Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- OYTBlood Establishment Computer Software, User DevelopedUProduct Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- QHRBlood Grouping ReagentUProduct Code
- QHSAnti-Human GlobulinUProduct Code
- QHTReagent Red Blood CellsUProduct Code
- KSJSystem, Identification, Hepatitis B Antigen3Product Code
- MTHTray, Leukocyte TypingNProduct Code
- MTKKit, Sample Collection, Hiv3Product Code
- MTLMonitor,Test,Hiv-13Product Code
- MTNTest, Syphilis, TreponemalNProduct Code
- MTOSoftware, Management, Microplate AssayNProduct Code
- MTPAntibody To Htlv-1, Elisa3Product Code
- MTQSoftware, Blood Virus ApplicationsNProduct Code
- MTRProgenitor Cell Enumeration2Product Code
- MTSVials, Challenge, EndotoxinNProduct Code
- MVWKit, Western Blot, Hiv-1NProduct Code
- MVXAntibody, Monoclonal Blocking, Hiv-1NProduct Code
- MVYMonoclonal, Hiv-1NProduct Code
- MVZSystem, Test, Home, Hiv-13Product Code
- MWBKit, Test, Saliva, Hiv-1&23Product Code
- MWOReagent, Blood Bank, Quality ControlNProduct Code
- MYKKit, Cord Blood CollectionNProduct Code
- MYPTest, Platelet Antibody2Product Code
- MYQKit, Antibody, ElutionNProduct Code
- MYSDevice, Ahf, Automated CryoprecipitationNProduct Code
- MYWIrradiation, Blood IndicatorsNProduct Code
- MYYSeparator, Semi-Automated, Blood Component1Product Code
- MZHTest, Quantitative, For Hla, Non-DiagnosticNProduct Code
- MZITest, Qualitative, For Hla, Non-DiagnosticUProduct Code
- MZJSystem, Concentration, Hematopoietic Stem Cell3Product Code
- MZKSystem, Separation, Hematopoietic Stem Cell3Product Code
- NDVTest, Ecarin Clotting Time (Ect)FProduct Code
- OTQResearch Use Only/Hematology DevicesNProduct Code
- OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)FProduct Code
- PBAEcarin Clotting TimeFProduct Code
- PCZInvestigational Use Only - ImmunologyNProduct Code
- PDCInvestigational Use Only - HematologyNProduct Code
- PEPMolecular Erythrocyte Typing Test3Product Code
- PJFIlluminator System For Blood Products3Product Code
- PZTPeripheral Blood Processing Device For OsteoarthritisNProduct Code
- PZUBone Marrow Processing Device For Clinical UseNProduct Code
- PZVPeripheral Blood Processing Device For Clinical UseNProduct Code
- QBGAssay, Oral Direct Thrombin InhibitorNProduct Code
- QCZMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator3Product Code
- QPWReagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection TubeNProduct Code
- QTYVon Willebrand Factor Assay2Product Code
- QWYMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator3Product Code
- SACAdamts13 Activity Test System2Product Code
- QZVPediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury3Product Code
- SALDevice, Automated Cell Locating, Bone Marrow3Product Code
- SCKLdt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative IvdNProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
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- UnknownReview Panel
Ecarin Clotting Time
- Page Type
- Product Code
- Definition
- The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure.
- Physical State
- The system requires pooled normmal human plasma to dilute the citrate whole blood usingpolypropylene plastic tube. The system's performance is monitored by two levels of quality control plasma avialble from Cardiovascular Diagnostics, Inc.
- Technical Method
- The TAS ECT provides one stage test which measures the clotting time of a plasma diluted, citrate whole blood after combining it with the prothrombin activator, ecarin. It is composed of a thin plastic card in which a flat, shallow reaction chamber containing all reagents necessary for the ECT test. In the reaction chamber, it also contains paramagnetic iron peroxide particles (PIOP) which is impeded by a clot. The signal produced by the relative movement of the PIOP is interpreted by the TAS Analyzer and reported in seconds. The greater amount of recombinant hirudin in the patient blood, the longer the clotting time is generated by the TAS system.
- Target Area
- Patient's citrated whole blood
- Review Panel
- Hematology
- Submission Type
- HDE - Humanitarian Device Exemption
- Device Classification
- F
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
The FDA has not linked product code PBA to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:
- The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
- The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
- The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.