(231 days)
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No
The document describes a standard electrochemical blood glucose meter and does not mention any AI or ML components or functionalities.
No
The device is a blood glucose monitoring system used to measure glucose levels, not to provide therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The Contour Next USB blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus."
No
The device description explicitly states it consists of a handheld blood glucose meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Device Description: The description details the chemical principle used to measure glucose in the blood sample on the test strip. This process of analyzing a biological sample to obtain a diagnostic measurement is characteristic of an IVD.
- Components: The system includes test strips and control solutions, which are common components of IVD systems used for calibration and quality control.
The fact that it's used by patients in a home setting and is over-the-counter does not preclude it from being an IVD. IVDs can be used in various settings, including home use.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The Contour Next USB Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next USB Blood Glucose Monitoring System.
The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
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
Fingertip and palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Home settings for persons with diabetes.
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
Bench testing was conducted to ensure that the error checks acted as intended and gave error messages for:
- . test strips that had been exposed to a reducing agent
- . un-mixed control test solution
- . samples that had been disturbed during the test countdown
Software verification testing was conducted to ensure that no good results were classified as errors as a result of the modifications.
Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different.
An internal user study was conducted to ensure the modifications did not impact the blood glucose result accuracy of the Contour Next USB system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, software verification testing, equivalency testing, and an internal user study were conducted.
Key results: Based on the outcome of the performance testing conducted, the modified Contour Next USB Blood Glucose Meter is substantially equivalent to the predicate Contour Next USB Blood Glucose Meter (K121087).
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.
Contour Next USB Blood Glucose Meter (Reference: Contour Next USB Blood Glucose Monitoring System (K121087))
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The symbol is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
BAYER HEALTHCARE JENNIFER GREGORY REGULATORY AFFAIRS SPECIALIST 430 SOUTH BEIGER ST. MISHAWAKA IN 46544
Re: K150942
Trade/Device Name: Contour Next USB Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: October 29, 2015 Received: October 30, 2015
Dear Jennifer Gregory:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For:
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150942
Device Name
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 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.
| 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/1 description: The image is the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a circle. The circle is colored with green at the top and blue at the bottom.
510(k) Summary
Date prepared: November 23, 2015
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 | Jennifer Gregory
Regulatory Affairs Specialist
Bayer Healthcare LLC
430 South Beiger Street
Mishawaka, IN 46544
Telephone: (574) 256-3447
Fax: (574) 256-3519 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade name: Bayer Contour® Next USB Blood Glucose
Monitoring System
Common name: Blood Glucose Meter
Classification name: Blood Glucose Test System, Over-
the-Counter, 75 NBW, LFR (21 CFR § 862.1345) |
| 3) Predicate
device: | Contour Next USB Blood Glucose Meter (Reference:
Contour Next USB Blood Glucose Monitoring
System (K121087)) |
| 4) Device
description: | The Contour Next USB Blood Glucose Meter consists of a
small handheld blood glucose meter that utilizes dry
reagent test strips for the measurement of glucose in
capillary whole blood by persons with diabetes. Liquid
control solution is used to check the performance of the
system. The meter, together with the test strips and
control solutions, is referred to as the Contour Next USB
Blood Glucose Monitoring System.
The chemical principle utilized for both the predicate and
modified devices is based on measurement of electrical
current caused by the reaction of glucose in the blood with
chemicals on the reagent strip. The blood sample is drawn
into the tip of the reagent strip through capillary action.
Glucose in the sample reacts with FAD glucose
dehydrogenase (FAD-GDH) enzyme on the reagent strip.
The electrons generated by this reaction are shuttled to an |
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Image /page/4/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once vertically and once horizontally, with the letters intersecting in the middle. The logo is surrounded by a circle that is green on the top and blue on the bottom.
electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
-
- Intended Use: 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.
- Intended Use: 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 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.
Data demonstrating substantial equivalence
The Contour Next USB Blood Glucose Meter consists of a small handheld blood qlucose meter that is substantially equivalent to the predicate device, the Contour Next USB Blood Glucose Meter (K121087). The modified and predicate devices use the same glucose calculation algorithm. Both devices also use dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes and liquid controls to check the performance of the system. The same Contour Next test strips and Contour Next control solutions are used by both the modified and predicate devices.
A detailed comparison of the characteristics featured between the modified and predicate devices is provided in the tables below:
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Image /page/5/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" written vertically in the center. The letters are arranged in a cross shape. The circle is green at the top and fades to blue at the bottom. The letters are gray with a silver outline.
Modified Device (Contour Next USB meter)
Image /page/5/Picture/3 description: The image shows a Bayer Contour Next One blood glucose meter. The meter's display shows a reading of 93 mg/dL, taken before a meal at 1:33 PM on November 10th. The meter has a sleek, black design with a gray button on the right side that has the Bayer logo.
