(58 days)
The UCP Rapid™ Drug Screening Test Strips and UCP Rapid™ Drug Screening Test Devices are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana 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 |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| MDMA | D, L-MDMA | 500 ng/mL |
| Opiates 300 | Morphine | 300 ng/mL |
| Opiates 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Cannabinoids | 11-nor-Δ9-THC-9 COOH | 50 ng/mL |
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations 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 Rapid TM Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of drugs 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 information for the UCP Rapid™ Drug Screening Tests, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a legally marketed predicate device and confirmation by GC/MS, aiming for high accuracy. The reported performance is a single accuracy metric for all drugs rather than individual criteria per drug.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High accuracy compared to predicate device and GC/MS | > 96% accuracy for all drugs |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 128 clinical specimens per drug type. This included approximately:
- 10% of specimens with drug concentrations between -50% of the cutoff and the cutoff.
- 10% of specimens with drug concentrations between the cutoff and +50% of the cutoff.
- Total: 64 positive clinical urine specimens and 64 negative clinical urine specimens tested against each drug.
- Data Provenance: "Clinical specimens" is mentioned, implying human urine samples. The country of origin is not specified but is likely the U.S. given the FDA submission. The study is retrospective, as it gathered existing clinical specimens for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is a laboratory method, not reliant on human experts in this context.
4. Adjudication Method for the Test Set
This information is not provided as the ground truth was established by GC/MS, an objective analytical method. Adjudication by human experts is typically relevant when ground truth itself is subject to interpretation (e.g., image-based diagnosis).
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
There was no MRMC comparative effectiveness study and no "human readers" involved in the product's intended use as a rapid, qualitative immunoassay. The device provides visual, qualitative results without requiring specialized interpretation expertise in the same manner as, for instance, a radiologist reading an image. The comparison was between the UCP Rapid™ device, a predicate device, and GC/MS.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The UCP Rapid™ Drug Screening Tests are described as providing visual, qualitative end results without the use of an instrument, indicating a standalone test that is interpreted by the user without real-time "human-in-the-loop" assistance from the device itself.
7. The Type of Ground Truth Used
The primary ground truth for the test set was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an objective and highly accurate laboratory method for confirming the presence and concentration of drugs and their metabolites.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is common for this type of immunoassay device submission, as such devices are typically developed and validated using biochemical principles, and performance characteristics are then confirmed with clinical samples. They are not "trained" in the same way an AI/ML algorithm would be.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicitly mentioned "training set" in the context of an AI/ML model, the ground truth for any internal development or validation (implied as part of "performance characteristics" and "precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study") would have been established through well-defined laboratory methods, likely including spiked samples with known concentrations and confirmed clinical samples, analogous to how the test set's ground truth was established with GC/MS. The document does not detail these specific methods for internal development.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).