(45 days)
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' office and convalescent care facility bedside testing. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell carcinoma.
The Chol+Glu Test Panel system is intended to measure cholesterol and glucose in whole blood on a BioScamer Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.
The Lipid Panel Test system is intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure three blood analytes: cholesterol and triglycerides. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
The PTS PANELS HDL Cholesterol Test system is intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
The PTS PANELS CHOL+HDL Panel Test system is intended to be used by medical professionals to measure cholesterol and high density lipoprotein cholesterol in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases.
The PTS PANELS CHOL+HDL+GLU Panel Test system is intended to be used by medical professionals to measure cholesterol, high density lipoprotein cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.
The PTS PANELS Metabolic Chemistry Panel Test system is intended to be used by medical professionals to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism or various endocrine disorders.
The above named test systems are for in vitro diagnostic use with the prescription use BioScanner Plus (CardioChek PA) reflectance photometer.
The above named test systems are modified in this submission by the addition of a CardioChek ChekMate strip for use only with the prescription use analyzer. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.
The provided document describes the BioScanner Plus Glucose Test System and related PTS PANELS test systems. The primary focus of the performance characteristics section is on the CardioChek ChekMate strips, which are a modification to the system. While the document mentions several test systems and their intended uses (glucose, cholesterol, triglycerides, HDL cholesterol), the performance data specifically addresses the ChekMate strips, which are used to check the analyzer's optics, calibration, and result handling. The information regarding the various analyte test systems largely defers to previously cleared strips and an unmodified analyzer, indicating their performance was established in prior submissions.
Here's a breakdown of the acceptance criteria and study information for the CardioChek ChekMate Strips:
Table of Acceptance Criteria and Reported Device Performance (for CardioChek ChekMate Strips)
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment: Range Appropriateness | Range (MAX – MIN) must be at least 5% R but not more than 10% R. | Not explicitly stated what the calculated ranges were, but the document states "The range is acceptable if it is at least 5% R, but not more than 10% R." |
| Value Assignment: Individual Strip Verification | Every ChekMate strip, when measured on a different CardioChek PA meter, must pass the established acceptable ranges. | The document states, "Every ChekMate strip is then measured...to verify that every strip will pass these ranges." Implies compliance. |
| Real-time Stability: Percent Recovery | Percent recovery ((Result - Result baseline) * 100) must be 100±20%. | All four lots at each of the two levels passed the criterion. |
| Re-use Stability: Failure Rate on First Test | Less than 2% failures on the first test. | The acceptance criteria was met for 1,253 uses. (Implying |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.