(95 days)
The FreeStyle Freedom 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 Freedom 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 Freedom 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 Freedom Lite Meter, in conjunction with the FreeStyle Lite Blood Glucose 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 Freedom Lite Meter consists of the following major features: Strip Port, Buttons, Display Window. The device is prepared for use by inserting a FreeStyle Lite 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. 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 provide text is a 510(k) premarket notification for the FreeStyle Freedom Lite Blood Glucose Monitoring System, with a focus on incorporating cleaning and disinfection procedures.
Here's an analysis of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the modification of adding cleaning and disinfection procedures for the FreeStyle Freedom Lite Blood Glucose Monitoring System. The acceptance criteria for this specific modification would revolve around the device's ability to maintain its functionality and accuracy after repeated cleaning and disinfection cycles.
While the document details many characteristics of the device itself (measurement range, sample volume, etc.), it explicitly states the performance related to the modification which is the focus of this submission:
| Acceptance Criteria (Related to the specified modification) | Reported Device Performance |
|---|---|
| Meter Cleaning & Disinfection Cycles | 522 cleaning and 522 disinfection cycles (equivalent of 2 cycles per week for 5 years) with Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12 |
| Lancing Device Cleaning & Disinfection Cycles | 210 cleaning and 210 disinfection cycles (equivalent of 2 cycles per week for 2 years) with Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12 |
Note: The document does not provide a separate table of defined acceptance criteria for the performance of the glucose monitoring itself post-disinfection. Instead, it implies that the device remains "safe and effective for its intended use and technological characteristics" after undergoing these cycles, suggesting that the initial performance criteria for glucose measurement (e.g., accuracy against a reference method) are still met. The detailed performance characteristics like measurement range, sample volume, etc., are similarities to the predicate device and were likely established during the initial clearance or previous submissions.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes disinfection and cleaning cycle testing for the device components themselves, not directly on patient samples to assess glucose accuracy after disinfection.
- Sample Size for Test Set:
- For the meter: The testing was performed for 522 cleaning and 522 disinfection cycles. It is implied that a sufficient number of devices were tested to demonstrate this durability, but the exact number of physical meters tested is not specified.
- For the lancing device: The testing was performed for 210 cleaning and 210 disinfection cycles. Similar to the meter, the exact number of lancing devices tested is not specified.
- Data Provenance: Not explicitly stated, but given this is a US FDA submission from Abbott Laboratories (headquartered in Alameda, CA, USA), the testing would typically be performed in-house or by a US-based contracted lab. The data is retrospective in the sense that the testing has already been completed and is being submitted to the FDA. It's not prospective in nature as part of a future clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable for this type of testing. The "ground truth" here is the durability and continued functionality of the device components (meter and lancing device) after repeated exposure to cleaning and disinfection agents, not clinical diagnostic accuracy. The assessment would likely involve engineering evaluations, visual inspections, and continued functional testing (e.g., still powers on, buttons work, reads test strips accurately) by qualified technical personnel, rather than medical experts establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study that involves human interpretation or consensus directly on diagnostic outcomes. The "adjudication" would be based on predefined failure criteria for device functionality and integrity after the specified cleaning/disinfection cycles.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This submission is about the physical durability and functionality of a blood glucose meter system after cleaning/disinfection, not about the comparative effectiveness of human readers, with or without AI assistance, in interpreting results.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This device is a physical medical device (blood glucose meter and strips), not an AI algorithm. Its performance is intrinsic to its electrochemistry and hardware, demonstrated as a system ("algorithm" here would be the meter's internal processing of electrical signals).
7. Type of Ground Truth Used:
The ground truth for this specific submission (the modification) is the continued physical integrity and functional performance of the meter and lancing device after exposure to the specified cleaning and disinfection agents for a prescribed number of cycles. This would be established through a combination of:
- Engineering specifications and standards: Confirming the device still meets its original operating specifications (e.g., accuracy, display functionality, button responsiveness) after the cycles.
- Visual inspection: Assessing for material degradation, cracking, label fading, etc.
- Functional testing: Ensuring the device continues to successfully perform its core glucose measurement function (e.g., successful blood application, accurate reading of control solutions).
For the overall glucose measurement accuracy, the ground truth would be a laboratory reference method (e.g., YSI analyzer), likely established in prior submissions (like the predicate K092602) and implicitly maintained after the disinfection cycles.
