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The Glucose Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure glucose 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.

The Glucose Flex® reagent cartridge (GLUC) for the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid. The technology is Enzymatic: Hexokinase- glucose-6 phosphate dehydrogenase. Detection is Bichromatic endpoint measurement- NADH (340 & 383 nm). Reaction Time is 120 seconds. Reagents are Liquid.

Here's a breakdown of the acceptance criteria and study details for the Glucose Flex® reagent cartridge (GLUC) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific slope, intercept, or correlation coefficient ranges. However, the study aims to demonstrate substantial equivalence to the predicate device (GLU Flex® reagent cartridge) through split-sample comparison. The reported performance is presented as correlation statistics.

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

• Sample Size for Test Set:
  • Serum/Plasma: 162 samples
  • Urine: 64 samples
  • Cerebrospinal Fluid: 70 samples
• Data Provenance: The data used was from "clinical patient samples." The country of origin is not specified, but given the submitter (Dade Behring Inc., Newark, DE) and the FDA submission, it can be inferred to be from the United States or a region with similar clinical practices. The data is retrospective as it involves "clinical patient samples" that were already collected and tested for the comparison.

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

This information is not provided in the document. For in vitro diagnostic devices like glucose test systems, the "ground truth" for the test set is typically established by comparing the device's results to a well-established, highly accurate reference method or a legally marketed predicate device. The document explicitly states a "split sample comparison" with the predicate device, implying the predicate device serves as the reference, but it doesn't mention human experts establishing ground truth for individual samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this type of study. Adjudication methods like 2+1 or 3+1 are typically used in imaging or clinical trial settings where human interpretation of results might vary. For a quantitative in vitro diagnostic device comparing its performance to a predicate, the comparison is direct numerical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Glucose Flex® reagent cartridge is an in vitro diagnostic test system that provides a quantitative measurement directly, without human interpretation in the same way an imaging study would require.

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

This is an inherently standalone device. The "algorithm" here is the enzymatic reaction and detection process within the clinical chemistry system. The performance presented (correlation statistics) represents the device's measurement capabilities directly, without a human-in-the-loop to interpret or modify its output as part of the primary measurement.

7. The Type of Ground Truth Used

The ground truth for this study was established using comparison to a legally marketed predicate device, specifically the "GLU Flex® reagent cartridge also on the Dimension® clinical chemistry system." The "split sample comparison" means that portions of the same patient samples were tested on both the new device (GLUC) and the predicate device (GLU), and the results were then statistically compared.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. For in vitro diagnostic devices like this, the development process might involve internal studies and method optimization, but a distinct "training set" with established ground truth as understood in machine learning contexts is typically not described in these 510(k) summaries for chemical analyzers. The provided data is for the performance evaluation that supports the 510(k) submission.

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

As no training set is described, this information is not applicable/provided.

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