(29 days)
The N Lp(a) Control SY is an assayed control for accurancy and precision of the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.
N Lp(a) Control SY is a lyophilized control prepared from human serum with stabilizers and preservative. It is intended to be used as an accuracy and precision control for the determination of human lipoprotein(a) [Lp(a)] by immunochemical with BN™ Systems.
The provided text describes a medical device, the N Lp(a) Control SY, which is a quality control material. The performance characteristics section primarily focuses on stability rather than analytical performance metrics like sensitivity, specificity, or accuracy compared to a ground truth for a diagnostic device.
Therefore, the requested information elements (especially those pertaining to AI/algorithm performance, ground truth, expert adjudication, multi-reader studies, and sample sizes for test/training sets) are not applicable or cannot be extracted from this document, as it describes a control material, not a diagnostic algorithm.
Here's the relevant information that can be extracted:
Acceptance Criteria and Device Performance for N Lp(a) Control SY (Stability)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability for packaged product at +2° to +8° C | Stable for at least 24 months |
| Stability for reconstituted product at +2° to +8° C | Stable for at least 5 days |
Missing or Not Applicable Information (due to device type):
- Sample size used for the test set and the data provenance: Not applicable. This device is a control material, not a diagnostic device relying on a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for a control material's stability.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Ground truth adjudication for diagnostic performance is not relevant for a control material's stability.
- 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 device is a control material, not an AI-powered diagnostic tool requiring human-in-the-loop studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control material, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a control material relates to its assigned value and stability over time, which is determined by analytical methods and manufacturing specifications, not patient outcomes or expert consensus on clinical data.
- The sample size for the training set: Not applicable. This device is a control material, not an algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable. This device is a control material, not an algorithm that requires a training set.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.