(179 days)
Not Found
No
The document describes a standard blood glucose monitoring system and a change in packaging for the test strips. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used to monitor glucose levels, not to provide therapy or treatment.
No
Explanation: The document explicitly states multiple times that the device "is not intended for the diagnosis of or screening for diabetes mellitus." It is intended as an aid to monitor the effectiveness of diabetes control.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, and control solutions, which are hardware components. The submission focuses on a change in packaging for the test strips, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states the following for multiple variations of the CONTOUR® NEXT Blood Glucose Monitoring System:
- "The system is intended for self-testing outside the body (in vitro diagnostic use)"
- "The system is intended for in vitro diagnostic use only."
This clearly indicates that the device is designed to be used outside of the body to diagnose or monitor a condition, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
persons with diabetes at home (self-testing), lay-users
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K160430, K150942, K160682, K162336
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 System
CONTOUR® NEXT USB Blood Glucose Monitoring System
CONTOUR® NEXT ONE Blood Glucose Monitoring System
CONTOUR® NEXT EZ Blood Glucose Monitoring System
CONTOUR® 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.
1
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
2
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
3
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-Atiya
Principal Regulatory Affairs Specialist
Ascensia Diabetes Care
100 Summit Lake Drive
Valhalla, NY 10595 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade names:
CONTOUR® NEXT Blood Glucose Monitoring System
CONTOUR® NEXT USB Blood Glucose Monitoring System
CONTOUR® NEXT ONE Blood Glucose Monitoring System
CONTOUR® NEXT EZ Blood Glucose Monitoring System
CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring
System |
| | Common name: Glucose Test System |
| | Classification name: NBW; Glucose Test System, OTC
(21 C.F.R. Section 862.1234) |
| 3) Predicate
device: | 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) Device
description: | 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 |
8
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
9
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 Monitor
| System | Indications for Use |
|---|---|
| Contour® Next | 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 screning for diabetes | |
| mellitus and its not intended for use on neonates. |
10
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 Monitor
| System | Indications for Use |
|---|---|
| Contour® Next USB | 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 single-patient 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. |
11
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 Monitor
| System | Indications for Use |
|---|---|
| Contour® Next One | 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. |
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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 Monitor
| System | Indications for Use |
|---|---|
| Contour® Next EZ | The CONTOUR® NEXT EZ blood glucose monitoring |
| system is an over the counter (OTC) device utilized for | |
| self-testing 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 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. | |
| Blood Glucose Monitor | |
| System | Indications for Use |
| Contour® Next Link | |
| Wireless | 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 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 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. |
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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® NEXT | |
| Glucose Monitoring | ||
| System (K160430) | CONTOUR® NEXT Blood | |
| Glucose Monitoring | ||
| System | ||
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Test | |
| strips | Same as predicate | |
| Test Strip Packaging | 25, 35 or 50 Test Strips in | |
| desiccated-lined bottle | Alternative package | |
| consists of a desiccated- | ||
| lined foil pouch, with each | ||
| pouch containing five | ||
| individually sealed, test | ||
| strips. |
| Predicate Device | Proposed Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT USB | |
| Glucose Monitoring | ||
| System (K150942) | CONTOUR® NEXT USB | |
| Glucose Monitoring | ||
| System | ||
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Test | |
| strips | Same as predicate | |
| Test Strip Packaging | 25, 35 or 50 Test Strips in | |
| desiccated-lined bottle | Alternative package | |
| consists of a desiccated- | ||
| lined foil pouch, with each | ||
| pouch containing five | ||
| individually sealed, test | ||
| strips. |
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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 ONE | |
| Glucose Monitoring | ||
| System (K160682) | CONTOUR® NEXT ONE | |
| Glucose Monitoring | ||
| System | ||
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Test | |
| strips | Same as predicate | |
| Test Strip Packaging | 25, 35 or 50 Test Strips in | |
| desiccated-lined bottle | Alternative package | |
| consists of a desiccated- | ||
| lined foil pouch, with each | ||
| pouch containing five | ||
| individually sealed, test | ||
| strips. |
| Predicate Device | Proposed Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT EZ | |
| Glucose Monitoring | ||
| System (K162336) | CONTOUR® NEXT EZ | |
| Glucose Monitoring | ||
| System | ||
| CHARACTERISTICS | ||
| Test strip | CONTOUR® NEXT Test | |
| strips | Same as predicate | |
| Test Strip Packaging | 25, 35 or 50 Test Strips in | |
| desiccated-lined bottle | Alternative package | |
| consists of a desiccated- | ||
| lined foil pouch, with each | ||
| pouch containing five | ||
| individually sealed, test | ||
| strips. |
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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 Device
CONTOUR® NEXT LINK
Wireless Glucose
Monitoring System
(K160430) | Proposed Device
CONTOUR® NEXT LINK
Wireless Glucose
Monitoring System |
|----------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTICS | | |
| Test strip | CONTOUR® NEXT Test
strips | Same as predicate |
| Test Strip Packaging | 25, 35 or 50 Test Strips in
desiccated-lined bottle | Alternative package
consists of a desiccated-
lined foil pouch, with each
pouch containing five
individually sealed, test
strips. |
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