(266 days)
The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine:
| Test | Calibrator | Cut-off |
|---|---|---|
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Amphetamine | D-Amphetamine | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 500 ng/mL |
| Cocaine | Benzoylecgonine | 150 ng/mL |
The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use.
The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liguid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format beyond the overarching statement regarding performance. However, based on the accuracy study, the implied acceptance criterion for accuracy against both a legally marketed device and GC/MS or LC/MS is essentially that the device performs at a high level.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | High performance (e.g., ≥95% agreement/correlation with predicate and confirmatory methods) | ≥ 97% for all drugs when compared to a legally marketed device and GC/MS or LC/MS |
| Qualitative Detection | Detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine, and their metabolites at specified cut-off levels | Successfully detects Buprenorphine (10 ng/mL), Amphetamine (300 ng/mL), Methamphetamine (500 ng/mL), Cocaine (150 ng/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 80 clinical urine specimens per drug (Buprenorphine, Amphetamine, Methamphetamine, Cocaine), totaling 320 specimens (80 specimens * 4 drugs).
- Approximately 10% (8 specimens per drug) were at concentrations between -50% cutoff and cutoff ranges.
- Approximately 10% (8 specimens per drug) were at concentrations between cutoff and +50% cutoff ranges.
- Data Provenance: Clinical urine specimens. The country of origin is not specified, but the study was conducted at "point of care sites." The data is retrospective in the sense that these were "clinical urine specimens," implying they were collected prior to this specific study for testing. However, the study itself is designed to prospectively test the new device against established methods.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the "number of experts" or their qualifications for establishing ground truth. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which are analytical laboratory methods considered the gold standard for confirmatory drug testing. These methods are performed by trained laboratory personnel, rather than medical "experts" in the clinical sense (e.g., radiologists).
4. Adjudication Method for the Test Set
The document describes a comparison study where the UCP device's results were compared to both GC/MS or LC/MS results and the predicate devices. It doesn't detail a specific "adjudication method" involving human consensus for discrepancies. The GC/MS or LC/MS results are considered the definitive ground truth, and device performance is measured against them.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the device's accuracy against laboratory gold standards and predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance study of the device (UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests). These are rapid, qualitative, competitive binding immunoassays that can be performed "without the use of an instrument," implying visual interpretation of results. While human observation is part of reading the test, the performance being evaluated is that of the assay itself in detecting the target analytes in urine, not for an algorithm in an AI system.
7. The Type of Ground Truth Used
The type of ground truth used was confirmatory analytical methods: Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS).
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of device (rapid, qualitative immunoassay) typically does not involve machine learning or AI models that require specific training sets in the same way. The "training" for such devices is usually in the manufacturing process and quality control to ensure consistent chemical reactivity.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned for this type of immunoassay device, the information on how its ground truth was established is not applicable or provided in the document.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).