Search Results
Found 1 results
510(k) Data Aggregation
(75 days)
ABBOTT AXSYM B12
The AxSYM B12 reagent is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma on the AxSYM System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The AxSYM B12 Specimen Diluent is used for manually diluting specimens for testing using the AxSYM B12 assay.
The AxSYM B12 assay is a Microparticle Enzyme Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum or plasma. The AxSYM B12 assay is calibrated with Abbott B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
The Abbott AxSYM® B12 assay is intended for the quantitative determination of vitamin B12 in human serum or plasma. The study conducted to demonstrate its safety and effectiveness compared its performance against the Abbott ARCHITECT® B12 assay, as stated in the 510(k) summary (K051327).
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, or correlation coefficient. However, the performance is reported through a correlation analysis. Since the conclusion states that the device is "substantially equivalent" to the predicate, it implies that the reported performance values were deemed acceptable by the FDA for this determination.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (AxSYM B12 vs. ARCHITECT B12) |
|---|---|---|
| Correlation (r) | High (close to 1) | 0.98 |
| Slope (Least Squares) | Close to 1 | 1.09 |
| Intercept (Least Squares) | Close to 0 | 3.7 |
| Slope (Passing-Bablok) | Close to 1 | 1.12 |
| Intercept (Passing-Bablok) | Close to 0 | -13.9 |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: n = 441 specimens.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a quantitative diagnostic test, these are typically clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. For this type of in vitro diagnostic device, the "ground truth" is typically another established, legally marketed diagnostic assay (the predicate device, in this case, the Abbott ARCHITECT® B12 assay), not expert consensus from radiologists or similar medical specialists.
4. Adjudication method for the test set
Not applicable. The study involves a direct comparison of quantitative results between two assays, not the interpretation of results by multiple human readers that would require an adjudication method.
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 was not an MRMC study. This study evaluated the performance of an in vitro diagnostic device (a blood assay) against a predicate device, not the effectiveness of AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The study evaluated the performance of the AxSYM B12 assay (which operates independently of human interpretation of the results through an algorithm) against the ARCHITECT B12 assay. The "algorithm" here refers to the underlying chemical and analytical processes of the assay, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the performance study was established by the Abbott ARCHITECT® B12 assay, which is the legally marketed predicate device to which the AxSYM B12 assay was compared for substantial equivalence.
8. The sample size for the training set
This information is not applicable and not provided. Clinical diagnostic assays like the AxSYM B12 are developed and validated using a different process than machine learning algorithms, which typically involve distinct training and test sets. The calibration of the AxSYM B12 assay is done with Abbott B12 Calibrators, but this is not analogous to a machine learning training set sample size.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, this is not a machine learning study with a "training set" in the conventional sense. The assay is calibrated using specific Abbott B12 Calibrators, which are themselves traceable to a known standard for vitamin B12 concentration.
Ask a specific question about this device
Page 1 of 1