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510(k) Data Aggregation
(31 days)
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
The FreeStyle InsuLinx Meter, in conjunction with the FreeStyle InsuLinx Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.
The device automatically logs blood glucose results and other events to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Patient and Healthcare Professionals can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
Weekly messages feature assist the patient in identifying patterns in their blood glucose results. Using a rolling report, the measured glucose values are summarized according to the proportion within, above. or below the predetermined target range entered by the patient or HCP. These results are displayed in a simple graphical format and include a count of the tests performed. An additional algorithm compares the prevailing blood glucose levels during the preceding week with simple messages relating to achievement versus target glucose levels.
The FreeStyle InsuLinx System has 'plug and play' software that automatically installs on a computer without the need for a CD or internet access (via the meter's USB port and a provided cable). It also provides access to the structured reports for both the healthcare professionals and patients.
The FreeStyle Auto-Assist software produces six different reports to facilitate discussion between patients and their health care professionals in the review, and evaluation of historical blood glucose test results to support an effective diabetes management program. The software also shows trends in blood glucose data in both graphical and text format for guided interpretation.
The Snapshot Report is a general summary of the data for a specified date range.
The Modal Day Report shows the daily patterns of blood glucose levels over a specified date range
The Logbook Report is a table of blood glucose for each day in the specified date range.
The Daily Statistics Report provides an overview of blood glucose over the date range in a series of charts and tables.
The Meal Event Averages Report compares the before and after meal blood glucose level averages for the morning, mid-day and evening times over the specified date range.
The Meter Settings Report shows current meter settings.
These reports provide detailed information on glucose monitoring, and are designed to enable healthcare professionals and patients to assess the effectiveness of diabetes management and then plan appropriate changes to therapy regimens.
Here's an analysis of the provided text regarding the FreeStyle InsuLinx Blood Glucose Monitoring System, focusing on acceptance criteria, studies, and ground truth:
The provided text (510(k) summary) does not contain detailed information about specific studies, sample sizes, or expert qualifications for the device's performance. The submission primarily focuses on establishing substantial equivalence to a predicate device for a modification (the inclusion of a lancing device and lancets). Therefore, much of the requested information cannot be extracted directly from this document.
However, based on the "Comparison to Predicate Device" table, we can infer the acceptance criteria for performance characteristics that the device is expected to meet, as they are listed as "Same" as the predicate device (K111874).
Here's the information that can be gleaned and assumptions made:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Inferred as 'Same' as predicate) |
|---|---|---|
| Precision | At glucose levels |
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(230 days)
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
FreeStyle Control Solutions are for use with the FreeStyle InsuLinx Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The FreeStyle InsuLinx Meter, in conjunction with the FreeStyle InsuLinx Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.
The device automatically logs blood glucose results and other events to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Patient and Healthcare Professionals can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
Weekly messages feature assist the patient in identifying patterns in their blood glucose results. Using a rolling report, the measured glucose values are summarized according to the proportion within, above, or below the predetermined target range entered by the patient or HCP. These results are displayed in a simple graphical format and include a count of the tests performed. An additional algorithm compares the prevailing blood glucose levels during the preceding week with simple messages relating to achievement versus target glucose levels.
The FreeStyle InsuLinx System has 'plug and play' software that automatically installs on a computer without the need for a CD or internet access (via the meter's USB port and a provided cable). It also provides access to the structured reports for both the healthcare professionals and patients.
The FreeStyle Auto-Assist software produces six different reports to facilitate discussion between patients and their health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program. The software also shows trends in blood glucose data in both graphical and text format for guided interpretation.
- The Snapshot Report is a general summary of the data for a specified date range.
- The Modal Day Report shows the daily patterns of blood glucose levels over a specified date range
- The Logbook Report is a table of blood glucose for each day in the specified date range.
- The Daily Statistics Report provides an overview of blood glucose over the date range in a series of charts and tables.
- The Meal Event Averages Report compares the before and after meal blood glucose level averages for the morning, mid-day and evening times over the specified date range.
- The Meter Settings Report shows current meter settings.
These reports provide detailed information on glucose monitoring, and are designed to enable healthcare professionals and patients to assess the effectiveness of diabetes management and then plan appropriate changes to therapy regimens.
The FreeStyle InsuLinx System may be packaged within a cardboard carton, in addition to the following components and accessories listed below.
- (A) FreeStyle InsuLinx Meter
- (B) 10 count vial of FreeStyle InsuLinx Test Strips (may be sold separately)
- (C) FreeStyle Auto-Assist software (resides in the FreeStyle InsuLinx Meter)
- (D) Carrying Case
- (E) Owner's Booklet
- (F) Quick Start Guide
- (G) USB Cable
- (H) FreeStyle Control Solutions (may be obtained by contacting Customer Service)
The provided text describes the FreeStyle InsuLinx Blood Glucose Monitoring System and compares it to a predicate device, but it does not contain a dedicated section detailing acceptance criteria or a specific study proving the device meets those criteria, nor does it provide the requested sample sizes, expert qualifications, or ground truth establishment methods in a comprehensive manner.
However, based on the "Comparison to Predicate Device" table, we can infer the acceptance criteria for certain performance characteristics and the device's reported performance against those metrics, as they are presented as equivalent to a previously cleared device.
Here's an attempt to extract the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the performance characteristics of the predicate device, which the FreeStyle InsuLinx Blood Glucose Monitoring System claims to be substantially equivalent to.
| Performance Characteristic | Acceptance Criteria (inferred from predicate) | Reported Device Performance (FreeStyle InsuLinx) |
|---|---|---|
| Precision | At glucose levels below 75mg/dL average SD is ≤ 5mg/dL and at glucose levels ≥ 75mg/dL average CV is ≤ 5% | At glucose levels below 75mg/dL average SD is ≤ 5mg/dL and at glucose levels ≥ 75mg/dL average CV is ≤ 5% |
| Accuracy | 95% of results should fall within ± 15mg/dL of the comparative method results at glucose concentrations |
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