(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text to the right of the square.
Hangzhou Alltest Biotech Co.,Ltd % Jenny Xia Director LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K241428
Trade/Device Name: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, NGM, QAW, NFW Dated: May 16, 2024 Received: May 20, 2024
Dear Jenny Xia:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve
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changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph A.
Kotarek -S
Digitally signed by Joseph A. Kotarek -S Date: 2024.06.17 15:25:55 -04'00'
Joseph Kotarek Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241428
Device Name
AllTest Multi-Drug Urine Test Cup AllTest Multi-Drug Rapid Urine Test Cup
Indications for Use (Describe)
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 |
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| 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K241428
- June 15, 2024 1. Date: Hangzhou AllTest Biotech Co., Ltd. 2. Submitter: Plant Bldg. 3, 4, 5, No. 550 Yinhai Street, Baiyang Street, Hangzhou ETDZ, Jianggan District Contact person: 3. Jenny Xia LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 301-525-6856 Email: jxia@lsi-consulting.org
- Device Name: AllTest Multi-Drug Urine Test Cup 4. AllTest Multi-Drug Rapid Urine Test Cup Classification: 5. Class II
| Product CodeTarget Drug | Regulation Section | Panel |
|---|---|---|
| NFTAmphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTHSecobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGLBuprenorphine (BUP)Fentanyl (FYL)Morphine (MOP/OPI)Oxycodone (OXY) | 862.3650, Opiate Test System | Toxicology |
| NFVOxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFYCocaine (COC) | 862.3250, Cocaine and cocainemetabolite test system | Toxicology |
| PTGMethadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGGMethylenedioxymethamphetamine (MDMA)Methamphetamine (MET) | 862.3610,Methamphetamine Test System | Toxicology |
| NGMPhencyclidine (PCP) | Unclassified | Toxicology |
| QAWNortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugstest system | Toxicology |
| NFW | 862.3870, Cannabinoids Test System | Toxicology |
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Predicate Devices: 6.
AllTest Multi-Drug Rapid Test Cup (K233019)
7. Intended Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, 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 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.
{6}------------------------------------------------
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, 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-9COOH | 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 is the recommended confirmatory method.
8. Device Description
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.
{7}------------------------------------------------
| 9. Substantial Equivalence InformationSimilarities | ||
|---|---|---|
| Item | Device | Predicate (K233019) |
| Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | Same. |
| Methodology | Competitive binding, lateral flowimmunochromatographicassay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug andCut Off Values | Target Drugs | Cutoff (ng/mL) |
| Amphetamine(AMP) | 500 | |
| Secobarbital (BAR) | 300 | |
| Buprenorphine (BUP) | 10 | |
| Oxazepam (BZO) | 300 | |
| Cocaine (COC) | 150 | |
| Fentanyl (FYL) | 1 | |
| Methylenedioxymethamphetamine (MDMA) | 500 | |
| Methamphetamine (MET) | 500 | |
| Morphine (MOP/OPI) | 300 | |
| Methadone (MTD) | 300 | |
| Oxycodone (OXY) | 100 | |
| Phencyclidine (PCP) | 25 | |
| Nortriptyline (TCA) | 1000 | |
| Cannabinoids (THC) | 50 | |
| Configurations | Test Cup | Same |
Substantial Equivalence Information 0
10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
AllTest Multi-Drug Urine Test Cup or AllTest Multi-Drug Rapid Urine Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
{8}------------------------------------------------
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
12. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Samples were prepared by spiking target drugs in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:
| Drug | LotNumber | +100%cutoff | +75%cutoff | +50%cutoff | +25%cutoff | Cutoff | -25%cutoff | -50%cutoff | -75%cutoff | -100%cut-off |
|---|---|---|---|---|---|---|---|---|---|---|
| AMP500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| BAR300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| BZO300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| MDMA500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| MET500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{9}------------------------------------------------
| MOP/OPI300 | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
|---|---|---|---|---|---|---|---|---|---|---|
| MTD300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| OXY100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| TCA1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| THC50 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| COC150 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| FYL 1 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30℃ for 24 months based on real time stability study.
d. Analytical specificity/Interference:
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.
