(135 days)
In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BN™ Systems. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction 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 the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Equivalence in measurement between serum and heparinized or EDTA plasma | Correlation coefficients between 0.96 and 0.98 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance. It only mentions that "method comparisons were performed."
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 an in vitro diagnostic reagent, and the assessment of its performance focuses on analytical equivalence rather than diagnostic interpretation requiring expert review of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The study involved method comparisons for analytical performance, not clinical adjudication.
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 an in vitro diagnostic reagent, not an AI-powered diagnostic system requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics described are for the standalone analytical performance of the N Antisera to Human Transferrin assay on the BN™ Systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance demonstration relies on established laboratory measurement methods for transferrin in different sample types (serum, heparinized plasma, EDTA plasma). The "ground truth" implicitly refers to the measurements obtained by these established methods, and the study aims to show equivalence between the modified assay and a legally marketed predicate device (K972840) using these established measurement principles.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device that typically employs training sets. The device is a diagnostic reagent.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set mentioned or implied 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).