(33 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 BN™ Systems: IgG, IgG7, IgA, IgM, C3c, C4, Transferrin, in Innonophobionou y ma2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Albumin, c.y antill Jpon) @2 maor J.g/L-chain lambda & kappa, β2-microglobulin, soluble Transferrin Receptor (STFR), Ferritin, IgE, and Total protein; and by immunoturbidimetry with the TurbiTimeSystem: IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, α4acid glycoprotein.
N/T Protein Control SL is a liquid control prepared from human serum with sfabilizers and preservative. It is intended to be used as an accuracy and precision control for the presentation of human serum proteins by immunonephelometry with BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the N/T Protein Control SL device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability (unopened) | At least 14 days at +2° to +8° C, as originally packaged |
| Stability (opened) | At least 14 days at +2° to +8° C, once opened |
Note: The document primarily focuses on stability as the performance characteristic. It doesn't explicitly state quantitative acceptance limits for accuracy or precision, but rather implies they are met based on the "substantially equivalent" claim to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set. It mentions "Dade Behring protocols" for stability evaluation but gives no details about the number of samples or runs.
The data provenance is not specified in terms of country of origin. The study appears to be prospective in nature, as it describes evaluations performed to support the 510(k) submission for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The device is a quality control material and its performance evaluation for stability would not typically involve expert ground truth in the same way a diagnostic imaging device would. The "ground truth" here would be the measured analyte concentrations and their stability over time, determined by the instrument itself.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for this type of device and study. Adjudication methods are typically used to resolve discrepancies in expert interpretations (e.g., in clinical trials or diagnostic studies), which is not relevant for evaluating the stability of a control material.
5. 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The N/T Protein Control SL is a quality control material, not a diagnostic device requiring human reader interpretation or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study was not applicable/not done in the context of an algorithm. This device is a chemical control material for laboratory instruments, not an AI algorithm. Its "performance" refers to its chemical and physical stability and its ability to produce consistent results on specified analytical systems.
7. The Type of Ground Truth Used
For this device (a quality control material), the "ground truth" for the performance evaluation (stability) is established through instrument measurements of known analyte concentrations at different time points and under different conditions. The "accuracy" and "precision" mentioned in the intended use refer to the device's ability to verify the accuracy and precision of an analytical system using its known analyte values. The stability study aims to ensure these known values remain constant over time.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device is a control material, not an algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for this device, this question is not applicable.
§ 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.