(90 days)
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the rapid detection of the following drugs in urine at the cut-off concentrations listed in Table 1. It is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a single-use device utilizing a cup format.
The device is based upon the Phamatech At Home 12 Drug Test Models 9308Z cleared in K070009 for home use for the detection of amphetamines(AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine(MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) in urine samples. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z adds testing for tricyclic antidepressants (TCA) (imipramine) and buprenorphine (BUP).
The QuickScreen Pro Multi-Drug Screening Test System is intended for use in prescription point-of-care settings.
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a chromatographic absorbent device in which drugs or drug metabolites in a urine sample compete with drug / protein conjugate immobilized on a porous membrane of the test device for a limited number of antibody / dye conjugate binding sites. The test device employs a unique combination of monoclonal and polyclonal antibodies to selectively identify drugs of abuse in urine. The test device also contains a self-timer that indicates when test results are ready to be interpreted.
Here's a breakdown of the acceptance criteria and study information for the QuickScreen Pro Multi Drug Screening Test, Model 9395Z, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the performance characteristics beyond the cut-off concentrations. Instead, it describes the established cut-off concentrations for each analyte and implies that the device's performance (sensitivity/precision) was evaluated against these cut-offs. The study focused on proving substantial equivalence to a predicate device, particularly for the newly added analytes (TCA and BUP).
Therefore, the "acceptance criteria" can be inferred to be the ability of the device to qualitatively detect the analytes in urine at or around the specified cut-off concentrations with acceptable precision/sensitivity. The "reported device performance" is a general statement that the device performs as intended and is substantially equivalent to the predicate for all analytes, with specific studies for TCA and BUP.
| Analyte | Abbreviation | Cut-off Concentration (ng/ml) (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Amphetamines | AMP | 1000 | Performs as intended, substantially equivalent to predicate |
| Barbiturates | BAR | 200 | Performs as intended, substantially equivalent to predicate |
| Benzodiazepines | BZD | 200 | Performs as intended, substantially equivalent to predicate |
| Cocaine | COC | 300 | Performs as intended, substantially equivalent to predicate |
| Ecstasy | MDMA | 500 | Performs as intended, substantially equivalent to predicate |
| Methadone | MTD | 300 | Performs as intended, substantially equivalent to predicate |
| Methamphetamine | MET | 500 | Performs as intended, substantially equivalent to predicate |
| Opiates | OPI | 300 | Performs as intended, substantially equivalent to predicate |
| Oxycodone | OXY | 100 | Performs as intended, substantially equivalent to predicate |
| Phencyclidine | PCP | 25 | Performs as intended, substantially equivalent to predicate |
| Marijuana | THC | 50 | Performs as intended, substantially equivalent to predicate |
| Tricyclic Antidepressants | |||
| (Imipramine) | TCA (Imipramine) | 1000 | Performance testing conducted, performs as intended |
| Buprenorphine | BUP | 10 | Performance testing conducted, performs as intended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test sets for each type of performance study (Method Comparison, Assay Interference, Assay Precision/Sensitivity, Prozone Response, Sample pH, Read Time, Sample Temperature, Specific Gravity).
Data provenance is not explicitly stated regarding country of origin; however, the manufacturer is Phamatech, Inc. in San Diego, CA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve testing the device to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For a drug screening test, the ground truth is typically established by analytical methods (like GC/MS) or by spiking urine samples with known concentrations of analytes.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method by human readers for the test set. For a qualitative immunoassay, the result is read directly from the test lines (presence or absence), and the comparison is to the confirmed analytical result.
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
No MRMC comparative effectiveness study was done, nor does the document describe any AI component to the device. This is a point-of-care, qualitative immunoassay designed for direct interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm-only device. It is a physical immunoassay kit that produces a visual result. The "standalone" performance would refer to the device itself providing a result that is then compared to an analytical standard, which is implied by the performance studies (e.g., precision/sensitivity). There are no "human-in-the-loop" aspects in terms of interpretation algorithms to evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of device is established by analytical methods, specifically by preparing urine samples with known concentrations of the analytes (e.g., using fortified samples at various concentrations around the cut-off) and comparing the device's results to these known concentrations, or by confirming positive results with a gold standard like Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating this is the expected ground truth for confirmation.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This is common for immunoassay devices, where performance is typically established through analytical validation studies rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described for a machine learning algorithm, the concept of establishing ground truth for a training set does not apply here. The device's performance is validated against analytical standards and comparative methods.
§ 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).