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The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

For use in clinical laboratories and point of care laboratory settings.

For prescription use only.

Afinion™ Lipid Panel is a fully automated assay for quantitative determination of Chol. HDL and Trig in serum. LDL, non- HDL and Chol/HDL are calculated by the Afinion™ AS100 Analyzer.

The Afinion™ Lipid Panel Test Cartridge contains all reagents necessary for determination of Chol, HDL and Trig in serum. The sampling device integrated in the test cartridge is filled with sample material. The test cartridge is then placed in the Afinion™ AS100 Analyzer. The analyzer inspects the sampling device, and the sample is then diluted.

Total Cholesterol (Chol) is measured by an enzymatic colorimetric method.
Triglycerides (Trig) are measured by an enzymatic colorimetric method.
HDL cholesterol is measured by an enzymatic colorimetric method with direct determination of HDL by initial antibody blocking of apolipoprotein B (apo-B).
LDL cholesterol is calculated by use of the Friedwald formula: LDL (mg/dL) = Chol - HDL - Trig/5.
non-HDL cholesterol is calculated as total cholesterol minus HDL: non-HDL = Chol - HDL.
Chol/HDL ratio is calculated as Total Cholesterol/ HDL Cholesterol.

Acceptance Criteria and Device Performance for Afinion™ Lipid Panel

This document outlines the acceptance criteria and the study that demonstrates the Afinion™ Lipid Panel's performance, as derived from the provided 510(k) summary (K132031).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for bias, precision (repeatability and within-device), or linearity. Instead, it presents the results of these studies and implies that these results were considered acceptable for demonstrating substantial equivalence to predicate devices. The reported device performance based on acceptable outcomes from comparison studies is presented below.

Interference: No significant interference (<10%) was observed from 26 common substances at specified concentrations. Limitations were noted for Calcium dobesilate, Methyldopa, Acetylcysteine, and Levodopa at certain levels.

Reporting Ranges (supported by linearity and LoQ studies):

Accuracy (Method Comparison with Predicate Devices):

Bias at Medical Decision Levels (Implied Acceptance: Low Bias):

Precision (Repeatability and Within-device %CV - Implied Acceptance: Low %CV):

Precision results are presented for control samples at two levels and one serum sample across three sites. The Coefficients of Variation (CV%) are generally low, indicating good precision. For example:

• Total Cholesterol: Repeatability CVs range from 1.7% to 3.5%, Within-device CVs range from 2.3% to 3.9%.
• HDL Cholesterol: Repeatability CVs range from 2.1% to 3.9%, Within-device CVs range from 2.6% to 4.9%.
• Triglycerides: Repeatability CVs range from 1.8% to 4.4%, Within-device CVs range from 2.2% to 4.9%.

2. Sample Sizes and Data Provenance

• Linearity Testing:

  • Test Set Sample Size: 11 concentration levels for each analyte, produced by intermixing one low and one high serum sample. Each level was measured in 4-6 replicates.
  • Data Provenance: Not explicitly stated, but the studies were performed by the manufacturer, Axis-Shield PoC AS (located in Oslo, Norway). The samples were described as "serum samples." It's retrospective in the sense that it's test data generated for regulatory submission, but the samples themselves could have been collected prospectively or retrospectively.

• Limits of Quantitation (LoQ) Testing:

  • Test Set Sample Size: 5 samples with concentrations near 0 mg/dL (LoB samples) and 5 low concentration samples (LoD samples). Each sample was measured in a total of 60 replicates (likely 12 replicates per sample, using 3 analyzers and 2 test cartridge lots).
  • Data Provenance: Not explicitly stated, but performed by the manufacturer. "Serum" is the sample type.

• Analytical Specificity (Interference) Testing:

  • Test Set Sample Size: "Samples covering two medical decision concentrations of each lipid analyte" were measured.
  • Data Provenance: Not explicitly stated, but performed by the manufacturer.

• Accuracy (Method Comparison) Testing:

  • Test Set Sample Size:
    • Cholesterol: 348 samples
    • Triglycerides: 246 samples
    • HDL: 251 samples
  • Data Provenance: The study was "performed at four point-of-care sites." No specific country of origin is mentioned, but the manufacturer is based in Norway. The samples were "serum." The nature of sample collection (retrospective or prospective) is not specified.

• Precision Testing:

  • Test Set Sample Size: Two control samples and one serum sample were tested. For each sample, 80 replicates were performed at each of the three point-of-care sites (2 replicates per run, 2 runs per day for 20 days).
  • Data Provenance: "Performed at three point-of-care sites." The origin of the control and serum samples is not detailed, but the study was conducted by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic (IVD) for quantitative determination of analytes in serum. The ground truth for such devices is established by reference methods or highly accurate laboratory methods, not by expert interpretation of images or clinical assessments.

• Traceability:
  • Cholesterol (Chol) and HDL are traceable to the National Reference System for Cholesterol (NRS/CHOL).
  • Triglycerides (Trig) are traceable to a Centers for Disease Control and Prevention (CDC) reference method.
  • The device is CRMLN certified for Total Cholesterol and HDL Cholesterol, indicating its accuracy against reference measurement procedures.

Therefore, "experts" in the traditional sense (e.g., radiologists) are not used to establish ground truth for this type of device. The ground truth is established by recognized reference standards and methods in clinical chemistry.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments (e.g., image reading). This is a quantitative diagnostic device, and the ground truth is established by objective, highly accurate reference methods or laboratory instruments. Therefore, no "adjudication method" in this context is applicable or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Afinion™ Lipid Panel is a standalone quantitative measurement device, not an AI-assisted human reading system.

6. Standalone Performance Done

Yes, a standalone performance study was done. The studies detailed (linearity, limits of quantitation, analytical specificity, accuracy/method comparison, and precision) all represent the performance of the Afinion™ Lipid Panel device (algorithm only, without human-in-the-loop performance) in measuring lipid levels in serum samples.

7. Type of Ground Truth Used

The ground truth used is based on:

• Reference Methods: Specifically, the National Reference System for Cholesterol (NRS/CHOL) for Total Cholesterol and HDL Cholesterol, and a CDC reference method for Triglycerides.
• Comparison to Predicate Devices/Automated Laboratory Methods (CM): For accuracy evaluation, the Afinion™ Lipid Panel's results were compared against an "automated laboratory method (CM)" for Chol, Trig, and HDL, which are themselves established and validated lab instruments.

8. Sample Size for the Training Set

This document describes a 510(k) submission for an in vitro diagnostic device that measures specific analytes. It is highly unlikely that this device uses machine learning or AI models that require a "training set" in the conventional sense (i.e., iterative learning from labeled data). The device's operation is based on established enzymatic colorimetric methods and pre-programmed algorithms. Therefore, a "training set" size is not applicable or stated in this context.

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

As stated in point 8, a "training set" as understood in machine learning is not applicable to this type of IVD device. The methods for establishing the device's accuracy and performance are described under "Traceability" and "Accuracy" (method comparison with reference and predicate methods).

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