(230 days)
Not Found
No
The device description mentions algorithms for summarizing and comparing glucose values and software for generating reports and showing trends, but these appear to be based on predefined rules and calculations rather than learning from data, which is characteristic of AI/ML. There is no mention of training or test sets, which are typically associated with AI/ML development.
No.
The device is a blood glucose monitoring system, which aids in monitoring the effectiveness of diabetes control by providing measurements, but it does not directly treat or prevent a disease.
No
The device explicitly states: "The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use." This indicates it is for monitoring and management, not diagnosis.
No
The device description explicitly includes hardware components such as the FreeStyle InsuLinx Meter, test strips, and a USB cable, which are integral to its function of measuring blood glucose. While it includes software (FreeStyle Auto-Assist), it is not solely a software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- Measurement of Glucose in Blood: The system is designed to measure glucose in fresh capillary whole blood samples. This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample outside of the body to provide information about a person's health status.
- Aid to Monitor Diabetes Control: The intended use is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose related to managing a disease.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by a single person for self testing at home by people with diabetes.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Precision: 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 75 mg/dL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FreeStyle Tracker Diabetes Management (K020866)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
FEB 1 6 2012
510(k) Summary
According to the requirements Per 21 CFR §807.92, the following information is provides sufficient detail to understand the basis for a determination of substantial equivalence.
| Company: | Abbott Laboratories |
|---|---|
| Division: | Abbott Diabetes Care, Inc. |
| Street Address: | 1360 South Loop Road |
| City, State Zip: | Alameda, CA 94502 |
| Telephone No: | 510-749-5400 |
| Fax No: | 510-864-4791 |
| Contact Person: | Arul Sterlin; |
| Tel No. 510-864-4310; | |
| Fax No. 510-864-4791; | |
| arul.sterlin@abbott.com | |
| Proprietary Name: | FreeStyle InsuLinx Blood Glucose Monitoring System |
| Common Name: | Glucose Test System |
| Classification Name: | Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345) |
| Product codes: NBW; | |
| Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345) | |
| Product codes: LFR: | |
| Predicate Device: | FreeStyle Tracker Diabetes Management (K020866) |
| Legal Manufacturer: | Establishment: |
| Abbott Diabetes Care Inc. | |
| 1360 South Loop Rd. | |
| Alameda, CA 94502 | |
| Registration Number: 2954323 |
1
Indications For Use:
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.
Description of the Device:
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.
2
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.
3
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)
4
Figure 1 - FreeStyle InsuLinx System Components and Accessories
(A)
Image /page/4/Picture/2 description: The image shows a FreeStyle InsuLinx blood glucose meter. The meter has a rectangular shape with rounded corners and a screen that takes up most of the front surface. Below the screen, the words "FreeStyle InsuLinx" are printed. There is a button on the bottom right corner of the meter.
5
(B)
(C)
Meter
Welcome to FreeStyle Auto-Assist.
It appears no mater has been connected to this computer.
Connect a FreeStyle Insul inx meter
FreeStyle
Auto-Assist
Software Version 1.0
Owner's Booklet
FreeStyle
Insulinx
(E)
FreeStyle
Insulinx
Blood Glucose Monitoring System
Blood Glucose Monitoring System
Quick Start Guide
Quick Start Guide
(F)
(D)
(G)
6
Image /page/6/Picture/0 description: The image shows a small, white bottle with a label on it. The bottle appears to be a medication or cosmetic product. The label has some text on it, but it is difficult to read due to the image quality. The bottle has a rounded top and a cylindrical body.
Principles of Operation:
The FreeStyle InsuLinx Meter (in conjunction with FreeStyle InsuLinx blood glucose test strips) utilizes coulometric biosensor technology to quantitatively measure the glucose concentration in whole blood samples and in FreeStyle Control Solutions.
The FreeStyle InsuLinx Meter measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood or control solutions by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip. The electrons liberated by this reaction are transferred via a co-factor and mediator to the meter where they are read as a small electrical current is integrated over the analysis time to generate charge which is directly proportional to the level of the glucose in the applied sample.
The FreeStyle InsuLinx Meter does not require calibration prior to use with the FreeStyle InsuLinx Test Strips. The device is prepared for use by inserting a FreeStyle InsuLinx test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The 'apply blood' message is displayed for the user to apply blood to the test strip until the meter begins the test. Blood detect will occur when the meter detects trigger current from the test strip, when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.
7
Comparison to Predicate Device:
The similarities between FreeStyle InsuLinx System and the predicate are highlighted below:
| PRODUCT NAME | FreeStyle InsuLinx Blood
Glucose Monitoring
System (K111874) | Freestyle Tracker
Diabetes
Management
System (K020866) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTICS | | |
| Classification Product
Code | NBW, LFR, JJX | NBW, LFR |
| Fundamental
Technology | The FreeStyle InsuLinx
Meter (in conjunction with
blood glucose test strips)
utilizes coulometric
biosensor technology to
quantitatively measure the
glucose concentration in
whole blood samples and
in FreeStyle Control
Solutions | The FreeStyle Tracker
Meter (in conjunction
with blood glucose test
strips) utilizes
coulometric biosensor
technology to
quantitatively measure
the glucose
concentration in whole
blood samples and in
FreeStyle Control
Solutions |
| Sample Volume | 0.3 µL | 0.3 µL |
| Measurement Glucose
Range | 20 to
500 mg/dL | 20 to
500 mg/dL |
| Meter Operating
Humidity | 5 to 90% Relative
Humidity, Non-
Condensing | 5 to 90% Relative
Humidity, Non-
Condensing |
| Storage Operating
Temperature | -4°F to 140°F (-20°C to
+60°C) | -4°F to 140°F (-20°C to
+60°C) |
| 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 | 95% of results should fall
within ± 15mg/dL
of the comparative
method results at
glucose concentrations