(30 days)
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 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.
The provided document is a 510(k) premarket notification for the FreeStyle InsuLinx Blood Glucose Monitoring System, detailing its substantial equivalence to a predicate device. This submission primarily focuses on a modification to include a different lancing device and a change in the recommended cleaning and disinfection wipes. While it outlines the acceptance criteria for accuracy and precision, it does not include a detailed study proving the device meets these criteria in the traditional sense of a clinical trial report with specific patient data, expert ground truth establishment, or statistical analyses like MRMC studies.
Instead, the document asserts substantial equivalence based on the device's fundamental technology, indications for use, and performance characteristics (accuracy and precision) being identical to the predicate device (K120568). The only differences noted are related to the lancing device and the disinfectant wipes.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (as per predicate device) | Reported Device Performance (as per predicate device, asserted to be same for modified device) |
|---|---|---|
| Precision | At glucose levels below 75 mg/dL, average SD is ≤ 5 mg/dL. At glucose levels ≥ 75 mg/dL, average CV is ≤ 5%. | Same |
| Accuracy | 95% of results should fall within ± 15 mg/dL of the comparative method results at glucose concentrations < 75 mg/dL and within ± 20% at glucose concentrations ≥ 75 mg/dL. | Same |
| Measurement Glucose Range | 20 to 500 mg/dL | Same |
| Sample Volume | 0.3 µL | Same |
| Measurement Time | Average 5 seconds | Same |
| Hematocrit Range | 15% - 65% | Same |
| Meter Operating Temperature | 40°F to 104°F (4°C to 40°C) | 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 |
| Meter Operating Pressure (Altitude) | Up to 10,000 feet (3048 meters) | Same |
| Double Application (Time for additional blood) | 60 seconds | Same |
| Coding | No coding required | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document for the K152328 submission does not provide details on the sample size for any test set or the provenance of data. It asserts that the modified device is substantially equivalent to the predicate (K120568), implying that the performance data from the predicate device is applicable. To find this information, one would need to review the K120568 submission details, which are not included in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document does not contain any information about experts or their qualifications used to establish ground truth. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way it might be for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This document does not specify any adjudication method. This methodology is generally not applicable to quantitative measurements like blood glucose, where comparison is made against a scientific reference standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done or is applicable to this type of device. This device is a blood glucose monitoring system, which provides a direct quantitative measurement and does not involve human interpretation of complex data (like medical images) that would benefit from AI assistance or warrant an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is fundamentally a standalone device in terms of its glucose measurement function. The "algorithm" (coulometric biosensor technology) performs the measurement independently. There isn't a "human-in-the-loop" for the measurement itself, though a human uses the device and interprets the result. The document doesn't explicitly describe a "standalone study" in the context of advanced AI algorithms, but the core functionality is algorithm-driven by the meter and test strip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated in this document, for blood glucose monitoring systems, the ground truth is typically established against laboratory reference methods (e.g., YSI analyzer). The document mentions "comparative method results" in the accuracy section, which refers to these lab-based reference standards.
8. The sample size for the training set
The document does not provide any information regarding a training set sample size. This type of information is usually relevant for machine learning or AI models. The FreeStyle InsuLinx Blood Glucose Monitoring System is based on established electrochemical biosensor technology, which does not typically involve a "training set" in the same way modern AI systems do. Its performance is based on the robust chemical and electrical properties of the test strip and meter.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. For the performance validation of the underlying biosensor technology, ground truth would have been established by laboratory reference methods for the predicate device.
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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.
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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 TatavartyTel No. 510-749-5105Fax No. 510-864-4791sai.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 RoadAlameda, 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.
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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.
