(66 days)
The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. Measurement also aids in the diagnosis and treatment of heart diseases or thyroid disorders which are characterized by proteinuria or albuminuria.
The Dade Behring Dimension® Microalbumin Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in the determination of albumin in urine.
Method
The Microalbumin (MALB) method (DF114) is based on a particle-enhanced turbidimetric inhibition immunoassay (PETINIA) adapted to the Dimension® clinical chemistry system which allows direct quantitation of albumin in urine samples. The MALB Flex® reagent cartridge contains a particle reagent (PR) consisting of latex particles with human albumin bound to the surface. Aggregates of these particles are formed when a monoclonal antibody (Ab) to human albumin is introduced. Albumin (ALB) present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of albumin in the sample. The rate of aggregation is measured using bichromatic turbidimetric reading at 340 and 700 nm. The concentration is determined by means of a mathematical function.
PR + Ab + ALB (sample) → PR-Ab Complex + Ab-ALB (scatters at 340 nm)
Calibrator
The Dade Behring Dimension® Microabumin Calibrator (DC114) is a buffered aqueous product containing weighed-in quantities of human albumin. The calibrator is packaged as a 5-level kit at nominal albumin concentrations of 0, 12.5, 25, 50, and 110 mg/L.
Here's a breakdown of the acceptance criteria and study findings for the Dimension® Microalbumin (MALB) Flex® reagent cartridge and Calibrator, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Metric (Comparison to Predicate) | Acceptance Value/Range | Reported Device Performance (Dimension® MALB vs. BN II) |
|---|---|---|---|
| Method Comparison | Slope | Not explicitly stated as a numerical range, but "good agreement" is implied. The predicate's performance serves as the benchmark for "substantial equivalence." | 0.97 |
| Intercept | Not explicitly stated as a numerical range, but "good agreement" is implied. | 0.45 mg/L | |
| Correlation Coefficient | "Good agreement" (correlation) implied. | 0.999 | |
| (Implied) | Intended Use | Same as predicate | Quantitatively measure albumin in human urine. Aids in diagnosis of kidney/intestinal disease, heart disease, thyroid disorders characterized by proteinuria/albuminuria. |
| (Implied) | Design | Similar to predicate | Particle-enhanced turbidimetric inhibition immunoassay (PETINIA) for method; buffered aqueous product with human albumin for calibrator. |
Note: The document focuses primarily on demonstrating substantial equivalence to a predicate device rather than setting explicit numerical acceptance criteria for various performance metrics (like lower and upper bounds for slope, intercept, or correlation coefficient). The "acceptance" is based on the comparative performance showing "good agreement" and "correlation" which supports the claim of substantial equivalence.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 50 samples were used for the comparative performance evaluation.
- Data Provenance: The study was conducted "at Dade Behring," implying it was internally generated clinical or analytical data. The document does not specify the country of origin of the samples or if they were retrospective or prospective, but given it's an in-house comparison, it's likely retrospective analysis of stored or newly collected samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for comparison was the results from the predicate device (BN II nephelometric N Antiserum to Human Albumin assay). The document does not mention any expert review or consensus for the results from either device.
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Adjudication method for the test set:
- None specified. The study directly compared the measurements between the new device and the predicate device, not against a manually adjudicated "gold standard" where consensus among experts would be needed.
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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 a diagnostic assay for measuring albumin, not an imaging or AI-assisted diagnostic tool. Therefore, the concept of "human readers" and "AI assistance" doesn't apply to this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The study focuses on the standalone performance of the Dimension® Microalbumin method. It is a fully automated assay system, and its performance is evaluated directly by comparing its quantitative output to that of another automated assay system (the predicate). There is no "human-in-the-loop" aspect to the measurement itself, only to the interpretation of the results by a clinician.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the quantitative measurement obtained from a legally marketed predicate device (Dade Behring BN II nephelometric N Antiserum to Human Albumin assay). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It's essentially comparing to a "reference standard" provided by an existing, approved method.
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The sample size for the training set:
- Not applicable/Not provided. This document describes a K033525 510(k) submission for an in vitro diagnostic reagent and calibrator. It is not a machine learning or AI-based device, so there is no "training set" in the context of algorithm development. The development of the assay method itself would involve research and development, but the concept of a separate "training set" as understood in AI/ML is not relevant here.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm for this device.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.