(504 days)
Not Found
No
The device description and performance studies focus on electrochemical measurement and standard analytical and clinical performance metrics, with no mention of AI or ML algorithms.
No.
This device is a diagnostic tool used for monitoring blood glucose levels, not a therapeutic device that treats or prevents a disease. Its clinical utility is to "aid in monitoring the effectiveness of your diabetes control program," which is a diagnostic purpose.
Yes
The device aids in monitoring the effectiveness of a diabetes control program by measuring glucose levels, which is a form of diagnostic information used to manage the condition.
No
The device description explicitly states it consists of a "small handheld blood glucose meter" which is a hardware component. The summary also describes the use of "dry reagent test strips" and "liquid control solution," which are also physical components of the system.
Based on the provided information, the CONTOUR®NEXT EZ blood glucose monitoring system is indeed 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 patient use only" and "to aid in monitoring the effectiveness of your diabetes control program." This involves testing a biological sample (whole blood) outside of the body to provide information about a patient's health status.
- Device Description: The description details how the device works by measuring the electrical current caused by the reaction of glucose in the blood with chemicals on a reagent strip. This is a classic example of an in vitro diagnostic method.
- Sample Type: It uses "fresh fingertip capillary whole blood samples," which is a biological sample.
- Clinical Utility: The clinical utility is to "aid in monitoring the effectiveness of your diabetes control program," which is a diagnostic purpose.
Therefore, the CONTOUR®NEXT EZ blood glucose monitoring system fits 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 self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for singlepatient use only, and should not be shared. The Contour Next EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The Contour Next EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour Next 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The Contour Next EZ 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 EZ 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use on neonates.
Intended User / Care Setting
self-testing by persons 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)
Accuracy Study (Analytical)
The accuracy of the Contour Plus System was evaluated according to ISO 15197:2003 using three lots of Contour Plus test strips.
Results for glucose concentrations 1.0, meeting the acceptance criteria of Cp values ≥ 0.65.
EMC and Electrical Safety
The Contour Plus meter was evaluated and found to be compliant with applicable sections of IEC 62316-2-6:2005, IEC 61010-1:2001 and IEC 61010-2-101:2002.
Clinical Trial
The accuracy of the Contour Plus System was evaluated in the hands of intended users according to ISO 15197:2003.
Sample size: 220 persons with diabetes.
Results for glucose concentrations
§ 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
JUN 2 3 2014
Image /page/0/Picture/3 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with each letter of the word forming one arm of the cross. The entire logo is enclosed within a circle.
510(k) Summary
Date prepared: May 20, 2014
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: Contour® Next EZ Blood Glucose Meter Common name: Blood Glucose Meter Classification name: Blood Glucose Test System, Over- the-Counter, 75 NBW (21 CFR § 862.1345) |
| 3) Predicate device: | Contour Next EZ Blood Glucose Meter (Reference: Contour Next EZ Blood Glucose Monitoring System (K111268)) |
| 4) Device description: | The Contour Next EZ 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 EZ 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 |
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is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
The Contour Next EZ blood qlucose monitoring system is 5) Intended Use: an over the counter (OTC) device utilized for self-testing bv persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for singlepatient use only, and should not be shared. The Contour Next EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The Contour Next EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour Next 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.
Data demonstrating substantial equivalence
The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that is substantially equivalent to the predicate device, the Contour Next EZ Blood Glucose Monitoring System (K111268). The modified device uses 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 control solutions are used by both the modified and predicate device.
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/2/Picture/1 description: The image shows the Bayer company logo. The logo consists of the name "BAYER" arranged vertically in a circular shape. The letters are bold and evenly spaced, and the entire design is enclosed within a double-lined circle.
Modified Device (Contour Next EZ meter)
Image /page/2/Picture/3 description: The image shows a Contour NEXT EZ blood glucose meter. The meter's display shows a reading of 93 mg/dL, with the date as 10/13 and the time as 12:24 PM. The meter also has buttons for navigation and a Bayer logo at the bottom.
