(179 days)
The CONTOUR® NEXT EZ Blood Glucose Monitoring System is an over the counter (OTC) device utilized for selftesting by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.
The system is intended for self testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ Blood Glucose Monitoring System is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EX EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The CONTOUR® NEXT Blood Glucose Monitoring System is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The CONTOUR® NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a CONTOUR® NEXT blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions. CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The CONTOUR® NEXT Blood Glucose Monitoring System is not intended for the diagnosis or screening for diabetes mellitus and its not intended for use on neonates.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE 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.
The CONTOUR® NEXT ONE Blood Glucose Monitoring System should be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood draw from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared.
The system consists of a CONTOUR® NEXT USB blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions.
The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The CONTOUR® NEXT USB Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood.
The CONTOUR® NEXT Blood Glucose Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The Blood Glucose Test Strips are to be used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of glucose in whole blood. There is no change in either intended use or indications for use. The strips remain the same; and the only change is the new alternative packaging.
The modification discussed in this Special 510K consists a new, alternative packaging configuration of a desiccated-lined foil pouch, with each pouch containing five individually sealed, test strips in comparison to the existing blood glucose test strips in a desiccated-lined bottle.
The CONTOUR® NEXT Blood Glucose Test Strips are for use with the following CONTOUR® NEXT Blood Glucose Monitoring Systems:
CONTOUR® NEXT
CONTOUR® NEXT USB
CONTOUR® NEXT ONE
CONTOUR® NEXT EZ
CONTOUR® NEXT LINK Wireless
This document describes the FDA's 510(k) clearance for several CONTOUR® NEXT Blood Glucose Monitoring Systems, specifically focusing on a change to the packaging of the test strips. The core of the submission is to demonstrate that the new packaging, a desiccated-lined foil pouch containing five individually sealed test strips, performs equivalently to the existing desiccated-lined bottle packaging.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria defined by specific performance metrics for glucose measurement accuracy (e.g., ISO 15197:2013 standards for accuracy, precision). Instead, it states:
"Verification and validation testing against well-established methods showed that the CONTOUR® NEXT test Strips with the proposed, alternative foiled packaging, performed as intended and met the system specifications."
This implies that the acceptance criteria are the "system specifications" and "well-established methods" for glucose measurement devices. The reported device performance is that the new packaging met these specifications. However, no specific numerical data or thresholds are provided in this summary.
Given the nature of the device (blood glucose monitoring system) and the regulatory context (FDA 510(k) summary), the implicit acceptance criteria would relate to the accuracy, precision, and clinical usability of the blood glucose measurements compared to a reference method, typically governed by standards like ISO 15197. The document asserts that these were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing (the "test set") or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "Verification and validation testing."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth, as this type of device (blood glucose meter) typically uses laboratory reference methods for ground truth, not expert human interpretation of images.
4. Adjudication Method for the Test Set
The concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies involving human readers or interpretation of complex data (like medical images) where there can be disagreement among experts. For a blood glucose monitoring system, the ground truth is established through a laboratory reference method, so no adjudication method as described would be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for imaging devices or AI tools that assist human interpretation. Since this device is a blood glucose meter, which provides a quantitative measurement, an MRMC study is not applicable or described. The device does not assist human readers in diagnosing or interpreting images, but rather provides a direct numerical measurement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This device is an in-vitro diagnostic device that provides a direct measurement, not an AI algorithm for interpretation. Therefore, the concept of "standalone performance" in the context of an algorithm without human-in-the-loop is not applicable. The device itself is the "standalone" measurement system.
7. Type of Ground Truth Used
While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth for performance evaluation is typically established using a laboratory reference method (e.g., a YSI STAT 2300 Glucose & Lactate Analyzer or similar highly accurate laboratory instrument) that measures glucose concentration in blood samples. This provides a gold standard against which the device's measurements are compared. The phrase "well-established methods" strongly implies the use of such a reference standard.
8. Sample Size for the Training Set
This document describes a 510(k) submission for a change in packaging for an existing device. It does not indicate that this submission involves a "training set" in the context of machine learning. Blood glucose meters are electrochemical or optical devices, not machine learning algorithms that require training data. Therefore, the concept of a "training set" as it pertains to AI/ML is not applicable here.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" in the context of AI/ML for this device, this question is not applicable.