| Drug/Cutoff | Compound | Minimumconcentrationrequired to obtaina positive result | % Cross-Reactivity |
|---|---|---|---|
| (ng/mL) | |||
| Hydroxyamphetamine | 5000 | 10% | |
| (+/-)- Methylenedioxyamphetamine(MD A) | 25 | 2000% | |
| D,L-Amphetamine | 500 | 100% | |
| D-Amphetamine | 500 | 100% | |
| Diethylstilbestrol | >100000 | <0.5% | |
| L-Amphetamine | 500 | 100% | |
| Phentermine | 500 | 100% | |
| ẞ-Phenylethylamine | >100000 | <0.5% | |
| Tyramine | >100000 | <0.5% | |
| p-Hydroxynorephedrine | >100000 | <0.5% | |
| D,L-Norephedrine | >100000 | <0.5% | |
| AMP 500 | p-Hydroxyamphetamine | 5000 | 10% |
| D-Methamphetamine | >100000 | <0.5% | |
| L-Methamphetamine | >100000 | <0.5% | |
| Ephedrine hydrochloride | >100000 | <0.5% | |
| (+/-)3,4-Methylenedioxymethamphetamine(MDMA) | 100000 | 0.5% | |
| Phenylpropanolamine | >100000 | <0.5% | |
| Benzphetamine | >100000 | <0.5% | |
| L-Ephedrine | >100000 | <0.5% | |
| L-Epinephrine | >100000 | <0.5% | |
| D,L-Epinephrine | >100000 | <0.5% | |
| (+/-)3,4-Methylenedioxyethylamphetamine(MDEA) | 100000 | 0.5% | |
| Alphenal | 300 | 100% | |
| Amobarbital | 300 | 100% | |
| BAR 300 | Aprobarbital | 300 | 100% |
| Butabarbital | 500 | 60% | |
| Butethal | 200 | 150% | |
| Cyclopentobarbital | 500 | 60% | |
| Pentobarbital | 200 | 150% | |
| Phenobarbital | 200 | 150% | |
| Secobarbital | 300 | 100% | |
| Butalbital | 2000 | 15% | |
| Barbital | 300 | 100% | |
| BUP 10 | Buprenorphine | 10 | 100% |
| Buprenorphine-3-D-Glucuronide | 20 | 50% | |
| Norbuprenorphine | 20 | 50% | |
| Norbuprenorphine-3-D-Glucuronide | 20 | 50% | |
| Morphine | >100000 | <0.01% | |
| Oxymorphone | >100000 | <0.01% | |
| Hydromorphone | >100000 | <0.01% | |
| Codeine | >100000 | <0.01% | |
| Nalorphine | >100000 | <0.01% | |
| a-Hydroxyalprazolam | 10000 | 3% | |
| Alprazolam | 200 | 150% | |
| Bromazepam | 1000 | 30% | |
| Chlordiazepoxide | 300 | 100% | |
| Clobazam | 200 | 150% | |
| Clonazepam | 200 | 150% | |
| Clorazepate Dipotassium | 300 | 100% | |
| Desalkylflurazepam | >100000 | <0.3% | |
| BZO 300 | Diazepam | 300 | 100% |
| Estazolam | 100 | 300% | |
| Flunitrazepam | 300 | 100% | |
| D,L-Lorazepam | 1000 | 30% | |
| Midazolam | 1000 | 30% | |
| Nitrazepam | 200 | 150% | |
| Norchlordiazepoxide | 200 | 150% | |
| Nordiazepam | 200 | 150% | |
| Oxazepam | 300 | 100% | |
| R S-Lorazepam glucuronide | 1000 | 30% | |
| Temazepam | 100 | 300% | |
| Triazolam | 300 | 100% | |
| Demoxepam | 2000 | 15% | |
| Flurazepam | 300 | 100% | |
| Delorazepam | 2000 | 15% | |
| Lormetazepam | 100 | 300% | |
| Benzoylecogonine | 150 | 100% | |
| Cocaethylene | 250 | 60% | |
| Cocaine hydrochloride | 125 | 120% | |
| COC 150 | Ecgonine | >100000 | <0.2% |
| Norcocaine | >100000 | <0.2% | |
