(27 days)
N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.
The proposed control, N/T Protein Control SL is a control prepared from human serum (liquid) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, Albumin, alpha1-antitrypsin (alpha1-proteinase inhibitor), 02-macroglobulin, Haptoglobin, alpha1-acid_αλνcoprotein, Pre-albumin (transthyretin), laG 3, laG 4, B2-microglobulin, Ferritin, laE.
This is a 510(k) summary for a quality control material, not a diagnostic device that detects disease. Therefore, many of the typical performance metrics for diagnostic devices (like sensitivity, specificity, AUC) and associated study design elements (like ground truth establishment with experts, training/test sets, MRMC studies) are not applicable here.
The "acceptance criteria" for a control material primarily revolve around its stability and its performance in precision/reproducibility.
Here's an analysis based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Them: N/T Protein Control SL/L, M, and H
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied/Expected for a QC Material) | Reported Device Performance (N/T Protein Control SL) |
|---|---|---|
| Precision (CV%) | Acceptable range for quality control materials for nephelometry systems (typically low single-digit percentages, though specific limits are not stated in the document). | Behring Nephelometer system: 0.6% to 8.2% (range across analytes) |
| TurbiTimeSystem™: 1.6% to 6.1% (range across analytes) | ||
| Reproducibility | Consistent results over time and across different runs (implied by precision study). | Demonstrated by precision study performed on two different systems. |
| Stability (Unopened) | Stable for a specified duration when stored as originally packaged under recommended conditions. | At least 12 months at +2 to +8°C. |
| Stability (Opened) | Stable for a specified duration once opened and stored under recommended conditions. | At least 15 days at +2 to +8°C once opened. |
Note: The document does not explicitly state numerical "acceptance criteria" but presents performance data that would implicitly meet expected standards for a quality control material. For instance, precision (CV%) values in the single digits are generally considered good for these types of assays.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "one lot of N/T Protein Control SL" was used for precision studies. The number of replicates or individual measurements within this lot is not provided.
- Data Provenance: Not specified, but implied to be from internal laboratory testing conducted by Behringwerke AG or Behring Diagnostics Inc. It is retrospective in the sense that the data was collected prior to submission. Country of origin not explicitly stated, but the manufacturer is based in Germany, and the distributor in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. For a quality control material, there isn't a "ground truth" established by experts in the same way there would be for a diagnostic test (e.g., radiologists interpreting images). The purpose is to ensure the control itself provides consistent and reproducible results on the target instruments.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is typically used when human interpretation or a subjective clinical assessment is involved in establishing a ground truth for diagnostic accuracy, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is designed to compare the performance of human readers, often with and without AI assistance, on a set of cases. This is not relevant for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable in the typical sense of a diagnostic algorithm. The "device" is a physical control material. Its performance is evaluated on automated nephelometry systems (which are themselves algorithms/instruments). The precision and stability studies represent the "standalone" performance of the control material when used with these systems.
7. The Type of Ground Truth Used
- For the precision studies, the "ground truth" is essentially the expected consistent performance of a stable control material. The acceptable variation (precision) defines what constitutes "truth" in this context. The reference values for the analytes within the control are established during its manufacturing and characterization, but the study here focuses on its performance as a control.
- For the stability studies, the "ground truth" is the established concentration of the analytes within the control material at the initial time point. Stability is demonstrated by showing that these concentrations remain within acceptable limits over time under specified storage conditions.
8. The Sample Size for the Training Set
- Not applicable. This is a quality control material, not an AI or machine learning algorithm that requires a "training set." The product is manufactured and then its performance (precision, stability) is characterized.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm.
§ 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.