(132 days)
For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
The Randox Triglycerides kit assay consists of ready to use reagent solutions.
Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Not explicitly stated as a single numerical criterion. Evaluated consistent with C.L.S.I documents EP5-A2. Implied goal is acceptable variability across runs, days, and total. | Lot 1 (RX Daytona Plus): |
- Sensitivity Pool (13.3 mg/dl): Total CV 13.4%
- Serum Pool 1 (96.4 mg/dl): Total CV 2.1%
- QC 1 (96.5 mg/dl): Total CV 2.3%
- Patient Pool 2 (104 mg/dl): Total CV 2.5%
- Patient Pool 1 (117 mg/dl): Total CV 2.5%
- Serum Pool 2 (237 mg/dl): Total CV 2.1%
- CAL (240 mg/dl): Total CV 2.0%
- QC 2 (259 mg/dl): Total CV 1.5%
- Serum Pool 3 (326 mg/dl): Total CV 1.6%
Lot 2 (RX Daytona Plus):
- Sensitivity Pool (17.7 mg/dl): Total CV 11.6%
- 801UN QC 2 (97.3 mg/dl): Total CV 3.2%
- Serum Pool 1 (111 mg/dl): Total CV 3.6%
- 832UE CAL (235 mg/dl): Total CV 3.0%
- Serum Pool 2 (252 mg/dl): Total CV 2.6%
- 587UE QC 3 (265 mg/dl): Total CV 2.5%
- Serum Pool 3 (326 mg/dl): Total CV 3.7%
- Serum Pool 4 (514 mg/dl): Total CV 2.8% |
| Linearity/Assay Reportable Range | Deviation from linearity less than 5%. | Linearity: Slope 0.96, Intercept 3.30, r = 1.000.
Reportable Range: 12.4 – 1000 mg/dl. (The linearity study covered up to approximately 1000 mg/dl, and the device has an auto-dilution feature for samples >1000 mg/dL). |
| Detection Limit | Not explicitly stated as acceptance criteria, but rather defined properties. | LoD: 3.96 mg/dl (based on 240 determinations, 4 low-level samples)
LoB: 2.65 mg/dl
LoQ: 12.4 mg/dl (lowest concentration at which precision is met) |
| Analytical Specificity (Interference) | Recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL. | Hemoglobin: No significant interference up to 750mg/dL
Total Bilirubin: No significant interference up to 60mg/dL
Conjugate Bilirubin: No significant interference up to 60mg/dL
Ascorbic Acid: No significant interference up to 3.0mg/dL |
| Method Comparison with Predicate Device | Not explicitly stated as a single numeric criterion for the regression, but the goal is "substantially equivalent" to the predicate. Implied acceptable correlation (r) and agreement (slope, intercept). | Comparison: Y = 0.97x + 1.22
Correlation coefficient: r = 0.999 (This indicates a very strong positive correlation) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Reproducibility:
- Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
- Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
- Linearity:
- Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
- Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
- Detection Limit:
- Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
- Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
- Analytical Specificity (Interference):
- Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
- Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
- Method Comparison:
- Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
- Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.
- No mention of human experts or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.
7. The Type of Ground Truth Used
- Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
- Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.
8. The Sample Size for the Training Set
This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine 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.