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510(k) Data Aggregation
(39 days)
Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use
The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips. This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.
Here's a breakdown of the acceptance criteria and the study details for the Glucose Meter-Check® Solution for TaiDoc, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Glucose Meter-Check Solution are derived from its intended use as a quality control material to assess the performance of TaiDoc blood glucose meters and test strips. The "performance" in this context refers to its ability to consistently produce glucose measurements within specified target ranges when tested on the intended meters and strips.
| Characteristic / Acceptance Criteria | Reported Device Performance |
|---|---|
| Traceability of Glucose Concentration | Confirmed utilizing YSI-supplied calibrators traceable to NIST SRM 917. |
| Closed Bottle Stability (un-opened shelf-life) | 2 years (24 months) at 15°C to 30°C (59°F to 86°F), as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials. |
| Stability After Opening (percent glucose recovery) | Less than 5% change in percent glucose recovery on YSI from a single lot evaluated over 3 months (93 days in real time) when stored at ambient temperature (21-23 °C / 70-75 °F) compared to refrigerated vials (2-8 °C). |
| Value Assignment Range (for each lot and level) | Mean of all measurements ± 15 mg/dL (if glucose < 80 mg/dL) OR ± 15% (if glucose ≥ 80 mg/dL). |
| Expected Values / Reference Ranges (Target Ranges) | GOD & GDH Enzymes: - Level 1 (Low): 60-80 mg/dL (GOD), 35-65 mg/dL (GDH) - Level 2 (Normal): 100-150 mg/dL (GOD), 112-168 mg/dL (GDH) - Level 3 (High): 250-350 mg/dL (GOD), 224-336 mg/dL (GDH) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Analytical Performance Tests (Traceability, Stability, Value Assignment):
- Closed Bottle Stability: Three lots of equivalent product were used.
- Stability After Opening: Vials from a single lot were evaluated.
- Value Assignment: For each lot and level of control solution, 8 samples were measured on 5 meters using three lots of commercially distributed test strips, totaling 120 measurements (8 samples * 5 meters * 3 test strip lots = 120 measurements).
- Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, given that Bionostics, Inc. is located in Devens, MA, USA, and the submission is to the FDA, it is highly probable that the studies were conducted in the USA. The nature of stability studies and value assignment are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts and Qualifications: The document does not describe the use of human "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth for glucose concentrations is established through quantitative laboratory methods and traceable calibrators.
- Traceability of Glucose Concentration: NIST SRM 917 (National Institute of Standards and Technology Standard Reference Material) is used as the reference standard, indicating a highly certified and recognized ground truth.
- Measurement Devices: YSI 2300 and YSI-supplied calibrators are used, which are standard laboratory instruments for glucose measurement. The expertise lies in the certified nature of these instruments and calibrators, and the adherence to established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of this device. The 'ground truth' for glucose concentration is established through instrumental measurement and traceability to reference standards rather than expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers' performance is compared with and without AI assistance to assess improved accuracy or efficiency. The Glucose Meter-Check Solution is a quality control material for in vitro diagnostic devices, not an AI diagnostic tool.
6. Standalone Performance Study
- Standalone Performance: Yes, the described analytical performance studies (traceability, stability, value assignment) represent the standalone performance of the control solution. The control solution itself is tested to ensure its glucose concentrations are accurate, stable, and fall within the specified ranges, independent of a human operator's interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is primarily traceable laboratory measurements / reference standards.
- Specifically, glucose concentration is traceable to NIST SRM 917, a highly regarded primary reference standard.
- Measurements are performed using a YSI 2300 calibrated with N.I.S.T. traceable materials, which acts as the gold standard for glucose measurement in this context.
8. Sample Size for the Training Set
- Training Set Sample Size: The concept of a distinct "training set" for a machine learning algorithm is not directly applicable here, as this device is a chemical control solution, not an AI or algorithm. The "training" in this context refers to the development and formulation of the control solution to have specific characteristics and target ranges. The document states that the control solutions "are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation," implying an iterative development and testing process. However, specific "training set" sample sizes as defined in AI studies are not provided or relevant.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Similar to point 8, the concept of a "training set" and its ground truth is not directly applicable in the AI sense.
- The "grounding" for the product's development and expected performance is based on the performance characteristics of predicate devices (FORA, TaiDoc Control Solutions) and the functional requirements of the TaiDoc blood glucose monitoring systems.
- The control solution is "optimized to simulate the response of whole blood on the relevant blood glucose test systems" and is formulated to contain d-glucose, the same analyte detected by the meters. This implies that the 'ground truth' for its development involved understanding the physiological range of glucose, the performance specifications of the TaiDoc meters, and the established ranges of existing control solutions.
- The "Target Ranges" for the control solution (e.g., Level 1: 60-80 mg/dL) are themselves a form of ground truth established based on clinical relevance (low, normal, high glucose levels) and the measurement capabilities of the TaiDoc meters. These ranges would have been derived from extensive testing during the development of both the meters and the control solutions.
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