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The Rapidpoint™Coag Enoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, ≥ 1.0 IU/ml, of the low molecular weight heparin (LMWH), Lovenox®/Clexane® (enoxaparin sodium)¹, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.0 IU/ml and the absence of drug. The test provides information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician

The RapidPoint Enoxaparin (ENOX) test is a one-step dry coagulation method performed on the RapidPoint Coag analyzer. All of the components necessary to perform the assay, with the exception of patient sample, are included in the reaction chamber of the test card. In the ENOX test, factor X is rapidly converted to factor Xa by a specific factor X activator initiating the clotting process. Enoxaparin, from the patient's blood, complexes with antithrombin (AT), to inhibit factor Xa and lengthen the clotting time. Reported clotting times in excess of the assay cut-off indicate an enoxaparin concentration greater than or equal to 1.0 International Units per milliliter. The results generated by the ENOX test are indicative of the anticoagulant effect produced by enoxaparin in citrated arterial whole blood. The test card formulation contains purified Factor Xa activator, calcium, phospholipid and stabilizers. Paramagnetic iron oxide particles (PIOP) are included to provide an optical detection mechanism in the presence of patient sample.

The Rapidpoint Low range Heparin Management Test Card is to be used with the Rapidpoint Coag (formerly TAS) Analyzer to monitor the effects of low to moderate levels of unfractionated heparin on coagulation in noncitrated arterial whole blood samples from patients undergoing diagnostic and interventional procedures. The test is for in vitro diagnostic use. It is especially suited for professional use in decentralized areas of the hospital near the patient's bedside, in the cardiac catheterization lab, and other areas where patients are treated with low to moderate levels of heparin.

The Rapidpoint LHMT provides a method to measure the response of a patient to heparin. A noncitrated whole blood sample can be used for this test. The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample flows into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.

The new Rapidpoint Coaq HMP controls are intended to be used exclusively with the Rapidpoint Coag Analyzer and the Rapidpoint Coag Heparin Management Test (HMT), Heparin Titration Test (HTT), and Protamine Response Test (PRT) cards to provide a method for quality control of the system. The controls produce clotting times that must be within accepted, standard ranges, when tested at CVDI before release of product for sale, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of HMT. HTT. and PRT card results.

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The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. When used in conjunction with the Rapidpoint Coag and the Heparin Management Panel Cards (Heparin Management Test, Heparin Titration Test, and Protamine Response Test) Cards, its intended use is to generate information on heparin management.

The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. The Analyzer is a point of care instrument designed to determine hemostatic parameters of blood and plasma samples. The Accent works in conjunction with the Analyzer to provide dosing information for heparin and protamine during cardiopulmonary bypass procedures. The Accent determines this information by combining test results from the Analyzer with patient data entered into the Accent by the user. During the course of a CPB procedure, the user must perform a series of tests using the Analyzer, The test cards that must be used include the Heparin Management Test (HMT™), the Heparin Titration Test (HTT™), and the Protamine Response Test (PRT™). The results of these tests provide the Accent with information on how the patient's blood will respond to the addition of Heparin and Protamine. The Accent uses this information to calculate recommended dosages of Heparin or Protamine to be given to the patient to reach a target value entered into the Accent by the user. The target value may be either a heparin concentration or a clotting time. The Accent includes an eight-inch diagonal touch screen for user interface and a built in printer for recording test results. The case is designed with a protective front cover that doubles as a holder for the Analyzer when the system is in use. The Accent is powered by an internal power supply that also orovides power to the Analyzer. The Accent and the Analyzer communicate through a serial cable that must be plugged into the Analyzer and is permanently attached to the Accent. The HTT card provides a method to determine the response of a patient to heparin. Before heparin administration, baseline Heparin Management Test (HMT) and HTT values are determined for the patient with the Rapidpoint" Coag (formerly TAS) Analyzer. Using these values, the Rapidpoint ACCENT will calculate the dose of heparin necessary to produce a desired concentration or effect of this drug in the patient's blood. Both citrated or noncitrated whole blood samples can be used for these tests. The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time. The PRT card is made for use with citrated or noncitrated blood samples containing heparin. The PRT is a modification of the HMT card and consists of a single test card that contains calcium chloride to initiate coagulation in citrated blood samples, celite as activator, stabilizers. and protamine sulfate. The test results will depend on heparin activity in the blood, which in turn depend on the levels of heparin, of coagulation factors, and of heparin inhibitors in the sample. The higher the level of heparin activity, the greater the protamine sulfate dosage required to inhibit it. The results of the PRT card are used with values produced on HMT cards with samples taken just before protamine administration, to determine the response of the individual to the agent. The values are stored by the ACCENT, which performs the calculations to determine dose recommended to neutralize the heparin present in the patient. The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.

The TAS analyzer with software version 4.0 is intended to be used with TAS test cards to monitor the hemostatic activity of whole blood and plasma samples. The TAS analyzer is a portable system designed to be used in non-laboratory testing environments by healthcare professionals. TAS test results are reported in quantitative units of measurement.

