(8 days)
Abbott AxSYM® Folate is an Ion Capture Assay intended to measure the vitamin folic acid in serum, plasma, and red blood cells. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma, or red blood cells. AxSYM Folate is calibrated with Abbott Folate calibrators. Abbott Folate controls are assayed for the verification of the accuracy and precision of the AxSYM System.
Here's a breakdown of the acceptance criteria and the study details for the Abbott AxSYM® Folate device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria are established by demonstrating substantial equivalence to the IMx® Folate assay, a legally marketed predicate device. The primary performance metric is the correlation between the new AxSYM Folate assay and the predicate IMx Folate assay.
| Acceptance Criteria (Substantial Equivalence to IMx Folate) | Reported Device Performance (AxSYM Folate vs. IMx Folate) |
|---|---|
| Correlation Coefficient (r) | |
| Serum: Close to 1.0 | Serum: 0.979 |
| Red Blood Cells: Close to 1.0 | Red Blood Cells: 0.906 |
| Slope | |
| Serum: Close to 1.0 | Serum: 0.991 |
| Red Blood Cells: Close to 1.0 | Red Blood Cells: 0.885 |
| Y-Intercept (ng/mL) | |
| Serum: Close to 0.0 | Serum: 0.5 |
| Red Blood Cells: Close to 0.0 (but value is higher) | Red Blood Cells: 39.7 |
| Standard Error of Y Estimate | |
| Serum: Low value, indicating good fit | Serum: 0.864 |
| Red Blood Cells: Low value, indicating good fit | Red Blood Cells: 43.290 |
| Intended Use | Quantitative determination of folate in human serum, plasma, or red blood cells. |
| Dynamic Range | Comparable to IMx Folate (0.82 to 20 ng/mL) |
Note on "Acceptance Criteria" for Slope, Y-Intercept, and Standard Error: While not explicitly stated as numerical targets in the text, for substantial equivalence, the expectation is that these values demonstrate a strong agreement and linearity between the new device and the predicate. The "reported device performance" are the values obtained and presented as sufficient for substantial equivalence.
Study Details
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Sample size used for the test set and the data provenance:
- Serum: 261 samples
- Red Blood Cells: 145 samples
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study evaluates the performance of a diagnostic assay against a predicate assay, not against a "ground truth" established by human experts in the traditional sense (like image interpretations). The predicate device (IMx Folate) itself serves as the reference standard for comparison.
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Adjudication method for the test set:
- Not applicable. This is a comparison of quantitative measurements from two different lab assays, not a subjective interpretation requiring adjudication.
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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:
- Not applicable. This is a study comparing an automated diagnostic assay to a predicate assay, not involving human readers or AI assistance in interpretation.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, this is a standalone study. The AxSYM Folate assay is an automated in vitro diagnostic (IVD) device, and its performance is evaluated directly against another automated IVD device (IMx Folate). There is no "human-in-the-loop" aspect to the measurement or its comparison.
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The type of ground truth used:
- The "ground truth" in this context is the results obtained from the predicate device, the IMx® Folate assay. Substantial equivalence is demonstrated by the agreement of results between the new device and the predicate. The IMx Folate assay itself is presumed to be a validated and legally marketed method for folate determination.
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The sample size for the training set:
- Not specified. This document only describes the performance study comparing the AxSYM Folate assay to the predicate IMx Folate assay. Information regarding the development and internal validation (which might involve training sets for the assay's calibration or internal algorithms) is not provided.
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How the ground truth for the training set was established:
- Not specified, as information on a distinct "training set" and its ground truth establishment is not included in this summary. The "calibration" of AxSYM Folate is mentioned as being performed with "Abbott Folate calibrators," implying internal standards are used during the device's operational setup.
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.