(84 days)
The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assav is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
The measurement of transferrin in serum or other body fluids aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia.
The SYNCHRON LX Systems Transferrin (TRFN) Reagent in conjunction with SYNCHRON LX Calibrator 1, is intended for use on Beckman's SYNCHRON LX™20 Clinical Systems.
Here's a breakdown of the acceptance criteria and the study information for the SYNCHRON LX™ Systems Transferrin (TRFN) Reagent, as derived from the provided text:
Acceptance Criteria and Device Performance
The provided document describes the predicate device as the basis for substantial equivalence. Therefore, the acceptance criteria are implicitly based on demonstrating performance comparable to the predicate device, the Beckman Transferrin (TRFN) Reagent (K780913) on the ARRAY® Systems.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported SYNCHRON LX TRFN Reagent Performance |
|---|---|---|
| Method Comparison | Close agreement with predicate method (e.g., slope near 1, intercept near 0, high correlation) | Slope: 1.041 |
| Intercept: -20.7 mg/dL | ||
| r (Correlation Coefficient): 0.9844 | ||
| Shelf-Life Stability | Indefinite (based on predicate) or demonstrated over a reasonable period | 24 months |
| Calibration Stability | Indefinite (based on predicate) or demonstrated over a reasonable period | 14 days |
| On-Board Stability | Indefinite (based on predicate) or demonstrated over a reasonable period | 60 days |
| Within-Run Imprecision (Low Level) | Low Coefficient of Variation (CV%) | Mean: 135.7 mg/dL |
| S.D.: 2.00 mg/dL | ||
| %C.V.: 1.47 | ||
| Within-Run Imprecision (Mid Level) | Low Coefficient of Variation (CV%) | Mean: 218.6 mg/dL |
| S.D.: 2.95 mg/dL | ||
| %C.V.: 1.35 | ||
| Within-Run Imprecision (High Level) | Low Coefficient of Variation (CV%) | Mean: 303.5 mg/dL |
| S.D.: 4.08 mg/dL | ||
| %C.V.: 1.34 |
2. Sample Size and Data Provenance for Test Set:
- Sample Size (n) for Method Comparison: 80 samples were used for the method comparison study.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied to be clinical samples used for comparison.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
- Not Applicable. For a quantitative assay like this, the "ground truth" for the test set is established by the reference method (the predicate device, Beckman's TRFN Transferrin Reagent on the ARRAY® Systems) rather than expert consensus on interpretation. There is no mention of experts establishing a ground truth for individual samples.
4. Adjudication Method for Test Set:
- Not Applicable. Since the ground truth for this type of quantitative assay is based on chemical measurement by a reference method, there is no expert adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a quantitative in vitro diagnostic (IVD) assay designed to measure the concentration of transferrin in serum or plasma. MRMC studies are typically performed for imaging or qualitative diagnostic devices where human reader interpretation is a critical component. There is no human-in-the-loop performance involved in this specific device's operation or evaluation.
6. Standalone (Algorithm Only) Performance Study:
- Yes, implicitly. The method comparison, stability, and imprecision studies directly evaluate the performance of the SYNCHRON LX TRFN Reagent and the SYNCHRON LX™20 Clinical Systems without human interpretation influencing the measurement results. The results are quantitative values obtained directly from the automated system.
7. Type of Ground Truth Used (Test Set):
- Comparative Measurement (Predicate Device): The ground truth for the method comparison study was established by the measurements obtained from the Beckman's TRFN Transferrin Reagent on the ARRAY® Systems (K780913), which served as the predicate method. For stability and imprecision, the ground truth would be the known concentration of control materials or the inherent stability/repeatability of the assay itself.
8. Sample Size for Training Set:
- The document does not explicitly state a specific "training set" size. For IVD reagents, development often involves extensive internal testing and optimization (which can be considered analogous to training) using a variety of samples and conditions. However, the FDA submission focuses on the validation (test set) data.
9. How Ground Truth for Training Set was Established:
- As above, the document does not provide details on how ground truth was established for any "training" or development phase. For such an assay, the "ground truth" during development would typically involve:
- Reference materials/standards: Samples with known, accurately determined concentrations of transferrin.
- Established analytical methods: Using highly accurate and precise analytical techniques (e.g., gravimetric, spectrophotometric, or other validated methods) to determine the true values in samples used for optimization.
- Internal validation against existing, validated methods: Comparing results during development to other established and reliable methods for transferrin determination.
§ 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).