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The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates.

The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions. The StatStrip Xpress Glucose Control Solutions are intended for use with the StatStrip Xpress Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results. There are 3 levels of controls (Levels 1, 2, and 3).

The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).

The StatStrip Xpress Blood Glucose Monitoring System consists of a hand held StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), Instructions for Use Manual, and Quick Reference Guide.

The StatStrip Xpress Blood Glucose Monitoring System is identical in fit, form, and function to the StatStrip Xpress Glucose Hospital Meter System which was previously cleared in K150461. The Blood Glucose Monitor, Test Strip, and Control Solutions for both the StatStrip Xpress Blood Glucose Monitoring System (subject device) and StatStrip Xpress Glucose Hospital Meter System (reference device) are identical. The only difference between them is the intended use and labeling. The StatStrip Xpress Glucose Hospital Meter System was cleared in K150461 for use with critical care patients. This submission is to expand the intended use of Nova's StatStrip Xpress Glucose Meter System to include Over-the-Counter (OTC) use for single-patient home use.

The predicate device Nova Max Blood Glucose Monitoring System (K070255) was intended for OTC/home use.

As demonstrated in Table 2-1 below, the StatStrip Xpress Blood Glucose Monitoring System has the same intended use as the Nova Max Blood Glucose Monitor System. In addition, they are the same in the following characteristics:

• The Glucose Methodology: Glucose Oxidase Biosensor
• Test results: mg/dL, plasma equivalent values
• Sampling types : capillary whole blood obtained from the fingertip
• The size and weight
• The power source
• The monitor data storage

The major difference between the subject device and the predicate device is in their test strips. The Nova Max Blood Glucose Test Strips have two measurement wells; while the StatStrip Xpress Glucose Test Strips have four measurement wells. Both test strips utilize a Reference well and a Glucose measurement well. The two additional wells designed into the StatStrip Xpress Glucose Test Strips measure and correct for Electrochemical Interferences and Hematocrit. The improved design of the StatStrip Xpress Glucose Test Strip provides increased glucose measurement accuracy even under variable electrochemical interferences and hematocrit extremes. Therefore, the test range and acceptable Hematocrit range are different between the two systems as stated in the Table 2-1.

The StatStrip Glucose Test Strip reacts with the glucose in the test sample. The reaction produces an electrical current which is proportional to the amount of glucose in the sample, and the electrical current is detected by the monitor and displayed to the user as a glucose value.

Three levels of control solutions (Level 1, Level 3) are available for use with the StatStrip Xpress Blood Glucose Monitoring System and these were previously cleared in K150461.

The Nova Biomedical Corporation's StatStrip Xpress Blood Glucose Monitoring System underwent a clinical study to demonstrate its accuracy and usability for over-the-counter (OTC) home use.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 360 unique subjects. Each subject used a different StatStrip Xpress Blood Glucose Monitor.
• Data Provenance: The document states "An external lay person clinical study was conducted at one site by one principal investigator." While the specific country of origin is not explicitly mentioned, the company is based in Waltham, MA, USA, and the study was approved by an Institutional Review Board (IRB), suggesting it was a prospective study conducted in the USA.

3. Number of Experts and Qualifications for Ground Truth

• The document does not explicitly state the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method

• The document does not describe an adjudication method for the test set.

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

• No MRMC comparative effectiveness study was done. This study focuses on the standalone performance of the device used by laypersons (self-testing) compared to a laboratory reference method.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted. The accuracy of the StatStrip Xpress Blood Glucose Monitoring System (the algorithm and hardware used by laypersons without human-in-the-loop assistance beyond the user following instructions) was evaluated against a Yellow Springs International (YSI) reference method.

7. Type of Ground Truth Used

• Expert Consensus: Not explicitly stated as the primary ground truth.
• Pathology: Not applicable for glucose monitoring.
• Outcomes Data: Not applicable for glucose monitoring.
• Other: The ground truth was established by a Yellow Springs International (YSI) reference method, which is a highly accurate laboratory method for measuring glucose concentrations.

8. Sample Size for the Training Set

• The document does not provide details on a separate training set or its sample size. The study described is a clinical validation study, not a development or training study for an AI algorithm.

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

• This information is not provided as the document describes a clinical validation study and not an AI model training process.

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