995SE |
| K945078 | Hemochron Hnpt/Factor Vi Pt+GJS · Traditional | 04/28/1995SE |
| K944691 | Itc Whole Blood Control Normal/Abnormal Level I or IIGGN · Traditional | 03/15/1995SE |
| K940957 | Hemochron Verigy System/Factor Vi Qualify SystemJPA · Traditional | 10/18/1994SE |
| K941007 | Catalog No. J-Act+ & Qc-Act+JBP · Traditional | 06/30/1994SE |
| K941159 | Directdraw Superserum-G Directdraw Superserum-Mini-GJKA · Traditional | 05/19/1994SE |
| K940432 | Microcoagulation Prothrombin Time TestGJS · Traditional | 05/18/1994SE |
| K940401 | Jr. Microcoagulation SystemJPA · Traditional | 05/11/1994SE |
| K935081 | Directdraw Superserum-MiniJKA · Traditional | 01/11/1994SE |
| K924637 | Hemochron Citra Onestep Aptt/Fac Vi Singshot ApttGFO · Traditional | 01/27/1993SE |
| K923302 | Tenderlett FingerFMK · Traditional | 01/22/1993SE |
| K923761 | Itc Microsample Coagulation Analyzer SystemJPA · Traditional | 01/21/1993SE |
| K924638 | Hemochron Direct Draw Aptt/Fac Vi Vacu-ApttGFO · Traditional | 01/14/1993SE |
| K923593 | Hemochron/Factor Vi Fibrinogen Assay and Cont PlasKQJ · Traditional | 09/22/1992SE |
| K921778 | Directdraw SuperserumGIM · Traditional | 05/28/1992SE |
| K915344 | Hemochron Onestep Aptt TestGFO · Traditional | 02/11/1992SE |
| K913861 | Hemochron(R) KactJBP · Traditional | 10/18/1991SE |
| K911997 | Tenderfoot(R), ModificationFMK · Traditional | 07/17/1991SE |
| K911996 | Surgicutt-Bleeding Time Device, ModificationJCA · Traditional | 07/17/1991SE |
| K911995 | Prothrombin Time (PT) by Hemochron, ModificationGJS · Traditional | 07/17/1991SE |
| K911994 | Hemochron(R) Aptt, ModificationGFO · Traditional | 07/17/1991SE |
| K910646 | Superserum Reagent (SSR)JKA · Traditional | 05/10/1991SE |
| K910181 | Hitt by Hemochron(R)KFF · Traditional | 05/10/1991SE |
| K910105 | Protamine Response Test Catalogue Number PRT 200GFT · Traditional | 02/26/1991SE |
| K904454 | Hemochron(R) Prothrombin Time/ModificationGJS · Traditional | 12/17/1990SE |
| K900126 | TT and HNTT by HemochronGJA · Traditional | 02/05/1990SE |
| K893378 | Prothrombin Time (PT) by HemochronGJS · Traditional | 06/22/1989SE |
| K883968 | TenderfootFMK · Traditional | 12/01/1988SE |
| K882481 | Hemochron Control Act Test Tube Normal/Abnor. I/IiGGN · Traditional | 08/30/1988SE |
| K882480 | Hemochron Control Plasma Normal/Abnormal Lev. I/IiGGN · Traditional | 08/30/1988SE |
| K870831 | PDA699/PDA700 Protamine Dose Assay for Hep. NeutraJPA · Traditional | 06/01/1987SE |
| K850542 | Surgicutt - Bleeding Time DeviceJCA · Traditional | 03/01/1985SE |
| K832189 | Hemochron ThrombochronometerJBP · Traditional | 10/14/1983SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0837-2013 Class II | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50.…Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin… | 09/28/2012Terminated |
| Z-2954-2011 | IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation…Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than… | 05/10/2011Terminated |
| Z-2953-2011 | Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine…Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when… | 05/10/2011Terminated |
| Z-2218-2011 | AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that…An incorrect calibration code that affects the total hemoglobin measurement was applied to affected… | 03/23/2011Terminated |
| Z-1093-2011 | Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label…Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification… | 11/30/2010Terminated |
| Z-2108-2010 | GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD.…Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the… | 07/08/2010Terminated |
| Z-2107-2010 | GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk.…Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the… | 07/08/2010Terminated |
| Z-2200-2010 | International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls…The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable… | 06/25/2010Terminated |
| Z-2110-2010 | RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and…An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may… | 06/24/2010Terminated |
| Z-1786-2010 | directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.Indication not cleared or approved. The acceptable performance range published in the directCHECK… | 04/15/2010Terminated |
| Z-2438-2010 | Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen…A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in… | 04/09/2010Terminated |
| Z-0893-2011 | Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is…There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron… | 03/31/2010Terminated |
| Z-1732-2009 | Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes…One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet… | 05/05/2009Terminated |
| Z-1239-2008 | International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers:…Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were… | 02/13/2008Terminated |
| Z-1238-2008 | International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers:…Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were… | 02/13/2008Terminated |
| Z-1237-2008 | International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers:…Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were… | 02/13/2008Terminated |
| Z-0548-2008 | ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International…An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the… | 11/19/2007Terminated |
| Z-0547-2008 | ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST, International…An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the… | 11/19/2007Terminated |
| Z-0546-2008 | ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International…An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages. | 11/19/2007Terminated |
| Z-0470-2007 | International Technidyne Corporation (ITC) ProTime Microcoagulation System…Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect… | 12/06/2006Terminated |