(86 days)
Not Found
No
The device is a control solution for a blood glucose monitoring system, which is a chemical solution with a known glucose concentration used for calibration and quality control. There is no indication of any computational or algorithmic processing, let alone AI/ML.
No
This device is a control solution used to test the accuracy of a blood glucose monitoring system, not to directly treat or diagnose a medical condition.
No
This device is a control solution used to verify the accuracy of a blood glucose monitoring system, not to diagnose a medical condition itself.
No
The device description clearly states that the device is an aqueous glucose solution in a plastic bottle, which is a physical substance and container, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the control solutions are "aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic device.
- Device Description: The description explains that the control solution is used to "assure the customer that their Bayer Contour Next blood glucose monitoring system is reading accurately." This is a direct function of quality control for an in vitro diagnostic device (the blood glucose monitoring system).
- Nature of the Product: The control solution itself is a reagent (a substance used in a chemical reaction to detect, measure, or produce other substances) containing a known amount of glucose. Reagents used for quality control of diagnostic tests are considered IVDs.
While the control solution doesn't directly diagnose a condition, it is an essential component for ensuring the accuracy and reliability of an IVD (the blood glucose monitoring system), making it an IVD itself.
N/A
Intended Use / Indications for Use
CONTOUR NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.
Product codes
JJX
Device Description
Contour Next Control Solution is used as a quality control check to assure the customer that their Bayer Contour Next blood glucose monitoring system is reading accurately. The control solution has a very controlled amount of glucose in it. The bottles of Contour Next test strips have a range of acceptable values on every bottle that is used to compare the result obtained when the control solution is applied to the test strip. When the reading from the control solution is within the range on the bottle, the system has been quality control checked and shown to be accurate. If the reading from the control solution is outside the stated range, then the customer is instructed by the user guide to not use the system until trouble-shooting can be done and/or customer service is called for help.
The Solution is a prescribed amount of glucose in water and includes a buffer, red dye, and a thickening agent. The control solution comes in a 2.5mL plastic bottle with an applicator tip. It comes in two glucose levels, Level 1 (about 45mg/dL) and Level 2 (about 125mg/dL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing by people 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
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Summary of Performance Studies
Bench testing conducted showed that the modified Contour Next Control Solution performed as intended and met the system specifications.
Stability testing was conducted to ensure the modifications did not impact the shelf-life or use-life claims for the Contour Next Control Solution. The results of the testing showed there was no impact to the claimed shelf-life or use-life.
Usability testing was conducted to ensure that the modified solution did not impact the ability of end users to perform a control test. The results of the testing showed there was no impact in the ability of end users to perform control tests using the modified solution.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23,2015
BAYER HEALTHCARE JENNIFER GREGORY PRINCIPAL REGULATORY AFFAIRS SPECIALIST 430 SOUTH BEIGER STREET MISHAWAKA IN 46544
Re: K151742
Trade/Device Name: Contour Next Control Solution Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: July 24, 2015 Received: July 27, 2015
Dear Ms. 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.
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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) K151742
Device Name CONTOUR®NEXT Control Solution
Indications for Use (Describe)
CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circle. The letters are in a sans-serif font and are colored gray. The circle is outlined in green and blue, with the green on the top half and the blue on the bottom half.
510(k) Summary
Date prepared: September 3, 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
Principal 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 Control Solution
Common name: Control Solution
Classification name: Quality Control Material, 75 JJX (21
CFR 862.1660) |
| 3) Predicate device: | Contour Next Control Solution (Reference: Contour Next
EZ Blood Glucose Monitoring System (K111268)) |
| 4) Device description: | Contour Next Control Solution is used as a quality control
check to assure the customer that their Bayer Contour
Next blood glucose monitoring system is reading
accurately. The control solution has a very controlled
amount of glucose in it. The bottles of Contour Next test
strips have a range of acceptable values on every bottle
that is used to compare the result obtained when the
control solution is applied to the test strip. When the
reading from the control solution is within the range on the
bottle, the system has been quality control checked and
shown to be accurate. If the reading from the control
solution is outside the stated range, then the customer is
instructed by the user guide to not use the system until
trouble-shooting can be done and/or customer service is
called for help. |
| 5) Intended Use: | CONTOUR®NEXT control solutions are aqueous glucose
solutions intended for use in self-testing by people with
diabetes as a quality control check to ensure that the
Contour Next Blood Glucose Monitoring Systems are
working properly. |
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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 vertically in the center of a circle. The circle is divided into two halves, with the top half being green and the bottom half being blue.
