(172 days)
Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic Use Only.
The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-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 HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then react with the LDLcholesterol present in the sample.
The provided text describes the acceptance criteria and a study for the "Direct LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system" used for quantitative determination of LDL-C.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from predicate device) | Reported Device Performance |
|---|---|---|
| Method Comparison | Correlation with predicate device (LDL Cholesterol Plus calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche)) | Correlation coefficient of 0.9969 and a regression equation of y = 1.025x - 4.0289 |
| Precision | "within acceptable range" (specific criteria not detailed) | "within acceptable range" |
| Linearity | "acceptable range" (specific criteria not detailed) | Linear to 700 mg/dL |
| Sensitivity | "acceptable range" (specific criteria not detailed) | A change of 0.001 absorbance units is equivalent to approximately 0.4 mg/dL of LDL Cholesterol |
| Interference | "acceptable range" (specific criteria not detailed) | "within acceptable range" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 62 patient samples.
- Data Provenance: The text does not specify the country of origin. It indicates "patient samples" without further details, so it's not possible to definitively classify it as retrospective or prospective based solely on the provided information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the text. The ground truth for the device's performance relies on comparison with a predicate device, not on expert consensus.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation method was a method comparison study against a predicate device, not a human expert review process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study was a method comparison of the new device against a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance data provided (method comparison, precision, linearity, sensitivity, interference) are for the device's standalone analytical performance. This device is a quantitative, in vitro diagnostic system, and its performance is evaluated based on its direct measurement capabilities, not with human interpretation as part of its core function.
7. The Type of Ground Truth Used
- The ground truth for the study was established by the measurements obtained from the legally marketed predicate device, "LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche)." This is a form of comparative reference standard.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The device is a reagent and calibrator system for direct measurement, not an AI or machine learning algorithm that requires a training set in the conventional sense. The performance data presented are for the analytical validation of the device itself.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reasons as in point 8.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.