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510(k) Data Aggregation
(78 days)
ABBOTT ARCHITECT B12
The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
Here's an analysis of the acceptance criteria and the study used to demonstrate substantial equivalence for the Abbott ARCHITECT™ B12 assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Abbott ARCHITECT™ B12 assay are implicitly derived from demonstrating substantial equivalence to a legally marketed predicate device, the AxSYM® B12 Assay. Substantial equivalence is shown through a statistical comparison of results from both assays.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (ARCHITECT B12 vs. AxSYM B12) |
|---|---|
| Least Squares Linear Regression: | |
| Correlation Coefficient (r) should be strong (e.g., typically > 0.9) | 0.956 |
| Slope should be close to 1 (indicating proportional agreement) | 0.96 (95% CI of 0.93 to 0.98) |
| Intercept should be close to 0 (indicating minimal systematic bias) | -27 pg/mL (95% CI of -42 to -12) |
| Passing-Bablok Linear Regression: | |
| Correlation Coefficient (r) should be strong (e.g., typically > 0.9) | 0.956 |
| Slope should be close to 1 (indicating proportional agreement) | 0.91 (95% CI of 0.89 to 0.93) |
| Intercept should be close to 0 (indicating minimal systematic bias) | -7 pg/mL (95% CI of -18 to 2) |
| Quantitative determination of vitamin B12 in human serum and plasma over the specified range | Demonstrated over the range of 60 to 2000 pg/mL, yielding the statistical results above. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 544 serum specimens.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study used "serum specimens," which implies human samples. The study appears to be retrospective in nature, as it's a comparison of an existing assay (AxSYM B12) with a new assay (ARCHITECT B12) using a collected set of samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in-vitro diagnostic (IVD) assay comparison study does not typically involve human experts establishing "ground truth" in the same way as, for example, an imaging study. The "ground truth" here is the measurement obtained from the predicate device (AxSYM B12 Assay), which is already an FDA-cleared and accepted method for quantitative determination of B12. Therefore, no human experts were used to establish ground truth for this test set; rather, the predicate device served as the reference.
4. Adjudication Method for the Test Set
Not applicable. As described above, the comparison is directly between two quantitative assays, with the predicate assay serving as the reference. There's no need for human adjudication of results in this context.
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
Not applicable. This is an in-vitro diagnostic device (an assay for vitamin B12), not an imaging or interpretive AI device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is essentially a standalone performance evaluation of the ARCHITECT B12 assay. It directly compares the results generated by the new assay (which operates without human interpretation of the final B12 value) to an established predicate assay. The human component is limited to collecting the samples and running them on both automated systems.
7. The Type of Ground Truth Used
The ground truth used is the measurements obtained from a legally marketed predicate device, the AxSYM® B12 Assay. This is a form of reference standard comparison, where the established performance of an existing device serves as the benchmark.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. For this type of IVD, the development and initial validation of the assay (e.g., establishing reagents, calibration curves, and internal controls) would typically happen during product development before the 510(k) submission. The 544 specimens described are for the clinical validation/equivalence study (i.e., the test set) comparing the new device to the predicate.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" for an AI model in this document, the concept of establishing ground truth for a training set as typically understood in AI development does not directly apply. For the development of the ARCHITECT B12 assay itself, the internal "ground truth" would have been established through rigorous analytical performance studies (e.g., accuracy, precision, linearity, limit of detection, interference studies) using certified reference materials or established laboratory methods, but these details are not provided in this summary. The 510(k) summary focuses on demonstrating substantial equivalence to an existing device rather than the foundational development of the assay's methodology.
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