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For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.

The Albumin BCP reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry systems. Reagents are supplied in two configurations: fill volume of 18 mL in a 20 mL wedge or 35 mL in a 40 mL wedge, 4 wedges/kit.

The calibrator is a multi-analyte human serum based product containing albumin derived from human serum. The kit consists of 3 vials of one-level calibrator which are lyophilized. The target concentration of this calibrator is 4.3 g/dL. The volume per vial (after reconstitution with deionized water) is 2.0 mL.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. Instead, it describes various performance studies and concludes that the results were "acceptable" and support "substantial equivalence" to the predicate device. For the purpose of this analysis, I will infer general acceptance by demonstrating performance comparable to or better than the predicate, or by meeting internal and CLSI guidelines for analytical performance.

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

• Precision:
  • Serum sample pools and serum-based controls were assayed.
  • Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days.
  • Number of data points (N) for each control/pool: 80.
  • Provenance: Not explicitly stated, but clinical laboratory studies typically use samples from diverse patient populations to represent the intended use environment. The term "Serum Control" and "Serum Pool" suggest internally generated or purchased control materials, which are representative of human serum. Retrospective, as these are controlled studies based on pre-collected samples or control materials.
• Linearity/Assay Reportable Range:
  • Eleven dilutions across the measuring range.
  • Provenance: Not explicitly stated, but likely laboratory-prepared dilutions of human serum or control materials. Retrospective.
• Limit of Blank, Limit of Detection, Limit of Quantitation:
  • 720 determinations: 240 blank replicates and 480 low-level sample replicates.
  • Provenance: Not explicitly stated, but laboratory-prepared blank and low-level samples. Retrospective.
• Method Comparison with Predicate Device:
  • Sixty-nine (69) serum samples.
  • Provenance: Not explicitly stated, but these would be human serum samples covering a range of albumin concentrations. Retrospective, as samples are collected and then tested.
• Matrix Comparison:
  • Forty-seven (47) paired plasma/serum samples (Lithium Heparin and Potassium EDTA plasma vs. serum).
  • Provenance: Human plasma and serum samples. Retrospective.
• Analytical Specificity (Interference):
  • Not specified, but likely involved multiple spiked samples for each interferent at varying concentrations.
  • Provenance: Laboratory-prepared samples spiked with interferents. Retrospective.

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

This document describes a diagnostic assay for quantitative measurement of albumin. The "ground truth" in this context is the actual albumin concentration in the samples, determined by a reference method or validated control materials, not by expert interpretation of images or clinical cases.

• No human experts are used for establishing "ground truth" in the interpretive sense (e.g., radiologist for imaging).
• The "ground truth" is established analytically:
  • Through the inherent reference values of commercial controls.
  • By the established methodology of the predicate device.
  • By traceability to the ERM-DA470k Reference Material.
  • By preparing samples with known (expected) concentrations for linearity and LoQ studies.
  • The "experts" involved are implied to be laboratory scientists and method developers who establish and validate these analytical reference points based on established scientific principles and guidelines (e.g., CLSI).

4. Adjudication Method for the Test Set:

Not applicable. This is an analytical chemistry assay, not a device requiring human interpretation and multi-reader adjudication for ground truth establishment. The performance is assessed against quantitative analytical targets.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or other interpretive devices where human readers provide diagnoses, and the AI assists or performs the interpretation. This device is a quantitative chemistry assay.

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

Yes, all studies described (precision, linearity, LoB/LoD/LoQ, method comparison, matrix comparison, analytical specificity) are standalone performance evaluations of the ADVIA Chemistry Albumin BCP Assay on the ADVIA 1650 Chemistry system. The device (assay and instrument combination) performs the measurement automatically without human intervention once the sample is loaded.

7. The Type of Ground Truth Used:

The ground truth for the performance studies is primarily derived from:

• Known concentrations: For linearity, LoB, LoD, and LoQ studies, samples are prepared with known (expected) albumin concentrations or are blank.
• Reference materials: Traceability to ERM-DA470k Reference Material provides a foundation for accurate quantification.
• Predicate device measurements: For method comparison, the results from the legally marketed predicate device (Dimension Clinical Chemistry System Albumin Flex® reagent cartridge) serve as a comparative ground truth.
• Validated control materials: Commercial serum controls with established target values.

8. The Sample Size for the Training Set:

The document describes an analytical assay, not an AI/ML algorithm that undergoes a distinct "training" phase. Therefore, there is no explicit "training set" in the context of machine learning. The assay's performance characteristics (e.g., reagent formulations, instrument parameters, calibration curves) are developed and validated through extensive internal R&D and optimization processes, which would involve numerous samples, but these are not referred to as a "training set" in the same way an ML model would have one.

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

As noted above, there isn't a "training set" in the AI/ML sense. The "ground truth" for the development and optimization of the assay and its associated calibrator involves:

• Reference methods for quantifying albumin.
• Gravimetric or optical methods for preparing known concentration standards.
• Traceability to international reference materials like ERM-DA470k.
• Empirical data collected during the assay development process to optimize reagent concentrations, reaction conditions, and instrument parameters to achieve desired analytical performance.

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