(31 days)
Not Found
No
The description focuses on basic data logging, reporting, and simple pattern identification based on pre-set ranges and averages. There is no mention of algorithms that learn or adapt from data, which are characteristic of AI/ML.
No.
Explanation: The device is a blood glucose monitoring system, used for quantitative measurement of glucose and monitoring the effectiveness of diabetes control. It does not actively treat or provide therapy.
No
The "Intended Use / Indications for Use" section 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 mentions a "FreeStyle InsuLinx Meter" and "FreeStyle InsuLinx Test Strips" which are hardware components used for the quantitative measurement of glucose. While the system includes software for data logging and reporting, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "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."
This statement clearly identifies the device as being used for diagnostic purposes outside of the body, which is the definition of an in vitro diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
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, 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.
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, 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.)
Not Found
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 InsuLinx Blood Glucose Monitoring System (K111874)
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
MAR 2 9 2012
120568
510(k) Summary
According to the requirements of 21 CFR §807.92, the following information 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: | System, test, blood glucose, over the counter, 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 InsuLinx Blood Glucose Monitoring System (K111874) |
| 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.
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.
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
2
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.
3
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.
Description of Modification:
The basis for this submission, is to include the FreeStyle Lancing Device and Lancets in the FreeStyle InsuLinx System Kit, which is packaged with 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)
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- (D) Carrying Case
- (E) Owner's Booklet
- (F) Quick Start Guide
- (G) USB Cable
- (H) FreeStyle Control Solutions (mạy be obtained by contacting Customer Service)
Comparison to Predicate Device:
The similarities between the modified FreeStyle InsuLinx System and the predicate are highlighted below:
| PRODUCT NAME | FreeStyle InsuLinx Blood Glucose Monitoring System (K111874) | Modified FreeStyle InsuLinx Blood Glucose Monitoring System |
|---|---|---|
| CHARACTERISTICS | ||
| 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 | Same |
5
| PRODUCT NAME | FreeStyle InsuLinx Blood
Glucose Monitoring System
(K111874) | Modified 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. | | |
| Classification Product
Code | NBW, LFR | Same | |
| 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 | Same | |
| Enzyme | GDH - FAD | Same | |
| Sample Type | Whole blood & capillary | Same | |
| Test Sites | Finger | Same | |
| Sample Volume | 0.3 µL | Same | |
| Measurement Glucose
Range | 20 to 500 mg/dL | Same | |
| Meter Operating
Humidity | 5 to 90% Relative Humidity,
Non-Condensing | Same | |
| Storage Operating
Temperature | -4°F to 140°F (-20°C to
+60°C) | Same | |
| Precision | At glucose levels below
75mg/dL average SD is ≤
5mg/dL and at glucose levels
≥ 75mg/dL average CV is ≤
5% | Same | |
| Accuracy | 95% of results should fall
within ± 15mg/dL of the
comparative method results at
glucose concentrations