Summary of what the document implies about the study:
The document indicates that the study performed was a verification and validation of the new packaging's effect on the performance of the existing CONTOUR® NEXT test strips. The key finding is that the test strips in the new foil pouch packaging deliver performance that "met the system specifications" when tested against "well-established methods" (likely laboratory reference methods). Additionally, "Usability testing was conducted on the proposed foiled packaging to ensure that the packaging was easy to use and labeling understood by typical customers." This suggests that the study primarily focused on ensuring the new packaging did not negatively impact the established analytical performance of the test trips, and that it was still user-friendly.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 8, 2019
Ascensia Diabetes Care Stacie Geffner-Atiya Principal Regulatory Affairs 100 Summit Lake Drive Valhalla, NY 10595
Re: K191286
| Trade/Device Name: | CONTOUR® NEXT Blood Glucose Monitoring SystemCONTOUR® NEXT USB Blood Glucose Monitoring SystemCONTOUR® NEXT ONE Blood Glucose Monitoring SystemCONTOUR® NEXT EZ Blood Glucose Monitoring SystemCONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System |
|---|---|
| Regulation Number: | 21 CFR 862.1345 |
| Regulation Name: | Glucose Test System |
| Regulatory Class: | Class II |
| Product Code: | NBW |
| Dated: | October 10, 2019 |
| Received: | October 11, 2019 |
Dear Stacie Geffner-Ativa:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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510(k) Number (if known) K191286
Device Name
The CONTOUR® NEXT EZ Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR® NEXT EZ Blood Glucose Monitoring System is an over the counter (OTC) device utilized for selftesting by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.
The system is intended for self testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ Blood Glucose Monitoring System is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EX EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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510(k) Number (if known) K191286
Device Name
The CONTOUR® NEXT Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR® NEXT Blood Glucose Monitoring System is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The CONTOUR® NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a CONTOUR® NEXT blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions. CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The CONTOUR® NEXT Blood Glucose Monitoring System is not intended for the diagnosis or screening for diabetes mellitus and its not intended for use on neonates.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{4}------------------------------------------------
510(k) Number (if known) K191286
Device Name
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{5}------------------------------------------------
510(k) Number (if known) K191286
Device Name
The CONTOUR® NEXT ONE Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE 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.
The CONTOUR® NEXT ONE Blood Glucose Monitoring System should be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood draw from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{6}------------------------------------------------
510(k) Number (if known) K191286
Device Name
The CONTOUR® NEXT USB Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared.
The system consists of a CONTOUR® NEXT USB blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions.
The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The CONTOUR® NEXT USB Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter 'A' in purple, with a blue teardrop shape attached to the right side of the 'A'. Below the symbol, the word 'ASCENSIA' is written in a bold, sans-serif font, and below that, the words 'Diabetes Care' are written in a smaller, lighter font.
510k Summary: K191286
Date prepared: November 4, 2019
According to the requirements of 21 CFR 807.92, the following information is being submitted in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.
| 1) Submitter | Stacie Geffner-AtiyaPrincipal Regulatory Affairs SpecialistAscensia Diabetes Care100 Summit Lake DriveValhalla, NY 10595 |
|---|---|
| 2) Device name: | Trade names:CONTOUR® NEXT Blood Glucose Monitoring SystemCONTOUR® NEXT USB Blood Glucose Monitoring SystemCONTOUR® NEXT ONE Blood Glucose Monitoring SystemCONTOUR® NEXT EZ Blood Glucose Monitoring SystemCONTOUR® NEXT LINK Wireless Blood Glucose MonitoringSystem |
| Common name: Glucose Test System | |
| Classification name: NBW; Glucose Test System, OTC(21 C.F.R. Section 862.1234) | |
| 3) Predicatedevice: | CONTOUR® NEXT ONE Blood Glucose Monitoring Systems:CONTOUR® NEXT (K160430)CONTOUR® NEXT USB (K150942)CONTOUR® NEXT ONE (K160682)CONTOUR® NEXT EZ (K162336)CONTOUR® NEXT LINK Wireless (K160430) |
| 4) Devicedescription: | The CONTOUR® NEXT Blood Glucose Test Strips areintended for self-testing by persons with diabetes for thequantitative measurement of glucose in whole blood samplesfrom 20 to 600 mg/dL. The Blood Glucose Test Strips are tobe used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of |
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Image /page/8/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below these shapes, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" written in a smaller font underneath.
glucose in whole blood. There is no change in either intended use or indications for use. The strips remain the same; and the only change is the new alternative packaging.
The modification discussed in this Special 510K consists a new, alternative packaging configuration of a desiccated-lined foil pouch, with each pouch containing five individually sealed, test strips in comparison to the existing blood glucose test strips in a desiccated-lined bottle.
The CONTOUR® NEXT Blood Glucose Test Strips are for use with the following CONTOUR® NEXT Blood Glucose Monitoring Systems:
CONTOUR® NEXT CONTOUR® NEXT USB CONTOUR® NEXT ONE CONTOUR® NEXT EZ CONTOUR® NEXT LINK Wireless
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Image /page/9/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple, next to a blue teardrop shape. Below these shapes, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" appearing in a smaller font size underneath.
