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For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma of adults and neonates on the ADVIA® Chemistry systems. Measurement of total bilirubin, an organic compound formed and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

The ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) reagents are liquid ready to use. They are packaged as a kit with two kit sizes available as follows.
Kit Size – 70 mL Wedge Reagent 1 and 70 mL Reagent 2 Wedge
Reagent 1: 4 wedges x 68 mL
Reagent 2: 4 wedges x 25 mL
Kit Size - 40 mL Reagent 1 and 20 mL Reagent 2 Wedge
Reagent 1: 4 wedges x 38 mL
Each reagent kit consists of reagents of components and concentrations summarized below.
Reagent 1: Citrate buffer, pH 2.9 (0.1 mol/L); Detergent
Reagent 2: Phosphate buffer, pH 7.0 (10mmol/L); Sodium metavanadate (4 mmol/L)

Here's a breakdown of the acceptance criteria and study information for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) device, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance characteristic as a distinct set of pre-defined thresholds. Instead, it presents the results of validation studies for various parameters. However, we can infer the implicit "acceptance criteria" by looking at industry standards (like CLSI guidelines cited) and typical performance expectations for such devices. The "reported device performance" directly comes from the study results.

Note: For some parameters, the "acceptance criteria" are implied by the method and regulatory guidelines (e.g., CLSI EP09-A3 for method comparison, which focuses on demonstrating accuracy through strong correlation and acceptable bias at medical decision points).

• Indican: 10 mg/dL
• Cyanokit: 40 ug/mL
• HbF: 1000 mg/dL
• HbA: 1000 mg/dL |
  | Expected Values (Reference Interval) | Reference intervals established or verified in accordance with CLSI guidelines and supported by literature. (Based on CLSI EP28-A3c and Wu AHB. Tietz Clinical Guide) | Verified expected values:
• 0-1 day: 5 days – 60 years: 0.3-1.2 mg/dL
• 60 - 90 years: 0.2-1.1 mg/dL

• 90 years: 0.2-0.9 mg/dL (Reference: Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th edition, 2006:172) |

Detailed Study Information:

The provided document describes analytical performance studies for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) device. It is a standalone (algorithm only without human-in-the-loop performance) study, as it evaluates the analytical performance of a clinical chemistry assay, not a diagnostic imaging device with human interpretation.

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

   • Method Comparison: N = 119 patient samples.
   • Analytical Measuring Range/Linearity: The document states "9 levels" for linearity but does not specify the number of individual samples tested at each level or overall (implied to be an internally prepared linearity panel).
   • Limits of Detection and Quantitation: Not explicitly stated for specific test sets, usually involves multiple replicates of blank and low-concentration samples.
   • Interferences: Not explicitly stated for specific test sets; involved samples with low and high concentrations of bilirubin plus various interferents.
   • Data Provenance: Not explicitly stated. These are typically laboratory-generated samples or de-identified patient samples obtained for research purposes within the testing laboratory's region. The adult population data were previously cleared under K063845, implying this testing focused on neonatal-specific aspects or reaffirming general performance on the new instrument.

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

   • For this type of in vitro diagnostic device, "ground truth" is established through well-characterized reference methods or highly accurate comparator devices/methods. There are no "experts" in the human interpretation sense (like radiologists) involved in establishing the ground truth for these analytical measurements.
   • The "comparator method" for the method comparison study served as the reference for ground truth in that context. Its specifics (e.g., gold standard, reference material) are not detailed beyond being a "legally marketed comparator method."

3. Adjudication Method for the Test Set:

   • Not applicable. This is an analytical performance study of a quantitative assay, not a study involving human readers' interpretations of images or clinical reports requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. This document describes the analytical performance of an in vitro diagnostic assay, which traditionally does not involve human readers interpreting "cases" in the way an imaging device might.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone study was done. The entire document details the analytical performance of the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) assay on an automated instrument (ADVIA® Chemistry 1800 System) without human interpretive input for the final result beyond loading samples and running the assay.

6. The Type of Ground Truth Used:

   • For the Method Comparison study, the ground truth was established by a legally marketed comparator method.
   • For Linearity, LoD/LoQ, and Interference studies, the ground truth involves carefully prepared samples (e.g., spiked samples, diluted samples, reference materials) with known concentrations or expected responses, tested against established analytical validation protocols.
   • For Expected Values (Reference Interval), the ground truth was established by literature reference (Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th edition, 2006:172) and verified according to CLSI guidelines.

7. Sample Size for the Training Set:

   • Not applicable. This document describes the validation of a finished assay and instrument system. Clinical chemistry assays are developed and optimized through iterative research and development, but there isn't a "training set" in the machine learning sense. The "reagent formulation and method parameters" (mentioned as remaining the same for adult claims from K063845) represent the output of prior development.

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

   • Not applicable. As a traditional in vitro diagnostic assay, the concept of a "training set" and associated ground truth is not relevant in the machine learning context. The assay's performance is governed by its chemical reaction principle and instrument calibration/characteristics.

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