(115 days)
The FreeStyle Lite 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 in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.
The FreeStyle Lite Meter, in conjunction with the FreeStyle Lite 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 FreeStyle Lite Meter consists of the following major features:
- Strip Port where the FreeStyle Lite Test Strip is inserted. ●
- . Buttons - used to turn the meter on/off and recall information stored in the meter.
- . Display Window - where test results, messages and information stored in the meter appear.
The device is prepared for use by inserting a glucose test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The meter will then display the time, month and day (if set). 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, initiated when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.
The provided document is a 510(k) summary for the FreeStyle Lite Blood Glucose Monitoring System. It outlines the device's indications for use, description, principles of operation, and a comparison to a predicate device.
However, the document does not contain specific acceptance criteria tables, reported device performance data, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case study results, standalone performance study results, or training set information.
The primary focus of this submission is to incorporate new cleaning and disinfection procedures. Therefore, the performance studies mentioned near the end of the document likely pertain to the stability and accuracy of the device after repeated cleaning and disinfection cycles, rather than a general performance evaluation of the glucose measurement accuracy itself.
Without the specific performance study report, I cannot fulfill all parts of your request. I can, however, extract what is available regarding the cleaning and disinfection aspects, which seem to be the core of this particular submission's changes.
Here's a summary of the information that is available in the provided text, related to the device's characteristics and the changes in cleaning/disinfection:
1. Acceptance Criteria and Reported Device Performance:
Based on the "Differences" section, the main change and associated performance pertains to the cleaning and disinfection procedures.
| Acceptance Criteria (Implied for Cleaning/Disinfection) | Reported Device Performance (Implied) |
|---|---|
| Meter Cleaning/Disinfection: Effectiveness and durability of the meter after extended cleaning and disinfection cycles. | The Modified FreeStyle Lite Blood Glucose Monitoring System (K150332) was tested for 522 cleaning and 522 disinfection cycles (stated as the equivalent of 2 cycles per week for 5 years) using Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12. Note: The document states "The results obtained from performance studies demonstrate that the FreeStyle Lite Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K092602)." This implies the device maintained its intended performance after these cleaning/disinfection cycles, but specific accuracy data post-disinfection is not provided in this summary. |
| Lancing Device Cleaning/Disinfection: Effectiveness and durability of the lancing device after extended cleaning and disinfection cycles. | The lancing device was tested for 210 cleaning and 210 disinfection cycles (stated as the equivalent of 2 cycles per week for 2 years) using Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12. Note: Similar to the meter, the document implies the lancing device remained safe and effective after these cycles. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text. The number of cleaning/disinfection cycles (522 for meter, 210 for lancing device) refers to the duration/intensity of the test, not the number of individual devices or patients in a test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified, as this document focuses on device cleaning/disinfection performance rather than diagnostic accuracy requiring expert ground truth in the typical sense.
4. Adjudication method for the test set:
- Not applicable/not specified.
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. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The "performance studies" mentioned would have evaluated the device's physical integrity and functional accuracy after the cleaning/disinfection procedures. This constitutes a standalone performance evaluation of the device itself under specific conditions. However, the specifics of how "performance" was measured (e.g., whether glucose accuracy remained within specifications) are not detailed in this summary.
7. The type of ground truth used:
- For the cleaning/disinfection changes, the "ground truth" would be the device's ability to maintain its specified performance and physical integrity (e.g., no degradation of materials, continued accurate glucose measurements) after the specified number of cleaning/disinfection cycles. The detailed technical reports for these studies (not included here) would have defined the pass/fail criteria for this performance.
- For the core glucose measurement function, the "ground truth" would typically be a reference method for glucose concentration, against which the device's readings are compared for accuracy. This information is usually detailed in the original 510(k) for the device's core functionality (K092602, the predicate).
8. The sample size for the training set:
- Not applicable/not specified, as this is not an AI/machine learning device requiring a training set in that context. If "training set" refers to data used to validate the core glucose measurement, that information is not in this document.
