(166 days)
The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Unine Protein Calibrator, is intended for the quantitative determination of transferin in urine by rate nephelometry.
The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of transferrin in human urine samples.
Analysis of IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent
This document describes the performance of the IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent, a device intended for the quantitative determination of transferrin in human urine samples. The submission focuses on demonstrating substantial equivalence to a predicate device, the Beckman Transferrin Kit (Urine application) K926272.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" with numerical thresholds for all performance metrics. Instead, it presents performance data and implies acceptance based on substantial equivalence to the predicate device. For the purpose of this analysis, we will infer the acceptance criteria from the context of demonstrating equivalence and the reported values themselves.
| Performance Metric | Implied Acceptance Criteria (Based on Equivalence) | Reported Device Performance (IMMAGE TRU Reagent) |
|---|---|---|
| Method Comparison | Demonstrated correlation and agreement with the predicate Beckman Transferrin Kit Reagent. (Specific correlation coefficients or bias not explicitly stated as criteria, but implied to be acceptable for equivalence). | Not explicitly quantified in this section; states "Equivalence is demonstrated through method comparison... that relate results obtained from the Beckman Transferrin Kit Reagent to the IMMAGE TRU Reagent." |
| Shelf-life Stability | Maintain performance specifications for claimed shelf-life. | 24 month shelf-life |
| Open Container Stability | Maintain performance specifications for claimed open container stability. | 14 day open container stability |
| Calibration Stability | Maintain performance specifications for claimed calibration stability. | 14 day calibration stability |
| Within-Run Imprecision (Level 1) | Low Coefficient of Variation (CV) | Mean: 0.38 mg/dL; SD: 0.010 mg/dL; %CV: 2.7% (N=80) |
| Within-Run Imprecision (Level 2) | Low Coefficient of Variation (CV) | Mean: 1.55 mg/dL; SD: 0.041 mg/dL; %CV: 2.6% (N=80) |
| Within-Run Imprecision (Level 3) | Low Coefficient of Variation (CV) | Mean: 3.02 mg/dL; SD: 0.077 mg/dL; %CV: 2.6% (N=80) |
Note on Method Comparison: The document states "Equivalence is demonstrated through method comparison," but does not provide specific data such as correlation coefficients (e.g., R-squared), slope, intercept, or bias information for the method comparison study in the provided text. This information would typically be present in a full submission to quantitatively demonstrate equivalence. The fragmented table under "Method Comparison Study Results" is unreadable and does not provide useful data.
2. Sample Size for the Test Set and Data Provenance
- Method Comparison Study: The sample size for the method comparison study is not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.
- Imprecision Study: The sample size for the imprecision study is 80 results for each of the three levels tested. The data provenance is not provided. It is typically conducted as a prospective study in a controlled laboratory setting.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
This device is an in vitro diagnostic (IVD) for quantitative determination of a biomarker, not an imaging or diagnostic AI device that requires expert interpretation for defining "ground truth." Therefore, the concept of "experts" establishing a disease diagnosis or image annotation ground truth is not applicable to this type of device.
For IVDs:
- The "ground truth" for method comparison is the result obtained from the predicate device (Beckman Transferrin Kit Reagent).
- The "ground truth" for imprecision and stability studies is the expected value or the reference method value for control materials.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (e.g., 2+1, 3+1) is typically associated with studies where multiple human readers independently interpret data (e.g., medical images) and their disagreements need to be resolved to establish a consensus ground truth.
Since this is an IVD device for quantitative measurement, and not an interpretative AI system, no adjudication method as described is applicable or mentioned. The performance is assessed against instrumental measurements and established reference methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation to assess if the AI improves human performance. As the IMMAGE TRU Reagent is a standalone IVD for quantitative measurement, it is not designed to assist human readers in an interpretative task, and therefore, an MRMC study is not applicable.
6. Standalone Performance Study
Yes, a standalone performance study was done for the IMMAGE TRU Reagent. The summaries of performance data (method comparison, stability, and imprecision experiments) represent the performance of the IMMAGE TRU Reagent itself (algorithm only, in the context of an automated analyzer) without a human-in-the-loop for result generation. The device is designed to provide quantitative results directly.
7. Type of Ground Truth Used
- Method Comparison: The ground truth for the method comparison study was established by the predicate device, the Beckman Transferrin Kit (Urine application). Results from the IMMAGE TRU Reagent were compared to those obtained from the predicate to demonstrate substantial equivalence.
- Stability and Imprecision: The ground truth for these studies would typically involve the use of certified reference materials or quality control materials with known target values. The reported mean values (e.g., 0.38 mg/dL, 1.55 mg/dL, 3.02 mg/dL) for the imprecision study represent the measured concentration in these materials.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable in the context of this traditional immunochemistry reagent. This device is not an AI/machine learning algorithm that requires a training set to "learn" patterns or parameters. Its performance is based on the chemical and immunological principles of rate nephelometry and the characteristics of the reagents.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no training set for this type of device. Thus, the method for establishing its ground truth is not applicable. The device's operational parameters and performance characteristics are determined by its design, manufacturing processes, and validation against a predicate device and established analytical standards.
§ 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).