8. Sample Size for the Training Set:
Not applicable. This device does not employ machine learning or AI that would require a "training set." Its operational principles are based on established coulometric biosensor technology.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device/submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
ABBOTT LABORATORIES SAI TATAVARTY REGULATORY AFFAIRS SPECIALIST 1360 SOUTH LOOP ROAD ALAMEDA CA 94502
Re: K150531
Trade/Device Name: Freestyle Freedom 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:
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.
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) K150531
Device Name
FreeStyle Freedom Lite Blood Glucose Monitoring System
Indications for Use (Describe)
The FreeStyle Freedom 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 Freedom 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 with the FreeStyle Freedom 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 healthcare company. The logo is a stylized letter "a" in a blue color. The "a" is enclosed in a rounded square shape, and the letter is formed by a continuous line that curves around to create the shape.
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 Freedom 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 Freedom 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 Freedom 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 Freedom 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 Freedom Lite Meter, in conjunction with the FreeStyle Lite Blood Glucose 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 Freedom Lite Meter consists of the following major features:
- . Strip Port - where the FreeStyle 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 FreeStyle Lite 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. 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 Freedom 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 Freedom 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
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and mediator to the meter where they are read as a small electrical current. The 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 Freedom 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 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. 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 Freedom Lite System, which may be packaged with the following components and accessories listed below.
- A. FreeStyle Freedom 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 Freedom 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 Freedom 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/15 description: The image shows the logo for Abbott. On the left is a blue abstract symbol. To the right of the symbol is the word "Abbott" in a bold, sans-serif font. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.
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Comparison to Predicate Device:
The similarities and differences between the FreeStyle Freedom 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 FreeStyleFreedom Lite BloodGlucose MonitoringSystem (K150531) |
|---|---|---|
| CHARACTERISTICS | ||
| Indications for Use | The FreeStyle Freedom LiteBlood Glucose MonitoringSystem is intended for use inthe quantitative measurementof glucose in capillary wholeblood from the finger, upperarm and palm, and venouswhole blood.The FreeStyle Freedom LiteBlood Glucose MonitoringSystem is intended for use byhealthcare professionals andpeople with diabetes mellitusat home as an aid inmonitoring the effectivenessof a diabetes control program.The FreeStyle Freedom LiteBlood Glucose MonitoringSystem is not intended for thediagnosis of or screening fordiabetes mellitus, and is notintended for use on neonatesor arterial blood. | The FreeStyle Freedom LiteBlood Glucose MonitoringSystem is intended for self-testing outside the body (invitro diagnostic use) by peoplewith diabetes at home as an aidin monitoring the effectivenessof a diabetes control programby quantitatively measuringglucose in fresh whole bloodfrom the finger, upper arm andpalm. The FreeStyle FreedomLite Blood 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 FreedomLite Blood Glucose Meter toquantitatively measure glucose(sugar) in fresh capillary wholeblood samples drawn from thefingertips, upper arm and palm. |
| PRODUCT NAME | FreeStyle Lite BloodGlucose Test Strips(K092602) | Modified FreeStyleFreedom Lite BloodGlucose MonitoringSystem (K150531) |
| Classification Product Code | NBW, LFR | Same |
| Fundamental Technology | The FreeStyle Freedom LiteMeter (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 | Venous or capillary wholeblood | Same |
| AST | Upper arm & palm | Same |
| Sample Volume | 0.3 uL | Same |
| Measurement GlucoseRange | 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 | 1000 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 andcontrol solution tests withdate 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 lithiumbattery, replaceable | Same |
| PRODUCT NAME | FreeStyle Lite BloodGlucose Test Strips(K092602) | Modified FreeStyleFreedom Lite BloodGlucose Monitoring System(K150531) |
| CHARACTERISTICS | ||
| Meter cleaning and disinfection | Clean with:Mild detergent/soap and water, or70% isopropyl alcohol, orA mixture of 1 part household bleach, 9 parts water | 522 cleaning and 522disinfection cycles (theequivalent of 2 cycles per weekfor 5 years) with CloroxHealthcare Bleach GermicidalWipes, EPA Reg. #67619-12 |
| Lancing device cleaning anddisinfection | Clean with:Isopropyl alcohol orSoap 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/6/Picture/4 description: The image shows the Abbott logo. On the left is a blue abstract shape. To the right of the shape is the word "Abbott" in bold, black font. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.
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Image /page/7/Picture/1 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 tagline "A Promise for Life" in a smaller font size.
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Differences:
Image /page/8/Picture/2 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 font. Below the word "Abbott" is the tagline "A Promise for Life".
§ 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.