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For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TRUEresult ™ and TRUE2go™ Meters and TRUEtest™ Test Strips.

The AbT Glucose Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.

This document, K091460, is a 510(k) Premarket Notification for the AbT Glucose Control Solutions. It aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for each performance characteristic. Instead, it implies acceptance by the successful completion of the studies and the comparison to the predicate device's characteristics. The performance study details are limited to the types of studies performed without specific quantitative results.

However, based on the Comparison to Predicate Devices section, we can infer some target ranges for glucose levels, which could be considered an implicit acceptance criteria tied to the predicate's performance.

Important Note: The document states for the predicate's Target Range "(1) Estimated from the manufacturer's published control ranges." This means the predicate's ranges are not direct measurements from this submission but publicly available information used for comparison. The new product also provides specific target ranges, which are the intended performance of the device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide any specific sample sizes for the performance studies (Accelerated Stability, Open Vial, Test Precision).

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "Tests were performed to verify specific performance characteristics."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The type of device (glucose control solutions, which are laboratory reagents) typically involves analytical testing rather than interpretation by human experts to establish ground truth for performance.

4. Adjudication Method for the Test Set:

This information is not provided and is generally not applicable for this type of device where objective analytical measurements are performed rather than subjective assessments.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that require human interpretation, not for glucose control solutions which are used to verify the performance of a measuring instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is a chemical control solution, not an algorithm or a device with an AI component. The "performance" being evaluated is the stability and precision of the chemical solution itself, and its ability to elicit expected readings on the specified meters.

7. The Type of Ground Truth Used:

For the AbT Glucose Control Solutions, the ground truth is established by analytical measurement of the glucose concentration in manufactured lots of the control solutions. The "known quantities of glucose" in the solution form the basis of the ground truth. This is implied by the product description "containing known quantities of glucose." The stability and precision studies then assess how well the device maintains these known quantities over time and delivers consistent results when tested.

8. The Sample Size for the Training Set:

This information is not applicable as the AbT Glucose Control Solutions are not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

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