(305 days)
The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
The ARCHITECT iCarbamazepine Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma.
The ARCHITECT iCarbamazepine assay is a one-step immunoassay for the quantitative measurement of carbamazepine in human serum or plasma using CMIA technology with flexible assay protocols referred to as Chemiflex.
In the ARCHITECT iCarbamazepine assay, sample, anti-carbamazepine coated paramagnetic microparticles, and carbamazepine acridinium-labeled conjugate are combined to create a reaction mixture. The anti-carbamazepine coated microparticles bind to carbamazepine present in the sample and the carbamazepine acridinium-labeled conjugate. After washing, pre-trigger and 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 carbamazepine in the sample and the RLUs detected by the ARCHITECT i System optics.
The provided 510(k) summary (K103627) describes the ARCHITECT iCarbamazepine assay, an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine in human serum or plasma.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines analytical performance studies but does not explicitly state specific numerical acceptance criteria for each study (e.g., a required correlation coefficient for linearity or specific CV% for precision). Instead, it lists the types of studies performed to demonstrate substantial equivalence to the predicate device, the AxSYM Carbamazepine assay. The overall conclusion is that the ARCHITECT iCarbamazepine assay "is substantially equivalent to the AxSYM Carbamazepine assay in terms of analytical performance data."
| Acceptance Criteria (Stated as study types performed to show equivalence) | Reported Device Performance (Implied as meeting criteria for substantial equivalence) |
|---|---|
| Precision | Studies demonstrated substantial equivalence to predicate. |
| Sensitivity (Limit of Blank, Limit of Detection, and Limit of Quantitation) | Studies demonstrated substantial equivalence to predicate. |
| Linearity | Studies demonstrated substantial equivalence to predicate. |
| Interferences | Studies demonstrated substantial equivalence to predicate. |
| Recovery | Studies demonstrated substantial equivalence to predicate. |
| Manual Dilution | Studies demonstrated substantial equivalence to predicate. |
| Matrix Comparison (Tube Type) | Studies demonstrated substantial equivalence to predicate. |
| Method Comparison (Correlation) | Studies demonstrated substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the test sets in any of the analytical performance studies.
The document also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are typically detailed in the full 510(k) submission but are not present in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not refer to "experts" or "ground truth" in the context of clinical interpretation or decision-making, as this is a quantitative immunoassay device. The "ground truth" for this type of device would be established by reference methods or comparison to a legally marketed predicate device, as seen in the "Method Comparison (Correlation)" study. Therefore, the concept of qualified experts establishing ground truth in the way it might apply to image-based diagnostic AI is not relevant here.
4. Adjudication Method for the Test Set:
Not applicable, as the device performs quantitative measurements and does not involve human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices that assist human readers (e.g., radiologists for medical images). The ARCHITECT iCarbamazepine assay is a standalone quantitative measurement device, not an AI assistant for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT iCarbamazepine assay. The device provides a quantitative measurement of carbamazepine levels directly, without human interpretation of the assay results in the way one would interpret an image. The "Method Comparison (Correlation)" study, for instance, directly compares the device's quantitative output to that of the predicate device.
7. The Type of Ground Truth Used:
For a quantitative diagnostic device like this, the "ground truth" for performance evaluation is typically established through:
- Reference methods: Highly accurate and precise methods known to provide true values.
- Comparison to a legally marketed predicate device: This is explicitly stated in the document ("Method Comparison (Correlation)") where the ARCHITECT iCarbamazepine assay's results are compared to those of the AxSYM Carbamazepine assay (K935374).
- Known concentrations: For studies like linearity, sensitivity, and recovery, samples with precisely known concentrations of the analyte are used.
8. The Sample Size for the Training Set:
The document does not mention a "training set" as this device does not appear to employ machine learning or artificial intelligence in a way that requires a distinct training phase. It is a traditional immunoassay, and its performance is determined by its chemical and mechanical design, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for this traditional immunoassay device.
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.