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.

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).

AI/ML Overview

The provided text is a 510(k) Summary for the Bayer Contour Next Control Solution. It describes the device, its intended use, and compares it to a predicate device. However, the document does not contain the specific details required to answer all parts of your request about acceptance criteria and a study proving those criteria are met, especially concerning numerical performance data, sample sizes, expert involvement, and ground truth methodologies.

This document is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study report with raw performance data. It summarizes testing done but does not provide the granular information you're asking for.

Here's an attempt to answer based on the available information, with significant limitations and explicit mentions of missing data:

Acceptance Criteria and Device Performance

The document states that "Bench testing conducted showed that the modified Contour Next Control Solution performed as intended and met the system specifications." However, specific numerical acceptance criteria for performance (e.g., accuracy ranges for control solutions) and the detailed results demonstrating those are not provided in this document. It generally claims the device met specifications.

The provided differences table suggests implicit performance targets related to glucose concentration levels. For example, Level 1 is about 45 mg/dL for the predicate and 0.03% (equivalent to 30 mg/dL if 1% is 1000 mg/dL, which is unusual for glucose concentrations in this context, 0.03% is more likely a weight/volume percentage meaning 30 mg/mL, not mg/dL), and Level 2 about 125 mg/dL for the predicate and 0.07% for the modified. The exact equivalence or acceptance criteria for these specific concentrations are not detailed.

Given the nature of a control solution, the primary performance acceptance criteria would usually revolve around:

Stability: Maintaining glucose concentration within specified ranges over shelf-life and use-life.
Accuracy: When tested with the blood glucose meter, the control solution results fall within the expected range printed on the test strip vial.
Usability: End-users can successfully perform a control test.

The document claims these were met, but without numerical specifics.

Study Details

Due to the limited information in the 510(k) Summary, many of your questions cannot be fully answered.

Table of Acceptance Criteria and Reported Device Performance:

Feature / Test Category	Acceptance Criteria	Reported Device Performance
Bench Testing	"Met system specifications" (details not provided)	"Performed as intended and met the system specifications"
Stability Testing	Preservation of "shelf-life or use-life claims" (specific parameters not provided)	"No impact to the claimed shelf-life or use-life"
Usability Testing	Ability of end-users to "perform a control test" (specific metrics not provided)	"No impact in the ability of end users to perform control tests"
Glucose Concentration (Level 1)	Implicit: New nominal concentration of 0.03%	Modified: 0.03%
Glucose Concentration (Level 2)	Implicit: New nominal concentration of 0.07%	Modified: 0.07%
Impact of Surfactant	Implicit: No negative impact on performance	Surfactant added, assumed to not negatively impact performance, as overall conclusion is substantial equivalence.
Control Test Temperature Range	Implicit: Functional within 15C-35C	Modified: 15C-35C

Note: The "acceptance criteria" column is largely inferred from the "reported device performance" due to the lack of explicit, detailed criteria in the document. The exact numerical ranges that define "met system specifications" or "no impact" are not provided.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document does not mention the number of units tested for bench, stability, or usability testing.
- Data Provenance: Not specified. It's a Bayer Healthcare LLC internal study, but the geographical origin of the data (e.g., country of testing, participants in usability study) is not mentioned. It is an internal, retrospective summary of performance testing for a regulatory submission.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. This device is a control solution for a blood glucose monitor. Performance testing would likely involve laboratory equipment, chemical analysis, and potentially human factors testing, but not typically "experts establishing ground truth" in the sense of clinical interpretation (e.g., radiologists reviewing images). The accuracy of glucose concentration is determined by analytical methods.
Adjudication Method for the Test Set:
- Not applicable/Not specified. Adjudication is typically for resolving discrepancies in expert interpretation. Given the nature of performance testing for a control solution, this wouldn't be relevant.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is relevant for diagnostic devices requiring human interpretation (e.g., imaging devices). This is a quality control material.
Standalone Performance:
- Yes, to an extent. The "bench testing" and "stability testing" sections refer to the performance of the control solution itself, independent of a human operator, in terms of its chemical properties and stability. "Usability testing" does involve human interaction, but its goal is to ensure the control solution's design doesn't hinder the user, not to assess human interpretation of outputs.
Type of Ground Truth Used:
- For glucose concentration and stability: Likely analytical measurements against certified standards or reference methods. The "ground truth" for a control solution's glucose level is its actual chemical concentration determined by precise laboratory techniques.
- For usability: Ground truth for successful control testing would be the successful completion of the test and obtaining a result within the expected range, often observed or reported by test participants.
Sample Size for the Training Set:
- Not applicable. This device is a chemical control solution, not an AI/machine learning algorithm that requires a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).

Summary

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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)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 GregoryPrincipal Regulatory Affairs SpecialistBayer Healthcare LLC430 South Beiger StreetMishawaka, IN 46544Telephone: (574) 256-3447Fax: (574) 256-3519
2) Device name:	Trade name: Contour® Next Control SolutionCommon name: Control SolutionClassification name: Quality Control Material, 75 JJX (21CFR 862.1660)
3) Predicate device:	Contour Next Control Solution (Reference: Contour NextEZ Blood Glucose Monitoring System (K111268))
4) Device description:	Contour Next Control Solution is used as a quality controlcheck to assure the customer that their Bayer ContourNext blood glucose monitoring system is readingaccurately. The control solution has a very controlledamount of glucose in it. The bottles of Contour Next teststrips have a range of acceptable values on every bottlethat is used to compare the result obtained when thecontrol solution is applied to the test strip. When thereading from the control solution is within the range on thebottle, the system has been quality control checked andshown to be accurate. If the reading from the controlsolution is outside the stated range, then the customer isinstructed by the user guide to not use the system untiltrouble-shooting can be done and/or customer service iscalled for help.
5) Intended Use:	CONTOUR®NEXT control solutions are aqueous glucosesolutions intended for use in self-testing by people withdiabetes as a quality control check to ensure that theContour Next Blood Glucose Monitoring Systems areworking properly.

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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).

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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Composition of the Modified Control Solution Compared to Predicate
SIMILARITIES to Predicate
Composition of Predicate Contour NextControl Solution (K111268)	Composition of Modified Contour NextControl 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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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 15times before every use" in product insert	No	Yes
Addition of warning statements to productinsert: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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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).

Regulation Number and Section

§ 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.