Predicate Device (Contour Next EZ meter)
Image /page/2/Picture/5 description: The image shows a Contour NEXT blood glucose meter. The display shows a reading of 93 mg/dL. The date is 10/13 and the time is 12:24 PM.
| Summary of the Technological Characteristics of the Modified Device Compared to
| Predicate | |||
|---|---|---|---|
| SIMILARITIES to Predicate | |||
| Characteristic | Predicate | ||
| Contour Next EZ | |||
| (K111268) | Contour Next EZ | ||
| (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, minimum | Same as Predicate | |
| Countdown time displayed | 5 Seconds | Same as Predicate | |
| Illuminated Strip Port | No | Same as Predicate | |
| Operational Buttons | 2 button choice selection and | ||
| menu/power button | Same as Predicate | ||
| Battery Type | Two 3-volt lithium batteries | ||
| (DL2032 or CR2032) | Same as Predicate | ||
| Operating Temperature Range | 41°-113° F | Same as Predicate | |
| Operating Humidity Range | 10-93% RH | Same as Predicate | |
| Sound | A beep sounds when the meter | Same as Predicate | |
| SIMILARITIES to Predicate | |||
| Predicate | Contour Next EZ | ||
| (Modified Device) | |||
| Characteristic | Contour Next EZ | ||
| (K111268) | |||
| is turned | |||
| on, a test strip is inserted, | |||
| when a test strip is | |||
| filled with blood, or when a test | |||
| result appears on the | |||
| display. Two beeps sound | |||
| when the meter turns off or to | |||
| indicate an error. | |||
| You will hear twenty beeps | |||
| when a programmed reminder | |||
| sounds. | |||
| Meter life | 5 Years | Same as Predicate | |
| Validated Product Used for | |||
| Cleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate | |
| Test Reminder | Yes | Same as Predicate | |
| Calibration/Coding | Autocoding (no coding for | ||
| users) | Same as Predicate | ||
| Display (technology) | Segmented (LCD), | ||
| Alphanumeric characters & | |||
| Icons | Same as Predicate | ||
| Display Visibility | Daylight only | Same as Predicate | |
| Error Message Displays | No, but error codes and | ||
| symbols are displayed and | |||
| their meanings are provided in | |||
| the system's User Guide | Same as Predicate | ||
| Communication Link to | |||
| Computer | Via serial to USB cable | Same as Predicate | |
| Test Results in Memory | 480 Results | Same as Predicate | |
| Meter Materials | Case Top/Bottom: ABS | ||
| Buttons: AS | Same as Predicate | ||
| Before and After Meal | |||
| Markers | Yes, when used in advanced | ||
| setting | Same as Predicate |
BAYER CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically and horizontally, intersecting at the "Y". The letters are in a simple, sans-serif font and are surrounded by a thin, circular border.
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Image /page/4/Picture/1 description: The image shows the Bayer company logo. The logo consists of the name "BAYER" written twice, once horizontally and once vertically, forming a cross shape. The logo is enclosed within a circle.
| DIFFERENCES from Predicate | |||
|---|---|---|---|
| Predicate | Contour Next EZ | ||
| Characteristic | Contour Next EZ (K111268) | (Modified Device) | Risk Assessment Summary |
| Glucose | |||
| Calculation | |||
| Algorithm that | |||
| ensures | |||
| consistent | |||
| performance at | |||
| low temperatures | |||
| ( 1.0, so the acceptance criteria was met. |
EMC and Electrical Safety
The Contour Plus meter was evaluated and found to be compliant with applicable sections of IEC 62316-2-6:2005, IEC 61010-1:2001 and IEC 61010-2-101:2002
Clinical Trial
The accuracy of the Contour Plus System was evaluated in the hands of intended users according to ISO 15197:2003 using three lots of Contour Plus test strips. A total of 220 persons with diabetes were enrolled as subjects in the trial, which was conducted at two sites. The subjects ranged in age from 26 to 86 with a mean age of 60.
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Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically in the center. The letters are arranged in a cross shape, with the "Y" in the middle. The logo is black and white.
Results for glucose concentrations Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."