(307 days)
No
The document describes a standard blood glucose monitoring system based on electrochemical measurement and does not mention any AI or ML components. The performance studies focus on analytical accuracy and precision, not algorithmic performance.
Yes
The device is described as aiding in monitoring the effectiveness of a diabetes control program, which serves a therapeutic purpose by providing information used to manage the disease.
No
The "Intended Use / Indications for Use" section explicitly states, "The CONTOUR®NEXT EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus..."
No
The device description explicitly lists hardware components: a blood glucose meter, test strips, and control solutions.
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" for "self-testing by persons with diabetes at home." This is a classic definition of an in vitro diagnostic test.
- Device Description: The system includes a meter, test strips, and control solutions, all components typically associated with an IVD system for measuring analytes in biological samples.
- Performance Studies: The document details extensive performance studies (Accuracy, Precision, Linearity, Detection Limit, Analytical Specificity, Clinical Study) that are standard requirements for demonstrating the performance and reliability of an IVD device. These studies involve testing the device with biological samples (whole blood) and comparing the results to reference methods (YSI analyzer).
- Key Metrics: The document provides key metrics like accuracy percentages and precision values, which are crucial for evaluating the performance of an IVD.
- Predicate Device: The mention of a predicate device (K062058; Contour Blood Glucose Monitoring System) further indicates that this device is being compared to a previously cleared IVD.
The fact that it's an "over the counter (OTC) device utilized for self-testing" and "for single-patient use only" are specific characteristics of this particular IVD, but they don't change its fundamental classification as 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 single-patient 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.
The CONTOUR NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.
Product codes
LFR, NBW, JJX
Device Description
The Contour NEXT EZ Blood Glucose Monitoring System consists of:
- Contour NEXT EZ Blood Glucose Meter
- Contour NEXT Blood Glucose Test Strips
- Contour NEXT Control Solutions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
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)
SUMMARY OF NON-CLINICAL TESTS
Accuracy
System Accuracy Evaluation (ISO 15197 Section 7.3/7.4.1)
Reference: 510(k) submission, Section – 001_015 System Accuracy (Book Additional Information 2)
Protocol: Six Contour NEXT EZ meters, three lots of test strips and 100 blood samples were tested in replicates. The first replicate (a total of three hundred data points) was analyzed. Samples were also tested in parallel on a YSI 2300 STAT PLUS glucose analyzer as reference values
Acceptance Criteria: A minimum of 95 % of the individual glucose results shall fall within ± 15 mg/dL of the results obtained on the YSI analyzer at 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
K11268
510(k) SUMMARY
Summary of 510(k) safety and effectiveness in accordance with the requirements of 21 CFR § 807.92.
MAR - 6 20吸
| Submitter Information. | ||
|---|---|---|
| Name | Bayer Healthcare LLC., Diabetes Care | |
| Address | 430 South Beiger Street | |
| Mishawaka IN46544 | ||
| USA | ||
| Phone number | (574) 257-3075 | |
| Fax number | (574) 256-3519 | |
| Establishment | ||
| Registration | ||
| Number | 1826988 | |
| Name of contact | ||
| person | Weiping Zhong | |
| Date prepared | February 24 2012 | |
| Name of device | ||
| Trade or | ||
| proprietary name | Contour® NEXT EZ Blood Glucose Monitoring System | |
| Common or usual | ||
| name | Blood Glucose Monitoring System | |
| Classification name | Glucose Test System | |
| Classification panel | Clinical Chemistry and Clinical Toxicology | |
| Regulation | 21 CFR § 862.1345 | |
| Product Code(s) | LFR (Glucose Dehydrogenase, Glucose), NBW | |
| (System, Test, Blood Glucose, Over The Counter) | ||
| Legally marketed | ||
| device(s) to which | ||
| equivalence is claimed | Contour Blood Glucose Monitoring System (K062058) | |
| Reason for 510(k) | ||
| submission | Modified test strips and measurement algorithm | |
| Device description | The Contour NEXT EZ Blood Glucose Monitoring | |
| System consists of: |
- Contour NEXT EZ Blood Glucose Meter
- Contour NEXT Blood Glucose Test Strips
- Contour NEXT Control Solutions | |
| Intended use of the
device | The Contour NEXT EZ Blood Glucose Monitoring
System is intended to measure the glucose
concentration in whole blood. | |
| 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 single-patient 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.
