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The SmartCheck INRTM System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units. The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.

The SmartCheck INRTM system consists of a hand held battery- powered meter with ROM calibration chip, disposable, dual- chambered, test strips and high and low level external liquid controls. When blood is applied to the strip it migrates by capillary action to the reaction chambers of the strip. The reaction chamber contains a metallic disc and rabbit brain thromboplastin reagent. When blood enters the reaction chamber a magnetic field is applied to the strip to activate disc movement. Upon clot formation, the disc becomes immobilized and clotting is optically detected. Clotting time is calculated and displayed as an INR value.

The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation. For In Vitro Diagnostic Use

The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.

The Ischemia ACB® Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation. For In Vitro Diagnostic Use.

The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.

The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin. Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients. The safety and effectiveness of this device for use in patients with potential Acute Coronary Syndrome (ACS) with negative ECG; or positive ECG; or positive ECG combined with negative, low, or normal troponin levels; or positive troponin levels also has not been established. IMA results do not correlate with blood flow and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.

The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serum specimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), a colorimetric indicator, is added to the reacted specimen and the degree of color formation is detected spectrophotometrically on clinical chemistry analyzers. In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt to react with DTT and form a colored product. In serum of patients with ischemia, cobalt does not bind to the metal binding sites leaving more free cobalt to react with DTT and form a darker color.

The InDuo™ Blood Glucose Meter is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ meter is intended for use outside the body ( in vitro diagnostic use) by healthcare professionals and by diabetics at home as an aid to monitor the effectiveness of diabetes control. The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

The InDuo™ Blood Glucose Meter is a Class II Device for home use, as per 21 CFR § 862.1345. The changes made to the meter were done under design controls, and include ergonomic changes to allow for inclusion of the InDuo™ Insulin Doser to form a single unit for user convenience. The modified device has the same technological characteristics as the legally marketed predicate. The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.