(52 days)
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers.
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.
A device for the measurement of human apolipoprotein B in serum or plasma. Anti-apolipoprotein B antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
The provided text describes a 510(k) premarket notification for the "Tina-quant Apolipoprotein B ver.2" device. This device is an immunoturbidimetric assay for the quantitative determination of apolipoprotein B in human serum and plasma. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, the Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay (K860894), rather than providing a detailed study that establishes specific acceptance criteria against a defined clinical endpoint.
Therefore, the following information is extracted from the provided text, recognizing that it primarily details performance characteristics for demonstrating equivalence, not a standalone clinical validation against specific "acceptance criteria" in the way a new diagnostic test might typically undergo:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pre-defined manner for clinical utility against a specific disease outcome. Instead, it presents performance characteristics of the new device and compares them to a predicate device to establish substantial equivalence.
| Feature | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Tina-quant Apolipoprotein B ver.2) |
|---|---|---|
| Precision | Similar to predicate device (see predicate performance) | Within run CV: 1.5% @ 29 mg/dL (serum), 0.5% @ 112 mg/dL (serum), 0.8% @ 69 mg/dL (control), 0.5% @ 152 mg/dL (control) |
| Between Day CV: 2.5% @ 26 mg/dL (serum), 1.1% @ 127 mg/dL (serum), 1.0% @ 80 mg/dL (control), 1.9% @ 155 mg/dL (control) | ||
| Method Comparison | Correlation with predicate and/or nephelometric method | $y = 1.127 - 2.849$ mg/dL (vs. Nephelometric method X), $r = 0.884$ |
| Hook Effect | Not present within expected range | No effect up to 600 mg/dL |
| Analytical Sensitivity | Similar to predicate | 1.5 mg/dL |
| Interference (Icterus) | No significant interference | No significant interference up to an I index of 60 mg/dL (conjugated and unconjugated) |
| Interference (Hemolysis) | No significant interference | No significant interference up to an H index of 1000 |
| Interference (Lipemia) | No significant interference | No significant interference up to an L index of 1000 |
| Cross-reactivity | No cross-reactivity with related substances | Anti-human apolipoprotein B antibodies from sheep show no cross-reactivity with apolipoprotein A-I or A-II |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set in the context of clinical validation. The reported performance characteristics (precision, method comparison, etc.) would typically be derived from studies with a certain number of samples, but these numbers are not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The studies described are performance studies for the device itself, likely conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an in vitro diagnostic (IVD) quantitative assay. The "ground truth" for such devices is established by reference methods or validated comparative methods, not by expert consensus in the same way as, for example, image-based diagnostic AI.
4. Adjudication method for the test set
Not applicable. As described above, the ground truth is based on quantitative reference methods, not subjective expert reviews requiring adjudication.
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 automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the Tina-quant Apolipoprotein B ver.2 assay. The performance characteristics (precision, method comparison, sensitivity, interference, hook effect) are inherent to the assay and instrument combination, without human interpretation influencing the measurement result itself.
7. The type of ground truth used
The "ground truth" for the device's performance evaluation is established through:
- Comparative methods: Against a "Nephelometric method" for method comparison, and implicitly against the predicate device's performance.
- Validated laboratory reference standards and controls: Used for precision, sensitivity, and linearity studies.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set" in the conventional sense. The assay is based on established immunoturbidimetric principles.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of IVD 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).