(215 days)
UCP Compact Drug Tests Cards and UCP Compact Drug Tests Cups are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off |
|---|---|---|
| Marijuana: | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine: | Benzoylecgonine | 300 ng/mL |
| Amphetamine: | D-Amphetamine | 1000 ng/mL |
| Methamphetamine: | D-Methamphetamine | 1000 ng/mL |
| Opiates: | Morphine | 2000 ng/mL |
| Morphine: | Morphine | 300 ng/mL |
| Phencyclidine: | Phencyclidine | 25 ng/mL |
| Barbiturates: | Secobarbital | 300 ng/mL |
| Benzodiazepines: | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methadone: | Methadone | 300 ng/mL |
| EDDP: | EDDP | 300 ng/mL |
| Oxycodone: | Oxycodone | 100 ng/mL |
| MDMA: | MDMA | 500 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressants: | Nortriptyline | 1000 ng/mL |
The tests are intended for over-the-counter (OTC) consumer use as the first step process to provide the consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling.
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests will yield preliminary positive results when the prescription drugs Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidentessants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GCMS). 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 the drug levels.
UCP Compact Drug Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, EDDP (Methadone metabolite), Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Morphine, Oxycodone, Phencyclidine, Propoxyphene. Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
The document describes the performance of UCP Compact Drug Tests, which are rapid, qualitative, competitive binding immunoassays for detecting various drugs and their metabolites in human urine. The study presented aims to demonstrate the substantial equivalence of the device to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study data based on the provided text, structured to answer your specific questions:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical "acceptance criteria" in a table format for each drug test. Instead, it reports the accuracy in comparison to a reference method (GC/MS for most drugs, HPLC for TCA). The key performance metric mentioned is accuracy, particularly for the EDDP test. For consumer studies, the "agreement rate" with GC/MS results and understanding of instructions are the criteria.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Performance Metric | Implied Acceptance Criteria (Based on reported success) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Accuracy (EDDP test) | ≥ 98% accuracy (based on reported performance) | "UCP EDDP tests demonstrated performance of ≥ 98% accuracy when compared to the reference method GC/MS." |
| Lay User Agreement Rate (Consumer Study) | ≥ 97% agreement rate (based on reported success) | "The test results performed by the lay users showed 97% or above agreement rate with GC/MS results" |
| Lay User Understanding of Instructions/Interpretation | Sufficient understanding for satisfactory use | "Participants responses support that the lay users can understand how to run the test, interpret the test results, the importance of confirmatory test, and some issues concerning certain prescription medicines and foods may affect the test results." |
Note: For the other drug tests (Marijuana, Cocaine, Amphetamine, etc.), the document states that their accuracy studies "can be found in the following 510(k) submissions: K061457, K091588, K091612, K110515, K122419, K123863, K130463, K131811, K132812." This implies that the accuracy for these drugs was established in prior submissions and accepted previously, but the specific numerical accuracy values are not reiterated in this document for each drug.
Study Details
1. Sample Size Used for the Test Set and Data Provenance:
- EDDP Test: 80 clinical urine specimens per drug (EDDP test specific, implies 80 specimens for EDDP). The document specifies "containing approximately 10% of the specimens containing one type drug at concentrations between -50% cutoff ranges, another 10% of the specimens containing one type drug at concentrations between cutoffs to +50% cutoff ranges."
- Consumer Study: 230 lay persons participated.
- Data Provenance:
- Country of Origin: Not explicitly stated for either clinical specimens or consumer study participants.
- Retrospective or Prospective: Not explicitly stated. The description of preparing urine samples for the consumer study ("spiking pure drugs or drug metabolites into drug free human urine") suggests a prospective, controlled laboratory setting rather than purely retrospective clinical samples. For the EDDP test, "clinical urine specimens" suggests real-world samples, but it's not specified if they were collected prospectively for the study or retrospectively.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- EDDP Test & Consumer Study: The ground truth was established by laboratory reference methods (GC/MS or HPLC). There is no mention of human "experts" establishing the ground truth by consensus for the core performance metrics.
3. Adjudication Method for the Test Set:
- Since the ground truth was established by reference laboratory methods (GC/MS/HPLC), no human adjudication method (e.g., 2+1, 3+1) was applicable or used.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
- No, an MRMC comparative effectiveness study involving human readers assisting AI or vice-versa was not done. This device is a rapid diagnostic test for drug detection, where the output is directly observed (e.g., lines on a test card), not an AI algorithm assisting human interpretation of complex images. The "consumer study" evaluates lay user interpretation of the device's results, but it's not a comparative effectiveness study of human readers with vs. without AI assistance.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This question is not directly applicable in the context of this device. The device itself is a standalone diagnostic test (a chemical immunoassay) that produces a visual result. There is no "algorithm" in the sense of software processing images or complex data. The performance of the device itself (its ability to detect drugs at given cut-offs) is assessed independently of human interpretation in the accuracy studies (e.g., EDDP test vs. GC/MS). The "consumer study" then assesses the human-in-the-loop performance (lay users interpreting the device's results).
6. The Type of Ground Truth Used:
- Laboratory Reference Methods:
- For the EDDP accuracy study: Gas Chromatography/Mass Spectrometry (GC/MS).
- For the consumer study: GC/MS for most drugs, and HPLC for Tricyclic Antidepressants (TCA).
- This falls under "outcomes data" in a sense, but more precisely, it's highly accurate chemical analysis acting as the gold standard.
7. The Sample Size for the Training Set:
- This is not applicable as the device is a chemical immunoassay, not a machine learning or AI model that requires a training set. The "development" of the test involves chemical and manufacturing processes, not data-driven model training.
8. How the Ground Truth for the Training Set was Established:
- Not applicable (see point 7).
§ 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).