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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 BloodGlucose Monitoring System(K120568) | Modified FreeStyleInsuLinx Blood GlucoseMonitoring System |
|---|---|---|
| CHARACTERISTICS | ||
| Indications for Use | The FreeStyle InsuLinxBlood Glucose MonitoringSystem is intended for thequantitative measurement ofglucose in fresh capillarywhole blood samples drawnfrom the fingertip. TheFreeStyle InsuLinx BloodGlucose Monitoring Systemis intended to be used by asingle person and should notbe shared.The FreeStyle InsuLinxBlood Glucose MonitoringSystem is intended for self-testing outside the body (invitro diagnostic use) bypeople with diabetes at homeas an aid to monitor theeffectiveness of diabetes control.The FreeStyle InsuLinx BloodGlucose Monitoring Systemshould not be used for thediagnosis of or screening fordiabetes or for neonatal use.The FreeStyle InsuLinxBlood Glucose Test Strips arefor use with the FreeStyleInsuLinx Blood GlucoseMeter to quantitativelymeasure glucose in capillarywhole blood samples drawnfrom 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 InsuLinxMeter (in conjunction withblood glucose test strips)utilizes coulometric biosensortechnology to quantitativelymeasure the glucoseconcentration in whole bloodsamples and in FreeStyleControl Solutions | Same |
| Enzyme | GDH - FAD | Same |
| Sample Type | Whole blood & capillary | Same |
| Test Sites | Finger | Same |
| Sample Volume | 0.3 µL | Same |
| Measurement GlucoseRange | 20 to 500 mg/dL | Same |
| Meter Operating Humidity | 5 to 90% Relative Humidity,Non-Condensing | Same |
| Storage OperatingTemperature | -4°F to 140°F (-20°C to+60°C) | Same |
| Precision | At glucose levels below75mg/dL average SD is ≤5mg/dL and at glucose levels≥ 75mg/dL average CV is ≤5% | Same |
| Accuracy | 95% of results should fallwithin ± 15mg/dL of thecomparative method results atglucose concentrations <75mg/dL and within ±20% atglucose concentrations ≥ 75 | Same |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose Monitoring System(K120568) | Modified FreeStyleInsuLinx Blood GlucoseMonitoring System |
| mg/dL | ||
| Measurement Module | FreeStyle Super SpeedyAlgorithm (5 seconds) | Same |
| Double Application | 60 seconds | Same |
| Meter OperatingTemperature | 40°F to 104°F (4°C to 40°C) | Same |
| Meter Operating Pressure | Up to 10000 feet (3048meters) | Same |
| Hematocrit | 15% - 65% | Same |
| Data Management | FreeStyle Auto-Assistsoftware | Same |
| Measurement Time | Average 5 seconds | Same |
| Coding | No coding required | Same |
| Microprocessor | ST | Same |
| User Preferences | The device lets the user set:• Time and Date Changes• Time and Date Formats• Audible Alert• Personalized test screen• Weekly Message glucose ranges• Personalized notes and reminders | Same |
| Summary StatisticElements | • Snapshot Report• Modal Day Report• Logbook Report | Same |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose Monitoring System(K120568) | Modified FreeStyleInsuLinx Blood GlucoseMonitoring System |
| Daily Statistics Report Meal Event Averages Report Meter Settings Report Weekly messages | ||
| Communications | "Plug and Play" device set-upscreen that enablesconfiguration of the devicethrough the PC | Same |
| Lancets | FreeStyle/Thin Lancets | Same |
Image /page/6/Picture/5 description: The image shows the Abbott logo, which consists of a stylized blue letter 'A' on the left. To the right of the logo is the word "Abbott" in a bold, sans-serif font. Below the word "Abbott" is the tagline "A Promise for Life", and below that is the text "Page 7".
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Image /page/7/Picture/2 description: The image shows the Abbott logo, which 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." The text "Page 8" is located below the tagline, and the number "5" is located to the left of the logo.
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Image /page/8/Picture/2 description: The image shows the Abbott logo, which 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 9" is located below the tagline, indicating the page number within a document.
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Differences:
| PRODUCT NAME | FreeStyle InsuLinx Blood GlucoseMonitoring System(K120568) | Modified FreeStyle InsuLinxBlood Glucose MonitoringSystem |
|---|---|---|
| CHARACTERISTICS | ||
| Meter cleaning anddisinfection | 522 cleaning and 522 disinfectioncycles (equivalent to cleaning anddisinfecting once a week over the 5-year service life) with Dispatch®Hospital Cleaner Disinfectant Towelswith Bleach, EPA 56392-8 | 522 cleaning and 522disinfection cycles (2 cycles perweek for 5 years) with CloroxHealthcare Bleach GermicidalWipes, EPA Reg. #67619-12 |
| Lancing devicecleaning anddisinfection | 522 cleaning and 522 disinfectioncycles (equivalent to cleaning anddisinfecting once a week over the 5-year service life) with Dispatch®Hospital Cleaner Disinfectant Towelswith Bleach, EPA 56392-8 | 210 cleaning and 210disinfection cycles (2 cyclesper week for 2 years) withClorox Healthcare BleachGermicidal Wipes, EPA Reg.#67619-12 |
| Lancing device | FreeStyle Lancing Device | FreeStyle Lancing Device-II |
Image /page/9/Picture/4 description: The image shows the Abbott logo, which includes a stylized blue "a" symbol. Next to the symbol, the word "Abbott" is written in bold, black letters. Below the company name, the text "A Promise for Life" is written in a smaller font size. The text "Page 10" is at the bottom.
§ 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.