(273 days)
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
Device Name: Direct LDL Cholesterol (LDL)
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|---|
| Precision | Total CV % (within run, among run, among day) | Generally expected to be low for clinical assays, with specific targets often dependent on concentration levels. | QC 1 (92.0 mg/dl): 5.9% total CV |
| QC 2 (135.9 mg/dl): 4.6% total CV | |||
| QC 3 (186.7 mg/dl): 4.4% total CV | |||
| Serum pool 1 (65.0 mg/dl): 5.9% total CV | |||
| Serum pool 2 (154.0 mg/dl): 5.0% total CV | |||
| Serum pool 3 (200.1 mg/dl): 5.0% total CV | |||
| Serum pool 4 (343.7 mg/dl): 5.3% total CV | |||
| Linearity/Reportable Range | Linear Regression Correlation Coefficient (r) | Close to 1.0 (indicating a strong linear relationship) | r = 0.997 |
| Reportable Range | Defined range where results are linear. | 21 - 740 mg/dl | |
| Detection Limit | Limit of Blank (LoB) | Very low, ideally close to zero, to ensure no signal from blank. | 1.94 mg/dl |
| Limit of Detection (LoD) | Low enough to reliably detect the analyte. | 3.19 mg/dl | |
| Limit of Quantitation (LoQ) | Low enough for precise and accurate quantification at low concentrations (typically ≤20% imprecision). | 16.1 mg/dl (with ≤20% imprecision) | |
| Analytical Specificity | Interference (% of Control) | % of Control ± 10% for potential interferents at specified concentrations. | Hemoglobin: No significant interference up to 1000mg/dl. |
| Total Bilirubin: No significant interference up to 60mg/dl. | |||
| Conjugate Bilirubin: No significant interference up to 60mg/dl. | |||
| Triglycerides: No significant interference up to 500mg/dl. | |||
| Intralipid®: No significant interference up to 500mg/dl. | |||
| Ascorbic Acid: No significant interference up to 6mg/dl. | |||
| Method Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when compared to a predicate device, indicating substantial equivalence. | r = 0.998 (compared to predicate device) |
| Matrix Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when comparing serum and lithium heparin plasma, indicating equivalent performance across matrices. | r = 0.998 (serum vs. lithium heparin plasma) |
| Traceability | Conformance to reference materials/standards | Traceable to an internal master reference material. Not certified by CRMLN (stated as a disclaimer in labeling). | Traceable to an internal master reference. Labeling states "device has not been certified by the CRMLN." |
Study Details
- Sample size used for the test set and the data provenance:
- Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (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.