(28 days)
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Methamphetamine (MET) | d-Methamphetamine | 500 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl(FYL) | Fentanyl | 1 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
The document describes the "AllTest Multi-Drug Urine Test Cup" and "AllTest Multi-Drug Rapid Urine Test Cup" and their performance characteristics.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for qualitative drug tests are typically demonstrated through precision studies, where the device consistently identifies samples at, above, and below predefined cutoff concentrations. The performance data presented in the "Precision/Reproducibility" section serves as the primary evidence. For qualitative tests, the acceptance criteria relate to the agreement with expected results at various concentrations relative to the cutoff.
Acceptance Criteria (Implied from the study design):
- At or above +25% cutoff: Expected to report as "Positive" (drug detected).
- At or below -25% cutoff: Expected to report as "Negative" (no drug detected).
- Around cutoff (+/- 25% of cutoff): A mix of positive and negative results is expected, reflecting the inherent variability near the cutoff threshold. This range is often considered the "equivocal" zone.
- Specificity (Cross-Reactivity): Low cross-reactivity with non-target compounds.
- Interference: No significant interference from common urine interferents or variations in pH and specific gravity.
- Lay-person usability: High agreement rate for lay users.
Reported Device Performance (from "Precision/Reproducibility" and "Lay Person Study"):
| Drug | Cutoff (ng/mL) | Performance at -100% cutoff | Performance at -75% cutoff | Performance at -50% cutoff | Performance at -25% cutoff | Performance at +25% cutoff | Performance at +50% cutoff | Performance at +75% cutoff | Performance at +100% cutoff | Lay Person Agreement (-100% cutoff) | Lay Person Agreement (-75% cutoff) | Lay Person Agreement (-50% cutoff) | Lay Person Agreement (-25% cutoff) | Lay Person Agreement (+25% cutoff) | Lay Person Agreement (+50% cutoff) | Lay Person Agreement (+75% cutoff) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMP | 500 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 90.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| BAR | 300 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ to 49-/1+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| BUP | 10 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 95.0% Positive | 100% Positive | 100% Positive |
| BZO | 300 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 90.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| COC | 150 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 90.0% Negative | 95.0% Positive | 100% Positive | 100% Positive |
| MDMA | 500 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| MET | 500 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 95.0% Positive | 100% Positive | 100% Positive |
| MOP/OPI | 300 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 90.0% Negative | 95.0% Positive | 100% Positive | 100% Positive |
| MTD | 300 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 95.0% Positive | 100% Positive | 100% Positive |
| OXY | 100 | 49-/1+ to 50-/0+ (Predominantly Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| PCP | 25 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 95.0% Positive | 100% Positive | 100% Positive |
| TCA | 1000 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 95.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| THC | 50 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 49-/1+ to 50-/0+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 90.0% Negative | 90.0% Positive | 100% Positive | 100% Positive |
| FYL | 1 | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 50-/0+ (All Negative) | 48-/2+ to 49-/1+ (Predominantly Negative) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 0-/50+ (All Positive) | 100% Negative | 100% Negative | 100% Negative | 90.0% Negative | 100% Positive | 100% Positive | 100% Positive |
2. Sample Size and Data Provenance for Test Set
-
Precision/Reproducibility Study:
- Sample Size: For each drug concentration level (e.g., +100% cutoff, -100% cutoff, and 7 intermediate levels), tests were performed two runs per day for 25 days using three lots of test cups. This means for each drug and each concentration, there were 2 runs/day * 25 days/lot * 3 lots = 150 test results recorded (number of negative and positive results).
- Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. The origin of the "drug-free urine samples" is not explicitly stated (e.g., country of origin). The study is retrospective in the sense that samples were artificially prepared and spiked, but prospective in the sense of testing these prepared samples by the device.
-
Method Comparison Study:
- Sample Size: 80 unaltered urine clinical samples were used for each drug (40 negative and 40 positive). This means 80 clinical samples per drug were tested against LC-MS/MS.
- Data Provenance: "unaltered urine clinical samples" - the country of origin is not specified. The study is retrospective as pre-collected samples were tested.
-
Lay Person Study:
- Sample Size: 140 lay persons. 20 samples were tested per concentration level for each drug. The samples were prepared by spiking drug(s) into drug-free pooled urine specimens at various concentrations.
- Data Provenance: Not specified for the drug-free pooled urine or the participants' origin. This study is prospective for the participants interacting with the device, but the samples themselves were artificially prepared.
3. Number of Experts and Qualifications for Ground Truth - Test Set
- Precision/Reproducibility Study: The ground truth was established by the manufacturer. "Each drug concentration was confirmed by LC-MS/MS." LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly accurate analytical chemistry technique. The individuals performing or analyzing LC-MS/MS results are typically trained laboratory technicians or chemists, but their specific "expert" qualifications (e.g., years of experience, certification) are not detailed.
- Method Comparison Study: The ground truth was established using LC-MS/MS results. Similar to the precision study, this relies on a precise analytical method, implying expert knowledge in operating and interpreting LC-MS/MS, but specific qualifications of individuals are not provided.
- Lay Person Study: The ground truth for the spiked samples was confirmed by LC-MS/MS.
4. Adjudication Method for Test Set
- Precision/Reproducibility Study: Not applicable in the traditional sense, as the ground truth was analytically determined by LC-MS/MS concentrations. The results are presented as counts of positive/negative.
- Method Comparison Study: Not applicable. The device's results were directly compared to the LC-MS/MS results. Discordant results (where the device disagreed with LC-MS/MS) are listed individually, but no further adjudication process is described beyond the quantitative LC-MS/MS result being the "Accurate Result."
- Lay Person Study: Not applicable. Lay users interpreted the device, and their interpretations were compared to the LC-MS/MS confirmed concentrations of the spiked samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test cup, not an AI-powered diagnostic system requiring human interpretation comparison. The "Lay person study" involved human readers (lay persons) but it was to assess their ability to use and interpret the device alone, not in comparison to an assisted workflow.
6. Standalone Performance
Yes, a standalone performance study was done. The precision/reproducibility and method comparison studies directly assess the algorithm's (the device's) performance in detecting drugs in urine samples compared to established analytical methods (LC-MS/MS) without human-in-the-loop assistance influencing the result (though humans perform the test and read the result line on the cup). The "Lay person study" also shows standalone performance as interpreted by lay users.
7. Type of Ground Truth Used
- Analytical Ground Truth: For the "Precision/Reproducibility" and "Lay Person" studies, the ground truth was analytically determined concentrations confirmed by LC-MS/MS after spiking known amounts of drugs into drug-free urine.
- Confirmatory Method Ground Truth: For the "Method Comparison Study," the ground truth was established by LC-MS/MS results on unaltered urine clinical samples.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI model development. This device is a rapid immunochromatographic assay, which is a chemical and biological test, not typically an AI/machine learning device that requires a training set. The various studies (precision, method comparison, lay person) serve as validation of the device's performance.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned for an AI/ML algorithm, this question is not applicable. The device itself is based on antigen-antibody reactions, not a trained algorithm.
§ 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).