(57 days)
N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.
N Protein Standard UY (lyophilized) is a standard prepared from human urinary proteins with polygeline and preservative. It is intended to establish reference curves for the quantitative determination of a - microglobulin by immunonephelometry with the Behring Nephelometer Systems (particle enhanced nephelometry).
The provided text is a 510(k) summary for the N Protein Standard UY, a calibrator used for in-vitro diagnostic tests. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies or acceptance criteria in the manner that a specific diagnostic algorithm or device might. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability (Original Packaging) | Stable for at least 12 months at +2° to +8° C |
| Stability (Once Opened) | Stable for at least 14 days at +2° to +8° C |
| Intended Use Equivalence | Acknowledged as substantially equivalent to Protein Standard Urine Concentrate (K904254) for establishing reference curves for immunonephelometric determinations of α-microglobulin in urine using Behring Nephelometer Systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document states "Stability was evaluated according to in-house protocols," but does not detail the number of samples or test runs.
- Data Provenance: Not specified. The manufacturer is Dade Behring Marburg GmbH, Germany, which suggests the study data might originate from Germany, but this is not explicitly stated. The study appears to be internal to the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a calibrator, and its performance evaluation relates to its inherent stability and ability to function as a reference standard, not to diagnostic accuracy based on expert interpretation of biological samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As a calibrator, there is no expert adjudication process for its performance criteria in the way there would be for a diagnostic tool interpreting patient data.
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
- Not Applicable. This is not an AI-assisted diagnostic device or a device involving human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a calibrator, not an algorithm. Its performance is evaluated independently as a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Internal Lab Standards/Reference Methods: For stability, the "ground truth" would be the expected concentrations/performance of the standard over time, tested against established laboratory methods and controls. The substantial equivalence claim is based on comparison to a legally marketed predicate device (Protein Standard Urine Concentrate).
8. The sample size for the training set
- Not Applicable. This device is not an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This device is not an algorithm requiring a training set.
§ 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.