(30 days)
The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.
Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients.
The safety and effectiveness of this device for use in patients with potential Acute Coronary Syndrome (ACS) with negative ECG; or positive ECG; or positive ECG combined with negative, low, or normal troponin levels; or positive troponin levels also has not been established. IMA results do not correlate with blood flow and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.
The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serum specimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), a colorimetric indicator, is added to the reacted specimen and the degree of color formation is detected spectrophotometrically on clinical chemistry analyzers.
In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt to react with DTT and form a colored product. In serum of patients with ischemia, cobalt does not bind to the metal binding sites leaving more free cobalt to react with DTT and form a darker color.
Here's a breakdown of the acceptance criteria and study information for the Ischemia Albumin Cobalt Binding Test (ACB® Test), based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it lists the types of verification/validation testing performed. The "reported device performance" would be the results obtained from these tests, which are not detailed in this submission.
| Acceptance Criteria Category (Testing Performed) | Reported Device Performance |
|---|---|
| Typical Calibration Curve | Not specified |
| Linearity | Not specified |
| Sensitivity | Not specified |
| Precision | Not specified |
| Test Method Comparison | Not specified |
| On Board Component Stability | Not specified |
| Specificity | Not specified |
| Interfering Substances | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "patients presenting with chest pain suggestive of cardiac origin" for the intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not available in the provided document.
4. Adjudication Method for the Test Set
This information is not available in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic test for a biomarker, not an imaging or diagnostic device requiring human reader interpretation in the same way. The intended use is "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients."
6. Standalone (Algorithm Only) Performance Study
The Ischemia Albumin Cobalt Binding Test (ACB® Test) is an in-vitro diagnostic test that measures the cobalt binding capacity of albumin. While it's a quantitative test and can be run on clinical chemistry analyzers, it's not an "algorithm only" device in the sense of AI-driven image analysis or decision support. Its performance is inherent to the chemical reaction and measurement, not a separate algorithm. The "standalone performance" is implicitly covered by the "Typical Calibration Curve, Linearity, Sensitivity, Precision, Test Method Comparison, On Board Component Stability, Specificity, and Interfering Substances" testing.
7. Type of Ground Truth Used
For diagnostic tests like this, the "ground truth" would typically refer to the clinical diagnosis of Acute Coronary Syndrome (ACS) established by a combination of clinical assessment, ECG, cardiac troponin levels, and potentially other diagnostic procedures (e.g., angiography, outcomes data). The document itself does not specify how the ground truth was established for the study cohort, but mentions its use "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients presenting with chest pain suggestive of cardiac origin." The negative IMA result is used to "rule out Acute Coronary Syndrome (ACS) in low risk patients" with non-diagnostic ECG and normal troponin.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. For an in-vitro diagnostic device, this would typically refer to the samples used during development and optimization of the assay. This information is not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" in the AI/ML context, this information is not applicable and not provided in the document. The development processes for chemical assays involve different methodologies for optimizing performance and establishing reference ranges.
§ 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.