(23 days)
Not Found
No
The summary describes a standard blood glucose monitoring system with Bluetooth connectivity and a companion app. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a monitoring system intended to measure glucose levels, aid in monitoring a diabetes control program, and not for diagnosis or treatment. Therefore, it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Contour® next GEN 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." and "The system is intended for in vitro diagnostic use only." This indicates it performs a diagnostic function, even if not for initial diagnosis of diabetes.
No
The device description explicitly states that the system includes a "blood glucose meter with Bluetooth Low Energy technology built in" and uses "two replaceable CR2032 or DL2032 coin cell batteries," indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "The Contour® next GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- "The system is intended for in vitro diagnostic use only."
These statements clearly indicate that the device is designed to perform diagnostic tests on samples taken from the body (in this case, blood) outside of the body.
N/A
Intended Use / Indications for Use
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose test strips and the Contour® Diabetes app.
The Contour® next GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN 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 GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
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 GEN Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution. The meter can be connected to the CONTOUR® Diabetes app. It uses two replaceable CR2032 or DL2032 coin cell batteries. The meter's shape is a traditional oval form factor, and it includes an illuminated strip port with colors indicating if a glucose result is above, within, or below target.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips (for fresh capillary whole blood drawn from the fingertips)
Indicated Patient Age Range
Not Found (should not be used for neonatal use)
Intended User / Care Setting
Used by a single person and should not be shared; self-testing outside the body (in vitro diagnostic use) by people with diabetes at home.
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 testing against well-established methods showed that the modified CONTOUR® NEXT GEN Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications.
The meter circuit board changes were made due to the end-of-life of components and addition of alternative suppliers.
Validation testing with the proposed black and white pamphlet User Guide demonstrated that the CONTOUR® NEXT GEN Blood Glucose Monitoring System continued to be easy to use 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.
CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
November 18, 2022
Ascensia Diabetes Care US Inc. Larnie James Head of Regulatory Operations 100 Summit Lake Drive Valhalla, NY 10595
Re: K223293
Trade/Device Name: CONTOUR® next GEN Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: October 25, 2022 Received: October 26, 2022
Dear Larnie James:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Digitally signed by Paula Caposino -S Date: 2022.11.18
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223293
Device Name
Contour® next GEN Blood Glucose Monitoring System
Indications for Use (Describe)
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose test strips and the Contour® Diabetes app.
The Contour® next GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN 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 GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
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) | ☑ 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 letter "A" in purple, next to a blue teardrop shape. Below these symbols, the text "ASCENSIA" is written in a dark purple sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.
510(k) Summary K223293
Date prepared: November 18, 2022
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 | Larnie James
Head of Regulatory Operations
Ascensia Diabetes Care US Inc
100 Summit Lake Drive
Valhalla, NY 10595 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade name: Contour® NEXT GEN Blood Glucose
Monitoring System
Common name: Blood Glucose Monitoring System
Classification name: 75 NBW; Glucose Test System,
OTC
Regulation Number: 21 CFR 862.1345 |
| 3) Predicate device: | CONTOUR® NEXT GEN Blood Glucose Monitoring
System (K193407) |
| 4) Device description: | CONTOUR® NEXT GEN Blood Glucose Monitoring
System is a blood glucose meter with Bluetooth Low
Energy technology built in so that the meter can
communicate wirelessly to smart phones and tablets.
The meter uses the CONTOUR® NEXT blood glucose
test strips and CONTOUR® NEXT control solution. The
meter can be connected to the CONTOUR® Diabetes
app. It uses two replaceable CR2032 or DL2032 coin
cell batteries. The meter's shape is a traditional oval
form factor, and it includes an illuminated strip port with
colors indicating if a glucose result is above, within, or
below target. |
4
Image /page/4/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 symbols, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.
The CONTOUR® NEXT GEN Blood Glucose 5) Intended Use: Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app.
The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN 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 GEN Blood Glucose Monitoring System should not be used for the diaqnosis of or screening for diabetes or for neonatal use.
The system is intended for in vitro diagnostic use only.
5
Image /page/5/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple next to a blue water droplet. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" written in a smaller font below it.
Data demonstrating substantial equivalence
A comparison of the modified device and predicate device is provided in the table below:
| Feature | CONTOUR® NEXT GEN
(Predicate device K193407) | CONTOUR® NEXT GEN
(Subject Device) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Meter | CONTOUR® NEXT GEN Blood
Glucose Meter | Same as predicate |
| Meter circuit
board | CONTOUR® NEXT GEN Blood
Glucose Meter circuit board | Replacement or alternative meter
circuit board components with
same or equivalent specifications |
| Test strips | CONTOUR® NEXT Blood
Glucose Test Strips | Same as predicate |
| Meter Kit
outer carton
box | Carton Box Dimensions:
12.065 x 6.985 x 16.670 cm | Smaller Carton Box Dimensions:
11.5 x 5.0 x 16.5 cm |
| Meter Kit
packaging
configuration | The CONTOUR®NEXT GEN
Blood Glucose Monitoring System
Meter Kit contents are packed
alongside each other in the Meter
Kit. | The CONTOUR® NEXT GEN
Blood Glucose Monitoring System
Meter Kit contents are packed
inside the carrying case inside the
Meter Kit. |
| | The CONTOUR® NEXT Blood
Glucose Test Strips are bottled. | The CONTOUR® NEXT Blood
Glucose Test Strips are foil-
packed. |
| User Guide | Color booklet format | Folded black and white pamphlet
Minor content labeling changes |
Performance Testing
Verification testing against well-established methods showed that the modified CONTOUR® NEXT GEN Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications.
The meter circuit board changes were made due to the end-of-life of components and addition of alternative suppliers.
Validation testing with the proposed black and white pamphlet User Guide demonstrated that the CONTOUR® NEXT GEN Blood Glucose Monitoring System continued to be easy to use by typical customers.
6
Image /page/6/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it.
Conclusion
The modified CONTOUR® NEXT GEN Blood Glucose Monitoring System has been shown to be substantially equivalent to the predicate device, the CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407).