Search Results

Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

For In Vitro Diagnostic Use

Device Description

The AU Bicarbonate reagent kit is a liquid, ready to use and consists of four R1 reagent vials in vanous fill volumes. The calibrator is a Beckman Coulter lyophilized chemistry calibrator packaged as catalog number DR0070 and sold separately. The AU Bicarbonate reagent is an enzymatic method utilizing Bicarbonate (HCO3) and phosphoenolpyruvate (PEP), which are converted to oxaloacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). This oxidation of NADH results in a decrease in absorbance of the reaction mixture measured bichromatically at 380/410nm proportional to the Bicarbonate content of the sample.

The AU Bicarbonate reagent is designed for optimal performance on Beckman Coulter AU analyzers.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AU Bicarbonate Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Category	Acceptance Criteria	Reported Device Performance
Method Comparison	Slope: 0.900-1.100
Intercept: ±2.0 mEq/L
r (correlation coefficient): ≥ 0.95
N (sample size): > 100	Slope: 0.922
Intercept: 1.148 mEq/L
r: 0.9909
N: 133
Precision	Within-run (Low Pool): ≤3%CV or SD≤1
Within-run (Med Pool): ≤3%CV or SD≤1
Within-run (High Pool): ≤3%CV or SD≤1
Total (Low Pool): ≤7%CV or SD≤1.5 mEq/L
Total (Med Pool): ≤7%CV or SD≤1.5 mEq/L
Total (High Pool): ≤7%CV or SD≤1.5 mEq/L	Within-run (Low Pool): %CV 2.5, SD 0.30
Within-run (Med Pool): %CV 1.1, SD 0.35
Within-run (High Pool): %CV 0.8, SD 0.34
Total (Low Pool): %CV 7.5, SD 0.92
Total (Med Pool): %CV 4.0, SD 1.23
Total (High Pool): %CV 3.6, SD 1.47
Sensitivity	Not explicitly stated as acceptance criteria, but reported values are: LoB = 1.20 mEq/L, LoD = 1.95 mEq/L	LoB = 1.20 mEq/L
LoD = 1.95 mEq/L
Interfering Substances	Unconjugated Bilirubin: No significant interference up to 40 mg/dL (defined as recovery within 10% of initial value)
Conjugated Bilirubin: No significant interference up to 20 mg/dL (defined as recovery within 10% of initial value)
Hemolysis: No significant interference up to 500 mg/dL (defined as recovery within 10% of initial value)
Lipemia: No significant interference up to 1000 mg/dL Intralipid (defined as recovery within 10% of initial value)	Unconjugated Bilirubin: No significant interference up to 40 mg/dL
Conjugated Bilirubin: No significant interference up to 20 mg/dL
Hemolysis: No significant interference up to 500 mg/dL
Lipemia: No significant interference up to 1000 mg/dL Intralipid (No significant interference is recovery within 10% of initial value)
Linearity Range	2.0 - 45.0 mEq/L	2.0 - 45.0 mEq/L (implied, as this is the stated range)
Expected Values	23 - 29 mEq/L	23 - 29 mEq/L (implied, as this is the stated range)

All reported device performances met their respective acceptance criteria as indicated by "Pass" in the Method Comparison and Precision tables.

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

Method Comparison Test Set: N = 133 samples.
Precision Test Set: The document refers to "Low pool," "Med pool," and "High pool" samples. It doesn't specify an overall sample size for the precision study, but implies multiple measurements were taken for each pool (e.g., within-run and total precision across multiple runs/days).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is clinical laboratory data, likely gathered prospectively during validation studies.

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

This document describes an in vitro diagnostic reagent for quantitative determination of bicarbonate, not an imaging or diagnostic device requiring expert interpretation for ground truth.
The "ground truth" for method comparison is a reference method (Thermo Scientific, TR28321) and for precision is based on statistical measures of reproducibility. No human expert "ground truth" establishment is described for these types of studies.

4. Adjudication Method for the Test Set:

Not applicable. This is a quantitative chemical assay, not an interpretative diagnostic task requiring adjudication. The performance is assessed against predefined statistical and analytical criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for an in vitro diagnostic reagent.

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

Yes, this entire study represents the standalone performance of the AU Bicarbonate Reagent on Beckman Coulter AU analyzers. There is no human-in-the-loop component in the measurement and quantification of bicarbonate by this automated system.

7. The Type of Ground Truth Used:

Quantitative Reference Measurement: For the method comparison, the "ground truth" is a comparison against a commercially available and presumably validated reference method (Thermo Scientific TR28321).
Statistical Definitions: For precision, the "ground truth" is based on statistical definitions of within-run and total precision, where the target values are the mean concentrations of the control pools.
Defined Standards/Limits: For sensitivity, linearity, and interfering substances, the ground truth is established against predefined analytical limits and standards (e.g., NIST standard for calibrator traceability).

8. The Sample Size for the Training Set:

The document does not explicitly refer to a "training set" in the context of machine learning. This is a chemical reagent and instrument system, not an AI/ML algorithm that undergoes a distinct training phase with a labeled dataset. The development and optimization of the reagent itself would involve internal R&D studies, but these are not referred to as a "training set" in this context.

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

Not applicable, as this device does not involve a machine learning "training set." The performance characteristics are established through analytical validation studies rather than machine learning model training.

Ask a Question

Ask a specific question about this device

Page 1 of 1