(85 days)
The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
The TQ Lp(a) Gen.2 test principle is a particle-enhanced immunoturbidimetric assay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically. The Preciset Lp(a) Gen.2 calibrator set consists of five lyophilized calibrators based on a stabilized and lyophilized pool of human plasma. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. The PreciControl Lp(a) Gen.2 control set contains two lyophilized controls based on a human plasma matrix.
Here's a summary of the acceptance criteria and study information for the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and reports performance characteristics rather than explicit acceptance criteria. However, we can infer some criteria from the comparative data and the general performance evaluation.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate/Good Practice) | Reported Device Performance (TQ Lp(a) Gen.2 assay) |
|---|---|---|
| Measuring Range | Comparable to predicate (2.0 – 80.0 mg/dL) | 6.0 – 80.0 mg/dL |
| Lower Limits of Measure | LDL: 2.0 mg/dL (predicate) | LoB: 3 mg/dL, LoD: 4 mg/dL, LoQ: 6 mg/dL |
| Hook Effect | No significant effect within expected range | No hook effect up to 190 mg/dL |
| Precision (Within-run) | Comparable to predicate or better | Control L: 1.4% CV, Control H: 1.0% CV |
| Pool 1: 5.4% CV, Pool 2: 6.2% CV | ||
| Pool 3: 2.4% CV, Pool 4: 0.9% CV | ||
| Precision (Intermediate/Total) | Comparable to predicate or better | Control L: 1.6% CV, Control H: 1.1% CV |
| Pool 1: 7.6% CV, Pool 2: 6.4% CV | ||
| Pool 3: 2.9% CV, Pool 4: 1.1% CV | ||
| Icterus Interference | No significant interference | No significant interference up to an I index of 60 (approx. 60 mg/dL) |
| Hemolysis Interference | No significant interference | No significant interference up to an H index of 1000 (approx. 1000 mg/dL) |
| Lipemia Interference | No significant interference | No significant interference up to an L index of 2000 |
| Plasminogen Cross-Reactivity | No significant cross-reactivity | No significant cross-reactivity up to 150 mg/dL |
| Apolipoprotein B Cross-Reactivity | No significant cross-reactivity | No significant cross-reactivity up to 200 mg/dL |
| Rheumatoid Factor Interference | Not specified for predicate | No significant interference up to 1200 IU/mL |
| Drugs Interference | Not specified for predicate | No interference at therapeutic concentrations using common drug panels |
| Reagent On-board Stability | Stable for a reasonable period | 6 weeks |
| Reagent Unopened Stability | Stable until expiration date | 2-8°C until expiration date |
| Calibration Frequency | After reagent lot change and as required | Same |
Study Proving Acceptance Criteria:
The document describes the submission as a 510(k) premarket notification, indicating a substantial equivalence study. The study's purpose is to demonstrate that the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System (candidate device) is as safe and effective as a legally marketed predicate device. This is primarily achieved through direct comparison of features and performance characteristics, as summarized in the tables provided in the document. The document lists "Evaluations summary" in Section 9, indicating that performance characteristics were evaluated.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., precision, interference studies, linearity, method comparison). It mentions evaluating "several performance characteristics."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It is implied to be laboratory-generated data for performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the evaluation of an in vitro diagnostic (IVD) device like the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System. The "ground truth" for these tests is established by reference methods or accepted analytical principles, not by expert consensus in the same way it would be for, for example, image interpretation. The device measures a specific analyte concentration.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD device. Analytical performance is typically evaluated against defined statistical metrics and analytical specifications, not through expert adjudication of results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This is an in vitro diagnostic device for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an IVD assay, so its performance is inherently "standalone" in terms of measurement. The "algorithm" here refers to the immunoassay chemistry and detection system. Its performance is evaluated independently of human interpretation of raw signals, although human operators perform the testing and interpret the final quantitative results.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device would be established by:
- Reference materials/calibrators: The Preciset Lp(a) Gen.2 calibrator set is mentioned as being based on a "stabilized and lyophilized pool of human plasma," with concentrations adjusted for optimal calibration. This implies traceability to a higher-order reference method or material for determining Lp(a) concentrations.
- Method comparison against predicate device: The substantial equivalence comparison implies that the predicate device serves as a benchmark for acceptable performance.
- Physiological samples with known characteristics: For interference studies, samples spiked with known interferents would be used.
8. The Sample Size for the Training Set
No information is provided about a "training set" in the context of machine learning. For an IVD assay, method development involves extensive experimentation for optimization of reagents, reaction conditions, and calibration models. However, these are not typically referred to as "training sets" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable for a chemical immunoassay, as there is no machine learning "training set" in the conventional sense. The "ground truth" for assay development and validation is established through analytical chemistry principles, use of reference materials, and comparison to established methods.
§ 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).