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510(k) Data Aggregation
(118 days)
The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX DETERMINE / DIACHEX INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. DIACHEX* DETERMINE / DIACHEX* INFINITY provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes. The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
Here's a breakdown of the acceptance criteria and study information for the DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (DIACHEX* DETERMINE / INFINITY) | Study/Section Proving Compliance | Note |
|---|---|---|---|
| Precision (Day-to-Day) | |||
| Level 1 (low glucose) | CV% ≤ 4.69% (DETERMINE), CV% ≤ 4.68% (INFINITY) | Day to Day precision result table | Target CV% not explicitly stated but generally <5% for low glucose. |
| Level 2 (mid glucose) | CV% ≤ 2.74% (DETERMINE), CV% ≤ 2.62% (INFINITY) | Day to Day precision result table | Target CV% not explicitly stated but generally <5% for mid glucose. |
| Level 3 (high glucose) | CV% ≤ 1.71% (DETERMINE), CV% ≤ 1.65% (INFINITY) | Day to Day precision result table | Target CV% not explicitly stated but generally <5% for high glucose. |
| Precision (Within-Day) | |||
| Low glucose (37.7 - 40.4 mg/dL) | CV% ≤ 4.66% (DETERMINE), CV% ≤ 4.78% (INFINITY) | Within Day precision result table | Target CV% not explicitly stated but generally <5% for low glucose. |
| Mid glucose (85.8 - 224 mg/dL) | CV% ≤ 3.29% (DETERMINE), CV% ≤ 3.35% (INFINITY) | Within Day precision result table | Target CV% not explicitly stated but generally <5% for mid glucose. |
| High glucose (353 - 357 mg/dL) | CV% ≤ 2.11% (DETERMINE), CV% ≤ 2.10% (INFINITY) | Within Day precision result table | Target CV% not explicitly stated but generally <5% for high glucose. |
| Linearity (R²) | R² ≥ 0.9996 (DETERMINE), R² ≥ 0.9997 (INFINITY) | Linearity table | Generally, R² closer to 1 (e.g., >0.99) is considered excellent linearity. |
| Hematocrit Effect | Bias within ± 10 mg/dL for glucose < 75 mg/dL; Bias within ± 10% for glucose ≥ 75 mg/dL across 29%-59% HCT range. | Hematocrit effect table and text | All tested hematocrit levels (29%-59%) were within these criteria. |
| Altitude Effect | Bias within ± 10 mg/dL for glucose < 75 mg/dL; Bias within ± 15% for glucose ≥ 75 mg/dL at altitudes up to 7545 feet. | Altitude study text | All results met the criteria. |
| Interference | No interference (percent bias ≤ 10%) from tested substances (Acetaminophen, Ascorbic acid, Bilirubin, Cholesterol, Creatinine, EDTA, Galactose, Glycerol, Heparin, Ibuprofen, L-Dopa, Maltose, Salicylate, Sodium Fluoride, Tetracycline, Tolazamide, Tolbutamide, Triglyceride, Uric acid). | Interference table and text | Achieved for all listed interferents at specified therapeutic/high/no interference levels. |
| Clinical Accuracy (ISO 15197) | 95% of individual glucose results within ±15 mg/dL for glucose < 75 mg/dL AND within ±20% for glucose ≥ 75 mg/dL. | "The samples that met the ISO 15197 requirement were summarized below." table | Met for both devices (99.2% for DETERMINE, 99.2% for INFINITY) in technical testing. |
| Clinical Accuracy (Lay User - Fingertip) | 95% of individual glucose results within ±15 mg/dL for glucose < 75 mg/dL AND within ±20% for glucose ≥ 75 mg/dL. | "Percentage met ISO requirement" table under Lay user | 98.2% of results met the ISO 15197 requirement. |
| Clinical Accuracy (Lay User - Palm) | 95% of individual glucose results within ±15 mg/dL for glucose < 75 mg/dL AND within ±20% for glucose ≥ 75 mg/dL. | "Percentage met ISO requirement" table under Lay user | 99.1% of results met the ISO 15197 requirement. |
| Clinical Accuracy (Lay User - Forearm) | 95% of individual glucose results within ±15 mg/dL for glucose < 75 mg/dL AND within ±20% for glucose ≥ 75 mg/dL. | "Percentage met ISO requirement" table under Lay user | 97.30% of results met the ISO 15197 requirement. |
Study Details
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Accuracy (Technician vs. YSI): 118 participants (N=118 in "Clinical Accuracy of the DIACHEX* Blood Glucose Monitoring System" section).
- Clinical Accuracy (Lay User): 112 lay users for fingertip testing. For palm and forearm testing, 111 participants each (N=112 for lay user fingertip, N=111 for palm, N=111 for forearm in "Clinical Accuracy of the DIACHEX* system was performed with a total of 112 lay users..." section).
- Altitude Study: 20 volunteers for capillary whole blood samples.
- Hematocrit Study: Not explicitly stated, described as "whole blood samples spiked with 11 hematocrit levels for 4 glucose values."
- Linearity: 10 different glucose concentrations per lot of test strips.
- Precision:
- Day-to-day: 3 levels of control solutions, 3 different test strip lots, 10 measurements from 10 meters per level over 10 days (total 900 measurements per device model for day-to-day precision).
- Within-day: 5 levels of spiked whole blood, 10 measurements from 10 meters per level, 3 different test strip lots (total 1500 measurements per device model for within-day precision).
- Data Provenance: Conducted as "in-house study" performing by technician at 2 clinical sites and one OTC site. The manufacturer is Tyson Bioresearch Inc. located in Chun-nan, Miao-li County, CHINA (TAIWAN) 350. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth was established by a laboratory reference method, not by human experts in the sense of image interpretation. The YSI 2300 Glucose Analyzer was used as the reference method. No information on human expert qualifications is provided as it is not applicable for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth was established by the YSI 2300 Glucose Analyzer as a direct reference measurement, not through expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a blood glucose monitoring system, not an AI diagnostic tool for medical image analysis requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance characteristic studies (precision, linearity, hematocrit, altitude, interference) represent standalone algorithm performance as they compare meter readings directly to the YSI reference. The clinical accuracy studies also evaluate the meter's performance (standalone) compared to the YSI. The lay user studies assess the device's accuracy when operated by intended users, but the "performance" itself is the device's output compared to a ground truth, not human-in-the-loop AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established using the YSI 2300 Glucose Analyzer, which is a laboratory reference method for glucose measurement.
8. The sample size for the training set
Not applicable. This is a traditional in vitro diagnostic device, not an AI/ML device that requires a distinct "training set" for model development. The performance studies evaluate the fixed design of the device.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of AI/ML for this device. The YSI 2300 Glucose Analyzer was used as the reference standard for all performance evaluation.
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