(20 days)
The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.
The provided document is a 510(k) summary for a drug of abuse calibrator/control device (Preciset® DAT Amphetamine). It's important to note that this device is a calibrator/control for an assay, not the assay itself or a diagnostic device that directly determines patient outcomes. Therefore, the "acceptance criteria" and "device performance" are related to the stability and functionality of the calibrator/control with respect to the assays it's intended to calibrate. The document does not describe a clinical study comparing human readers with and without AI assistance, nor does it detail a standalone algorithm performance for diagnostic purposes.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format but describes performance in terms of stability and functionality with the target assays.
| Acceptance Criteria Category | Specific Criteria (Implicit from text) | Reported Device Performance Statement |
|---|---|---|
| Stability | The calibrator/control should maintain its intended concentration levels and performance over its shelf life and after opening. | "Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators/controls." |
| Functionality | The calibrator/control should perform effectively for the calibration of specified assays (Roche Abuscreen® OnLine assays for Amphetamines and COBAS INTEGRA® Amphetamines (AMPS)). | "When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use." |
| Equivalence | Substantial equivalence to a legally marketed predicate device. | "The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit® Calibrators/controls manufactured by Syva Company. Both feature similar matrices, constituents and stability claims." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical samples that would require a sample size. It refers to stability studies and testing with immunoassays.
- Sample Size for Test Set: Not applicable in the context of typical diagnostic device studies. The "test set" here refers to the calibrator/control vials themselves that were subjected to stability testing and functional evaluation with the specified assays. The number of such vials is not provided.
- Data Provenance: Not applicable in the context of patient data. The studies were laboratory-based (accelerated and real-time stability studies) performed by the manufacturer, Quantimetrix Corporation. There is no mention of country of origin of data in terms of patient samples, as this is a calibrator/control device. The studies were prospective in nature (designed to validate claims).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable for this type of device. Ground truth in the context of diagnostic devices usually refers to a definitive diagnosis or condition established by clinical experts or gold standard methods (e.g., pathology, follow-up). For a calibrator/control, the "ground truth" for the drug concentration is established through analytical methods like GC/MS.
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication Method for the Test Set
This section is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among expert readers in diagnostic image or clinical data interpretation. For a calibrator, the "truth" of its concentration is chemically determined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting diagnostic cases, often with and without AI assistance, to measure the impact of AI on reader performance. This device is a calibrator/control, not an AI diagnostic tool.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) performance study as typically understood for AI diagnostic devices was not done. This device is a chemical calibrator/control, not an algorithm. The performance described relates to its stability and its ability to function correctly with specific immunoassay systems.
7. Type of Ground Truth Used:
For assessing the concentration of the drug (d-amphetamine) in the calibrator/control, the ground truth was established using an analytical reference method.
- Ground Truth Type: Drug concentration determined using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and precise analytical chemistry technique used for quantifying substances.
8. Sample Size for the Training Set
This section is not applicable. This device is a calibrator/control, not a machine learning or AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this type of device.
§ 862.3550 Lead test system.
(a)
Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.(b)
Classification. Class II.