- Intended Use(s): The CONTOUR® NEXT Blood Glucose Test Strips are indicated for use with the following CONTOUR NEXT Blood Glucose Monitoring Systems:
| Blood Glucose MonitorSystem | Indications for Use |
|---|---|
| Contour® Next | The Contour® Next blood glucose monitoring system isan over-the-counter (OTC) device utilized by persons withdiabetes in home settings for the quantitativemeasurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The systemis intended for self-testing outside the body (in vitrodiagnostic use) and is to be used as an aid to monitor theeffectiveness of diabetes control. |
| The Contour® Next blood glucose monitoring system isindicated for use with fresh capillary whole blood samplesdrawn from the fingertip and palm only. Alternative sitetesting should be done only during steady state times(when glucose is not changing rapidly). | |
| The system consists of a Contour® Next blood glucosemeter, Contour® Next test strips and Contour Next controlsolutions. Contour® Next test strips are intended for self-testing by persons with diabetes for the quantitativemeasurement of glucose in whole blood samples. | |
| The Contour® Next blood glucose monitoring system isnot intended for the diagnosis or screning for diabetesmellitus and its not intended for use on neonates. |
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Image /page/10/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, with a blue teardrop shape incorporated into the design. Below the symbol, the word "ASCENSIA" is written in a sans-serif font, followed by the words "Diabetes Care" in a smaller font size.
| Blood Glucose MonitorSystem | Indications for Use |
|---|---|
| Contour® Next USB | The Contour® Next USB blood glucose monitoringsystem is an over the counter (OTC) device utilized bypersons with diabetes in home settings for thequantitative measurement of glucose in whole blood, andis for single-patient use only and should not be shared. |
| The system consists of a Contour® Next USB bloodglucose meter, Contour® Next test strips and Contour®Next control solutions. | |
| The Contour® Next USB blood glucose monitoringsystem is indicated for use with fresh capillary wholeblood samples drawn from the fingertip and palm only.Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly). | |
| The Contour® Next USB blood glucose monitoringsystem is not intended for the diagnosis of or screeningfor diabetes mellitus and is not intended for use onneonates. | |
| The Contour® Next Test Strips are for use with theContour® Next USB blood glucose monitoring system forthe quantitative measurement of glucose in whole blood. |
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Image /page/11/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a purple triangle on the left and a blue teardrop shape on the right. Below the shapes, the word "ASCENSIA" is written in a bold font, and below that, the words "Diabetes Care" are written in a smaller, less bold font.
| Blood Glucose MonitorSystem | Indications for Use |
|---|---|
| Contour® Next One | The Contour® Next One Blood Glucose MonitoringSystem is intended to be used for the quantitativemeasurement of glucose in fresh capillary whole blooddrawn from the fingertips or palm. The Contour® NextOne Blood Glucose Monitoring System is intended to beused by a single person and should not be shared. TheContour® Next One Blood Glucose Monitoring System isintended for self-testing outside the body (in vitrodiagnostic use) by people with diabetes at home as an aidin monitoring the effectiveness of a diabetes controlprogram. |
| The Contour® Next One Blood Glucose MonitoringSystem should be used for the diagnosis of or screeningfor diabetes or for neonatal use. Alternative site testing(palm) should be done only during steady state times(when glucose is not changing rapidly). The Contour®Next test strips are for use with the contour Next Oneblood glucose meter to quantitatively measure glucose infresh capillary whole blood draw from the fingertips orpalm. | |
| The system is intended for in vitro diagnostic use only. |
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Image /page/12/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle shape next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a bold font, and below that, the words "Diabetes Care" are written in a smaller, lighter font.
| Blood Glucose MonitorSystem | Indications for Use |
|---|---|
| Contour® Next EZ | The CONTOUR® NEXT EZ blood glucose monitoringsystem is an over the counter (OTC) device utilized forself-testing by persons with diabetes at home for thequantitative measurement of glucose in whole blood, isfor single-patient use only, and should not be shared. |
| The system is intended for self testing outside the body(in vitro diagnostic use) and is to be used as an aid tomonitor the effectiveness of diabetes control. TheCONTOUR® NEXT EZ blood glucose monitoring systemis indicated for use with fresh fingertip capillary wholeblood samples. | |
| The CONTOUR® NEXT EZ blood glucose monitoringsystem is not intended for the diagnosis of or screeningfor diabetes mellitus and is not intended for use onneonates. | |
| The CONTOUR® NEXT test strips are for use with theCONTOUR® NEXT EZ blood glucose meter toquantitatively measure glucose (sugar) in fresh capillarywhole blood samples drawn from the fingertips. | |
| Blood Glucose MonitorSystem | Indications for Use |
| Contour® Next LinkWireless | The Contour® Next Link Wireless blood glucosemonitoring system is an over the counter (OTC) deviceutilized by persons with diabetes in home settings for thequantitative measurement of glucose in whole blood, andis for single-patient use only and should not be shared.The System is intended for self-testing outside the body(in vitro diagnostic use) and is to be used as an aid tomonitor the effectiveness of diabetes control.The Contour® Next Link Wireless blood glucosemonitoring system is indicated for use with fresh capillarywhole blood samples drawn from the fingertip and palmonly. Alternative site testing should be done only duringsteady state times (when glucose is not changing rapidly).Contour® Next test strips are intended for self-testing bypersons with diabetes for the quantitative measurement ofglucose in whole blood samples.The Contour Next Link Wireless Blood GlucoseMonitoring System is intended to be used to transmitglucose values to Medtronic MiniMed Paradigm InsulinPumps or Medtronic MiniMed Paradigm REAL-TimeRevel Insulin Pumps or Medtronic MiniMed 530G InsulinPumps and facilitate transfer of information to MedtronicMiniMed Carelink Therapy Management Software throughuse of radio frequency communication.The Contour® Next Link Wireless blood glucosemonitoring system is not intended for the diagnosis of orscreening for diabetes mellitus and is not intended for useon neonates. |
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Image /page/13/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle on the left and a blue teardrop shape on the right. Below the shapes, the word "ASCENSIA" is written in a bold font, and below that, the words "Diabetes Care" are written in a smaller, less bold font.
