(88 days)
The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
| Test | Calibrator | Cut-off |
|---|---|---|
| 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 either single drug test or in combination with multiple other drug 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.
UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Acceptance Criteria and Study for UCP Rapid™ Drug Screening TCA, PPX Tests
This response describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each drug screening test were set against established predicate devices and confirmed by gold standard methods. The reported performance refers to the accuracy demonstrated in the clinical comparison study.
| Test (Drug) | Cut-off Concentration | Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) |
|---|---|---|---|
| Tricyclic Antidepressant (TCA) | 1000 ng/mL | ≥ 98% (vs. predicate & GC/MS) | ≥ 98% |
| Propoxyphene (PPX) | 300 ng/mL | ≥ 98% (vs. predicate & GC/MS) | ≥ 98% |
Note: The document explicitly states the "performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 128 clinical urine specimens per drug.
- This included approximately 10% of specimens with the target drug at concentrations between -50% of the cut-off and the cut-off.
- Another 10% of specimens contained the target drug at concentrations between the cut-off and +50% of the cut-off.
- Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug.
- Data Provenance: The document does not explicitly state the country of origin. It describes them as "clinical urine specimens." The study is described as a "clinical comparison study," implying prospective collection for the study purpose or retrospective use of clinically collected samples. Without more detail, it's hard to definitively state prospective or retrospective, but the phrasing suggests a dedicated collection or selection process for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The establishment of ground truth for the test set did not involve human experts in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth was established by laboratory analytical methods.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by objective laboratory analytical methods (HPLC or GC/MS), not by expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test for qualitative detection of drugs in urine, not an imaging device requiring human reader interpretation or AI assistance for human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "UCP Rapid™ Drug Screening Tricyclic Antidepressant Test" and "UCP Rapid™ Drug Screening Propoxyphene Test" are described as competitive binding, lateral flow immunochromatographic assays that "can be performed without the use of an instrument" and provide "visual, qualitative end results." The accuracy study directly assesses the performance of these devices in isolation against predicate devices and analytical gold standards.
7. Type of Ground Truth Used
The type of ground truth used was objective laboratory analytical methods:
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography/Mass Spectrometry (GC/MS)
All test results from the UCP Rapid™ devices and the predicate devices were "confirmed with HPLC or GC/MS analysis."
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. This type of device (lateral flow immunoassay) typically does not involve machine learning algorithms that require a distinct training phase with a labeled dataset in the same way modern AI algorithms do. The development and optimization of such assays rely on biochemical principles, antibody-antigen binding characteristics, and extensive experimental validation, rather than algorithmic training on a dataset. The performance data presented is for validation, not for training.
9. How the Ground Truth for the Training Set Was Established
As there is no explicitly defined "training set" in the context of an AI/machine learning algorithm for this device, the concept of establishing ground truth for a training set does not apply directly. The development of the assay would have involved extensive R&D and optimization using various known concentrations of analytes, where the "ground truth" (i.e., the known concentration and presence/absence of the drug) would be intrinsically understood and controlled during the development process.
§ 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).