Search Results

The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure alucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm,

The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

Our GE200 Blood Glucose Monitoring System consists of the following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and sterile lancets. The GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution.

Our Rightest Blood Glucose Monitoring System GM650 consists of the following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650. Rightest Blood Glucose Test Strips GS650, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.

Our GE300 Talking Blood Glucose Monitoring System consists of the following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter. GE300 Talking Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BIONIME Blood Glucose Monitoring Systems, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a numerical or percentage format for accuracy or other performance metrics. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through various tests.

The comparison tables (Exhibit #1, pages 4-5) primarily focus on the specifications of the new devices (GM700, GE200, GM650, GE300) against their respective predicate devices (K110737, K120423). These specifications represent the design parameters and functional characteristics rather than direct acceptance criteria for clinical accuracy.

However, the "Discussion of Non-Clinical Tests Performed" (Exhibit #1, page 6) mentions that the evaluation included:

Precision
Linearity
Interference
Sample volume
Hematocrit

The acceptance criteria for these tests are implied to be met if the results demonstrate substantial equivalence to the predicate devices and support the intended use. Without direct numerical targets for these (e.g., specific CV% for precision, correlation coefficient for linearity), a detailed "reported device performance" against stated acceptance criteria cannot be fully populated from this document.

Implied Acceptance Criteria and Performance (Based on Substantial Equivalence):

Acceptance Criterion (Implied)	Reported Device Performance (Implied by Substantial Equivalence)
Precision	Verified to be substantially equivalent to predicate devices.
Linearity	Verified to be substantially equivalent to predicate devices.
Interference	Performance with noted interferents (Uric acid, Xylose, Ascorbic acid, Dopamine HCI, L-Dopa) verified to be acceptable and comparable or improved, depending on the specific device model vs. predicate.
Sample Volume	Tested at 0.75 microliters (for new devices, different from predicate's 1.0 microliter), indicating acceptable performance at this volume.
Hematocrit Range	Performance verified within 30-55% range.
Measuring Range	20-600 mg/dL (identical to predicate).
Test Time	5 seconds (identical to predicate).
Other Physical/Functional Specs	All other 'similarities' listed in the comparison tables were met.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the verification and validation tests (precision, linearity, interference, sample volume, hematocrit).

The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus in the same way as image analysis.

4. Adjudication Method for the Test Set

This information is not provided. As noted above, ground truth for blood glucose measurements often relies on comparative analysis with a reference method, rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is generally not applicable to the evaluation of point-of-care blood glucose monitoring systems, which are objective measurement devices rather than diagnostic interpretation tools for human readers.

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

This refers to the performance of the device itself (the meter and test strip) without human interpretative intervention, which is precisely what the non-clinical tests (precision, linearity, interference, etc.) are designed to evaluate. So, yes, standalone performance was assessed through these verification and validation tests. The results of the meter measuring glucose in blood samples are inherently "standalone."

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods. While not explicitly stated, the comparison would have been against a highly accurate laboratory glucose analyzer. The document implies this by stating that the devices "quantitatively measures glucose in fresh capillary whole blood" and that performance was evaluated for "precision, linearity, interference, sample volume and hematocrit," which are all usually assessed against a known standard or reference method.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for conventional medical devices (blood glucose meters) which are based on electrochemical sensing technology, not machine learning or AI models that require "training sets." Therefore, the concept of a "training set" in the context of AI/ML is not applicable here.

9. How the Ground Truth for the Training Set was Established

As explained above, the concept of a "training set" is not applicable to this type of device.

Ask a Question

Ask a specific question about this device

Page 1 of 1