(230 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.
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 < 75mg/dL and within ±20% at glucose concentrations ≥ 75mg/dL | 95% of results should fall within ± 15mg/dL of the comparative method results at glucose concentrations < 75mg/dL and within ±20% at glucose concentrations ≥ 75mg/dL |
| 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) |
| Double Application (Time for) | 60 seconds | 60 seconds |
| Measurement Time | average of 15 seconds (predicate) | average 5 seconds (FreeStyle InsuLinx) |
Note: The document explicitly states "The similarities between FreeStyle InsuLinx System and the predicate are highlighted below," and then lists the exact same values for Precision and Accuracy for both devices. This indicates that the FreeStyle InsuLinx system is expected to meet these values, implying they are the acceptance criteria, and it reports meeting them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mainly focuses on device description and comparison to a predicate, not detailed study methodologies or data specifics.
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 information is not provided in the document. The ground truth for blood glucose monitoring systems is typically established by laboratory reference methods, not expert consensus in the same way it would be for imaging diagnostics. The document only mentions "comparative method results" in the accuracy section, implying a laboratory reference standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for studies where human interpretation is involved. For a blood glucose meter, the "ground truth" is typically a quantitative laboratory measurement, not subject to human adjudication in the same way.
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
An MRMC comparative effectiveness study is not mentioned and is not applicable to this type of device (blood glucose monitoring system). This type of study is relevant for imaging diagnostics where human readers interpret patient data. The FreeStyle InsuLinx system is a standalone diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance characteristics described for Precision and Accuracy are for the standalone device (algorithm only). The "comparative method results" used as ground truth indicate that the device's measurements are being compared directly to a reference standard performed in a laboratory setting, without human interpretation as part of the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used appears to be a laboratory comparative method for glucose measurement. The accuracy statement refers to "comparative method results," which in the context of blood glucose monitoring typically means a highly accurate laboratory analyzer.
8. The sample size for the training set
This information is not provided in the document. For a medical device like a blood glucose meter, the "training set" would refer to the data used during the development and calibration of the electrochemical biosensor and its algorithms. This is usually proprietary and not detailed in 510(k) summaries to this extent.
9. How the ground truth for the training set was established
This information is not provided in the document. Similar to point 8, the establishment of ground truth for the training/calibration phase would involve established laboratory reference methods, but the specific details are not disclosed here.
{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 94502Registration 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 BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
|---|---|---|
| CHARACTERISTICS | ||
| Classification ProductCode | NBW, LFR, JJX | NBW, LFR |
| FundamentalTechnology | The FreeStyle InsuLinxMeter (in conjunction withblood glucose test strips)utilizes coulometricbiosensor technology toquantitatively measure theglucose concentration inwhole blood samples andin FreeStyle ControlSolutions | The FreeStyle TrackerMeter (in conjunctionwith blood glucose teststrips) utilizescoulometric biosensortechnology toquantitatively measurethe glucoseconcentration in wholeblood samples and inFreeStyle ControlSolutions |
| Sample Volume | 0.3 µL | 0.3 µL |
| Measurement GlucoseRange | 20 to500 mg/dL | 20 to500 mg/dL |
| Meter OperatingHumidity | 5 to 90% RelativeHumidity, Non-Condensing | 5 to 90% RelativeHumidity, Non-Condensing |
| Storage OperatingTemperature | -4°F to 140°F (-20°C to+60°C) | -4°F to 140°F (-20°C to+60°C) |
| Precision | At glucose levels below75mg/dL average SD is ≤5mg/dL and at glucoselevels ≥ 75mg/dL averageCV is ≤ 5% | At glucose levelsbelow 75mg/dLaverage SD is ≤5mg/dL and at glucoselevels ≥ 75mg/dLaverage CV is ≤ 5% |
| Accuracy | 95% of results should fallwithin ± 15mg/dL of thecomparative methodresults at glucoseconcentrations < 75mg/dLand within ±20% atglucose concentrations > | 95% of results should fallwithin ± 15mg/dLof the comparativemethod results atglucose concentrations< 75mg/dL and within±20% at glucose |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
| 75 mg/dL | concentrations ≥ 75mg/dL | |
| Double Application | 60 seconds | 60 seconds |
{8}------------------------------------------------
The differences between FreeStyle InsuLinx System and the predicate are highlighted below:
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
|---|---|---|
| CHARACTERISTICS | ||
| Indications for Use | The FreeStyle InsuLinxBlood Glucose MonitoringSystem is intended for thequantitative measurementof glucose in freshcapillary whole bloodsamples drawn from thefingertip. The FreeStyleInsuLinx Blood GlucoseMonitoring System isintended to be used by asingle person and shouldnot be shared.The FreeStyle InsuLinxBlood Glucose MonitoringSystem is intended for selftesting outside the body (invitro diagnostic use) bypeople with diabetes athome as an aid to monitorthe effectiveness ofdiabetes control. TheFreeStyle InsuLinx BloodGlucose MonitoringSystem should not be usedfor the diagnosis of orscreening for diabetes orfor neonatal use.The FreeStyle InsuLinx | The TheraSense, Inc.,FreeStyle TrackerDiabetes ManagementSystem is intended foruse in the quantitativemeasurement ofglucose in wholeblood. It is intended foruse by healthcareprofessionals andpeople with diabetesmellitus at home as anaid in monitoring theeffectiveness ofdiabetes controlprogram. It is notintended for thediagnosis of orscreening for diabetesmellitus, and is notintended for use onneonates.Additionally, theTheraSense, Inc.FreeStyle TrackerDiabetes ManagementSystem is intended foruse in home andclinical setting to aidpeople with diabetes |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
