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N Latex Lp(a) Reagent is an in vitro diagnostic test for the quantitative determination of Lipoprotein(a) [Lp(a)] in human serum or plasma. N Latex Lp(a) aids in the diagnosis of disorders of lipid (fat) metabolism and helps to identify persons at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.

Polystyrene latex particles coated with specific antibodies to human Lp(a) are agglutinated when mixed with samples containing Lp(a). The intensity of scattered light in the BN™ Systems depends on the Lp(a) concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

Acceptance Criteria and Device Performance Study for N Latex Lp(a) Reagent

This report details the acceptance criteria and the study conducted to demonstrate the performance of the N Latex Lp(a) Reagent, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The 510(k) summary does not explicitly state numerical acceptance criteria for correlation and precision. However, substantial equivalence claims in medical device submissions are implicitly based on demonstrating performance comparable to a legally marketed predicate device. The reported values are generally considered acceptable for demonstrating equivalence in in-vitro diagnostic assays of this type.

2. Sample Size Used for the Test Set and Data Provenance

• Correlation Study: 86 laboratory serum samples.
• Precision (Intra-assay): 7 samples or pools (N Lp(a) Control SY and 6 patient samples). Each sample/pool was tested 20 times (n=20).
• Precision (Inter-assay): 6 samples or pools (N Lp(a) Control SY and 5 patient samples). Each sample/pool was tested 10 times (n=10).

Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "laboratory serum samples" and "patient samples or pools," suggesting these are clinical samples. The study appears to be retrospective as it involves commercially available samples and comparisons with an existing device, rather than a prospectively designed clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of in-vitro diagnostic device (quantitative measurement of a biomarker) does not typically rely on "experts" to establish ground truth in the same way imaging or pathology devices do. The "ground truth" for the correlation study is the measurement obtained from the predicate device, the Beckman Coulter Array® System LPA assay. The ground truth for precision studies is the expected value of the control or pooled sample. Therefore, direct "expert" consensus on individual cases is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by the predicate device's measurements for correlation and by predefined values for controls/pools in precision studies. There is no need for human adjudication of results in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in-vitro diagnostic reagent designed for automated quantitative measurement on BN™ Systems. MRMC studies are typically performed for devices that involve human interpretation of medical images or other complex data.

6. Standalone Performance Study

Yes, the studies described (correlation and precision) demonstrate the standalone performance of the N Latex Lp(a) Reagent on the BN™ Systems without human-in-the-loop interpretation. The reported results are directly from the device's output.

7. Type of Ground Truth Used

• Correlation Study: The quantitative measurements of Lp(a) obtained from the legally marketed predicate device (Beckman Coulter Array® System LPA assay) were used as the reference or "ground truth" for comparison.
• Precision Studies: The known concentrations of control materials (N Lp(a) Control SY) and the mean values of patient pools served as the reference for evaluating repeatability and reproducibility.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" for the N Latex Lp(a) Reagent. In-vitro diagnostic assays based on immunonephelometry typically involve a development phase where reagents are optimized, and calibration curves are established using known standards and calibrators. This process doesn't usually involve a distinct "training set" in the machine learning sense. The "samples" referenced in the performance studies are test or validation samples, not explicit training data.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" in the context of machine learning is not described. For the development and calibration of such assays, ground truth for calibrators and controls would be established through:

• Assay standardization: Using primary reference materials or secondary standards traceable to reference organizations.
• ** gravimetric/volumetric methods:** For preparing known concentrations of analytes.
• Consensus values: For commercially available control materials established by the manufacturer through rigorous testing.

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