Data demonstrating substantial equivalence
The Contour Next Control Solution is a quality control material used to ensure a customer's Contour Next blood glucose monitoring system is reading accurately and is substantially equivalent to the predicate Contour Next Control Solution (reference K111268 Contour Next EZ Blood Glucose Monitoring System).
The Solution is a prescribed amount of glucose in water and includes a buffer, red dye, and a thickening agent. The control solution comes in a 2.5mL plastic bottle with an applicator tip. It comes in two glucose levels, Level 1 (about 45mg/dL) and Level 2 (about 125mg/dL).
No technological changes have been made to the system since the previous submission, K111268.
A detailed comparison of the composition of the modified and predicate control solutions is provided in the tables below:
Modified Control Solution (Contour Next Control Solution) Predicate Control Solution (Contour Next Control Solution)
Image /page/4/Picture/9 description: The image shows a bottle of Contour Next Control Solution. The bottle is white with a blue cap and label. The label indicates that the solution is Level 2 and contains 2.5mL. The label also includes instructions to shake well about 15 times before use.
Bottle label for modified control
Image /page/4/Picture/11 description: The image shows a bottle of Contour Next Control Solution. The label indicates it is Level 2 and contains 2.5mL of solution. The label also includes the Bayer logo and states that the product is for in vitro diagnostic use and was made in the USA.
Bottle label for predicate control
BAYER CONFIDENTIAL
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Image /page/5/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a sans-serif font, with each letter in a separate row. The letters are in a light gray color with a darker gray shadow, giving them a three-dimensional appearance. The wordmark is enclosed within a circular shape that is divided into four quadrants, with the top left quadrant colored green and the bottom right quadrant colored blue.
| Composition of the Modified Control Solution Compared to Predicate | |
|---|---|
| SIMILARITIES to Predicate | |
| Composition of Predicate Contour Next | |
| Control Solution (K111268) | Composition of Modified Contour Next |
| Control Solution | |
| Buffer | Same as Predicate |
| Coloring Agent | Same as Predicate |
| Thickening Agent | Same as Predicate |
| Preservative | Same as Predicate |
| Glucose | 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 each letter of the word forming one arm of the cross. The logo is surrounded by a circular border that transitions from green at the top to blue at the bottom.
| DIFFERENCES from Predicate | ||
|---|---|---|
| Predicate | Modified Control Solution | |
| Composition/Characteristics | Contour Next Control Solution | |
| (K111268) | Contour Next Control Solution | |
| Surfactant | No | Yes |
| Control test temperature range | 5C-45C | 15C-35C |
| Glucose Concentration | 0.025% (level 1) | |
| 0.067% (level 2) | 0.03% (level 1) | |
| 0.07% (level 2) | ||
| Inactive ingredients | 99.975% (level 1) | |
| 99.933% (level 2) | 99.97% (level 1) | |
| 99.93% (level 2) | ||
| Instructions to "Shake well, about 15 times" | ||
| on control bottle label and "Shake control 15 | ||
| times before every use" in product insert | No | Yes |
| Addition of warning statements to product | ||
| insert: | ||
| Unmixed control solution may cause inaccurate control resultsDo not calibrate your continuous glucose monitoring device from a control resultDo not calculate a bolus based on a control result | No | Yes |
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Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with each letter in a bold, sans-serif font. The letters are a light gray color with a darker gray shadow, giving them a three-dimensional appearance. The wordmark is encircled by a ring that is green on the top half and blue on the bottom half.
Summary of Performance testing
Bench testing conducted showed that the modified Contour Next Control Solution performed as intended and met the system specifications.
Stability testing was conducted to ensure the modifications did not impact the shelf-life or use-life claims for the Contour Next Control Solution. The results of the testing showed there was no impact to the claimed shelf-life or use-life.
Usability testing was conducted to ensure that the modified solution did not impact the ability of end users to perform a control test. The results of the testing showed there was no impact in the ability of end users to perform control tests using the modified solution.
Conclusions from Performance Evaluations
Based on the outcome of the performance testing conducted, the modified Contour Next Control Solution is substantially equivalent to the predicate Contour Next Control Solution (K111268).