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The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System. For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The modified device microINR System containing the microINR Expert Meter is derived from the existing devices microINR Meter and microINR Link Meter. The change is for the incorporation of additional connectivity functions (Wi-Fi and Ethernet connectivity on top of the Bluetooth connectivity of the microINR Link), a touchscreen, a barcode scanner as well as other configurable settings and optional functions (such as the option of including operator and patient identification). All the actions related to the extra functionalities and configurable settings are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its initial clearance on K180780 and its home use clearance in K201185.

The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determinational Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

The Xprecia Prime™ Coagulation System has been specifically designed to monitor INR of patients undergoing anticoagulation therapy with warfarin (Vitamin K antagonist). It consists of the Xprecia Prime " Coagulation Analyzer, Xprecia Prime™ PT/INR Test Strips and Xprecia " Systems PT Controls. The Xprecia Prime™ Coagulation System analyses a blood sample taken from the patient by fingerstick. The sample is transferred from the patient's finger to a test strip that has been inserted in the Xprecia Prime™ Coagulation Analyzer. The blood is mixed with a reagent contained within the strip and the analyzer detects when clotting has occurred. The result is then displayed on the analyzer's screen in either units known as the International Normalized Ratio (INR) or in calibrated seconds.

The i-STAT PTP45 cartridge is intended for use in the in vitro quantitative measurement of the extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood (venous or capillary), using the i-STAT 1 System. Measurements of prothrombin time are used to aid in the monitoring of patients receiving anticoagulant therapy with coumarin derivatives. The i-STAT PT246 Prothrombin Time test result is reported in seconds and as an International Normalized Ratio (INR). The test is intended for point of care use and is for prescription use only.

The i-STAT 1 System consists of the i-STAT 1 analyzer and the i-STAT cartridges. Other components of the i-STAT 1 System are the Electronic Simulator, the i-STAT 1 Downloader/Recharger and the i-STAT Printer. The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only. The i-STAT PTPlus cartridge is a coagulation cartridge for determining the time required for complete activation of the extrinsic coagulation cascade. The cartridge contains electrochemical sensors and test reagents that must be mixed with the sample. The reagents include the reactive ingredient to activate the coagulation cascade as well as electrochemical markers that generate a sensor signal when the cascade is fully activated. The analysis time of the i-STAT PT2405 cartridge is up to 300 seconds (5 minutes). The sample volume required for the i-STAT PT2105 cartridge is approximately 20 ul of whole blood (venous or capillary) without added anticoagulant. The i-STAT PTplus cartridge is a single-use disposable unit that is self-contained. The test reagents and sample fluids do not contact the instrument or user. All the test steps and fluid movements occur within the cartridge. The i-STAT 1 System has an internal quality control (internal simulator) and an external quality control (Electronic Simulator). The internal and external simulators are used to check the instrument signal-reading function. In addition to the quality controls within the i-STAT 1 System, liquid quality controls are available as an optional quality control methodology to meet the regulatory compliance requirements applicable to the facility where they are to be used. The liquid quality controls are the i-STAT PT2008 Control Levels 1 and 2 and can be used for the quality control of the i-STAT PT2005 cartridge. The coagulation controls consist of lyophilized citrated human plasma and calcium chloride fluid for reconstitution. i-STAT PT2145 Control Level 1 has been formulated to produce a normal prothrombin time. Level 2 has been formulated to produce an extended prothrombin time. Each level of control is packaged as a box of 5 vials containing 1 mL of lyophilized citrated human plasma and 5 vials of 1.5 mL of calcium chloride diluent. The i-STAT PT2"45 controls are intended for use with the i-STAT PTP"46 cartridge on the i-STAT System, and values assigned to these controls may not be commutable with other commercial methods.

The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System. For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The modified device microINR System containing the microINR Link Meter is derived from the existing device microINR Meter. The change is for the addition of Bluetooth connectivity to the meter. Bluetooth functionality stays inactive during the testing/measuring process. All the actions related to Bluetooth functionality are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its clearance on K201185.

The STA- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R family, STA Compact family and STA Satellite family instruments. STA- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains: STA® - NeoPTimal 5: 6 x 5 ml vials of Reagent 1, 6 x 5 ml vials of Reagent 2 STA® - NeoPTimal 10: 12 x 10 ml vials of Reagent 1, 12 x 10 ml vials of Reagent 2 Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen. Reagent 2 is a solvent containing calcium. The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen). The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used: INR = ( Patient's PT / Mean Normal PT ) * ISI The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.

The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood. The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is not intended to be used for screening purposes. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.

