(268 days)
The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a]] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.
The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.
Tina-quant Lipoprotein (a) Gen.2 Molarity assay quantifies lipoprotein (a) in human serum and plasma and reports the values in nmoVL with calibrator values traceable to the WHO/IFCC SRM2B reference material.
Reagents - working solutions
R1: Glycine buffer: 170 mmol/L. pH 7.0: stabilizers: BSA: rabbit serum 0.1 %, preservative
R3: Latex particles coated with polyclonal anti-human lipoprotein (a) antibodies (rabbit): 0.5 %; glycine buffer: 170 mmol/L, pH 7.3, BSA; preservative
Here's a breakdown of the acceptance criteria and study details for the Tina-quant Lipoprotein (a) Gen.2 Molarity assay, based on the provided document:
This device is an in vitro diagnostic (IVD) assay, not an AI/ML-driven device. Therefore, the concepts of human readers, multi-reader multi-case (MRMC) studies, ground truth establishment by experts for images, training sets, and adjudication methods are not directly applicable in the typical sense as they would be for an AI model that interprets medical images. The "acceptance criteria" here refer to the predefined performance specifications for an analytical assay.
Device Name: Tina-quant Lipoprotein (a) Gen.2 Molarity
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "All acceptance criteria were met" for the non-clinical performance evaluation sections (Precision, Analytical Sensitivity, Linearity, Dilution, High Dose Hook Effect, Endogenous Interferences, Analytical Specificity/Cross-Reactivity, Sample Matrix Comparison, Method Comparison, and Stability). Specific pre-defined acceptance criteria are generally internal to the manufacturer's quality system and not explicitly listed in this 510(k) summary (which focuses on summarizing the results against those criteria). However, the reported device performance is provided, which demonstrates that the device met the manufacturer's internal criteria.
| Performance Characteristic | Acceptance Criteria (Implied/General) | Reported Device Performance (as stated in document) |
|---|---|---|
| Precision (Repeatability) | Within pre-defined CV% limits | CV% between 0.4% and 2.1% (for various samples) |
| Precision (Intermediate Precision) | Within pre-defined CV% limits | CV% between 0.7% and 2.6% (for various samples) |
| Limit of Blank (LoB) | LoB should be ≤ 6 nmol/L | LoB = 6 nmol/L |
| Limit of Detection (LoD) | LoD should be ≤ 7 nmol/L | LoD = 7 nmol/L |
| Limit of Quantitation (LoQ) | LoQ should be ≤ 7 nmol/L | LoQ = 7 nmol/L |
| Linearity/Assay Reportable Range | Linear within 7 – 240 nmol/L | Confirmed for the measuring range of 7 – 240 nmol/L |
| Dilution | Accurate dilution of samples > measuring range (1:3 rerun function) | Confirmed, supporting 1:3 dilution for samples above measuring range |
| High Dose Hook Effect | No false results up to a high concentration | Confirmed no false result up to 450 nmol/L |
| Endogenous Interferences | No significant interference from tested substances (Icterus, Hemolysis, Lipemia, Rheumatoid factors) | All predefined acceptance criteria were met. Claims: Icterus up to I index 60, Hemolysis up to H index 1000, Lipemia up to L index 2000, Rheumatoid factors up to 1200 IU/mL. |
| Analytical Specificity / Cross-Reactivity | No significant cross-reactivity from tested substances (Plasminogen, Apolipoprotein B) | No significant cross-reactivity in tested concentration ranges (Plasminogen up to 150 mg/dL, Apolipoprotein B up to 200 mg/dL). |
| Exogenous Interferences | No significant interference from common drug panels | All predefined acceptance criteria were met for 15 listed drugs at specified concentrations. |
| Sample Matrix Comparison | Acceptable performance across serum and different plasma types | All predefined acceptance criteria were met (Slope, Intercept, Correlation Coefficient for comparison of serum vs. serum with gel, Li-Heparin, K2-EDTA, K3-EDTA plasma). |
| Method Comparison to Lp(a) ELISA reference method | Strong correlation with reference method | Sample size (n) = 126. Deming regression: y = 1.023x + 0.692 nmol/L, r = 0.992. Sample concentrations 8.70 - 234 nmol/L. |
| Stability | Supports manufacturer's claims | Stability data supports Roche Diagnostic's claims as reported in the package labeling. |
2. Sample Sizes and Data Provenance
- Precision (Repeatability): n = 84 (number of individual measurements per sample level).
