(87 days)
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.
| Performance Metric | Implied Acceptance Criteria (Based on general IVD expectations & predicate comparison) | Reported Device Performance (SYNCHRON LX™ Systems) |
|---|---|---|
| Method Comparison (vs. Beckman Predicate) | ||
| ApoA Slope | Close to 1.0 | 0.953 |
| ApoA Intercept (mg/dL) | Close to 0 | 4.1 |
| ApoA Correlation Coefficient (r) | High (e.g., >0.95) | 0.9922 |
| ApoB Slope | Close to 1.0 | 0.943 |
| ApoB Intercept (mg/dL) | Close to 0 | 7.6 |
| ApoB Correlation Coefficient (r) | High (e.g., >0.95) | 0.9970 |
| Method Comparison (vs. NWLRL Nephelometric Procedure) | ||
| ApoA Slope | Close to 1.0 | 1.022 |
| ApoA Intercept (mg/dL) | Close to 0 | -3.4 |
| ApoA Correlation Coefficient (r) | High (e.g., >0.95) | 0.965 |
| ApoB Slope | Close to 1.0 | 1.006 |
| ApoB Intercept (mg/dL) | Close to 0 | 1.7 |
| ApoB Correlation Coefficient (r) | High (e.g., >0.95) | 0.991 |
| Imprecision (ApoA %C.V.) | ||
| ApoA Level 1 | Low (e.g., |
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.