The Coaq-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is a portable medical device for the measurement of the Prothrombin Time (PT) using fresh capillary whole blood obtained from a finger stick. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is a handheld device that directly detects clot formation. The System measures the PT of fresh capillary whole blood using micromechanical end point detection. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the disposable test strip. The test strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter. The PT test and the result is displayed as International Normalized Ratio (INR). The result is date/time stamped and stored in the memory of the meter. The device is powered by 4 AA batteries. This Coag-Sense Prothrombin Time (PT)//NR Monitoring System for Patient Self-Testing uses the exact same test and control strip as the predicate devices.

HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend. In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel. The fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.

The microlNR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microINR System consists of a microINR Meter and microINR Chip and uses fresh capillary whole blood from a fingerstick. The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System. For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action. The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection. The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.

The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density. DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate. The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR). For use with ONext. For clinical professional laboratory and prescription use only. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to: - Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results. - Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results. - Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process. To perform the operations for which it has been designed, QNext automatically follows the steps listed below: - Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes. - Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes. - Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes. - Management of test requests. ● - Execution of test procedures. - Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS. - Management of disposable components. ● The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module. DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw сар. DG-PT reagent is used to perform PT tests for: - the evaluation of the extrinsic and common coagulation pathways. - The monitoring Oral Anticoagulant Therapy with warfarin. The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.

The TruDiagnosis® System is an in vitro diagnostic device intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology. The TruDiagnosis® System consists of the TruDx® 2000 Imager, the TruArray® Warfarin Sensitivity Test Kit, and the ProFlex™ PCR System using the ProFlex™ 2x Flat Sample Block. The TruDx® 2000 Imager is an instrument intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology. The TruArray® Warfarin Sensitivity Test Kit is an in vitro diagnostic test for the detection and genotyping of the 2C9*2, 2C9*3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and Vitamin K epoxide reductase CL, VKORCI, gene promoter polymorphism (-1639) from genomic DNA of human saliva samples collected using the Oragene® Dx Device (OGD-500) as an aid in the identification of patients at risk for increased warfarin sensitivity. The TruArray® Warfarin Sensitivity Test Kit is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.

The TruDiagnosis® System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing on-slide Polymerase Chain Reaction (PCR) gel-drop microarray technology. The TruDiagnosis® System consists of the: - Hardware: TruDx® 2000 Imager ● - Software: TruSpot™ Software ● - . Test Kit: TruArray® Warfarin Sensitivity Test Kit - TruArray® Test Slide o - o TruPlex™ reagents - Thermal Cycler: ProFlex™ PCR System using the ProFlex™ 2x Flat Sample Block ● Hardware: Akonni's microarray imager (TruDx®2000) is an instrument that consists of a highintensity green light emitting diode (LED), custom optics, and a digital grayscale camera. - . The purpose of the TruDx® 2000 Imager is to capture a fluorescence image of the microarray after completing the test. - The user inserts the TruArray® Test Slide into the TruDx® 2000 Imager and follows . the on-screen prompts. The resulting microarray image is automatically analyzed and reported with the TruSpot™ Software. Software: Akonni's TruSpot™ Software, integrated within the imager, locates and segments each fluorescently labeled microarray Gel-Element and reports signal-to-noise ratios (SNR). Assay results interpreted by TruSpot™ Software program are assigned a genotype and presented to the end user in a report format. Test Kit: The TruArray® Warfarin Sensitivity Test Kit includes consumables and reagents necessary to perform multiplex on-slide PCR amplification, and fluorogenic target-specific microarray-based hybridization. Specifically: - The TruArray® Test Slide (loaded with target DNA) undergoes thermal cycling via . asymmetric amplification to enrich single stranded fluorescently labeled complimentary strands to capture probes printed on the microarray (asymmetric PCR and allele specific hybridization occur in the same chamber). After hybridization, arrays are washed and dried, and the user then inserts the microarray into the TruDx® 2000 Imager and follows the on-screen prompts. The warfarin assay performed with the test kit is an in vitro diagnostic test for the detection and genotyping of the 2C9*2, 2C9*3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and Vitamin K epoxied reductase C1, VKORC1 3673, gene promotor polymorphism (-1639) mutations from genomic DNA of human saliva samples collected using the Oragene® Dx OGD-500 Device (K110701). Thermal Cycler: The ProFlex™ PCR System with the ProFlex™ 2x Flat Sample Block, a component of the TruDiagnosis System, is an end-point thermal cycler, specifically designed for the amplification of nucleic acids using the Polymerase Chain Reaction (PCR) process. The user interface includes a touchscreen with a graphical display that shows the time, status, and temperature for each run. A touchscreen keypad allows you to enter information into fields on the display screen.