(156 days)
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No
The document describes a blood glucose monitoring system with Bluetooth connectivity and a mobile app for data viewing and editing. The modifications discussed are related to test strip packaging, user guide format, and outer carton size. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for "monitoring the effectiveness of a diabetes control program" and not for treatment.
No
The intended use states that the system "should not be used for the diagnosis of or screening for diabetes." Instead, it is for monitoring the effectiveness of a diabetes control program.
No
The device description explicitly states it is a "blood glucose meter with Bluetooth Low Energy technology built in" and uses "two replaceable CR2032 coin cell batteries," indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "The system is intended for in vitro diagnostic use only."
- Nature of the Test: The device measures glucose in fresh capillary whole blood. This is a test performed on a biological sample taken from the body, which is a characteristic of in vitro diagnostics.
- Purpose: The purpose is to aid in monitoring the effectiveness of a diabetes control program, which is a diagnostic purpose performed outside the body.
N/A
Intended Use / Indications for Use
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 not 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 gluosse 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 drawn from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
CONTOUR® NEXT ONE Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to a mobile smart device. The meter has a 7- segment display and icons in the display to aid the user with the features of the meter. It uses two replaceable CR2032 coin cell batteries. The associated CONTOUR Diabetes app is compatible with Apple iOS operating system and the Android operating system. The app communicates with the CONTOUR® NEXT ONE blood glucose meter using Bluetooth Low Energy wireless technology. Blood glucose test results are automatically sent to the mobile device for viewing and editing, and settings on the meter can be modified using the app. The meter remains unchanged.
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 CONTOUR® NEXT 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. CONTOUR® NEXT Blood Glucose Test Strips remain the same.
The modification discussed in this Special 510K consists of the following:
- Replacing the current CONTOUR NEXT Blood Glucose test strips in the CONTOUR NEXT ONE Blood Glucose Monitoring System packaging from CONTOUR NEXT glucose Test strips in a bottle to CONTOUR NEXT glucose test strips in foiled packaging ("Foiled Strips"). The Foiled Strips were cleared under K191286 for a retail box package. This new, alternative packaging configuration consists of the Foiled Strips (without a retail box) placed in a wallet with the other system components.
- Replacing the current CONTOUR NEXT ONE color, booklet User Guide with a black and white pamphlet User Guide. In addition, some format and minor content labeling changes to the User Guide and Quick Reference Guide have occurred with this transformation. Please see Volume 012 for proposed labeling changes.
- Replacing the current CONTOUR NEXT ONE Blood Glucose Monitoring System packaging with a smaller outer carton.
This modification represents an alternative labeling and packaging configuration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertips or palm
Indicated Patient Age Range
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Intended User / Care Setting
people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 ONE Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications.
Usability testing on the proposed black and white pamphlet User Guide was conducted to ensure that the CONTOUR® NEXT ONE Blood Glucose Monitoring System was easy to use by typical customers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 11, 2021
Ascensia Diabetes Care Stacie Geffner-Atiya Principal Regulatory Affairs Associate 100 Summit Lake Drive Valhalla, New York 10595
Re: K210687
Trade/Device Name: CONTOUR® NEXT ONE Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: March 9, 2021 Received: March 10, 2021
Dear Stacie Geffner-Atiya:
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.
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
1
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. 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
Enclosure
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Indications for Use
510(k) Number (if known) K210687
Device Name
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 not 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 gluosse 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 drawn from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
| Research Use Only. Not for use in diagnostic procedures. | |
|---|---|
| In Vitro Diagnostic. For use in diagnostic procedures. |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple, with a blue teardrop shape next to it. Below the shapes, the word "ASCENSIA" is written in a bold font, with the words "Diabetes Care" written in a smaller font underneath.
510k Summary: K210687
Date prepared: August 11, 2021
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 name: CONTOUR® NEXT ONE Blood Glucose
Monitoring System
Common name: Glucose Test System
Classification name: NBW; Glucose Test System, OTC
(21 C.F.R. Section 862.1345) |
| 3) Predicate
Device: | CONTOUR® NEXT ONE (K191286) |
| 4) Device
Description: | CONTOUR® NEXT ONE Blood Glucose Monitoring System
is a blood glucose meter with Bluetooth Low Energy
technology built in so that the meter can communicate
wirelessly to a mobile smart device. The meter has a 7-
segment display and icons in the display to aid the user with
the features of the meter. It uses two replaceable CR2032
coin cell batteries. The associated CONTOUR Diabetes app
is compatible with Apple iOS operating system and the
Android operating system. The app communicates with the
CONTOUR® NEXT ONE blood glucose meter using Bluetooth
Low Energy wireless technology. Blood glucose test results
are automatically sent to the mobile device for viewing and
editing, and settings on the meter can be modified using the
app. The meter remains unchanged. |
| | The CONTOUR® NEXT Blood Glucose Test Strips are |
al e intended for self-testing by persons with diabetes for the
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Image /page/4/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a purple triangle 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 font.
quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® NEXT 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. CONTOUR® NEXT Blood Glucose Test Strips remain the same.
