(143 days)
The FERR Flex™ reagent cartridge is used on the Dimension™ RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma.
The FERR Flex™ Reagent Cartridge is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for ferritin and conjugate reagent consisting of B-galactosidase labeled monoclonal antibodies specific for a second binding site on ferritin to form a particle-ferritin-conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound Bgalactosidase is combined with a chromogenic substrate chlorophenl red-b-dgalactopyranoside (CPRG). Hydrolvsis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of ferritin in the original sample.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
Summary of Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | (Not explicitly stated, but typically >0.95 for good agreement) | 0.983 |
| Slope | (Not explicitly stated, but typically close to 1) | 0.98 |
| Intercept | (Not explicitly stated, but typically close to 0) | -0.8 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 60 clinical patient samples
- Data Provenance: The text states "clinical patient samples," implying human samples, but the country of origin is not specified. The study is retrospective, as it compares the new device with an existing predicate device using collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided in the text. The ground truth appears to be established by comparison to a predicate device, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
- None directly mentioned in the context of expert review. The "adjudication" is essentially the statistical comparison (correlation, slope, intercept) between the new device and the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study is not relevant for this device, which is an in-vitro diagnostic (IVD) measurement system, not an imaging or diagnostic aid for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes. The study evaluates the performance of the "Ferritin Flex™ Reagent Cartridge" on the "Dimension™ RxL clinical chemistry system" in a standalone manner by comparing its output to a predicate device. There is no human intervention in generating the measurement results from either device once the sample is loaded.
7. The Type of Ground Truth Used
- The ground truth (or reference standard) is the measurement obtained from the Abbott Laboratories IMx® Ferritin assay, which is the predicate device.
8. The Sample Size for the Training Set
- This information is not provided in the text. As this is an immunoassay reagent cartridge, there might not be a "training set" in the machine learning sense. The device developers would have characterized the reagent performance during R&D, but the text does not detail those internal studies.
9. How the Ground Truth for the Training Set was Established
- This information is not provided in the text. Similar to point 8, the concept of a "training set" ground truth isn't applicable in the same way as for AI/ML algorithms. The predicate device's performance would have been established through its own validation studies.
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).