- Precision (Intermediate Precision): 2 aliquots per run, 2 runs per day, 21 days.
- LoB: One analyte-free sample measured with three reagent lots, 6 runs, 10-fold determination per run, distributed over >3 days.
- LoD: 5 serum samples with low analyte concentrations measured with three reagent lots, 2-fold determination per run, 6 runs distributed over 5 days.
- LoQ: 5 serum samples measured with three reagent lots, 5 runs distributed over 5 days.
- Linearity: 1 run using 3 reagent lots and 5 replicates per sample. A dilution series prepared from human serum (sample High) and NaCl 0.9% (sample Blank) to obtain 16 levels.
- Method Comparison (to Lp(a) ELISA): n = 126 native human serum samples.
- Sample Matrix Comparison: ≥ 50 samples.
- Reference Range Study:
- Caucasian/White: n = 425
- African-American/Black: n = 111
- Asian: n = 128
- Hispanic/Latino (among Caucasian/White): n = 110
- Non-Hispanic/Non-Latino (among Caucasian/White): n = 311
- Data Provenance for Reference Range Study: Samples from apparently healthy adults in the United States, with equal representation of males and females. This suggests prospective collection for the purpose of establishing reference ranges. Other studies (e.g., method comparison, precision) would typically use laboratory samples which could be retrospective or specifically prepared for the study. The document does not specify "retrospective" or "prospective" for all tests, but the nature of these analytical performance studies often involves controlled, prepared, or collected samples without a specific patient encounter context. The "native human serum samples" for method comparison generally implies biological samples.
3. Number of Experts and Qualifications for Ground Truth
For this in vitro diagnostic device, "ground truth" is established by reference methods or validated analytical measurements, not by human expert interpretation in the way it would be for an AI image analysis tool.
- Not Applicable in the traditional sense for AI/ML image analysis. The "ground truth" for analytical performance tests like precision, linearity, or interference is an established analytical value or the characteristic of the sample itself (e.g., known concentration, presence/absence of interfering substance). For "method comparison," the ground truth is provided by the designated "Lp(a) ELISA reference method."
4. Adjudication Method for the Test Set
- Not Applicable in the traditional sense for AI/ML image analysis. Adjudication is usually performed by multiple human experts reviewing a case. For an IVD, the "adjudication" is inherent in the rigorous analytical protocols, statistical methods (e.g., CLSI guidelines), and the use of reference methods or certified reference materials for traceability.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Performance
- Yes, implicitly. The performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Method Comparison) evaluate the device (assay on the cobas c 503 analyzer) as a standalone system. There is no human intervention in the measurement or calculation of results once the sample is loaded. The device generates a quantitative value for Lp(a).
7. The Type of Ground Truth Used
- Reference Method/Analytical Standards:
- Precision, Sensitivity, Linearity, Interferences: Ground truth is based on known concentrations in control materials, spiked samples, or by using analyte-free samples, following standardized laboratory practices and CLSI guidelines (e.g., CLSI EP05-A3, EP17-A2, EP06-A-Ed2).
- Method Comparison: The "ground truth" or reference values were derived from the Lp(a) ELISA reference method.
- Traceability: The device's calibration values are traceable to the WHO/IFCC SRM2B reference material for nmol/L, indicating a standardized and accepted reference for accuracy.
8. The Sample Size for the Training Set
- Not applicable in the AI/ML sense. This is a traditional IVD assay, not an AI model that requires a "training set" to learn features. The assay is based on well-understood principles of immunoturbidimetry and does not involve machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML training set, this question is not relevant to this device. The assay's "knowledge" is built into its chemical reagents, optical detection system, and pre-programmed algorithms for calculating concentration from turbidity measurements, based on established analytical principles and calibration to reference materials.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).