(272 days)
The Dade Behring QuikLYTE™ MetaboLYTE cartridge is a sub-system on The Dade Bentling QuikETTE - Meadeous andyzer. It performs two in die Differences indications for use indications for use:
Glucose: Measurements are used in the difficial and al hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Urea Nitrogen: Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Dade Behring QuikLYTE™ MetaboLYTE cartridge performs two in vitro diagnostic tests: glucose (GLU7) and urea nitrogen (BUN7). The glucose (GLU7) and urea nitrogen (BUN7) methods use a sample which is diluted automatically on-board the Dimension® XL or RxL clinical chemistry system. The diluted sample is then processed in a multisensor cartridge that uses Integrated Multisensor Technology (IMT). The glucose method uses amperometric detection and the urea nitrogen method uses potentiometric detection to measure the specific analyte in the sample.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring QuikLYTE™ MetaboLYTE Cartridge, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "substantially equivalent" claim to previously cleared devices (FLEX™ reagent cartridges). The specific quantitative criteria used for acceptance are not explicitly stated in the document as hard thresholds (e.g., "slope must be between 0.95 and 1.05"). Instead, the strong correlation coefficients and slopes close to 1, with small intercepts, demonstrate equivalence.
| Analyte | Acceptance Criteria (Implied) | Reported Device Performance (QuikLYTE™) |
|---|---|---|
| Glucose (Serum/Plasma) | Substantially equivalent to predicate device (FLEX™ GLU). Implies: | |
| - Slope ~1.0 | 0.99 | |
| - Intercept ~0 | 1.6 mg/dL | |
| - Correlation Coefficient >0.99 | 0.998 | |
| - Clinically acceptable range | 20 - 415 mg/dL | |
| Glucose (Cerebrospinal Fluid) | Substantially equivalent to predicate device (FLEX™ GLU). Implies: | |
| - Slope ~1.0 | 1.05 | |
| - Intercept ~0 | -1.2 mg/dL | |
| - Correlation Coefficient >0.99 | 0.996 | |
| - Clinically acceptable range | 3 - 260 mg/dL | |
| Urea Nitrogen (Serum/Plasma) | Substantially equivalent to predicate device (FLEX™ BUN). Implies: | |
| - Slope ~1.0 | 1.01 | |
| - Intercept ~0 | -0.1 mg/dL | |
| - Correlation Coefficient >0.99 | 0.996 | |
| - Clinically acceptable range | 4 - 80 mg/dL |
Study Information
Here's a breakdown of the study details based on the provided text:
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Sample sizes used for the test set and the data provenance:
- Glucose (Serum/Plasma): n = 239 (120 serum, 119 plasma)
- Glucose (Cerebrospinal Fluid): n = 60
- Urea Nitrogen (Serum/Plasma): n = 231 (118 serum, 113 plasma)
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in nature, comparing the new device against an existing, cleared predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an in vitro diagnostic device for quantitative measurement. The "ground truth" for the comparison study would be the results obtained from the predicate device (FLEX™ reagent cartridges).
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Adjudication method for the test set:
- Not applicable. This is a quantitative comparison against a predicate device, not a subjective interpretation study requiring adjudication. The method used was a "split sample comparison study," meaning samples were likely run on both the new device and the predicate device, and the results quantitatively compared (slope, intercept, correlation).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is an automated in vitro diagnostic test, not an AI-based diagnostic imaging or interpretive tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device (QuikLYTE™ MetaboLYTE cartridge on the Dimension® XL/RxL system) performed the measurements automatically without direct human intervention after sample loading. The comparison was device-to-device (new device vs. predicate device).
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The type of ground truth used:
- The "ground truth" for this comparative study was the measurement results obtained from the predicate device, the Dade Behring FLEX™ reagent cartridges for glucose and urea nitrogen, which were already cleared by the FDA.
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The sample size for the training set:
- Not applicable. This document describes a validation study for a substantially equivalent device, not the development or training of an algorithm in the machine learning sense. The device itself performs chemical assays.
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How the ground truth for the training set was established:
- Not applicable. As above, there's no "training set" in the machine learning context for this type of device. The device's operational parameters (its "logic" or "chemistry") are based on established chemical principles and optimized during its development phase. The "ground truth" for its development would involve known-concentration calibrators and controls.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.