(77 days)
N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.
The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine.
In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Here's an analysis of the provided text regarding the acceptance criteria and study for the N Antiserum to Human Transferrin device:
Acceptance Criteria and Device Performance Study for N Antiserum to Human Transferrin
The document describes the performance characteristics of the N Antiserum to Human Transferrin, primarily focusing on correlation and precision studies for urine samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Correlation | Correlation Coefficient (r) | High (close to 1) | 0.99 |
| Y-intercept | Close to 0 | 0.53 | |
| Slope | Close to 1 | 1.01 | |
| Precision (Intra-assay) | %CV Range | Low percentage | 2.52 to 5.86 |
| Precision (Inter-assay) | %CV Range | Low percentage | 1.22 to 7.46 |
Note: The document does not explicitly state "acceptance criteria" values. The values listed under "Acceptance Criteria (Implicit)" are inferred from general expectations for good performance in comparative and precision studies for diagnostic assays.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 53 urine samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a German manufacturer, the samples could be from Germany or elsewhere, and the study design (retrospective vs. prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The concept of "experts" to establish ground truth in the context of this device (an immunoassay for transferrin) is not directly applicable in the same way as for image-based diagnostics. For this type of device, the "ground truth" or reference method is typically the comparator device, which itself is a validated assay. The study compares the new device's measurements against these reference measurements. There's no mention of a ground truth panel established by human experts in this document.
4. Adjudication Method for the Test Set
Not applicable. The study is a quantitative comparison between two laboratory assays, not requiring human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices where multiple human readers interpret cases. The N Antiserum to Human Transferrin is a laboratory reagent for an immunoassay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are standalone performance evaluations of the N Antiserum to Human Transferrin Reagent when used with Behring Nephelometer Systems. The performance (correlation and precision) is inherent to the reagent and instrument system, operating without direct human interpretation of individual results beyond running the assay and reading the quantitative output.
7. Type of Ground Truth Used
The "ground truth" for the comparative studies was established by measurements from the legally marketed predicate device, Beckman Transferrin (TRF) Reagent. For the precision studies, the ground truth is essentially the inherent variability of the assay itself under controlled conditions.
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. For an immunoassay, the development often involves method optimization and validation, but not typically a distinct "training set" in the machine learning sense. The provided data relates to performance testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a distinct training set (with associated ground truth establishment) is not described or implicitly suggested in the provided submission for this type of device.
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).