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The GLUCOCARD™ 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

GLUCOCARD™ 01 Blood Glucose Meter:

The GLUCOCARD™ 01 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD™ 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips:

GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the palm. GLUCOCARD™ 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

CIECOCARD" 01 CONTROLA

For use with GLUCOCARD™ 01 Blood Glucose Meter and GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).

The GLUCOCARD 01 Blood Glucose Monitoring System consists of a meter, sensor test strips, and control solutions for use as an aid to monitor the effectiveness of diabetes control.

The ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The acceptance criteria and supporting study details are as follows:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format that compares against device performance. However, it indicates "a full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems." The conclusion states that "bench testing results and clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate," the Advance Micro-draw BGM.

Based on typical FDA expectations for blood glucose monitoring systems, common accuracy criteria include:

• ISO 15197:2003 (older standard applicable around 2008):
  • 95% of results must be within ±15 mg/dL of the laboratory reference method for glucose concentrations < 75 mg/dL.
  • 95% of results must be within ±20% of the laboratory reference method for glucose concentrations ≥ 75 mg/dL.
• Clinical Accuracy: Often assessed using Clarke Error Grid Analysis, where a high percentage of results fall within zones A and B (clinically acceptable accuracy).

Without specific numerical results or predefined criteria from the document, a direct table of acceptance vs. performance cannot be constructed. The study implies that the device met the existing FDA guidelines and demonstrated substantial equivalence to the predicate.

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

• Sample Size: The document does not specify the exact sample size for the clinical test set used to evaluate accuracy. It only states that "Clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission to the FDA, it is highly likely that the clinical studies were conducted in the USA and were prospective in nature to gather performance data for the specific device.

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical test set. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) operated by trained laboratory personnel, rather than interpretation by clinical experts in the same way an imaging device might use radiologists.

4. Adjudication Method for the Test Set

Not applicable in this context. Blood glucose measurements are quantitative and compared directly to a laboratory reference standard. There is no ambiguous interpretation that would require adjudication among multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a blood glucose meter, not an AI-assisted diagnostic tool where human readers interpret results. The study focuses on the accuracy of the device's quantitative measurement against a reference standard.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was a standalone study. The GLUCOCARD 01 Blood Glucose Monitoring System's performance (i.e., its accuracy in measuring glucose) was evaluated directly against a laboratory reference method. Although users operate the device and interpret the numerical output, the accuracy evaluation itself is of the device's measurement capability without an "AI assistance" component to be compared against human interpretation.

7. Type of Ground Truth Used

The ground truth used for the clinical accuracy evaluation was a laboratory reference method (e.g., a glucose analyzer like a YSI instrument), which provides a highly accurate and precise measurement of blood glucose concentration.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. Blood glucose meters typically do not involve AI algorithms that require a separate training set in the conventional sense. Their calibration and performance are based on chemical and electrochemical principles and are validated through standard bench and clinical testing.

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

As noted above, a "training set" in the context of an AI/ML algorithm is not applicable for this type of medical device based on the information provided. The device's internal calibration and analytical performance are established through rigorous engineering, chemical formulation, and extensive bench testing (linearity, analytical precision, interference studies) using samples with known glucose concentrations, rather than a separate "training set" with established ground truth.

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