The CONTOUR NEXT control solutions are aqueous
glucose solutions intended for use in self-testing by
people with diabetes as a quality control check. | |
| Summary of the Technological Characteristics of
the New Device Compared to Predicate | | |
| SIMILARITIES to Predicate | | |
| Characteristic | Predicate
Contour (K062058) | Contour NEXT EZ
(Candidate Device) |
| Blood Sample
Volume | $0.6\mu L$ | Same as predicate |
| Meal Markers | Yes | Same as predicate |
| Automatic Calibration | Yes | Same as predicate |
| Communication Port | Serial Interface | Same as predicate |
| User Interface | Alphanumeric, Iconic | Same as predicate |
| Display (Technology) | LCD | Same as predicate |
| Operational Buttons | 3 | Same as predicate |
| Battery Type | Two CR2032 (3-Volt each)
(or DL2032) | Same as predicate |
| Displayed Countdown
Time | 5 seconds | Same as predicate |
| Detection Technology | Amperometric measurement
of blood glucose | Same as predicate |
| Reference method | Plasma equivalent | Same as predicate |
| Test Strip enzyme | FAD-Glucose Dehydrogenase | Same as predicate |
| Calibration/Coding | Autocoding (no coding for users) | Same as predicate |
| DIFFERENCES from Predicate | | |
| Characteristic | Predicate
Contour (K062058) | Contour NEXT EZ
(Candidate Device) |
| Mediator in test strip | Potassium Ferricyanide | MLB Mediator |
| Control Solution buffer concentration | 50mM to 100 mM | 22 mM |
| Control Solution Levels and Ranges | Low / Normal / High | Low (Level 1) / Normal (Level 2) |
| Applied voltage during glucose measurement | Constant | Pulsed |
| Hematocrit range | 0%-70% | 15%-65% |
| Measurement range | 10-600mg/dL | 20-600 mg/dL |
| Measurement Reaction time | 5 seconds | 7 seconds |
| Sample type | • Fresh fingertip capillary whole blood samples
• Venous whole blood samples
• Arterial whole blood samples
• Neonatal blood samples | • Fresh fingertip capillary whole blood samples |
| Intended users | For home and professional uses | For home use, single user only |
| "Double Dip" function | No
Inadequate sample volume results in error message | Yes
System prompts for an additional application of blood in a certain time frame when a underfilled blood sample is detected |
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| PERFORMANCE DATA | |||||
|---|---|---|---|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR | |||||
| DETERMINATION OF SUBSTANTIAL EQUIVALENCE | |||||
| Performance Test Summary-New Device | |||||
| Characteristic | Results Summary | ||||
| Accuracy | System Accuracy Evaluation (ISO 15197 Section 7.3/7.4.1) | ||||
| Reference: 510(k) submission, Section – 001_015 System | |||||
| Accuracy (Book Additional Information 2) | |||||
| Protocol: Six Contour NEXT EZ meters, three lots of test strips and | |||||
| 100 blood samples were tested in replicates. The first replicate (a | |||||
| total of three hundred data points) was analyzed. Samples were also | |||||
| tested in parallel on a YSI 2300 STAT PLUS glucose analyzer as | |||||
| reference values | |||||
| Acceptance Criteria: A minimum of 95 % of the individual glucose | |||||
| results shall fall within ± 15 mg/dL of the results obtained on the YSI | |||||
| analyzer at glucose concentrations |