FDA 510K for Glucose Test System
A Glucose Test System is used for the quantitative measurement of glucose levels in biological samples, such as whole blood, plasma, or serum. It plays a crucial role in diagnosing and managing diabetes mellitus and other metabolic disorders. These systems include laboratory-based glucose analyzers, point-of-care (POC) glucose meters, and continuous glucose monitoring (CGM) systems.
Intended Use of Glucose Test System
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 hypoglycaemia, and idiopathic hypoglycaemia, and of pancreatic islet cell carcinoma.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Glucose Test System
FDA 510K for Glucose Test System Device Code and Regulation Number
Hexokinase, Glucose
Intended Use
Glucose measurements are used to diagnose and manage carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell disorders.
Device Description
A Glucose Test System is an in vitro diagnostic (IVD) device designed for the quantitative measurement of glucose levels in biological samples like whole blood, plasma, or serum. It aids in the diagnosis, monitoring, and management of diabetes mellitus, hypoglycaemia, and other metabolic disorders.
The system typically includes glucose reagents or test strips, an analyzer or meters, control solutions for calibration, and software for data management (if applicable). Glucose measurement is commonly performed using enzymatic methods such as hexokinase or glucose oxidase, with detection based on spectrophotometry, electrochemical, or colorimetric principles. These systems are used in clinical laboratories, point-of-care settings, and for patient self-monitoring.
Glucose Oxidase, Glucose
Intended Use
It is an IVD device used by trained professionals for quantitative glucose testing in blood, serum, and plasma samples. It aids in diagnosing and treating diabetes, hypoglycemia, and pancreatic disorders but is not intended for neonatal screening or point-of-care use. Prescription use only.
Device Description
Glucose measurement relies on the electrochemical detection of H₂O₂ produced by the glucose oxidase reaction. The oxidation of H₂O₂ at the platinum anode generates an electrical current proportional to the glucose concentration.
System, Test, Blood Glucose, Over the Counter
Intended Use
A Blood Glucose Monitoring System is an IVD device for self-testing glucose levels in capillary whole blood from the fingertips. It helps individuals with diabetes monitor glucose control at home but is not for neonatal use, diagnosis, or screening. Designed for single-person use only.
Device Description
A Blood Glucose Monitoring System measures glucose concentration in capillary whole blood using amperometry detection. Glucose reacts with glucose oxidase on the test strip, generating an electrical current proportional to glucose levels. The result, displayed in plasma equivalents, appears on the meter screen.
Prescription Use Blood Glucose Meter for Near-Patient Testing
Intended Use
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining Dysglycemia.
Device Description
A Blood Glucose Monitoring System consists of glucose test strips and a meter that measures and displays glucose levels. The system includes glucose test strips and a meter for accurate measurement. The user applies a whole blood sample to the test strip, where an enzyme reacts with glucose, and the meter analyzes the reaction to provide a quantitative glucose reading. It is specifically designed for use with whole blood samples.
Performance Testing (Analytical) for Glucose Test System
- Linearity
- Precision (Reproducibility and Repeatability)
- Reagent On Board Stability
- Calibration stability
- Sensitivity
- Comparison studies
- Anticoagulant studies
- Limit of Detection (LoD), Limit of Quantification (LoQ) and Limit of Blank (LoB)
- Interference studies
- Reference range
- Disinfection validation test
- Robustness test
- Flex studies
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
Clinical Testing
No Guidance available for 510k submission