(88 days)
Dimension Vista™ B2MIC Flex® reagent cartridge: The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the ßmicroglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control M and H: PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.
Dimension Vista™ B2MIC Flex® reagent cartridge: Polystyrene particles coated with specific antibodies to human β2-microglobulin are aggregated when mixed with samples containing human ß2-microglobulin. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing β2microalobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).
Dimension Vista" Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, liquid, human serum based products containing ß2-microglobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ B2MIC Flex® reagent cartridge:
This document describes a 510(k) submission for an in vitro diagnostic device, specifically a reagent cartridge for measuring β2-microglobulin. The acceptance criteria and supporting study are focused on demonstrating substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation to predicate device | Correlation Coefficient: 0.998 |
| Slope close to 1 | Slope: 0.942 |
| Intercept close to 0 | Intercept: -0.029 |
Note: The document directly states the performance results from a method comparison study, but it does not explicitly list pre-defined "acceptance criteria" in numerical terms (e.g., "correlation coefficient must be ≥ 0.95"). However, the strong correlation (0.998) and slope/intercept values close to the ideal (1 and 0, respectively) implicitly demonstrate that the device met the unstated performance expectations for substantial equivalence in a method comparison study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 143 samples
- Data Provenance: The samples consisted of "serum and plasma samples with β2-Microglobulin assay values from 0.81 to 21.94 mg/L." The country of origin is not specified, but the manufacturer is based in Germany and the submitting office is in the US. The study appears to be retrospective, as it uses existing samples to compare the new device against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (method comparison for an in vitro diagnostic assay) does not typically use "experts" to establish ground truth in the same way, for example, an imaging AI study would.
- Ground Truth Establishment: The "ground truth" or reference values for comparison were established by running the same samples on the predicate device, the "Dade Behring N Latex β₂-Microglobulin assay on the BN ProSpec® System." The predicate device’s results are considered the reference against which the new device's performance is measured.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a quantitative method comparison study using a predicate device as the reference, not a study requiring human expert adjudication of results.
5. 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a study for an in vitro diagnostic reagent and system, not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The "Method Comparison Study" evaluates the Dimension Vista™ B2MIC assay "standalone" performance against the predicate device. The results (slope, intercept, correlation coefficient) reflect the performance of the device's analytical algorithm and reagents without human-in-the-loop adjustments to the measurement itself.
7. The Type of Ground Truth Used
The "ground truth" for this method comparison study was established by the results obtained from the legally marketed predicate device (Dade Behring N Latex β₂-Microglobulin assay on the BN ProSpec® System). The predicate device's measured β2-microglobulin concentrations served as the reference values.
8. The Sample Size for the Training Set
The document does not provide information on a training set size. This is typical for a traditional in vitro diagnostic device validation, particularly a reagent, where the emphasis is on analytical performance and comparison to a predicate, rather than a machine learning model that requires a distinct training dataset. The device's calibration and controls are described, but not a "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" for an algorithm is not described in this submission. The "ground truth" (or reference values) for the calibrator and controls would be established by the manufacturer through rigorous analytical methods and traceability to reference materials where appropriate.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.