(34 days)
Architect CEA MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System.
Architect CEA MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers. Architect CEA MasterCheck Levels 1, 2, 3 and 4 contain CEA (human) prepared in HEPES buffer with protein (bovine) stabilizers. Preservative: Antimicrobial Agent.
The provided text describes the "Architect CEA MasterCheck" device, which is intended for verifying the sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System. However, this document is a 510(k) summary for a control product, not a diagnostic device that outputs performance metrics like sensitivity or specificity based on patient data. Therefore, the typical "acceptance criteria" and "study" framework for a medical device that analyzes patient data to produce a diagnosis or risk assessment does not directly apply here.
Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set) for its intended use as a quality control material. The "performance" described relates to its characteristics as a control, not its diagnostic accuracy in patient samples.
Given this context, I will adapt the request to what can be extracted from the document regarding the characteristics and comparison of the control device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a control product for assay verification and not a diagnostic device, there are no "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC based on patient outcomes. Instead, the "performance" described is in terms of its formulation, intended use, and comparison to a predicate device. The primary "acceptance criteria" for 510(k) clearance in this context are demonstrating substantial equivalence.
| Feature / Criterion | Architect CEA MasterCheck (This Device) | Casco Standards Document Serum Multi-Analyte Verification Test Set (Predicate Device) |
|---|---|---|
| Intended Use | Verification of sensitivity, calibration linearity, and reportable range of the CEA assay 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 | CEA | Multiple |
| Open Vial Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the Architect CEA assay. (More specific to one assay and analyte, different matrix and stability from predicate.) | Calibration verifier for multiple analytes. |
Study to Prove Device Meets Acceptance Criteria (Substantial Equivalence):
The document does not describe a clinical study of the Architect CEA MasterCheck's performance in diagnosing patients. Instead, the "study" implied is the submission of information to the FDA to demonstrate substantial equivalence to a previously cleared device. This involves comparing the technological characteristics of the new device to the predicate device and asserting that any differences do not raise new questions of safety or effectiveness.
The explicit evidence presented in the document to support this claim is the comparison table above. The manufacturer has provided documentation (the 510(k) submission) that details these comparisons, and the FDA has reviewed this information to make a substantial equivalence determination.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the traditional sense of patient samples for diagnostic performance. The "test set" here refers to the device itself and its formulation. The document does not describe a "test set" of patient samples or data.
- Data Provenance: Not applicable. The data being presented is a comparison of product characteristics, not data derived from patient populations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. There is no "ground truth" to establish for a medical device as one would for diagnostic imaging or pathology. The "ground truth" for a control product is its verified formulation and stability, which would be established internally by the manufacturer's quality control and analytical chemistry experts, rather than clinical experts.
4. Adjudication Method for the Test Set:
- Not applicable. There is no expert adjudication process described for the assessment of this control product's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, like imaging) to compare human reader performance with and without AI assistance. The Architect CEA MasterCheck is a quality control material, not a diagnostic device for patient data interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- No, a standalone performance study was not done. This device is a biochemical reagent/control, not an algorithm. Its "performance" is in its chemical stability and ability to verify an assay's performance, not in classifying data.
7. The Type of Ground Truth Used:
- For the device itself, the "ground truth" for its characteristics (e.g., CEA concentration, pH, stability) would be established through analytical chemistry techniques and internal validation studies to confirm its formulation and performance as a control material. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical control product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, there is no training set for this type of device.
§ 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.