9. How the ground truth for the training set was established:
- Not applicable/not specified for the reasons above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 5, 2016
ABBOTT LABORATORIES SAI TATAVARTY REGULATORY AFFAIRS SPECIALIST 1360 SOUTH LOOP ROAD ALAMEDA CA 94502
Re: K150332
Trade/Device Name: FreeStyle Lite Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: May 7, 2015 Received: May 8, 2015
Dear Sai Tatavarty:
This letter corrects our substantially equivalent of June 02, 2015.
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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. 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) K150332
Device Name
FreeStyle Lite Blood Glucose Monitoring System
Indications for Use (Describe)
The FreeStyle Lite 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 in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.
| 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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June 4, 2015
Abbott Diabetes Care Inc. 1360 South Loop Road, Alameda, CA 94502
510.749.5105 Tel: Fax: 510.864.4791 sai.tatavarty@abbott.com
Image /page/3/Picture/3 description: The image shows the logo for Abbott, a global healthcare company. The logo consists of a stylized letter 'a' in a bold, sans-serif font. The letter is rendered in a solid blue color and has a rounded, geometric design. The logo is simple, modern, and easily recognizable.
510(k) Summary
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 Lite 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 Lite Blood Glucose Test Strips (K092602) |
| Legal Manufacturer: | Establishment:Abbott Diabetes Care Inc.1360 South Loop RoadAlameda, CA 94502 |
Image /page/3/Picture/7 description: The image shows the Abbott logo. On the left is a blue abstract symbol that resembles the letter "a". To the right of the symbol is the word "Abbott" in a bold, serif font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, sans-serif font.
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Indications for use:
The FreeStyle Lite 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 in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.
Description of the Device:
The FreeStyle Lite Meter, in conjunction with the FreeStyle Lite 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 FreeStyle Lite Meter consists of the following major features:
- Strip Port where the FreeStyle Lite Test Strip is inserted. ●
- . Buttons - used to turn the meter on/off and recall information stored in the meter.
- . Display Window - where test results, messages and information stored in the meter appear.
The device is prepared for use by inserting a glucose test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The meter will then display the time, month and day (if set). 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, initiated when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.
Principles of Operation:
The FreeStyle Lite Meter (in conjunction with FreeStyle Lite 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 Lite 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.
Image /page/4/Picture/12 description: The image shows the Abbott logo. The logo consists of a blue abstract shape on the left and the word "Abbott" in bold black letters on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.
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The FreeStyle Lite Meter does not require calibration prior to use with the FreeStyle Lite Test Strips. The device is prepared for use by inserting a FreeStyle Lite test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The meter will then display the time, month and day (if set). 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. initiated 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 incorporate cleaning and disinfection procedures into the FreeStyle Lite System, which may be packaged with the following components and accessories listed below.
- A. FreeStyle Lite Meter
- B. 10 count vial of FreeStyle Lite Test Strips (may be sold separately)
- C. Carrying Case
- D. FreeStyle Lancing Device II Lancing Device
- E. FreeStyle/Thin Lancets
- F. Owner's Booklet
- G. Quick Start Guide
- H. USB Cable
- I. FreeStyle Control Solutions (may be obtained by contacting Customer Service)
Substantial Equivalence:
The FreeStyle Lite Blood Glucose Monitoring System is substantially equivalent to the predicate, which was cleared by the Agency on May 14, 2010, under K092602: FreeStyle Lite Blood Glucose Test Strips. The results obtained from performance studies demonstrate that the FreeStyle Lite Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K092602).
Image /page/5/Picture/14 description: The image contains 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, lighter font.
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Comparison to Predicate Device:
The similarities and differences between the FreeStyle Lite Blood Glucose Monitoring System and the predicate (K092602) are highlighted in the table below.
