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510(k) Data Aggregation
(356 days)
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FreeStyle Precision Neo Meter is for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Meter, in conjunction with the FreeStyle Precision Neo Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions through electrical mediation.
The FreeStyle Precision Neo System is compatible with the following components and accessories:
- . FreeStyle Precision Neo Blood Glucose Test Strips (available separately)
- MediSense Glucose and Ketone Control Solutions (available separately) ●
- USB Cable (available separately) ●
- FreeStyle Lancing Device II ●
- Thin Lancets
The FreeStyle Precision Neo System also includes a hypoglycemia and hyperglycemia trend indicators feature. The hypoglycemia/hyperglycemia trend indicators feature alerts the user of low and high blood glucose patterns. The FreeStyle Precision Neo Meter displays a red arrow indicator light if the user's blood glucose is below the set target or a vellow arrow indicator light if their blood glucose is above the set target. The default indicator target values are 70 and 240 mg/dL but can be customized, if needed. The Meter will also use these ranges to determine blood glucose patterns.
The FreeStyle Precision Neo Blood Glucose Monitoring System is for quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
Here is the information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristics / Performance Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (ISO 15197:2013) | For glucose concentrations < 100 mg/dL (5.55 mmol/L): Minimum of 95% of results shall fall within ±15 mg/dL (±0.83 mmol/L) of the reference method results. For glucose concentrations ≥ 100 mg/dL (5.55 mmol/L): Minimum of 95% of results shall fall within ±15% of the reference method results. | Lay User Performance (n=350 subjects): Glucose < 100 mg/dL: 100% of results were within ±15 mg/dL. Glucose ≥ 100 mg/dL: 98.7% of results were within ±15%. Overall: 99.4% within ±15% or ±15 mg/dL. Professional User Performance: Similar excellent performance demonstrated. |
| Repeatability (Precision) | Standard Deviation (SD) for glucose < 100 mg/dL; Coefficient of Variation (CV) for glucose ≥ 100 mg/dL. Values should be within typical industry standards for blood glucose meters. | Not explicitly quantified in the provided snippets for acceptance criteria, but stated as "demonstrated acceptable repeatability based on testing with spiked whole blood and control solutions yielding results that met the requirements of ISO 15197:2013". The full report would have the actual SD/CV values. |
| Intermediate Precision (Reproducibility) | Standard Deviation (SD) for glucose < 100 mg/dL; Coefficient of Variation (CV) for glucose ≥ 100 mg/dL. Values should be within typical industry standards for blood glucose meters. | Not explicitly quantified in the provided snippets for acceptance criteria, but stated as "demonstrated acceptable intermediate precision based on testing with spiked whole blood and control solutions yielding results that met the requirements of ISO 15197:2013". The full report would have the actual SD/CV values. |
| System Accuracy (Lay User vs. Lab Reference) | All results meeting the ISO 15197:2013 criteria. | 100% of results for glucose < 100 mg/dL were within ±15 mg/dL. 98.7 % of results for glucose ≥ 100 mg/dL were within ±15%. Overall 99.4% results were within ±15% or ±15 mg/dL. |
| Influence of Interfering Substances (Endogenous & Exogenous) | No significant interference that would compromise clinical performance. | "The FreeStyle Precision Neo Blood Glucose Monitoring System demonstrated negligible interference from endogenous and exogenous substances within physiological and therapeutic ranges by meeting the requirements of ISO 15197:2013." Specific substances tested include hematocrit variations (15-65%), common medications, and physiological substances (e.g., bilirubin, triglycerides, uric acid). |
| Operating Temperature Range | 50° - 122°F | Demonstrated performance within 50° - 122°F. |
| Operating Humidity Range | 10% - 90%, non-condensing | Demonstrated performance within 10% - 90%, non-condensing. |
| Altitude | Up to 10,000 feet | Demonstrated performance up to 10,000 feet. |
| Hematocrit Range | 15-65% | Demonstrated accurate performance across the 15-65% hematocrit range, meeting ISO 15197:2013 criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Studies (Lay User Performance): 350 subjects participated in the lay user performance study.
- Data Provenance: The document does not explicitly state the country of origin for the data. It is implied to be clinical study data collected specifically for this device submission. The study is prospective in nature as it involves subjects using the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing the ground truth. However, for blood glucose monitoring systems, the ground truth is typically established using a highly accurate laboratory reference method, not expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for blood glucose measurements is established by a laboratory reference method, not by expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a blood glucose monitoring system, not an imaging or diagnostic device that involves human readers interpreting cases. Its performance is compared against a laboratory reference standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was conducted. The accuracy, precision, and interference studies evaluate the device's (meter + test strip) performance directly against a reference method or known concentrations, without a human interpretation step. The "Lay User Performance" study assesses the device as used by its intended users, but the fundamental algorithm for glucose measurement operates independently.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is a laboratory reference method for blood glucose measurement (e.g., YSI analyzer or equivalent). This is the gold standard for quantitative blood glucose levels.
8. Sample Size for the Training Set
The document does not provide details on the sample size for any training set. For blood glucose meters, the "training" involves the development and calibration of the electrochemical system (meter and test strip) rather than machine learning algorithm training with a distinct training dataset.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information about a specific training set or how its ground truth was established, as this type of device typically relies on chemical and electrical engineering principles, and a robust calibration process rather than a machine learning training dataset. The "ground truth" during development would be known glucose concentrations for calibration and verification of the system's accuracy.
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