The modification discussed in this Special 510K consists of the following:
-
- Replacing the current CONTOUR NEXT Blood Glucose test strips in the CONTOUR NEXT ONE Blood Glucose Monitoring System packaging from CONTOUR NEXT glucose Test strips in a bottle to CONTOUR NEXT glucose test strips in foiled packaging ("Foiled Strips"). The Foiled Strips were cleared under K191286 for a retail box package. This new, alternative packaging configuration consists of the Foiled Strips (without a retail box) placed in a wallet with the other system components.
-
- Replacing the current CONTOUR NEXT ONE color, booklet User Guide with a black and white pamphlet User Guide. In addition, some format and minor content labeling changes to the User Guide and Quick Reference Guide have occurred with this transformation. Please see Volume 012 for proposed labeling changes.
-
- Replacing the current CONTOUR NEXT ONE Blood Glucose Monitoring System packaging with a smaller outer carton.
This modification represents an alternative labeling and packaging configuration.
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Image /page/5/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 water droplet. Below the graphic are the words "ASCENSIA" and "Diabetes Care" in a smaller font size.
- Intended The CONTOUR® NEXT ONE Blood Glucose Monitoring System is Use(s): 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 selftesting 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 not 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 time (when glucose is not changing rapidly).
The CONTOUR® NEXT Blood Glucose Test Strips are for use with the CONTOUR NEXT ONE Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
| Predicate Device | Subject Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONE Blood | |
| Glucose Monitoring System | ||
| (K191286) | CONTOUR NEXT ONE Blood | |
| Glucose Monitoring System | ||
| CHARACTERISTICS | ||
| Meter | CONTOUR® NEXT One | |
| Meter | Same as predicate | |
| Test strip | CONTOUR® NEXT Test | |
| Strips | Same as predicate | |
| CONTOUR® NEXT | ||
| ONE Blood Glucose | ||
| Monitoring System | ||
| Packaging | ||
| Configuration | CONTOUR® NEXT Blood | |
| Glucose Test Strips in | ||
| desiccated-lined bottle or | ||
| CONTOUR® NEXT Blood | ||
| Glucose Test Strips in | ||
| desiccated-lined foil pouch | CONTOUR® NEXT Blood | |
| Glucose Test Strips in | ||
| desiccated-lined foil pouch, | ||
| place in a wallet, included in | ||
| the Contour Next One |
A detailed comparison of the modified device and predicate device is provided below:
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Image /page/6/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.
| Predicate Device | Subject Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONE Blood | |
| Glucose Monitoring System | ||
| (K191286) | CONTOUR NEXT ONE Blood | |
| Glucose Monitoring System | ||
| sold separately in retail | ||
| packaging. | Blood Glucose Monitoring | |
| System Packaging. | ||
| CONTOUR® NEXT | ||
| ONE Blood Glucose | ||
| Monitoring System | ||
| Outer Carton Box | Carton Box Dimensions: | |
| 12.065 x 6.985 x 16.670 cm | Carton Box Dimensions: | |
| 11.50 x 5.00 x 16.50 cm |
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Image /page/7/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" formed by a purple triangle and a blue teardrop shape. 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.
| Predicate Device | Subject Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONE Blood | |
| Glucose Monitoring System | ||
| (K191286) | CONTOUR NEXT ONE Blood | |
| Glucose Monitoring System | ||
| CHARACTERISTICS | ||
| CONTOUR NEXT ONE | ||
| Blood Glucose | ||
| Monitoring System User | ||
| Guide | Color Booklet Format | Folded black and white |
| pamphlet, along with some | ||
| format and minor content | ||
| labeling changes have | ||
| occurred with this | ||
| transformation |
Summary of Performance testing
Verification and validation testing against well-established methods showed that the CONTOUR® NEXT ONE Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications.
Usability testing on the proposed black and white pamphlet User Guide was conducted to ensure that the CONTOUR® NEXT ONE Blood Glucose Monitoring System was easy to use by typical customers.
Conclusions from Performance Evaluations
Based on the outcome of the performance testing conducted, the modified CONTOUR® NEXT ONE Blood Glucose Monitoring System is substantially equivalent to the CONTOUR® NEXT ONE Blood Glucose Monitoring System (K191286).