(42 days)
N Protein Standard SL is intended to be used for the establishment of reference curves.
The proposed standard, N Protein Standard SL is a standard 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) to establish reference curves for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Albumin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, IgG 3, Albumin α1-antitrypsin (α1-proteinase inhibitor) α2-macroglobulin Haptoglobin α1-acid glycoprotein Pre-albumin (transthyretin), laG 3, laG 4, B2-microalobulin, Ferritin, IGE.
Here's the information extracted from the provided text, structured according to your request:
Acceptance Criteria and Study for N Protein Standard SL
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and discussing performance characteristics such as precision and stability, rather than explicitly stating acceptance criteria as a table with numerical targets for a specific clinical outcome or diagnostic accuracy. Instead, the document describes the observed performance of the device, which implicitly serves as the demonstration of its suitability.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | The device should exhibit acceptable levels of precision (low variability) when establishing reference curves for the listed analytes on Behring Nephelometer Systems. (Implicitly, the precision should be comparable to or better than the predicate device, N Protein Standard SY, or within acceptable ranges for clinical nephelometry.) | Precision studies using one lot of N Protein Standard SL on the Behring Nephelometer yielded %CVs ranging from 0.9% to 3.9%. |
| Reproducibility | The device should exhibit acceptable reproducibility when establishing reference curves. (Implicitly, this is covered by the precision study and suggests consistent performance across repetitions.) | Covered by the precision study results (0.9% to 3.9% CVs). |
| Stability (Unopened) | The device should maintain its performance characteristics for a clinically relevant period when stored as packaged. (Implicitly, comparable to the predicate device and sufficient for practical use.) | Found to be stable for at least 12 months at +2 to +8°C, as originally packaged. |
| Stability (Opened) | The device should maintain its performance characteristics for a clinically relevant period after opening and storage. (Implicitly, sufficient for practical laboratory use after initial opening.) | Found to be stable for at least 15 days at +2 to +8°C, once opened. |
| Equivalence to Predicate | The device should demonstrate substantial equivalence in intended use and performance to the legally marketed device, N Protein Standard SY. (This is the overarching acceptance criterion for a 510(k).) | N Protein Standard SL is "substantially equivalent in intended use to the N Protein Standard SY." Both are multi-constituent, blood-based matrix standards for calibrating immunology assays. The primary difference is physical state (liquid vs. lyophilized). Performance characteristics (precision, stability) support this claim of equivalence. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states "Precision studies using one lot of N Protein Standard SL..." This indicates the study was conducted on one lot of the product. The number of individual measurements or replicates within that study is not specified.
- Data Provenance: The study appears to be prospective (generated specifically for this submission) as it describes performance characteristics of the "Proposed Device." There is no mention of country of origin for the data, but it's generated by Behring Diagnostics Inc. (distributed) and Behringwerke AG (manufactured), which are US and German entities, respectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is Not Applicable (N/A). The device is a calibrator, not a diagnostic device that interprets patient data. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy. The performance data (precision, stability) are objective measurements from laboratory testing, not subjective expert interpretations.
4. Adjudication method for the test set
This section is Not Applicable (N/A) for the same reasons as (3). There is no adjudication required for objective laboratory measurements like precision and stability.
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
This section is Not Applicable (N/A). The device is a calibrator. It is not an AI-powered diagnostic tool, nor does it directly involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). The device is a physical calibrator standard, not an algorithm.
7. The type of ground truth used
This section is Not Applicable (N/A). As a calibrator, the concept of "ground truth" in the diagnostic accuracy sense (e.g., pathology, outcomes data) does not apply. The "truth" for the calibrator is its manufactured concentration values, which are the basis for its intended use in establishing reference curves. The performance metrics (precision, stability) assess the consistency and integrity of these established values over time and repeated use.
8. The sample size for the training set
This section is Not Applicable (N/A). The device is a calibrator, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is Not Applicable (N/A) for the same reasons as (8).
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.