(30 days)
No
The description focuses on standard blood glucose monitoring technology and data logging, with no mention of AI or ML algorithms for analysis or prediction.
No
The device is a blood glucose monitoring system, which aids in monitoring diabetes control by measuring glucose levels, but it does not directly treat or prevent a disease or condition.
No
The "Intended 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, not diagnosis.
No
The device description explicitly mentions a "FreeStyle InsuLinx Meter" and "FreeStyle InsuLinx Test Strips" which are hardware components used for measuring glucose. The software is described as being installed on a computer via the meter's USB port, indicating it is part of a system that includes hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
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) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being for in vitro diagnostic use.
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
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 to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Users can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
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.
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 II into the FreeStyle InsuLinx System kit, which may be 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)
- 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
self testing outside the body (in vitro diagnostic use) by people with diabetes at home
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)
The results obtained from performance studies demonstrate that the FreeStyle InsuLinx Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K120568).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: At glucose levels below 75mg/dL average SD is = 75mg/dL average CV is = 75 mg/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2015
ABOTT LABORATORIES SAI TATAVARTY REGULATORY AFFAIRS SPECIALIST 1360 SOUTH LOOP ROAD ALAMEDA CA 94502
Re: K152328
Trade/Device Name: Freestyle InsuLinx Blood Glucose Monotioring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: August 17, 2015 Received: August 18, 2015
Dear Ms. Tatavarty:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152328
Device Name
FreeStyle InsuLinx Blood Glucose Monitoring System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------- |
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FreeStyle InsuLinx Blood Glucose Monitoring System-Special 510(k)
Abbott Diabetes Care Inc. 1360 South Loop Road, Alameda, CA 94502
August 17, 2015
510(k) Summary
510.749.5105
Fax: 510.864.4791
sai.tatavarty@abbott.com
Tel:
According to the requirements per 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 |
| Contact Person: | Sai Sriharshada Tatavarty |
| Tel No. 510-749-5105 | |
| Fax No. 510-864-4791 | |
| sai.tatavarty@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,LFR | |
| Predicate Device: | FreeStyle InsuLinx Blood Glucose Monitoring System (K120568) |
| Legal Manufacturer: | Establishment: |
| Abbott Diabetes Care Inc. | |
| 1360 South Loop Road | |
| Alameda, CA 94502 |
Image /page/3/Picture/6 description: The image contains the Abbott logo. The logo consists of a blue stylized letter "a" on the left, followed by the word "Abbott" in bold, black letters. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
4
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 to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Users can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
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.
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
Image /page/4/Picture/13 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" in blue, followed by the word "Abbott" in bold, black letters. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller font. The text "Page 5" is located below the tagline.
5
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 II into the FreeStyle InsuLinx System kit, which may be 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)
- 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)
Substantial Equivalence:
The FreeStyle InsuLinx Blood Glucose Monitoring System is substantially equivalent to the predicate, which was cleared by the Agency on March 29, 2012, to market under K120568: FreeStyle InsuLinx Blood Glucose Monitoring System. The results obtained from performance studies demonstrate that the FreeStyle InsuLinx Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K120568).
Image /page/5/Picture/15 description: The image shows the Abbott logo, which consists of a stylized letter "a" in blue, followed by the word "Abbott" in bold, black font. Below the company name is the tagline "A Promise for Life" in a smaller font size. At the bottom of the image, the text "Page 6" is visible.
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Comparison to Predicate Device:
The similarities and differences between the FreeStyle InsuLinx Blood Glucose Monitoring System and the predicate (K120568) are highlighted in the table below.
Similarities:
| PRODUCT NAME | FreeStyle InsuLinx Blood
Glucose Monitoring System
(K120568) | 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
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. | Same |
| PRODUCT NAME | FreeStyle InsuLinx Blood Glucose Monitoring System (K120568) | Modified FreeStyle InsuLinx Blood Glucose Monitoring System |
| 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