(42 days)
N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, IgGirl IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, α2-macroglobulin, Haptoglobin, a - acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, β>-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, lgE; and, by immunoturbidmetry with the TurbiTimeSystem: (gG, IgGj1, IggA, controls con also be has be haptoglobin, a ;- acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.
N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.
The provided document describes the N/T Protein Control SL, a liquid control prepared from human serum for use as an accuracy and precision control for human serum proteins. The only performance characteristic mentioned and evaluated in this document is Stability.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability | At least 12 months at +2° to +8° C (unopened) |
| Stability | At least 14 days at +2° to +8° C (once opened) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Stability was evaluated according to in-house protocols".
- Sample Size: Not explicitly stated.
- Data Provenance: The study was conducted in-house by Dade Behring. It is a retrospective evaluation of the control's stability under specified conditions. The country of origin of the data is Germany (Dade Behring Marburg GmbH) and/or USA (Dade Behring Inc.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for stability testing of a control material typically involves analytical measurements and comparison to defined specifications, not expert consensus in the traditional sense.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or clinical cases to establish ground truth, which is not relevant for this type of chemical stability testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is a quality control material for laboratory assays, not a diagnostic imaging device that would typically involve human readers.
6. Standalone Performance Study
- Standalone Study Done: Yes. The stability evaluation is inherently a standalone assessment of the control material's performance over time, independent of human intervention beyond the initial testing and storage conditions.
7. Type of Ground Truth Used
- Type of Ground Truth: Analytical measurements (e.g., immunonephelometry, immunoturbidimetry) against predefined specifications for the various proteins, monitored over time. The "ground truth" for stability is maintaining the established concentration/activity levels within acceptable limits over the specified period.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a quality control material intended for use in an assay, not an algorithm that requires a training set in the machine learning sense. The "development" of the control material would involve formulation refinement and extensive analytical testing, but not a "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set in the AI/ML context. The formulation and initial characterization of the control material (its 'ground truth' values for protein concentrations) would be established through a rigorous process of assaying the prepared material against traceable reference materials or highly characterized methods.
§ 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.