(200 days)
For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.
The Cholesterol kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CH8310
R1. Reagent 4 x 20 ml
REAGENT COMPOSITION
Contents: R1. Reagent 4-Aminoantipyrine, Phenol, Peroxidase (E.C.1.11.1.7, Horse Radish, +25°C), Cholesterol esterase (E.C.3.1.1.13. Pseudomonas, +37°C), Cholesterol oxidase (E.C.1.1.3.6. Nocardia, +37°C), Sodium Azide
Concentrations in the Test: 0.25 mmol/l, 6.00 mmol/l, >=0.50 U/ml, >= 0.20 U/ml, >=0.10 U/ml, 0.09%
MATERIALS REQUIRED BUT NOT PROVIDED: Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458, Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153, RX series Saline (Cat. No. SA 8396)
Here's a breakdown of the acceptance criteria and study information for the Randox Laboratories Ltd. Cholesterol device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but rather presents the performance results of various analytical studies that demonstrate the device's capability. I've compiled the relevant performance data from the document into a table, noting the implicit acceptance measures (e.g., meeting CLSI guidelines, certain correlation coefficients, or imprecision percentages).
| Metric / Study | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Performed consistent with CLSI EP5-A2. Total CV % for controls and patient samples to be within acceptable limits (typically 0.975 for quantitative assays) and acceptable regression equation (slope close to 1, intercept close to 0) indicating substantial equivalence. | Serum samples (vs. Predicate): Y = 1.00x - 4.77, r = 0.997 |
| Matrix Comparison (Li Heparin) | High correlation coefficient (typically r > 0.975) and acceptable regression equation (slope close to 1, intercept close to 0) demonstrating equivalence between serum and lithium heparin plasma. | Serum vs. Li Heparin: Y = 1.01x - 6.54, r = 0.997 |
| Matrix Comparison (K₂EDTA) | High correlation coefficient (typically r > 0.975) and acceptable regression equation (slope close to 1, intercept close to 0) demonstrating equivalence between serum and K₂EDTA plasma. | Serum vs. K₂EDTA: Y = 0.99x + 2.85, r = 0.998 |
2. Sample Sizes and Data Provenance for the Test Set
- Precision/Reproducibility:
- Controls: Not explicitly stated as "sample size" but data is reported for commercial control materials (717UE, 724UE, 952UN).
- Patient Samples: 4 concentrations of unaltered human serum samples (3 diluted, 1 spiked for Linearity Pool, 1 Sensitivity Pool). Each sample run in 2 replicates per run, twice per day for 20 non-consecutive days, using 2 reagent lots on 2 RX Daytona plus systems.
- Data Provenance: "unaltered human serum samples" implies human origin, likely retrospective for spiking/dilution. No country of origin is specified.
- Linearity/Assay Reportable Range:
- Sample Size: 11 levels of samples covering the measuring range. Each level run in 5 replicates.
- Data Provenance: "linearity samples" were prepared. Implies in-vitro prepared samples to cover the range, likely based on human serum/plasma.
- Detection Limit (LoD), Limit of Blank (LoB), Limit of Quantitation (LoQ):
- Sample Size: LoD was based on 240 determinations with 4 low-level samples.
- Data Provenance: Not specified, but generally prepared samples for low-level determination.
- Analytical Specificity (Interference):
- Sample Size: Not explicitly stated for the number of interferent samples, but tested at Cholesterol concentrations of 150 mg/dl and 250 mg/dl for each interferent.
- Data Provenance: Prepared samples spiked with interferents.
- Method Comparison with Predicate Device:
- Sample Size: 107 serum patient samples.
- Data Provenance: "serum patient samples" spanning 25 to 599 mg/dl. Retrospective. No country of origin specified.
- Matrix Comparison:
- Sample Size (Lithium Heparin): Minimum of 54 matched patient sample pairs (serum vs. lithium heparin plasma).
- Sample Size (Potassium 2 EDTA): Minimum of 50 matched patient sample pairs (serum vs. potassium 2 EDTA plasma).
- Data Provenance: "Patient samples were drawn in matched pairs". Retrospective from human subjects. No country of origin specified.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
This device is an in vitro diagnostic (IVD) for quantitative measurement of cholesterol. The "ground truth" for such devices is established by precise laboratory reference methods or established commercially available controls and calibrators with known values.
- No "experts" in the sense of radiologists or pathologists establishing ground truth as would be the case for imaging devices.
- Ground truth is established by:
- Reference materials (e.g., NIST 1952a for the calibrators, mentioned under traceability).
- Established analytical methods used by the predicate device and in clinical laboratories.
- CLSI guidelines for experimental design and data analysis.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative IVD device. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative assessments, especially in imaging or pathology, where human expert discrepancy resolution is needed. For quantitative chemical measurements, the ground truth is often numerical and objectively determined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device for chemical analysis of cholesterol, not an imaging or qualitative assessment device involving human readers. Therefore, an MRMC study is not relevant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the entire performance evaluation presented is a standalone study of the device (Cholesterol assay on the RX Daytona plus system). The device performs the analytical measurement autonomously once the sample is loaded. The studies demonstrate the analytical performance of the device itself.
7. Type of Ground Truth Used
The ground truth for the performance studies is multi-faceted:
- Reference Materials: Randox Calibration Serum Level 3 is traceable to Cholesterol reference material NIST 1952a. This is a primary ground truth for calibration and accuracy.
- Predicate Device: For method comparison studies, the predicate device (Randox Cholesterol reagent, K923504) serves as a comparative ground truth, aiming to demonstrate substantial equivalence rather than absolute biological truth.
- CLSI Guidelines: The studies adhere to CLSI (Clinical and Laboratory Standards Institute) guidelines (EP5-A2 for precision, EP6-A for linearity, EP17-A2 for detection limits, EP9-A2 for method comparison), which represent an industry-accepted "ground truth" for how these analytical performance characteristics should be determined and evaluated.
- Prepared Samples: For linearity, sensitivity, detection limits, and interference, samples were prepared to known concentrations or spiked with known substances to create specific "ground truth" scenarios.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning or AI, as this device is a traditional in vitro diagnostic reagent system, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm in this context.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.