(9 days)
Architect Total ß-hCG MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Architect Total ß-hCG MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers. Architect Total ß-hCG MasterCheck Levels 1, 2, 3 and 4 contain ß-hCG (human) prepared in HEPES buffer with protein (bovine) stabilizers. Preservative: Antimicrobial agent.
This document is a 510(k) summary for the Architect Total ß-hCG MasterCheck, a control device used for verifying sensitivity, calibration linearity, and reportable range on the Abbott Architect i System. As a control product, the document does not contain information about clinical studies with human participants or an AI device. Therefore, many of the requested categories related to clinical studies are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format as would be seen for a diagnostic or therapeutic device. Instead, it focuses on the intended use and technological characteristics for substantial equivalence to a predicate device. The performance is implied by its intended use for "verification of sensitivity, calibration linearity, and reportable range."
| Feature/Characteristic | Architect Total ß-hCG MasterCheck (Reported Performance) | Casco Standards Document Serum Multi-Analyte Verification Test Set (Predicate Device) |
|---|---|---|
| Intended Use | Verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System. | In vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range using automated, semi-automated and manual methods. |
| Form | Liquid | Liquid |
| Matrix | HEPES buffer with protein (bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Total ß-hCG | Multiple |
| Open Vial Claim | 3 Days at 2-8°C | 30 Days at 2-8°C |
| Differences | Calibration verifier for the Architect Total ß-hCG assay | Calibration verifier for multiple analytes |
2. Sample size used for the test set and the data provenance
Not applicable. This is a control product, not a diagnostic device involving patient data. Performance is evaluated through laboratory testing of the control material itself, and the documentation does not specify a "test set" in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a control product is established through characterization of its known concentration, not expert consensus on patient cases.
4. Adjudication method for the test set
Not applicable. See point 3.
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 a control product, not an AI-powered diagnostic intended for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a control product, not an algorithm.
7. The type of ground truth used
For a control product, the "ground truth" would be the assigned value (concentration) of the analyte (Total ß-hCG) within each level of the MasterCheck. This is established through rigorous analytical methods and calibration against primary standards. The document states that Levels 1, 2, 3, and 4 contain ß-hCG (human) prepared in HEPES buffer with protein stabilizers, implying these are spiked or manufactured to specific concentrations.
8. The sample size for the training set
Not applicable. This is a control product, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.