(49 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein B in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Human apolipoprotein B forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
Here's a summary of the acceptance criteria and study information for the Tina-quant Apolipoprotein B ver.2 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" for each performance characteristic. However, we can infer the performance of the predicate device as a benchmark against which the new device is compared. The reported performance for the new device and the predicate are listed.
| Feature | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Tina-quant Apolipoprotein B ver.2) |
|---|---|---|
| Precision | Within run CV: 0.66% @ 1.30 g/L, 0.50% @ 2.22 g/L | |
| Total CV: 2.1% @ 1.30 g/L, 0.98% @ 2.22 g/L | Within run CV: 1.2% @ 0.8 g/L, 1.1% @ 1.5 g/L | |
| Between Day CV: 2.9% @ 0.8 g/L, 3.2% @ 1.5 g/L | ||
| Method Comparison | Correlation to a commercially available system (X): y = 1.06x + 0.10 g/L, r = 0.983 (Bablok/Passing) | Correlation to COBAS Integra Apolipoprotein B (X): y = 1.02x + 0.03 g/L, r = 0.954 (Bablok/Passing) |
| Prozone Effect | No effect up to 19.8 g/L | No effect up to 6 g/L |
| Analytical Sensitivity (LDL) | Determined by the lower limit of the standard curve; typical concentration approximately 0.26 g/L | 0.046 g/L |
| Limitations (Interferences) | Icterus: No significant interference | |
| Hemolysis: No significant interference | ||
| Lipemia: No significant interference | ||
| Rheumatoid factors: Levels > 300 IU/ml slightly increase apparent concentration | Icterus: No significant interference | |
| Hemolysis: No significant interference | ||
| Lipemia: No significant interference up to an Intralipid level of 1000 mg/dL | ||
| Rheumatoid factors: No significant interference | ||
| Measuring Range | 0.26 - 3.9 g/L (0.09 - 7.8 g/L with rerun) | 0.20 - 4.0 g/L (0.10 - 4.0 g/L with rerun) |
| Reagent Stability (On-board) | 12 weeks | 4 weeks |
| Expected Values (Females) | 0.50 - 1.30 g/L | 0.60 - 1.17 g/L |
| Expected Values (Males) | 0.60 - 1.40 g/L | 0.66 - 1.33 g/L |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the sample size used for the method comparison or precision studies. It only presents the results (e.g., CV values, regression parameters).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in vitro diagnostic reagent system designed to quantitatively measure apolipoprotein B. The concept of "experts" establishing ground truth for individual cases, as might be done in image analysis or clinical diagnosis, is not applicable here. The "ground truth" for method comparison would typically be the results obtained from a reference method or a predicate device, as indicated in the "Method Comparison" section where the Tina-quant Apolipoprotein B ver.2 (Y) is compared to the COBAS Integra Apolipoprotein B (X).
4. Adjudication method for the test set:
Not applicable. As described above, this is a quantitative measurement device, not one requiring 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 assay, not a device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a standalone in vitro diagnostic reagent system. Its performance characteristics (precision, method comparison, analytical sensitivity, etc.) are inherent to the assay and instrument system, operating without human interpretation other than performing the test and reviewing the quantitative result.
7. The type of ground truth used:
- For Method Comparison, the "ground truth" for the new device was established by comparing its results to those obtained from the predicate device (COBAS Integra Apolipoprotein B), which is established technology. For the predicate device's own method comparison, it was compared to a "commercially available system." This suggests established, validated methods are used as a comparative standard.
- For Precision, the ground truth is the statistical variation around the measured concentration.
- For Analytical Sensitivity, it's determined through laboratory testing procedures.
- For Interference studies, known concentrations of interfering substances are added to samples, and the results are compared to non-interfered samples.
8. The sample size for the training set:
Not applicable. This is a chemical/immunological assay, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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).