(38 days)
The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry.
The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is used in the determination of transferrin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
Here's an analysis of the provided text regarding the IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent, structured according to your request:
Acceptance Criteria and Study Details for IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent
The provided document describes the performance of the IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent by comparing it to a predicate device, the Beckman Immunochemistry Systems TRF Transferrin Reagent (on ARRAY). The acceptance criteria are implicitly defined by the performance of the predicate device and the new device's ability to demonstrate substantial equivalence through various studies.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" but rather presents performance data and claims of substantial equivalence based on comparisons to a predicate device. The performance of the predicate device, for which the new device aims to be equivalent, serves as the de facto acceptance target.
| Performance Metric | Implicit Acceptance Criteria (based on predicate) | Reported Device Performance (IMMAGE TRF Reagent) |
|---|---|---|
| Assay Method | Rate nephelometry | Rate nephelometry |
| Analytic Range | 75 - 750 mg/dL | 75 - 750 mg/dL |
| Extended Range | 12.5 - 4,500 mg/dL | 12.5 - 4,500 mg/dL |
| Sample and Reagent Ratios | Same as predicate | Same as predicate |
| Antibody | Same as predicate | Same as predicate |
| Shelf Life | 24 months (stored at 2 - 8°C) | 24 months |
| Open Container Stability | (Not explicitly stated for predicate, but typical for such reagents) | 14 day |
| Calibration Stability | (Not explicitly stated for predicate) | 14 day |
| Method Comparison (vs. predicate) | Slope close to 1, Intercept close to 0, r close to 1 | Slope: 0.990, Intercept: 0.692, r: 0.994 |
| Within-Run Imprecision (TRF Reagent) | (Implied to be comparable or better than predicate, or within acceptable clinical limits) | Level 1: 3.1 %CV (Mean 241 mg/dL) |
| Level 2: 3.9 %CV (Mean 361 mg/dL) | ||
| Level 3: 2.9 %CV (Mean 653 mg/dL) |
Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" to the predicate device. Therefore, the "acceptance criteria" are largely met by showing comparable performance in the described studies. Specific numeric acceptance thresholds (e.g., maximum allowable %CV, r-value threshold) are not explicitly stated within this summary document, but are inherent to the regulatory process for demonstrating equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set (Method Comparison): Not explicitly stated. The "Method Comparison Study Results" table only provides the slope, intercept, and 'r' value, without detailing the number of individual samples or patients used to generate these statistics.
- Data Provenance: Not explicitly stated. The submitting company, Beckman Instruments, Inc., is based in Brea, California, USA, but this does not confirm the origin of the samples. The study type is not specified as retrospective or prospective, but method comparison studies are typically prospective analyses of current samples.
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)
This device is an in vitro diagnostic reagent for quantitative biochemical measurement. The "ground truth" for such devices is established by the performance of a reference or predicate method. Experts (like radiologists) are not typically involved in establishing ground truth for quantitative chemical assays.
- The ground truth for the comparison was the Beckman's TRF Transferrin Reagent on the ARRAY® Systems. The implicit "expert" is the established and validated performance of this predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading). This is a quantitative chemical assay; therefore, such adjudication methods are not applicable nor mentioned. The results are numerical values obtained from the instruments.
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
- No MRMC study was done. This is an in vitro diagnostic device, not an AI or imaging diagnostic tool that involves human readers/interpreters in the diagnostic process. Therefore, the concept of human reader improvement with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a standalone (algorithm only) in the sense that the IMMAGE system performs the assay and generates a quantitative result without human subjective interpretation of the assay itself. The "algorithm" here refers to the instrument's programming for rate nephelometry and calculation, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance evaluation was established by a predicate device: Beckman's TRF Transferrin Reagent on the ARRAY® Systems. This is a common form of "ground truth" or reference in establishing substantial equivalence for in vitro diagnostic devices in regulatory submissions.
8. The sample size for the training set
This document does not refer to a "training set" in the context of typical machine learning or AI development. For in vitro diagnostic reagent development, "development" or "validation" samples are used, but they are not termed "training sets" in the AI sense. The document does not specify the number of samples used during the development or initial validation phases (if separate from the comparison studies).
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the AI context, this question is not applicable. For chemistry reagents, development and validation involve testing against known concentrations and established methods, ensuring linearity, accuracy, and precision across the assay range using reference materials.
§ 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).