(14 days)
Architect Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
Architect Ferritin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Ferritin MasterCheck Levels 1, 2, 3 and 4 contain ferritin (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
The provided text is related to the 510(k) submission for the Architect Ferritin MasterCheck device. This device is a single-analyte control intended for the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
It's important to understand that this submission is for a control material, not a diagnostic device that performs measurements or interpretations. Therefore, the "acceptance criteria" and "device performance" in the context of this document are related to the control material itself and its chemical characteristics, rather than the diagnostic accuracy of a measurement or an AI algorithm.
The document does not contain information on the acceptance criteria or a study proving the device meets those criteria in the way you've outlined for diagnostic devices or AI algorithms. Your requested information (sample sizes, ground truth, experts, MRMC studies, standalone performance, training sets, etc.) is typically associated with evaluating the performance of diagnostic tests or AI systems that interpret data, not with the characterization of a control material like the Architect Ferritin MasterCheck.
Here's a breakdown of why this document doesn't fit your requested format:
- No Diagnostic Performance Evaluation: The document describes a "MasterCheck" and its intended use as a "verification of sensitivity, calibration linearity, and reportable range." This means it's used to check if the assay (on the Abbott Architect i System) is performing correctly, not to perform a diagnosis itself or to be evaluated for its diagnostic accuracy.
- No AI Component: There is no mention of any artificial intelligence, machine learning, or algorithm in this submission.
- No Clinical Study for Performance: The document does not describe a clinical study to evaluate its performance against diseases or conditions. Instead, it compares its technological characteristics to a predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set) to establish substantial equivalence.
Therefore, I cannot populate your requested table and information based on the provided text because the nature of the device (a control material) and the content of the 510(k) summary do not include the type of performance data you are asking for.
The document's focus is on:
- Intended Use: Verifying the performance of another assay.
- Device Description: Chemical composition (HEPES buffer, bovine protein, human ferritin, antimicrobial agent).
- Comparison to Predicate: Highlighting similarities in intended use, form, matrix, storage, analytes, open vial claim, and differences (e.g., specific to the Architect Ferritin assay vs. multiple analytes).
- Regulatory Classification: Class I, product code JJX, CFR 862.1660.
If you have a document describing a diagnostic device or an AI-powered medical device, I would be able to apply your requested structure.
§ 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.