| Ecgonine methyl ester | >100000 | <0.2% | |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 250 | 200% | |
| (+/-)-Methylenedioxyamphetamine(MDA) | 1000 | 50% | |
| MDMA | 500 | 100% | |
| L-Methamphetamine | >100000 | <0.5% | |
| d-methamphetamine | >100000 | <0.5% | |
| MDMA 500 | d-amphetamine | >100000 | <0.5% |
| l-amphetamine | >100000 | <0.5% | |
| d,l-Amphetamine | >100000 | <0.5% | |
| d,l-Methamphetamine | >100000 | <0.5% | |
| Phentermine | >100000 | <0.5% | |
| Phenylephrine | >100000 | <0.5% | |
| Ephedrine | >100000 | <0.5% | |
| Pseudoephedrine | >100000 | <0.5% | |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 6000 | 8.3% | |
| MDMA | 1000 | 50% | |
| MET 500 | D-Methamphetamine | 500 | 100% |
| L-Methamphetamine | 10000 | 5% | |
| p-Hydroxymethamphetamine | 250 | 200% | |
| D,L-Methamphetamine | 250 | 200% | |
| β-Phenylethylamine | >100000 | <0.5% | |
| Mephetermine | 25000 | 2% | |
| Methoxyphenamine hydrochloride | 75000 | 0.7% | |
| L-Amphetamine | 100000 | 0.5% | |
| D-Amphetamine | 100000 | 0.5% | |
| D,L-Amphetamine | 250 | 200% | |
| Chloroquine | 25000 | 2.0% | |
| Ephedrine hydrochloride | >100000 | <0.5% | |
| (+/-)3,4-Methylenedioxyamphetamine(MDA) | >100000 | <0.5% | |
| Trimethobenzamide | >100000 | <0.5% | |
| l-phenylephrine | >100000 | <0.5% | |
| (1R,2S)-(-)-Ephedrine | >100000 | <0.5% | |
| Procaine hydrochloride | >100000 | <0.5% | |
| Phentermine | >100000 | <0.5% | |
| Pseudoephedrine | >100000 | <0.5% | |
| 6-acetylmorphine | 300 | 100% | |
| MOP/OPI300 | Codeine | 250 | |
| Dihydrocodeine | 5000 | 6% | |
| EthylMorphine | 200 | 150% | |
| Heroin | 500 | 60% | |
| Hydrocodone | 1000 | 30% | |
| Hydromorphone | 10000 | 3% | |
| Levorphanol tartrate | 1500 | 20% | |
| Morphine | 300 | 100% | |
| Nalorphine hydrochloride | 300 | 100% | |
| Thebaine | 20000 | 1.5% | |
| s-Monoacetylmorphine | 300 | 100% | |
| Morphine-3-β-d-glucuronide | 1000 | 30% | |
| 6-Monoacetylmorphine (6-MAM) | 300 | 100% | |
| Codeine-6-ß-D-glucuronide | 25000 | 1.2% | |
| Morphine-6-β-D-glucuronide | 1000 | 30% | |
| 6-Acetylcodeine | 25000 | 1.2% | |
| Normorphine | 50000 | 0.6% | |
| Oxycodone | >100000 | <0.3% | |
| Oxymorphone | >100000 | <0.3% | |
| Norcodeine | 25000 | 1.2% | |
| Procaine hydrochloride | >100000 | <0.3% | |
| Norpropoxyphene | >100000 | <0.3% | |
| MTD 300 | (±)-Methadone | 300 | 100% |
| EDDP | >100000 | <0.3% | |
| EMDP | >100000 | <0.3% | |
| LAAM | >100000 | <0.3% | |
| Alpha Methadol | >100000 | <0.3% | |
| Doxylamine | >100000 | <0.3% | |
| Disopyramide | 6000 | 5.0% | |
| Esomeprazole | 10000 | 3.0% | |
| Pheniramine | 100000 | 0.3% | |
| OXY 100 | Ethyl Oxycodone | 100 | 100% |
| Hydrocodone | 50000 | 0.2% | |
| Hydromorphone | 25000 | 0.4% | |
