(49 days)
The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection. The west The Scooper -- Drug/Adulterail: Test Sup Sup son and phencyclidine in human urine. The cutoff concentrations are as follows:
| OPI | Morphine | 2000 ng/m |
|---|---|---|
| AMP | Amphetamines | 1000 ng/m |
| THC | 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/m |
| COC | Benzoylecgonine | 300 ng/m |
| PCP | Phencyclidine | 25 ng/m |
The Scooper™ Drug/Adulteration Test Cup is used to obtain visual, qualitative results The Scooper - Drug/Additeration 2001 Super-the-counter sale to lay persons.
Not Found
This document is a 510(k) premarket notification from the FDA, approving a drug test cup. It does not contain information about a study with acceptance criteria and device performance in the way typically associated with AI-powered diagnostic devices or other medical imaging/diagnostic tools that require extensive clinical validation studies.
The device described, "Scooper™ Drug/Adulteration Test Cup," is an in vitro diagnostic (IVD) device for rapid detection of specific drugs and adulterants in human urine. The approval is based on "substantial equivalence" to legally marketed predicate devices, not on a new clinical study comparing its performance against a gold standard in a detailed manner as requested in the prompt.
Therefore, most of the requested information cannot be extracted from this document because the described approval process does not involve such a study with the specified acceptance criteria format.
However, I can provide the limited relevant information:
1. A table of acceptance criteria and the reported device performance:
The document lists "cutoff concentrations" for various drugs. These act as intrinsic performance specifications for the test cups. The approval indicates that the device meets these cutoffs effectively for its intended use as an in vitro screen test.
| Drug / Metabolite | Cutoff Concentration (ng/mL) |
|---|---|
| Morphine (OPI) | 2000 |
| Amphetamines (AMP) | 1000 |
| 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid (THC) | 50 |
| Benzoylecgonine (COC) | 300 |
| Phencyclidine (PCP) | 25 |
Note: This document does not provide a table of "reported device performance" against these cutoffs in terms of sensitivity, specificity, or accuracy based on a clinical study where the device results were compared to a gold standard. The approval is based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a clinical study with a test set of this nature. The approval is based on substantial equivalence to predicate devices, implying that the device was tested to perform as expected against its stated cutoffs, but not through a large-scale clinical trial with specified sample sizes and 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):
Not applicable. The approval process for this type of IVD device typically relies on analytical validation against known concentrations and comparison to predicate devices, rather than expert-established ground truth on a test set in a clinical setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No such clinical test set or adjudication method is described.
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:
Not applicable. This is not an AI-powered device, nor is it a device that requires human "readers" in the context of interpretation that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a point-of-care, visually read test cup, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the "ground truth" during its development and validation would primarily be the known concentrations of target analytes (drugs/metabolites) in synthetic or spiked urine samples, and comparison to established methods or predicate devices. It would not typically involve expert consensus, pathology, or outcomes data in the sense of a clinical trial for a diagnostic image analysis algorithm.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine 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).