(27 days)
Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.
Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087).
This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.
The ALB, AST, CRBM, ALT, and TIBC reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) submission for several reagent cartridges for the Dimension Vista™ system. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (Flex® reagent cartridges used on Dimension® clinical chemistry systems) due to a packaging modification. Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate devices.
The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." And in the conclusion: "Comparative testing also demonstrates substantially equivalent performance."
While explicit numerical acceptance criteria are not provided in the publicly available summary, the general acceptance criteria for this type of submission would be that the performance of the new device (Dimension Vista™ Flex® reagent cartridges) must be comparable or equivalent to the predicate device (Dimension® Flex® reagent cartridges). This comparison typically involves analytical performance characteristics such as:
- Accuracy: How close the measured values are to the true values.
- Precision: The reproducibility of measurements.
- Linearity/Measuring Range: The range over which the device accurately measures the analyte.
- Interferences: The effect of other substances on the measurement.
- Method Comparison: Correlation with the predicate device.
Since the submission states the reagents are the same, and only the packaging is modified for use on a different (but related) instrument, the expectation is that the analytical performance should remain unchanged or within acceptable variations for clinical use.
Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Performance Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Accuracy | Equivalent to predicate devices (Dimension® Flex®) | Demonstrated equivalent performance |
| Precision | Equivalent to predicate devices (Dimension® Flex®) | Demonstrated equivalent performance |
| Linearity/Range | Equivalent to predicate devices (Dimension® Flex®) | Demonstrated equivalent performance |
| Interferences | Equivalent to predicate devices (Dimension® Flex®) | Demonstrated equivalent performance |
| Method Comparison | High correlation with predicate devices | Demonstrated equivalent performance |
| Intended Use | Same as predicate devices | Same as predicate devices |
| Indications for Use | Same as predicate devices | Same as predicate devices |
Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided summary. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't detail the sample sizes for comparison studies.
- Data Provenance: Not explicitly stated. For in-vitro diagnostic devices, testing typically involves human serum and plasma samples, likely collected in a clinical laboratory setting. Whether it was retrospective or prospective is not mentioned, but validation studies for IVDs often involve prospective sample collection or the use of archived samples.
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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 as this is an in-vitro diagnostic test. Ground truth for such devices is established by the analytical performance against a reference method or validated calibrators, not by expert consensus in the way image analysis or clinical diagnosis might be.
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Adjudication method for the test set:
- Not applicable for an in-vitro diagnostic test. Results are quantitative measurements against established analytical standards.
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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. This is an in-vitro diagnostic device (reagent cartridge for laboratory analysis), not an AI-assisted diagnostic imaging or clinical decision support tool that involves "human readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is an inherent aspect of an in-vitro diagnostic device. The "algorithm" here is the chemical assay and instrument processing. The performance reported (e.g., accuracy, precision) is the standalone performance of the device without human interpretation of the primary data, beyond standard laboratory quality control and result reporting.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in-vitro diagnostic devices, the "ground truth" for analytical performance studies is typically established by:
- Reference Methods: Highly accurate and precise methods (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry for certain analytes) considered the gold standard.
- Validated Calibrators/Controls: Materials with known, assigned values traceable to reference standards.
- Clinical Diagnosis/Patient Outcome: For clinical utility, but analytical performance uses the above.
- The document implies that the ground truth for comparison was the established performance of the legally marketed predicate devices, which would have been validated against such reference methods or standards.
- For in-vitro diagnostic devices, the "ground truth" for analytical performance studies is typically established by:
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The sample size for the training set:
- Not explicitly stated. For reagent development, a "training set" in the context of machine learning isn't directly applicable. Instead, reagent formulations are optimized through R&D, and their performance is characterized using various samples (e.g., quality control materials, patient samples) during that development phase. The "study" described here is for validation, not training or development.
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How the ground truth for the training set was established:
- As noted above, a "training set" linked to a ground truth in the machine learning sense isn't directly relevant here. However, the development of the original reagents (predicate devices) would have involved extensive analytical characterization against reference methods and clinical samples to establish their performance specifications and clinical utility. The current submission leverages the established ground truth of these existing reagents.
§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.