Similarities:
| PRODUCT NAME | FreeStyle Lite BloodGlucose Test Strips(K092602) | Modified FreeStyle LiteBlood Glucose MonitoringSystem (K150332) |
|---|---|---|
| CHARACTERISTICS | ||
| Indications for Use | The FreeStyle Lite BloodGlucose Monitoring System isintended for use in thequantitative measurement ofglucose in capillary wholeblood from the finger, upperarm and palm, and venouswhole blood.The FreeStyle Lite BloodGlucose Monitoring System isintended for use by healthcareprofessionals and people withdiabetes mellitus at home as anaid in monitoring theeffectiveness of a diabetescontrol program.The FreeStyle Lite BloodGlucose Monitoring System isnot intended for the diagnosisof or screening for diabetesmellitus, and is not intended foruse on neonates or arterialblood. | The FreeStyle Lite BloodGlucose Monitoring System isintended for self-testing outsidethe body (in vitro diagnosticuse) by people with diabetes athome as an aid in monitoringthe effectiveness of a diabetescontrol program byquantitatively measuringglucose in fresh whole bloodfrom the finger, upper arm andpalm. The FreeStyle LiteBlood Glucose MonitoringSystem should not be used forthe diagnosis of or screening ofdiabetes or for neonatal use. Itis intended to be used by asingle person and should not beshared. Alternate site testingshould be done only duringsteady state times (whenglucose is not changingrapidly).The FreeStyle Lite BloodGlucose Test Strips are for usewith the FreeStyle Lite BloodGlucose Meter to quantitativelymeasure glucose (sugar) infresh capillary whole bloodsamples drawn from thefingertips, upper arm and palm. |
Image /page/6/Picture/4 description: The image shows the Abbott logo. The logo consists of a blue abstract shape on the left and the word "Abbott" in bold, black letters on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.
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| Classification Product Code | NBW, LFR | Same |
|---|---|---|
| Fundamental Technology | The FreeStyle Lite 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 | Venous or capillary whole blood | Same |
| AST | Upper arm & palm | Same |
| Sample Volume | 0.3 µL | Same |
| Measurement Glucose Range | 20 to 500 mg/dL | Same |
| Measurement Time | average 5 seconds | Same |
| Second sample application | Within 60 seconds | Same |
| Calibration | None | Same |
| Lancet | FreeStyle/Thin Lancets | Same |
| Battery life | 500 tests | Same |
| Hematocrit | 15% to 65% | Same |
| Measurement units | mg/dL | Same |
| Meter storage temperature | - 4° to 140° F (- 20° to 60° C) | Same |
| Memory | 400 blood glucose and control solution tests with date and time | Same |
| Operating relative humidity | 5% to 90% (non-condensing) | Same |
| Operating temperature | 40° to 104° F (4° to 40° C) | Same |
| Power Source | One CR 2032, 3V lithium battery, replaceable | Same |
Image /page/7/Picture/1 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 size.
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Differences:
| PRODUCT NAME | FreeStyle Lite BloodGlucose Test Strips(K092602) | Modified FreeStyle LiteBlood Glucose MonitoringSystem (K150332) |
|---|---|---|
| CHARACTERISTICS | ||
| Meter cleaning and disinfection | Clean with:Mild detergent/soap and water, or 70% isopropyl alcohol, or A mixture of 1 part household bleach, 9 parts water | 522 cleaning and 522disinfection cycles (theequivalent of 2 cycles perweek for 5 years) withClorox Healthcare BleachGermicidal Wipes, EPA Reg.#67619-12 |
| Lancing device cleaning anddisinfection | Clean with:Isopropyl alcohol or Soap and water or Warm water | 210 cleaning and 210disinfection cycles (theequivalent of 2 cycles perweek for 2 years) withClorox Healthcare BleachGermicidal Wipes, EPA Reg.#67619-12 |
| Lancing device | FreeStyle Lancing Device | FreeStyle Lancing Device-II |
Image /page/8/Picture/2 description: The image contains the Abbott logo. The logo consists of a stylized blue "A" symbol on the left and the word "Abbott" in bold, black letters on the right. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
§ 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.