The TAS Analyzer with software version 4.0 provides a method of testing for coagulation parameters in samples of citrated or non-citrated blood or citrated plasma. The instrument is designed to be used with disposable test cards. The test cards are approximately the size of a credit card with a magnetic stripe on the back which is encoded with data including the test type and lot specific test parameters. The cards contain dried reagent which includes paramagnetic iron oxide particles in a small thin reaction chamber. When a sample is added to the test card, the reagent, particles, and sample mix. The instrument has a permanent magnet and an electromagnet which move the particles in the sample. The particle motion is monitored with a light source and detector. The electromagnet is energized repeatedly for half a second then turned off for half a second. When the electromagnet is on, the particles alian themselves with the magnetic field lines produced by the electromagnet. When the electromagnet is off, the particles align with the weaker field lines of the permanent magnet. As the sample clots, the motion of the particles is restrained. Software algorithms monitor the change in particle motion and determine features such as clotting time, lysis time, or other mathematically derived characteristics. These values are then reported to the user. The software provides additional features to the operator such as optional operator identification codes, storage of 1000 test results, and a QC lockout mode which helps ensure that controls are performed. Most features are available to the user in one of two ways. Features which are intended for any operator to access are listed as options on the User menu. Features which are limited to supervisors are listed as options on the Supervisor menu. Access to the Supervisor menu is limited by a password. This new software version adds new features such as Electronic Quality Control and improves some existing features. Many of the changes are minor modifications to the user interface. Other changes are more significant, providing the user with four new test types and a few new options. A 510(k) will be filed for each of the new tests individually. In each case, the addition to the software of the capability to process the test does not allow the operator to perform the test without having the new test cards. The test cards for each of these tests will not be sold for human diagnostic or prognostic purposes until clearance has be granted by the FDA. This 510(k), which is for the new software version, does not address the clinical performance or efficacy of these new test cards. The 4.0 software version has been developed under design control with the features verified and the design validated. The design, verification, and validation of the new and modified operator features in the 4.0 software version are covered in this submission.

The TRAQS is a database management system that is designed specifically to collect, organize, and store Thrombolytic Assessment System (TAS) analyzer records

TRAQS is a software package designed for computers running the Windows 95 operating system. TRAQS provides features which allow the user to collect, view, and sort patient and control results from Thrombolytic Assessment System (TAS) analyzers. TRAQS also provides a method for the user to enter normal ranges and then compare the stored data set against the ranges. Stored results which fall outside the appropriate range are flagged on the screen and in printouts as out of range. Sets of stored TAS results displayed on the screen can be saved to archive files for later viewing or printing. TRAQS also keeps track of the number of results collected from TAS analyzers and can display this data by TAS serial numbers. No capability is provided to alter the data associated with TAS results. A comprehensive users manual is supplied with the software.

Intended for use with the TAS analyzer and TAB LHMT cards to provide a method for quality control of the system.

The controls for TAS LHMT cards consist of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient with a prolonged clotting time due to administration of heparin. These controls are made with pig plasma. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of Medtox, (Burlington, NC). This consists of a closed, crushable glass ampoule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter in the tip (to remove glass shards from the sample). The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampoule is crushed inside the plastic sleeve, which allows the diluent to mix with the Ivophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed and three drops of plasma suspension are discarded into a biohazard waste container (to eliminate the dilution effect of the diluent that is contained in the filter). A drop of the plasma suspension is added to a TAS LHMT card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.

The new TAS PT-NC Controls are intended to be used with the TAS Analyzer and PT-NC test cards to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of PT-NC test card results. These controls were designed to allow CVDI's point of care customers to maintain accepted laboratory standards and requirements. These controls also can be used to determine system (TAS Analyzer and PT-NC test cards) precision. The controls are substantially equivalent in Intended use to other control materials used in coagulation tests.

The controls for TAS PT-NC test cards consist of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient with an abnormally prolonged clotting time due to a deficiency of extrinsic coagulation factors. These controls are made with human plasma screened for antibodies to and antigens of hepatitis and Human Immunodeficiency viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDITek (Burlington, NC). This consists of a closed, crushable glass ampoule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter in the tip (to remove glass shards from the sample). The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampoule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed and three drops of plasma suspension are discarded into a biohazard waste container (to eliminate the dilution effect of the diluent that is contained in the filter). A drop of the plasma suspension is added to a TAS PT-NC test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.

The new TAS aPTT Controls are intended to be used with the TAS Analyzer and aPTT cards, cleared by the FDA, to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of aPTT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.

The controls for TAS aPTT cards consists of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient with a clotting factor deficiency of the intrinsic or common coagulation pathway. These controls are made with human plasma screened for antibodies to and antigens of human immunodeficiency and hepatitis viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDItek. This consists of a closed, crushable glass ampule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter tip. The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed, two drops of plasma are discarded into a biohazard waste container, and a drop of the plasma suspension is added to a TAS aPTT test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.