Predicate Device (Contour Next USB meter)
Image /page/5/Picture/5 description: The image shows a Bayer Contour Next blood glucose meter. The meter displays a reading of 93 mg/dL, taken before a meal. The display also shows the time as 1:33 PM and the date as 11/10. The meter has buttons for reminder and notes.
| Summary of the Technological Characteristics of the Modified Device Compared to Predicate | ||
|---|---|---|
| SIMILARITIES to Predicate | ||
| Characteristic | Predicate | |
| Contour Next USB | ||
| (K121087) | Contour Next USB | |
| (Modified Device) | ||
| Test Strip | Contour Next Test Strips | Same as Predicate |
| Control Solution | Contour Next Control Solution | |
| (Level 1 and 2) | Same as Predicate | |
| Detection Method | Amperometric | Same as Predicate |
| Measuring Range | 20-600 mg/dL | Same as Predicate |
| Sample Volume | 0.6 µL | Same as Predicate |
| Countdown time displayed | 5 Seconds | Same as Predicate |
| Illuminated Strip Port | Yes | Same as Predicate |
| Operational Buttons | 4 | Same as Predicate |
| Battery Type | Rechargeable (3.4-4.2V) | Same as Predicate |
| Operating Temperature | ||
| Range | 41°-113° F | Same as Predicate |
| Operating Humidity Range | 10-93% RH | Same as Predicate |
| Hematocrit Range | 15%-65% | Same as Predicate |
| Meter life | 5 Years | Same as Predicate |
| Validated Product Used for | ||
| Cleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate |
| Meal Markers | Yes | Same as Predicate |
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Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with the letters stacked vertically and horizontally. The letters are in a sans-serif font and are colored gray. The logo is surrounded by a circle that transitions from green at the top to blue at the bottom.
| Summary of the Technological Characteristics of the Modified Device Compared to
| Predicate | ||
|---|---|---|
| SIMILARITIES to Predicate | ||
| Predicate | Contour Next USB | |
| Characteristic | Contour Next USB | |
| (K121087) | (Modified Device) | |
| Calibration/Coding | Autocoding (no coding for | |
| users) | Same as Predicate | |
| User Interface | Alphanumeric, Iconic, Native | |
| Language | Same as Predicate | |
| Display (technology) | Graphical (OLED) | Same as Predicate |
| Display Visibility | Day and night | Same as Predicate |
| Communication Port | USB Interface | Same as Predicate |
| Communication Link to | ||
| Computer | Direct USB connection or | |
| optional USB cable | Same as Predicate | |
| Test Results in Memory | 2000 Results | Same as Predicate |
| User Contact | ||
| Materials/Surface Finish | Polycarbonite/ABS with AS | |
| plastics with mirror or matte | ||
| finish | Same as Predicate |
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Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once horizontally and once vertically, forming a cross shape. The logo is surrounded by a circle that is green on the top half and blue on the bottom half.
| DIFFERENCES from Predicate | |||
|---|---|---|---|
| Characteristic | Predicate | ||
| Contour Next | |||
| USB (K121087) | Contour Next USB | ||
| (Modified Device) | Risk Assessment Summary | ||
| Improved detection of test strips that | |||
| may have been exposed to a chemical | |||
| that can degrade the mediator. | No | Yes | The error check improves the ability of the |
| modified meter to detect exposed test strips and | |||
| provide an error message instead of a high | |||
| biased result. | |||
| Improved detection of un-mixed control | |||
| solution. | No | Yes | The error check improves the ability of the |
| modified meter to detect un-mixed control test | |||
| solutions and provide an error message instead | |||
| of a high biased result. | |||
| Improved detection of sample | |||
| 'perturbation' during a test. | No | Yes | The error check improves the ability of the |
| modified meter to detect a sample that is | |||
| disturbed during the countdown period and | |||
| provide an error message instead of a biased | |||
| result. |
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Summary of Performance testing
Bench testing was conducted to ensure that the error checks acted as intended and gave error messages for:
- . test strips that had been exposed to a reducing agent
- . un-mixed control test solution
- . samples that had been disturbed during the test countdown
Software verification testing was conducted to ensure that no good results were classified as errors as a result of the modifications.
Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different.
An internal user study was conducted to ensure the modifications did not impact the blood glucose result accuracy of the Contour Next USB system.
Conclusions from Performance Evaluations
Based on the outcome of the performance testing conducted, the modified Contour Next USB Blood Glucose Meter is substantially equivalent to the predicate Contour Next USB Blood Glucose Meter (K121087).