Search Results

The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

The provided text describes the SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents. It details method comparison studies, imprecision data, and stability information. However, it does not explicitly state specific acceptance criteria in a quantifiable fashion that the device must meet. Instead, it presents performance data and implies that this data demonstrates substantial equivalence to predicate devices.

Therefore, I cannot fully complete the table for "Acceptance Criteria" as it is not explicitly provided in the document in a numerical, predefined target format. I will fill in the "Reported Device Performance" based on the study results.

Here is an analysis based on the information provided:

1. Table of (Implicit) Acceptance Criteria and Reported Device Performance

As stated, explicit numerical acceptance criteria are not presented in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices and generally acceptable performance for in vitro diagnostic devices. The reported device performance is from method comparison and imprecision studies.

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

• Sample Size (n):
  • Method Comparison Study #1: 78 for ApoA, 73 for ApoB.
  • Method Comparison Study #2: 54 for ApoA, 54 for ApoB.
  • Within-Run Imprecision (ApoA): 80 for each level.
  • Within-Run Imprecision (ApoB): Not fully clear due to obscured data, but likely a similar number per level.
• Data Provenance: Not explicitly stated (e.g., retrospective/prospective, country of origin). The studies appear to be laboratory-based performance evaluations, likely using clinical samples, but details are not provided.

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

• This information is not applicable to this type of device and study. The "ground truth" for these studies is the measurement provided by the established predicate devices or reference methods (Beckman's existing Apolipoprotein reagents and NWLRL Nephelometric Procedure). There's no involvement of clinical experts establishing a diagnosis/ground truth for individual cases.

4. Adjudication Method for the Test Set

• Not applicable. This study involves quantitative biochemical measurements compared against reference methods, not subjective assessments requiring adjudication by experts.

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 imaging or diagnostic interpretation tasks involving human readers, which is not the nature of this device or its evaluation.

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

• Yes, the performance data presented is for the device (reagents and SYNCHRON LX™ Systems) operating in a standalone, automated fashion. The reported results (slope, intercept, correlation, %CV) represent the algorithm/system's performance directly. There is no "human-in-the-loop" component described for the measurement process itself.

7. The Type of Ground Truth Used

• The ground truth in these studies is established by comparison to predicate methods or established reference laboratory procedures:
  • Beckman's Apolipoprotein APA Reagent (for ApoA) and Beckman's APB Reagent (for ApoB).
  • Northwest Lipid Research Laboratories (NWLRL) Nephelometric Procedure.
• These are considered established methods for quantitatively determining apolipoprotein levels.

8. The Sample Size for the Training Set

• This information is not applicable. The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents are chemical reagents for diagnostic assays, not machine learning algorithms that require a "training set" in the conventional sense. The "training" for such systems would involve calibration and quality control procedures, but not a dataset as described for an AI model.

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

• Not applicable for the reasons stated in point 8.

Ask a specific question about this device