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510(k) Data Aggregation
(42 days)
The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The ARCHITECT Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma (lithium heparin or tripotassium EDTA). The ARCHITECT Ferritin assay is calibrated with Abbott ARCHITECT Ferritin Calibrators. Abbott Ferritin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
Here's the breakdown of the acceptance criteria and study details for the Abbott ARCHITECT™ Ferritin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation Coefficient (Least Squares) | 0.986 (against AxSYM® Ferritin) |
| Slope (Least Squares) | 1.18 (95% CI of 1.17 to 1.20) |
| Intercept (Least Squares) | -3.65 ng/mL (95% CI of -14.53 to 7.24) |
| Correlation Coefficient (Passing-Bablok) | 0.986 (against AxSYM® Ferritin) |
| Slope (Passing-Bablok) | 1.17 (95% CI of 1.16 to 1.19) |
| Intercept (Passing-Bablok) | -1.89 ng/mL (95% CI of -2.64 to -1.23) |
| Quantitative Range Tested | 1 to 2000 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 518 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The text only mentions "human serum and plasma."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. The study is a method comparison study comparing the performance of a new device (ARCHITECT Ferritin) against a legally marketed predicate device (AxSYM® Ferritin), not a study establishing ground truth based on expert review.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a method comparison study, there is no adjudication process involving human experts to establish a "ground truth" for each case. The comparison is directly between the measurements of the two devices.
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. This is not an MRMC study. The device is an in vitro diagnostic assay, not an imaging or diagnostic AI tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes. This study primarily evaluates the standalone performance of the ARCHITECT Ferritin assay by comparing its quantitative measurements directly against those obtained from the predicate AxSYM® Ferritin assay. There is no human-in-the-loop component described for the measurement process itself.
7. The Type of Ground Truth Used:
- The "ground truth" in this context is the measurements provided by the legally marketed predicate device, AxSYM® Ferritin assay. This is a common approach for demonstrating substantial equivalence for assays, where a new device's performance is shown to be comparable to an already approved device.
8. The Sample Size for the Training Set:
- Not Applicable. This is a method comparison study for an in vitro diagnostic assay, not a machine learning model that requires a training set. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. (As per point 8).
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