(450 days)
The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.
The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/ml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone , oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
The Phamatech QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of various drugs or their metabolites in urine. This analysis focuses on the performance studies for the change to a 150 ng/ml cutoff concentration for cocaine (benzoylecgonine).
1. Acceptance Criteria and Reported Device Performance for Cocaine (150 ng/ml cutoff)
The acceptance criteria for the device performance are implicitly demonstrated by the reported agreement percentages with GC/MS results and the precision at various concentrations around the cutoff. While explicit numerical acceptance criteria are not stated as "thresholds," the reported performance values are presented to demonstrate substantial equivalence to predicate devices.
| Category | Acceptance Criteria (Implicit) | Reported Device Performance (Cocaine 150 ng/ml cutoff) |
|---|---|---|
| Clinical Sample Correlation (Agreement with GC/MS) | High agreement percentage with GC/MS results for both positive and negative samples, particularly around the cutoff. | Dipcard: 98.75% agreement for positive results, 100% agreement for negative results. |
| Cassette: 98.75% agreement for positive results, 100% agreement for negative results. | ||
| Cup: 98.75% agreement for positive results, 100% agreement for negative results. | ||
| Multi-dip: 97.5% agreement for positive results, 100% agreement for negative results. | ||
| Precision around Cutoff | Consistent and accurate detection of positive samples above the cutoff and negative samples below the cutoff. | At Cutoff (150 ng/ml): |
| Multi Card: 12 positive, 68 negative | ||
| Cup: 21 positive, 59 negative | ||
| Cassette: 15 positive, 65 negative | ||
| At 125% of Cutoff (187.5 ng/ml): 100% positive detection across all formats. | ||
| At 75% of Cutoff (112.5 ng/ml): 100% negative detection across all formats. | ||
| Other Technical Performance Tests | Acceptable results for interference, lot-to-lot consistency, prozone response, and environmental factors. | "Other technical performance tests include: Assay Interference - Negative base, Assay Interference – Positive base, Lot to Lot Consistency, Prozone Response, Effect of Sample pH, Test Strip Dip Time Flex, Read Time Flex, Sample Temperature Flex, Specific Gravity Effects, Format Equivalency." (Results not detailed in provided text, but implied as acceptable). |
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- Method Comparison (Clinical Samples): 80 unaltered clinical urine samples were tested.
- Precision around Cutoff (Spiked Samples): For each concentration level (Negative, -75%, -50%, -25%, Cutoff, 125%, 150%, 175%, 200%), samples were tested across 3 sites by 3 technicians for 20 days. The number of individual tests per concentration can be inferred. For example, at "Cutoff", 80 tests were performed (e.g., 20 days * 3 technicians * X number of tests per technician per day, or a total of 80 combined tests). The provided table lists a total of 80 observations (e.g., 12 pos + 68 neg = 80 for "Multi Card" at cutoff). This implies a total of 80 tests per concentration per format.
- Data Provenance:
- Clinical Samples: Described as "unaltered clinical urine samples." The country of origin is not explicitly stated, but the submission is to the FDA in the USA, implying potential origin from the USA.
- Spiked Samples: "Standard drug solutions diluted in drug free urine." These are laboratory-prepared samples.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: For the method comparison study, "3 operators who are typical operators at this site" performed the tests on the QuickScreen devices.
- Qualifications of Experts: Their specific qualifications (e.g., years of experience, professional titles) are not detailed beyond "typical operators at this site."
- Ground Truth Qualification: The primary ground truth for the clinical samples was established by GC/MS results, which is a gold standard analytical method.
4. Adjudication Method for the Test Set
The adjudication method for the test set is not explicitly described in the provided text. The method comparison states that the 80 clinical samples were "blinded and sufficiently randomized and compared to GC/MS results." This indicates a direct comparison to the GC/MS reference, rather than an adjudication process between human readers or between a human reader and AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluates the performance of human readers with and without AI assistance. The QuickScreen Drug Screening Test System is an immunoassay device, not an AI-driven imaging or diagnostic software that assists human readers.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The entire performance evaluation described in the document, including the clinical sample correlation study and the precision studies, represents the standalone performance of the QuickScreen device itself, without human interpretation in a diagnostic workflow (beyond the initial visual reading for qualitative results). The agreementpercentages and precision values directly reflect the device's ability to detect the analytes.
7. Type of Ground Truth Used
- Clinical Samples: The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the confirmatory method and the "gold standard" for drug testing.
- Spiked Samples: The ground truth for the precision studies was based on the known concentrations of standard drug solutions diluted in drug-free urine.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI development. The QuickScreen device is a lateral flow immunoassay. Thus, there is no AI algorithm that requires a separate training set. The performance studies mentioned are for validation of the chemical assay.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of AI for this immunoassay device, this question is not applicable. The device's underlying chemical principles are developed and validated, not "trained" on data samples.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).