(148 days)
The ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
The ARCHITECT iPhenobarbital Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenobarbital in human serum or plasma.
The ARCHITECT i Phenobarbital assay is a one-step STAT immunoassay for the quantitative measurement of phenobarbital in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, antiphenobarbital coated paramagnetic microparticles, and phenobarbital acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-phenobarbital coated microparticles bind to phenobarbital present in the sample and to the phenobarbital 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 phenobarbital in the sample and the RLUs detected by the ARCHITECT i System optics.
The provided document describes the ARCHITECT iPhenobarbital assay, which is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital in human serum or plasma.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a dedicated table. Instead, it claims substantial equivalence to a legally marketed predicate device (AxSYM Phenobarbital) based on specific performance characteristics. The key performance metrics evaluated are:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (ARCHITECT iPhenobarbital) |
|---|---|---|
| Precision | Substantially equivalent to AxSYM Phenobarbital | Demonstrated substantial equivalence |
| Linearity | Substantially equivalent to AxSYM Phenobarbital | Demonstrated substantial equivalence |
| Interferences | Substantially equivalent to AxSYM Phenobarbital | Demonstrated substantial equivalence |
| Clinical Performance (Correlation Coefficient) | A high correlation coefficient (typically close to 1.0) compared to the predicate device | 1.0 (with AxSYM Phenobarbital) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "non-clinical performance data" and "clinical performance."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable and therefore not provided, as this is an in vitro diagnostic (IVD) device for measuring a chemical analyte (phenobarbital), not an imaging or diagnostic device that relies on expert human image interpretation for ground truth. The "ground truth" for this device would be established by reference methods or comparison to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable, as adjudication methods are typically used in studies involving human interpretation or subjective assessments, not for quantitative chemical measurements in an IVD device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This type of study is specifically relevant for devices where human readers interpret medical images or other complex data. The ARCHITECT iPhenobarbital assay is an automated in vitro diagnostic test for a chemical analyte.
6. Standalone Performance Study
Yes, a standalone study was done. The "Summary of Non-Clinical Performance" and "Summary of Clinical Performance" sections describe the device's performance in terms of precision, linearity, interferences, and clinical correlation with a predicate device. This is the standalone performance of the algorithm/assay itself.
- Non-Clinical Performance: Evaluated precision, linearity, and interferences of the ARCHITECT iPhenobarbital assay.
- Clinical Performance: Compared the ARCHITECT iPhenobarbital assay to the AxSYM Phenobarbital assay, yielding a correlation coefficient of 1.0.
7. Type of Ground Truth Used
The "ground truth" for the ARCHITECT iPhenobarbital assay's performance was established primarily through comparison to a legally marketed predicate device, the AxSYM Phenobarbital assay. The AxSYM Phenobarbital assay itself would have been validated against reference methods for phenobarbital measurement. The correlation coefficient of 1.0 indicates excellent agreement with the existing, validated method.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. This information is often proprietary and not typically included in 510(k) summaries for IVD devices, especially for established assay types.
9. How the Ground Truth for the Training Set Was Established
Similarly, the document does not detail how the ground truth for any potential training set was established. For an immunoassay like this, the development process would involve extensive analytical validation using characterized samples (e.g., spiked samples, patient samples with confirmed phenobarbital levels via reference methods) to optimize reagents and assay parameters. The ground truth for training would likely be based on these characterized samples and existing, validated methods for phenobarbital measurement.
§ 862.3660 Phenobarbital test system.
(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.