(45 days)
The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized 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 TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of transferrin (TRNF) by its polyclonal antibody.
The Acceptance Criteria for the device, TRNF Flex® Reagent Cartridge, are based on demonstrating substantial equivalence to its predicate device, the Beckman Array® TRF method. The primary criterion used for this determination is a strong statistical correlation between the results obtained from both methods when testing clinical patient samples.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Substantial Equivalence | Correlation Coefficient (r) between TRNF Flex® and Predicate Device | Expected to be high, indicating strong agreement (e.g., >0.95) | 0.984 |
| Slope of regression line (TRNF Flex® vs. Predicate Device) | Expected to be close to 1.0, indicating proportional agreement | 0.90 | |
| Intercept of regression line (TRNF Flex® vs. Predicate Device) | Expected to be close to 0, indicating minimal constant bias | 7.9 mg/dL | |
| Clinical Sample Type | Ability to measure Transferrin in Human Serum and Heparinized Plasma | Must be able to use both sample types for intended use | Serum and plasma (Predicate device only specified Serum) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: 95 clinical patient samples.
- Data Provenance: The data is retrospective, as it involves a "split sample comparison" of historical clinical patient samples. The country of origin is not explicitly stated, but given the submission is to the FDA in the USA, it's highly likely to be U.S.-based or a region with similar clinical practices.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The study relies on a comparative method (split sample comparison) rather than subjective expert interpretation for establishing ground truth. The "ground truth" for this device is effectively the measurements produced by the legally marketed predicate device, which is assumed to be accurate and reliable.
4. Adjudication Method for the Test Set
None. The ground truth is established by the measurements from the predicate device. There is no mention of independent expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not applicable to an in vitro diagnostic device for quantitative measurement like the TRNF Flex® Reagent Cartridge. MRMC studies are typically used for imaging or diagnostic aids where human interpretation is a key component.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, in essence. The entire evaluation of the TRNF Flex® Reagent Cartridge is a standalone performance assessment. The device itself (the reagent and the Dimension® clinical chemistry system) provides a quantitative measurement, and its performance is compared directly to another quantitative device (the predicate device). There is no "human-in-the-loop" interaction in the measurement process being tested.
7. Type of Ground Truth Used
The ground truth used is the measurements obtained from a legally marketed predicate device (Beckman Array® TRF method). This falls under a form of "established method comparison" or "reference method comparison."
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its size. The 95 clinical patient samples appear to be the primary dataset used for the performance evaluation and comparison to the predicate device. For quantitative assays like this, method development and calibration would typically involve a different process than the "training set" concept used in machine learning for image analysis, for instance.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" as commonly understood in AI/ML contexts is not mentioned, the method for establishing its ground truth is not applicable/not provided. The "ground truth" for the performance evaluation was established by running the same 95 clinical patient samples on the predicate 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).