(55 days)
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiate 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencylidine | 25 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine.
The provided text describes a 510(k) premarket notification for the "UCP Multiple Drug Screen Test Cups," which is an in vitro diagnostic device. The document issues a substantial equivalence determination for this device, meaning it is considered equivalent to legally marketed predicate devices.
However, the provided text does not contain detailed information about the specific acceptance criteria, a standalone study to prove the device meets these criteria, sample sizes for test or training sets, ground truth establishment methods, or the qualifications of experts. The document is an FDA clearance letter and an "Indication for Use" statement, not a scientific study report.
The "Indication for Use" section lists the drugs detected and their respective cutoff levels (calibrator and cutoff concentration), which could be interpreted as part of the performance specification. However, it does not explicitly state "acceptance criteria" and "reported device performance" in the format of a typical scientific or validation study. It describes what the device is designed to do.
Therefore, I cannot fulfill most of your request using the provided text.
Here's what I can extract or infer:
1. A table of acceptance criteria and the reported device performance:
The document describes the intended performance specifications (detection of specific drugs at specific cutoff levels). It does not provide a table of acceptance criteria (e.g., sensitivity, specificity thresholds) alongside reported device performance (actual experimental results against those thresholds).
The table below shows the inherent performance specification from the "Indication for Use" section:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 |
| Barbiturates | Secobarbital | 300 |
| Benzodiazepines | Oxazepam | 300 |
| Cocaine | Benzoylecgonine | 300 |
| Marijuana | Delta-9-THC-COOH | 50 |
| Methadone | Methadone | 300 |
| Methamphetamine | D-Methamphetamine | 1000 |
| MDMA | MDMA | 500 |
| Morphine | Morphine | 300 |
| Opiate 2000 | Morphine | 2000 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencylidine | 25 |
| Tricyclic Antidepressant | Nortriptyline | 1000 |
| Propoxyphene | Propoxyphene | 300 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information Not Found. The document does not provide details of specific studies, including sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Information Not Found. The document does not describe the establishment of ground truth or the involvement of experts for validation studies. The ground truth for drug tests like these is typically established through analytical chemistry methods, not expert consensus in the same way as medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Found. This concept is generally not applicable to a chemical immunoassay, which provides a direct quantitative or qualitative result based on chemical reaction, not human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Information Not Found. This device is an in vitro diagnostic test (immunoassay), not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information Not Found (but implied by device type). The device itself is a standalone test that produces a result (positive/negative based on cutoff levels). Its performance is inherently "standalone" in this context. However, the document does not describe such a study or its results. It simply states the device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred: For drug screen tests, the ground truth for validation is typically established by definitive analytical methods, most commonly Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This strongly implies GC/MS is the reference standard for confirmatory results and, therefore, the likely "ground truth" for validation studies.
8. The sample size for the training set:
- Information Not Found. The document refers to a commercial product, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Information Not Found. See point 8.
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).