(113 days)
The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressant. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. 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 results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
UCP Home Drug Screening Test Cups are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, Tricyclic Antidepressants 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 Summary for UCP Home™ Drug Screening Test Cups
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the UCP Home™ Drug Screening Test Cups are implicitly defined by the agreement rates obtained in the consumer study against GC/MS (or HPLC for TCA) reference method. While explicit numerical acceptance criteria (e.g., "must achieve >95% agreement") are not stated, the reported performance of "97% or above agreement rate with GC/MS results" indicates that this level of performance was deemed acceptable for market clearance.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Agreement Rate with Reference Method) |
|---|---|---|
| Consumer Study (Lay Users) | ≥97% Agreement | ≥97% agreement with GC/MS or HPLC results |
Note: An "Accuracy Study" comparing the device to predicate devices and reference methods (GC/MS/HPLC) also demonstrated "100% agreements between the candidate device and the predicate device" and "over 97.5% agreement between the candidate devices and the reference method GC/MS." This suggests that the internal accuracy criteria were met for healthcare professional use. However, for OTC clearance, the consumer study is the primary focus for usability and interpretability by lay users.
2. Sample Size and Data Provenance
Test Set (Consumer Study):
- Sample Size: 115 lay persons participated.
- Data Provenance: The study was conducted in "three geographic regions" within the United States. The data is prospective as participants performed the tests during the study.
Test Set (Accuracy Study):
- Sample Size: "Total 120 clinical urine samples per one drug test were included." (e.g., 120 samples for Marijuana, 120 for Cocaine, etc., implying multiple sets of 120 samples for each drug tested).
- Data Provenance: Clinical urine samples were obtained from "reference laboratories." The document does not specify the country of origin of these laboratories or whether the collection was retrospective or prospective, but the context of a 510(k) submission generally implies samples are relevant to the US population.
3. Number of Experts and Qualifications for Ground Truth
- Accuracy Study (Reference Method Confirmation): The reference method for confirming drug concentrations was GC/MS (Gas Chromatography/Mass Spectrometry), except for TCA which used HPLC (High-Performance Liquid Chromatography). These are instrumental methods that do not rely on human "experts" in the traditional sense of clinical interpretations. The "experts" would be the skilled technicians or analysts operating and interpreting the results from these analytical instruments. No specific number or qualification of these individuals is provided.
- Consumer Study (Reference Method Confirmation): Similar to the accuracy study, GC/MS (or HPLC for TCA) was used to confirm the final drug concentrations in the prepared urine samples.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for reconciling discrepancies between interpretations by multiple human readers (e.g., 2+1, 3+1). Instead:
- Accuracy Study: The device's results were directly compared against the objective reference methods (GC/MS/HPLC).
- Consumer Study: The lay users' interpretations of the device results were compared against the confirmed GC/MS/HPLC concentrations of the spiked urine samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The study mainly focused on:
- The device's accuracy against a gold standard (GC/MS/HPLC), simulating healthcare professional use.
- Lay user's ability to correctly perform and interpret the test according to instructions (consumer study).
There is no mention of human readers improving with or without AI assistance, as this is a qualitative immunoassay device, not an AI-powered diagnostic tool requiring human interpretation of complex images or data.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device itself.
- Accuracy Study: This study directly assessed the device's performance (results from the test cups as interpreted by trained professionals or objectively read) against the reference methods (GC/MS/HPLC). This represents the algorithm's (or device's intrinsic chemistry's) performance.
- Consumer Study: While involving lay users, the core assessment was whether the device's output could be correctly interpreted by them, thereby confirming the standalone performance as read by its intended (lay) user.
7. Type of Ground Truth Used for the Test Set
The ground truth used for both the accuracy study and the consumer study was objective chemical analysis:
- Gas Chromatography/Mass Spectrometry (GC/MS) for most drugs.
- High-Performance Liquid Chromatography (HPLC) for Tricyclic Antidepressants (TCA).
This provides a highly accurate and quantifiable measure of the drug and metabolite concentrations in the urine samples.
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" or sample size for training. This type of immunoassay device typically relies on established chemical and biological principles, and its performance characteristics are determined through analytical validation rather than machine learning training. The "training" in this context refers to the development and optimization of the assay components and parameters, which is not usually quantified by a "training set sample size" in regulatory submissions for such devices.
9. How Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of machine learning is not applicable here. The ground truth for the development and validation of the assay (analogous to how a training set informs an algorithm) would have been established through well-controlled laboratory experiments using known concentrations of drugs and their metabolites, confirmed by highly accurate analytical methods like GC/MS or HPLC. This iterative development and refinement process ensures the device's antibodies and reagents react appropriately to the target analytes at specified cut-off levels.
§ 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).