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The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.

The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times. Hardware modifications addressed in this submission are a direct response to the obsolescing of several major hardware components including the Print Circuit Board, the ADU Controller and the Printer. The HMS software has also been modified to run on Windows CE 5.0: A complete system verification and software verification of all requirements have been performed. The Display Adapter Hantronix PCBA and Power Interconnect PCBA have been incorporated into the Interface PCBA to reduce interconnects and have a more reliable device. The Common Processing Platform has been used to replace the Freescale HC11. A complete ADU software verification of all requirements has been performed. A new Printer has been selected that will work with the new Off the Shelf Computer PCBA. The voltage of the printer has been reduced from 24 V to 7V. The Operators Manual and Device labels have been updated to reference the IEC 61010-1: 2001, 2nd Edition standard.

For determining in vitro individual responses to heparinization using whole blood on the HMS Plus instrument. For in Vitro Diagnostic Use.

The modification to the current device is to replace old USP heparin with revised USP heparin. The heparin concentrations have been increased by 13.6% for heparinized channels (ch 1 & 2 and ch 3 &4). The source of the heparin remains porcine.

The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.

The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges.

The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly. The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly. The HDR Control set is similar in design and use (vial size and reconstitution method) to the existing liquid controls being used in the HMS platform. The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.