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Image /page/14/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of a purple triangle on the left and a blue teardrop shape on the right. Below the shapes, the word "ASCENSIA" is written in purple, and below that, the words "Diabetes Care" are written in a smaller font, also in purple.
Data demonstrating substantial equivalence
A detailed comparison of the modified device and predicate devices is provided in the tables below:
| Predicate Device | Proposed Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXTGlucose MonitoringSystem (K160430) | CONTOUR® NEXT BloodGlucose MonitoringSystem |
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Teststrips | Same as predicate |
| Test Strip Packaging | 25, 35 or 50 Test Strips indesiccated-lined bottle | Alternative packageconsists of a desiccated-lined foil pouch, with eachpouch containing fiveindividually sealed, teststrips. |
| Predicate Device | Proposed Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT USBGlucose MonitoringSystem (K150942) | CONTOUR® NEXT USBGlucose MonitoringSystem |
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Teststrips | Same as predicate |
| Test Strip Packaging | 25, 35 or 50 Test Strips indesiccated-lined bottle | Alternative packageconsists of a desiccated-lined foil pouch, with eachpouch containing fiveindividually sealed, teststrips. |
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Image /page/15/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below these shapes, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" written in a smaller font below it.
| Predicate Device | Proposed Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONEGlucose MonitoringSystem (K160682) | CONTOUR® NEXT ONEGlucose MonitoringSystem |
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Teststrips | Same as predicate |
| Test Strip Packaging | 25, 35 or 50 Test Strips indesiccated-lined bottle | Alternative packageconsists of a desiccated-lined foil pouch, with eachpouch containing fiveindividually sealed, teststrips. |
| Predicate Device | Proposed Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT EZGlucose MonitoringSystem (K162336) | CONTOUR® NEXT EZGlucose MonitoringSystem |
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Teststrips | Same as predicate |
| Test Strip Packaging | 25, 35 or 50 Test Strips indesiccated-lined bottle | Alternative packageconsists of a desiccated-lined foil pouch, with eachpouch containing fiveindividually sealed, teststrips. |
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Image /page/16/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, with a blue teardrop shape attached to the right side of the "A". Below the symbol, the word "ASCENSIA" is written in a bold, sans-serif font, and below that, the words "Diabetes Care" are written in a smaller, less bold font.
| PRODUCT NAME | Predicate DeviceCONTOUR® NEXT LINKWireless GlucoseMonitoring System(K160430) | Proposed DeviceCONTOUR® NEXT LINKWireless GlucoseMonitoring System |
|---|---|---|
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Teststrips | Same as predicate |
| Test Strip Packaging | 25, 35 or 50 Test Strips indesiccated-lined bottle | Alternative packageconsists of a desiccated-lined foil pouch, with eachpouch containing fiveindividually sealed, teststrips. |
Summary of Performance testing
Verification and validation testing against well-established methods showed that the CONTOUR® NEXT test Strips with the proposed, alternative foiled packaging, performed as intended and met the system specifications.
Usability testing was conducted on the proposed foiled packaging to ensure that the packaging was easy to use and labeling understood by typical customers.
Conclusions from Performance Evaluations
Based on the outcome of the performance testing conducted, the modified CONTOUR® NEXT Blood Glucose Test Strips are substantially equivalent to the CONTOUR® NEXT test strips cleared as part of the following Blood Glucose Monitoring Systems:.
CONTOUR® NEXT CONTOUR® NEXT USB CONTOUR® NEXT ONE CONTOUR® NEXT EZ CONTOUR® NEXT LINK Wireless
§ 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.