(17 days)
The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Vitamin B12 assay.
Elecsys CalCheck Vitamin B12 calibration verification solutions comprise three levels - low, mid, and high - each with a defined Vitamin B12 concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Vitamin B12 is intended for use in periodic verification of the calibration of the Elecsys Vitamin B12 assay.
The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is manufactured using human serum albumin, vitamin B12, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards.
The provided text describes the 510(k) summary for the Elecsys® CalCheck™ Vitamin B12, a calibration verification material. This device is not an AI/ML powered device, and thus many of the requested fields are not applicable (N/A) for this type of product. The information focuses on its intended use for verifying the calibration of a Vitamin B12 assay and its substantial equivalence to a predicate device, Elecsys® CalCheck™ TSH.
Here's an analysis of the provided text with respect to your requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as would be expected for a diagnostic device predicting an outcome. Instead, it states the device "was evaluated for value assignment and stability." The performance reported is that it "comprise[s] three levels - low, mid, and high - each with a defined Vitamin B12 concentration" and that these levels are positioned appropriately relative to the clinical deficiency range and the measuring range of the assay. This implies the acceptance criteria would be that the assigned values for low, mid, and high fall within specified ranges relative to the associated Elecsys Vitamin B12 assay's performance characteristics, and that the product remains stable over its shelf life. However, the specific numerical values or ranges are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Defined Vitamin B12 concentrations at low, mid, and high levels. | The Elecsys CalCheck Vitamin B12 comprises three levels - low, mid, and high - each with a defined Vitamin B12 concentration. |
| Low concentration near the clinical deficiency range. | The low solution concentration is near the clinical deficiency range of the assay. |
| Mid concentration in the middle point of the measuring range. | The mid solution is in the middle point of the measuring range. |
| High concentration near the upper limit of the measuring range. | The high solution is near the upper limit of the measuring range. |
| Stability of the material. | The Elecsys® CalCheck™ Vitamin B12 was evaluated for value assignment and stability. (Specific stability data or acceptance criteria for stability are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test set or the data provenance. It mentions "Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5," but this attachment is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a calibration verification material, not a diagnostic device that requires expert interpretation for a "ground truth" diagnosis in the clinical sense. The "ground truth" for this device relates to the accurately assigned concentrations of Vitamin B12 within the material, which would be established through metrological traceability and standard laboratory methods, not expert consensus on medical images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a calibration verification material.
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 not an AI/ML powered device, nor a diagnostic device requiring human reader interpretation in the context of a clinical study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device or an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this product would be the assigned analyte concentrations derived from reference methods or traceable standards. The document states: "The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards." This indicates an analytical ground truth based on spiking and internal quality control.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.