(170 days)
Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.
Here's a breakdown of the acceptance criteria and study information for the Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (R-value approaching 1) | Correlation coefficient (R-value): 0.9987 (vs. predicate device) |
| Bias (slope near 1, intercept near 0) | Regression equation: y = 1.01x - 0.4942 (vs. predicate device) | |
| Precision | Within acceptable range | "Results of these tests were within acceptable range." |
| Linearity (Analytical Range) | Clearly defined upper limit | Linear to 200 mg/dl |
| Sensitivity | Clearly defined lower detection limit | A change of 0.001 absorbance units is equivalent to approximately 0.4 mg/dl of HDL Cholesterol. |
| Interference Studies | Within acceptable range | "Results of these tests were within acceptable range." |
Note: The document does not explicitly state the numerical acceptance criteria for precision and interference. It only states that the results were "within acceptable range." For method comparison, the implied criterion is a strong correlation, which the reported 0.9987 satisfies. The regression equation also indicates minimal bias.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 50 patient samples were used for the correlation (method comparison) study.
- Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the phrasing "using 50 patient samples" suggests it was likely prospective for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the document. The study relies on method comparison against a predicate device, not expert consensus for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as the ground truth was established by comparison to a predicate device's measurements, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic device for quantitative determination of a biomarker, not an imaging device requiring human reader interpretation. Therefore, the effect size of human reader improvement with or without AI assistance is not relevant or measured.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, linearity, sensitivity, interference) was evaluated independently. The method comparison study also assesses the device's performance against a reference method without human interpretation as part of the measurement process.
7. Type of Ground Truth Used
- The ground truth for the method comparison study was established by the measurements obtained from a legally marketed predicate device: HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
- For other analytical performance studies (precision, linearity, sensitivity, interference), the ground truth is typically derived from established laboratory protocols and reference materials but this is not explicitly detailed beyond stating the results were "within acceptable range."
8. Sample Size for the Training Set
- This information is not applicable or provided. This device is a chemical reagent system, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" would relate to its chemical formulation and optimization during development, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable or provided for the reasons stated in point 8.
§ 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.