(140 days)
FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood ß-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the finger.
ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal capillary heelstick whole blood, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes.
FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood β-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and p-Ketone Meter to quantitatively measure fketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.
ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Pro Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
The FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System consists of: FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Meter (same as meter cleared under K101509, with addition of ketone testing capability), FORA ADVANCED GD40/GD40 Pro Glucose Test Strips, FORA Glucose Control Solutions (cleared under K093724), FORA ADVANCED GD40/GD40 Pro β-Ketone Test Strips, and ß-Ketone Control Solutions.
The provided document describes the FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System. The performance studies for both glucose and ß-ketone measurements are discussed, but specific details regarding the study design, sample sizes, ground truth establishment, or expert involvement are limited.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Metric | FORA ADVANCED GD40/GD40 Pro Blood Glucose System | FORA ADVANCED GD40/GD40 Pro ß-Ketone System |
|---|---|---|
| Glucose Measurement Accuracy | System Accuracy, ISO 15197:2013 | |
| Within ±15 mg/dL of YSI for glucose concentrations 3.0) | 4.49 | 0.20 |
2. Sample sizes for the test set and data provenance:
- Glucose Measurement:
- For glucose concentrations
§ 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.