(55 days)
Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. 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 and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Anti-transferrin antibodies react with the antigen in the sample to form an antigen/antibody complex. Following agglutination, this is measured turbidimetrically. Addition of PEG allows the reaction to progress rapidly to the end point and increases sensitivity.
This is a submission for a medical device (specifically, an in-vitro diagnostic assay) rather than a software-as-a-medical-device (SaMD) or AI/ML device. Therefore, many of the requested elements (like "experts used to establish ground truth," "adjudication method," "MRMC study," and "training set") are not applicable in the context of this traditional assay. The performance is evaluated through analytical studies, not clinical studies involving human interpretation of AI outputs.
Here's the information that can be extracted from the provided text, adapted for an in-vitro diagnostic assay:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalent or improved performance characteristics compared to the predicate device.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Transferrin ver.2) |
|---|---|---|
| Intended Use | Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. | Equivalent: Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. |
| Indication for Use | Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. | Equivalent: Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. |
| Measuring Range (Roche/Hitachi 704/902) | 80 - 500 mg/dl | Improved: 0.02 - 5.00 g/l (1 - 500 mg/dl) |
| Measuring Range (Roche/Hitachi 717/747) | 80 - 500 mg/dl (Extended with rerun: 80 - 1000 mg/dl) | Improved: 0.02 - 5.00 g/l (1 - 500 mg/dl) (Extended with rerun: 0.02 - 7.50 g/l (1-750 mg/dl)). Note: The ver.2 device states "Maximum reportable range is dependent on the highest standard concentration" for the extended range, which is similar wording to the predicate, but the values are lower and potentially offer wider usability. |
| Measuring Range (Roche/Hitachi 904/911/912/917/Modular P) | 15 - 500 mg/dl | Improved: 0.007 - 5.20 g/l (0.7 - 520 mg/dl) (Extended with rerun: 0.007 - 7.80 g/l (0.7 - 780 mg/dl)). Note: The ver.2 device states "Maximum reportable range is dependent on the highest standard concentration" for the extended range, which is similar wording to the predicate, but the values are lower and potentially offer wider usability. |
| Intra-assay precision (% CV) - Human Sera | 0.8% at 169 mg/dl | Comparable/Improved: 1.0% at 1.36 g/l (136 mg/dl), 2.7% at 3.59 g/l (359 mg/dl). Precision is concentration-dependent; the values are generally comparable across similar concentrations but the ver.2 provides more data points. |
| Intra-assay precision (% CV) - Controls | 0.8% at 217 mg/dl, 0.8% at 403 mg/dl | Comparable/Improved: 2.1% at 2.90 g/l (290 mg/dl), 1.0% at 4.31 g/l (431 mg/dl). Similar for controls, concentration-dependent, providing comparable performance across ranges. |
| Between Day Precision (% CV) - Human Sera | 3.0% at 169 mg/dl | Improved: 0.0% at 1.60 g/l (160 mg/dl), 1.4% at 3.38 g/l (338 mg/dl). Shows better or comparable between-day precision at different concentrations to the predicate. |
| Between Day Precision (% CV) - Controls | 1.4% at 217 mg/dl, 1.5% at 403 mg/dl | Comparable/Improved: 1.7% at 2.88 g/l (288 mg/dl), 1.4% at 4.35 g/l (435 mg/dl). Similar between-day precision for controls. |
| Icterus Interference | No significant interference from bilirubin up to an I index of 60 | Equivalent: No significant interference with up to an I index of 60 |
| Hemolysis Interference | No significant interference from hemoglobin up to an H index of 1000 | Equivalent: No significant interference up to an H index of 1000 |
| Lipemia Interference | No significant interference from lipemia up to an L index of 600 | Comparable: No significant interference up to an L index of 500 (slight reduction compared to predicate's L index of 600) |
| Rheumatoid Factors Interference |
§ 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).