(86 days)
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.
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).
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).
§ 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.