(105 days)
The Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an assayed control intended for use in the verification of calibration linearity and reportable range of the Glycated Hemoglobin assay on the Abbott ARCHITECT® i system.
Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an assayed control for the verification of calibration linearity and reportable range of the ARCHITECT® Glycated Hemoglobin assay on the Abbott ARCHITECT® i System.
The provided text is a 510(k) summary for a medical device called Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed information necessary to complete the requested table and study information.
The document states: "Substantial equivalence has been demonstrated between the ARCHITECT® Glycated Hemoglobin MasterCheck 10 and the Bio-Rad Lyphochek® Diabetes Control Level 1 and 2." This implies that the device is a control substance, not an analytical device that measures a patient's glycemic control directly. As a control, its performance is evaluated based on its stability, consistency, and ability to challenge the assay's performance over a range, rather than diagnostic accuracy against a ground truth of patient disease.
Therefore, many of the requested categories, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for the training set," are not applicable or cannot be extracted from this type of regulatory submission concerning a control material.
The document confirms that it is a control material for verifying calibration linearity and reportable range for an existing assay system (Abbott ARCHITECT® i System). Its "performance" would be related to its assigned values and how precisely and accurately it challenges the assay within its intended range, not its diagnostic accuracy in a clinical setting.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
This document does not provide specific acceptance criteria or reported device performance data in the way one would expect for an diagnostic algorithm. It only states that "Substantial equivalence has been demonstrated." This typically means that the control material performs similarly to the predicate control material in terms of its intended use (verifying calibration linearity and reportable range).
2. Sample sized used for the test set and the data provenance:
Not applicable. The device is a control material, not an analytical device tested on patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for a control material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a control material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The ground truth for a control material would be its assigned value, which is typically established through a reference method or validated against a reference material with known concentrations. This information is not in the provided text.
8. The sample size for the training set:
Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.