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The CoaguChek XS Plus system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041. Thus, the device description for the CoaguChek XS Plus System remains the same as that presented and cleared in K071041. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Plus System housing and components.

The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

No technological, material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460. Thus, the device description for the CoaguChek XS Pro System remains the same as that presented and cleared in K093460. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Pro System housing and components.

The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips. The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.

No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance on K121679. Thus, the Device Description for the ACCU-CHEK Inform II System remains the same as that presented and cleared in K121679. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the ACCU-CHEK Inform II System housing and components. Please note that we intend to modify the ACCU-CHEK Inform II System labeling by adding the Super Sani-Cloth for cleaning and disinfection of the system, in addition to the Clorox Germicidal Wipes, which were previously cleared for this purpose on K121679. The Super Sani-Cloth will not replace the current Clorox Germicidal Wipe. Both wipes will be included in the product labeling.

Vapo Solution™ is an alcohol solution intended to be used only in Harvey Chemiclave sterilizers to sterilize medical and dental surgical instrument. Vapo Solution™ is intended to be a direct substitute for Vapo-Steril®. Vapo Solution™ is recommended for use in the following Chemiclave models: 4000, 5500, 6000 and models covered under K924380 and K943654. Vapo Solution™ is compatible with Chemiclave cycle parameters as follows: - Model 4000, 5000, 5500, 6000, EM5000, EM5500, and EM6000 - Operating pressure: 20-40 psi (1.41 2.82 kg/cm²) - Operating Temperature: 132 +2 ℃ (270 + 5 0r) - Maximum load: Bagged instruments: - 6" Chamber (models 4000, 5000, EM5000) 0.6 Kg (1.3 lbs) - 8" Chamber (models 5500, EM5500) 1.2 Kg (2.6 lbs) - 10" Chamber (models 6000, EM6000) 2.4 Kg (5.3 lbs) - Maximum load: Unwrapped instruments: - 6" Chamber (models 4000, 5000, EM5000) 0.75 Kg (1.7 lbs) - 8" Chamber (models 5500, EM5500) 1.4 Kg (3.1 lbs) - 10" Chamber (models 6000, EM6000) 2.8 Kg (6.2 lbs) - Model 7000 and 8000 - Operating pressure: approximately 25 psi - Operating Temperature: 132 ± 2°C (270 ±5°F) - Maximum load: Bagged instruments: - 8" Chamber (model 7000) 1.2 Kg (2.6 lbs) - 10" Chamber (model 8000) 2.4 Kg (5.3 lbs) - Maximum load: Unwrapped instruments: - 8" Chamber (model 7000) 1.4 Kg (3.1 lbs) - 10" Chamber (model 8000) 2.8 Kg (6.2 lbs) Vapo Solution™ is compatible with but not limited to the following instruments and material types: - Surgical and cutting instruments, handpieces, and similar items. - Plastics that can tolerate in excess of 132 °C. i.e. Polysulfone, Phenolic, Nylon, Teflon, Polyethylene, Polyacetal, Polypropylene. Note: Polycarbonate is not chemically compatible. - Rubber components made of Silicone, Fluorosilicone Vapo Solution™ is not compatible with the following materials: - Linen, textiles or fabrics These are incompatible with the chemical vapor process. - Liquids and agars These are incompatible with high temperature processing (132°C). - Items contained in tightly woven packs or wraps, or sealed containers These cause poor vapor penetration. - Plastics which cannot tolerate temperatures in excess of 132ºC. - Polycarbonate - Chemically incompatible. - Nylon tubing and bags Inhibits penetration of chemical vapors. Vapo Solution™ is not recommended for use for "flash" sterilization cycles.

A specific solution of various alcohols, acetone, ketone, formaldehyde, and distilled water for use only in MDT Harvey Chemiclave® sterilizers.