(37 days)
ARCHITECT STAT CK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT CK-MB assay is a two-step assay to determine the presence of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-CK-MB coated paramagnetic microparticles are combined. After incubation and washing, anti-CK-MB acridinium conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of CK-MB in the sample and the RLUs detected by the ARCHITECT i* optical system.
Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT CK-MB immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | To demonstrate substantial equivalence to the predicate device (Abbott AxSYM® CK-MB Assay). | Achieved. The device "demonstrated substantially equivalent to the AxSYM® CK-MB assay" in clinical performance and "is substantially equivalent...in terms of precision, linearity, interferences, and stability" in non-clinical performance. |
| Precision | Not explicitly stated as a numerical criterion, but evaluated. | Demonstrated substantial equivalence to the predicate. |
| Linearity | Not explicitly stated as a numerical criterion, but evaluated. | Demonstrated substantial equivalence to the predicate. |
| Interferences | Not explicitly stated as a numerical criterion, but evaluated. | Demonstrated substantial equivalence to the predicate. |
| Stability (Sample) | No systematic gain or loss of detectability of CK-MB in serum or plasma samples under various storage conditions. | Achieved. "There was no systematic gain or loss of the detectability of CK-MB in serum or plasma samples under any of the storage conditions evaluated in this study." |
| Stability (Assay) | Not explicitly stated as a numerical criterion, but evaluated. | Demonstrated substantial equivalence to the predicate. |
| Method Comparison | Demonstrated substantial equivalence to the predicate based on the NCCLS Bias Estimation Standard (EP-9A). | Achieved. "the two systems demonstrated substantial equivalence as indicated by clinical data." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample size for the test set used in the clinical performance study. It mentions a "sample stability study" and a "method comparison using the NCCLS Bias Estimation Standard (EP-9A)" which imply a test set was used, but the number of samples is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The study involved a comparison against a predicate device (AxSYM® CK-MB assay), and the "ground truth" for the test samples would have been the results obtained from the predicate device or a clinical outcome implicitly associated with CK-MB levels. There's no mention of a ground truth established by external experts.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Since the "ground truth" was based on comparison to a predicate device, an explicit expert adjudication method for the test set is unlikely to have been employed in the traditional sense (e.g., multiple experts reviewing and reaching consensus).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is an immunoassay (a lab test), not an AI-assisted diagnostic imaging device or an AI system designed to aid human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is a standalone diagnostic test. The ARCHITECT® STAT CK-MB immunoassay is a device that itself performs the quantitative determination of CK-MB from a sample. It generates a numerical result, which is then interpreted by clinicians. It does not involve a human-in-the-loop performance analysis in the context of an algorithm. Its performance is evaluated compared to a predicate device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The primary "ground truth" used for evaluating the ARCHITECT® STAT CK-MB assay was the results obtained from the predicate device, the Abbott AxSYM® CK-MB Assay. The study aimed to demonstrate substantial equivalence, meaning the new device's measurements correlated well with the established predicate. The clinical utility of CK-MB values (used to assist in the diagnosis of MI) represents the broader clinical "ground truth" for both devices.
8. The Sample Size for the Training Set
- This information is not applicable/provided in the context of this device's development. Immunoassays are not "trained" in the same way machine learning models are. Their performance is established through rigorous analytical and clinical validation studies using samples, not through a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of an immunoassay. The development and validation of an immunoassay rely on established chemical reactions, antibodies, and measurement principles, with performance characterized through analytical studies and comparison to established methods.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.