Search Results

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

2. Sample sizes for the test set and data provenance:

• Glucose Measurement:
  • For glucose concentrations < 100 mg/dL: n=100
  • For glucose concentrations ≥ 100 mg/dL: n=490
  • Data Provenance: "clinical settings by healthcare professionals and lay users," implying prospective clinical data. The country of origin is not specified but the company is Taiwanese.
• ß-Ketone Measurement (Single-patient use):
  • For ß-ketone concentrations < 0.6 mMol/L: n=50
  • For ß-ketone concentrations ≥ 0.6 mMol/L: n=100
  • Data Provenance: "clinical settings by healthcare professionals and lay users," implying prospective clinical data. The country of origin is not specified but the company is Taiwanese.
• ß-Ketone Measurement (Multi-patient use):
  • For ß-ketone concentrations ≥ 0.6 mMol/L: n=190
  • Data Provenance: "clinical settings by healthcare professionals and lay users," implying prospective clinical data. The country of origin is not specified but the company is Taiwanese.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The ground truth refers to a "reference" method, specifically "YSI" for glucose (likely Yellow Springs Instruments, a common lab reference method) and an unspecified "reference" for ß-ketone. Since these are in vitro diagnostic devices, the ground truth would typically be established by laboratory reference methods rather than expert clinician consensus.

4. Adjudication method for the test set:

Not applicable. The ground truth is established by laboratory reference methods, not expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study is mentioned. The studies focus on the accuracy and precision of the device itself against a reference standard.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

These are in vitro diagnostic devices, not AI algorithms in the traditional sense of image analysis or complex decision support. The performance reported is the standalone performance of the device and test strips in measuring glucose and ß-ketone concentrations in blood samples.

7. The type of ground truth used:

• Glucose: YSI (Yellow Springs Instruments), a laboratory reference method.
• ß-Ketone: An unspecified "reference" method.

8. The sample size for the training set:

The document does not provide information about a separate "training set" or its sample size. For in vitro diagnostic devices, the development process generally involves analytical and clinical validation, but not typically a distinct "training set" in the machine learning sense.

9. How the ground truth for the training set was established:

Not applicable, as a distinct training set (in the machine learning sense) and its ground truth establishment are not mentioned for these in vitro diagnostic devices.

Ask a specific question about this device