(80 days)
The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.
For in vitro diagnostic use.
The ARCHITECT iDigoxin assay is a one-step STAT immunoassay for the quantitative measurement of digoxin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antidigoxin coated paramagnetic microparticles, assay diluent, and digoxiqenin acridinium-labeled conjugate are combined to create a reaction mixture. The antidigoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of digoxin in the sample and the RLUs detected by the ARCHITECT i System optics.
- Acceptance Criteria and Reported Device Performance:
The provided document describes a 510(k) submission for the ARCHITECT iDigoxin assay, claiming substantial equivalence to a predicate device. The primary performance metric reported is based on this equivalence.
| Acceptance Criteria | Reported Device Performance | Metric Type |
|---|---|---|
| Substantial Equivalence to predicate device (Aeroset Multigent Digoxin) | Pearson correlation coefficient of 0.993 | Correlation Coefficient |
- Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size used for the clinical performance study or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "non-clinical performance data" and "clinical performance data" without specifying details about the clinical study itself.
- Number and Qualifications of Experts for Ground Truth:
The document does not mention the use of experts to establish ground truth for the test set. For in vitro diagnostic devices like the ARCHITECT iDigoxin, the ground truth is typically clinical samples analyzed by a reference method or the predicate device itself, rather than expert interpretation of images or clinical scenarios.
- Adjudication Method:
The document does not mention any adjudication method, as it doesn't describe a scenario where expert consensus or conflict resolution would be required. The clinical performance is assessed by comparing results to a predicate device.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not performed or described. This type of study is typically relevant for interpretative devices where human readers assess cases (e.g., radiology images). The ARCHITECT iDigoxin is a quantitative immunoassay, not an interpretative device, so an MRMC study is not applicable. Therefore, there is no effect size reported for human readers with and without AI assistance.
- Standalone (Algorithm Only) Performance:
The device itself is a standalone algorithm (an immunoassay system). The "performance" section describes the device's ability to measure digoxin levels in comparison to a predicate device. So, the clinical performance reported (Pearson correlation coefficient of 0.993) is the standalone performance of the ARCHITECT iDigoxin assay against the predicate device.
- Type of Ground Truth Used:
For the clinical performance study, the "ground truth" was established by the measurements obtained from the legally marketed predicate device, Aeroset Multigent Digoxin. The ARCHITECT iDigoxin's readings were correlated with the readings from this established device.
- Sample Size for Training Set:
The document does not explicitly state the sample size used for any training set. For an immunoassay, "training" might involve calibrating the system and optimizing reagents, but details on sample sizes for these internal processes are not provided in this regulatory summary.
- How Ground Truth for Training Set was Established:
The document does not explicitly describe how ground truth for a training set was established. Immunoassays are typically "trained" or calibrated using a series of calibrator materials with known concentrations. The ARCHITECT iDigoxin Calibrators (A-F) are mentioned, which would be used for the calibration process. The ground truth for these calibrators would be established through a traceable reference method by the manufacturer.
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.