| Blood Glucose Test Stripsare for use with theFreeStyle InsuLinx BloodGlucose Meter toquantitatively measureglucose in capillary wholeblood samples drawn fromthe fingertip. | and healthcareprofessionals in thereview, analysis, andevaluation of historicalblood glucose testresults to support aneffective diabetesmanagement program. | |
| FreeStyle ControlSolutions are for use withthe FreeStyle InsuLinxBlood Glucose MonitoringSystem as a quality controlcheck to verify theaccuracy of blood glucosetest results. | The TheraSense, Inc.FreeStyle TrackerDiabetes ManagementSystem is specificallyindicated for use on thefinger, forearm, upperarm, thigh, calf andhand. | |
| Enzyme | GDH - FAD | GDH - PQQ |
| Sample Type | Whole blood, capillary &venous, | Whole blood, capillary |
| Test Sites | Finger | Finger, forearm, upperarm, thigh, calf andhand |
| Data Management | FreeStyle Auto-Assistsoftware | FreeStyle ConnectBlood GlucoseMonitoring System(K051802) |
| Measurement Module | FreeStyle Super SpeedyAlgorithm (5 seconds) | FreeStyle SpeedyAlgorithm (15seconds) |
| Application Software | Software running on themeter provides the Userwith an ElectronicLogbook, DataManagement and DiabetesManagementTools | Software running onthe PDA provides theUser with anElectronic Logbook,Data Management andDiabetes Managementtools |
| Measurement Time | average 5 seconds | average of 15 seconds |
| Meter FirmwareOperating Systemversion | The Auto-Assist softwareis compatible withWindows 7 Home | The PDA MeterFirmware iscompatible with |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
| Premium. | version 3.1 or newerversions of the PalmOS as delivered inHandSpring PDAs. | |
| Meter FirmwareUpgrade OrModification | N/A | The PDA MeterFirmware is not Usermodifiable or fieldupgradeable |
| Setting MeterPreferences | The device lets the Userset preferences of timeformat, and On or Offaudible alerts. | The device lets theUser set preferences ofunitsof measure, dateformat, time format,and audible alert level. |
| Application SwitchBefore MeasurementComplete | N/A | The User can attemptto switch to anotherapplication programduring a glucosemeasurement, and theglucose measurementis completed andsaved, if possible. |
| Coding | No coding required | Coding required |
| Microprocessor | ST | TI |
| DatabaseSynchronization | N/A | The PDA Applicationenables the user toselect/specify theMeasurement Moduledatabase (i.e., the last250 Glucosemeasurementsperformed by theMeasurement Module)to be downloadedfrom the MeasurementModule and mergewith the existing PDAdatabase (if any exists).When the PDA has nodatabase but has aDatabase ID(signifying an existing |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
| User), the PDAApplication promptsthe User to restore thePDA database from aPC back-up prior toperforming thedatabasesynchronization withthe Measurementmodule database. | ||
| User Preferences | The device lets the userset:• Time and DateChanges• Time and Date Formats• Audible Alert• Personalized test screen• Weekly Messageglucose ranges• Personalized notes andreminders | The device lets the userset:• Corrupt/MissingPreferenceDetection• ConcentrationUnits• Time and DateChanges• Time and DateFormats• Audible Alert• Tracking exercise• Tracking Insulin• Tracking Pump(Basal Rate)• TrackingMedication• TrackingMeal/Carbohydrate• Tracking State ofHealth• Default EventTracking• Basal Tracking |
| Summary StatisticElements | • Snapshot Report• Modal Day Report• Logbook Report• Daily Statistics Report• Meal Event Averages | • Highest ReadingDate• Lowest ReadingDate• CarbohydrateStatistics |
| PRODUCT NAME | FreeStyle InsuLinx BloodGlucose MonitoringSystem (K111874) | Freestyle TrackerDiabetesManagementSystem (K020866) |
| Meter Settings Report Weekly messages | Insulin Statistics Basal Insulin Statistics Glucose Line Graph Glucose Readings Pie Chart Modal Day Chart | |
| Diabetes ManagementTools | N/A | Carbohydrate table Insulin tables Prescribed Regimen (food and exercise patterns) Basal Rate Schedule Target glucose level |
| Communications | "Plug and Play" device set-up screen that enablesconfiguration of the devicethrough the PC | The HotSync protocolis used to transfer datato and from a PC |
| PC Utility Software | The PC Utility Software iscapable of running on anIBM-PC compatiblesoftware | The PC UtilitySoftware is capable ofrunning on an IBM-PCcompatible software |
| Meter OperatingTemperature | 40°F to 104°F (4°C to40°C) | 50°F to 95°F (10°C to35°C) |
| Meter OperatingPressure | Up to 10000 feet (3048meters) | 10.15 psi to 15.4 psi(700 hPa to 1060 hPa,20,000 ft to sea level ) |
| Hematocrit | 15% - 65% | 0 - 60% |
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Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
10903 New Hampshire Avenue Silver Spring, MD 20993
Abbott Laboratories c/o Arul Sterlin Senior Regulatory Affairs Specialist 1360 South Loop Road Alameda, CA 94502
FEB 1 6 2012
Re: K111874 Trade Name: FreeStyle InsuLinx Blood Glucose Monitoring System Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: February 14, 2012 Received: February 15, 2012
Dear Mr. Sterlin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{14}------------------------------------------------
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
$\qquad$
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{15}------------------------------------------------
Indications for Use
510(k) Number (if known): K111874
Device Name: FreeStyle InsuLinx Blood Glucose Monitoring System
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.
Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Burt Clander
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 111874
§ 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.