(37 days)
N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins α--microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.
N/T Protein Control LC is a lyophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.
Here's an analysis of the provided text regarding the acceptance criteria and study for the N/T Protein Control LC device:
Important Note: The provided document is a 510(k) summary for a quality control material, not a diagnostic device that performs interpretations on patient data. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML diagnostic tools (like sensitivity, specificity, human reader performance, expert consensus, etc.) are not applicable to this type of device. The primary performance characteristic for a control material is its stability and its ability to provide known, consistent values for assay accuracy.
Acceptance Criteria and Device Performance for N/T Protein Control LC
Given that this is a quality control material, the primary "acceptance criteria" revolve around its stability and its ability to consistently produce expected values within a defined range when used with the specified systems. The document explicitly mentions stability.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Stability (Unopened) | Stable for at least 24 months at +2° to +8° C, as originally packaged. |
| Stability (Reconstituted) | Stable for at least 14 days at +2° to +8° C, once reconstituted. |
| Intended Use | As an assayed accuracy control for immunonephelometric and immunoturbidimetric determination of specific proteins (α1-microglobulin, IgA, IgG, transferrin, albumin, total protein) in urine and CSF using Behring Nephelometer Systems and TurbiTimeSystem. |
| Equivalence to Predicate | Substantially equivalent in intended use to N/T Protein Control UY (K955858). Both are lyophilized, multi-analyte controls with known concentrations of specific proteins. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of patient samples or a dataset for diagnostic performance. For a quality control material, the "test set" would typically refer to the batches of the control material manufactured and tested. The document only mentions "in-house protocols" for stability evaluation. No specific number of control vials or batches tested is provided.
- Data Provenance: Not applicable in the traditional sense for a diagnostic device. The stability data would be generated internally by the manufacturer (Dade Behring Marburg GmbH) through laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This device is a quality control material, not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment based on clinical cases. Its "ground truth" (i.e., the expected concentration of an analyte) is established during its manufacturing and assaying process, typically against certified reference materials or established calibration methods.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a quality control material, there is no "adjudication" in the sense of resolving discrepancies in expert interpretations of patient data. The evaluation of its performance (e.g., stability) would be based on predefined analytical criteria and instrumental measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No. An MRMC comparative effectiveness study is not relevant for a quality control material. Such studies are designed to assess the impact of a diagnostic aid (like AI) on human reader performance, which doesn't apply here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- No. This is not an algorithm-driven device. It is a consumable laboratory reagent.
7. The Type of Ground Truth Used
- For a quality control material, the "ground truth" for the analyte concentrations in the control is established through analytical assaying using standardized methods and traceable calibrators. The product is "assayed" which means the manufacturer defines the expected ranges for the target proteins based on their internal testing and calibration. It is implied to be based on established analytical chemistry principles and potentially certified reference materials or primary standards for the relevant proteins.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of machine learning or AI for this product. The manufacturing process of a control material involves formulation, lyophilization, and subsequent quality control steps; it doesn't involve training an algorithm on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the control values themselves is established through the manufacturing and assaying process against established analytical standards.
§ 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.