| Levorphanol tartrate | 50000 | 0.2% | |
| Naloxone hydrochloride | 50000 | 0.2% | |
| Naltrexone hydrochloride | >100000 | <0.1% | |
| Oxycodone | 100 | 100% | |
| Oxymorphone | 100 | 100% | |
| Oxymorphone-3β-D-glucuronide | >100000 | <0.1% | |
| Noroxycodone | 1000 | 10% | |
| Noroxymorphone | 25000 | 0.4% | |
| Dihydrocodeine | 12500 | 0.8% | |
| Codeine | 100000 | 0.1% | |
| Morphine | >100000 | <0.1% | |
| Acetylmorphine | >100000 | <0.1% | |
| Buprenorphine | >100000 | <0.1% | |
| Ethylmorphine | >100000 | <0.1% | |
| Thebaine | >100000 | <0.1% | |
| 6-acetylmorphine | >100000 | <0.1% | |
| PCP 25 | PCP (Phencyclidine) | 25 | 100% |
| 4-Hydroxyphencyclidine | 15 | 167% | |
| Pheniramine | 50000 | 0.05% | |
| TCA 1000 | Amitriptyline | 1500 | 66.7% |
| Chlorpheniramine | >100000 | <1% | |
| Clomipramine | 1000 | 100% | |
| Cyclobenzaprine Hydrochloride | >100000 | <1% | |
| Desipramine | 300 | 333.3% | |
| Doxepine | 10000 | 10% | |
| Duloxetine | >100000 | <1% | |
| Imipramine | 500 | 200% | |
| Norclomipramine | 250 | 400% | |
| Nordoxepine | >100000 | <1% | |
| Nortriptyline hydrochloride | 1000 | 100% | |
| Promazine | 500 | 200% | |
| Trimipramine | 1500 | 66.7% | |
| Maprotiline | >100000 | <1% | |
| Promethazine hydrochloride | 50000 | 2% | |
| THC 50 | 11-nor-Δ8-THC-9-COOH | 20000 | 0.25% |
| (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% | |
| (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% | |
| 11-nor-Δ9-THC -carboxyglucuronide | 50 | 100% | |
| 11-hydroxy-Δ9- | |||
| Tetrahydrocannabinol | 5000 | 1.0% | |
| Δ8- Tetrahydrocannabinol | 100000 | 0.05% | |
| Δ9- Tetrahydrocannabinol | 100000 | 0.05% | |
| Cannabinol | >100000 | <0.05% | |
| Cannabidiol | >100000 | <0.05% | |
| FYL 1 | Fentanyl | 1 | 100% |
| Acetyl fentanyl | 1 | 100% | |
| Acrylfentanyl | 1 | 100% | |
| ω-1-Hydroxyfentanyl | 20000 | 0.005% | |
| Isobutyryl fentanyl | 1 | 100% | |
| Ocfentanil | 2.5 | 40% | |
| Butyryl fentanyl | 2.5 | 40% | |
| Furanyl fentanyl | 5 | 20% | |
| Valeryl fentanyl | 10 | 10% | |
| (±) β-hydroxythiofentanyl | 2 | 50% | |
| 4-Fluoro-isobutyrylfentanyl | 50 | 2% | |
| Para-fluorobutyryl fentanyl | 4 | 25% | |
| Para-fluoro fentanyl | 3 | 33.3% | |
| (±)-3-cis-methyl fentanyl | 50 | 2% | |
| Carfentanil | 2 | 50% | |
| Sufentanil | 10 | 10% | |
| Alfentanil | 5000 | 0.02% | |
| Despropionyl fentanyl (4-ANPP) | 2500 | 0.04% | |
| Remifentanil | >100000 | <0.001% | |
| Norfentanyl | >100000 | <0.001% | |
| Acetyl norfentanyl | >100000 | <0.001% | |
| Norcarfentanil | >100000 | <0.001% | |
| 6-Acetyl morphine | >100000 | <0.001% | |
| Amphetamine | >100000 | <0.001% | |
| Buprenorphine | >100000 | <0.001% | |
| Buprenorphineglucuronide | >100000 | <0.001% | |
| Codeine | >100000 | <0.001% | |
| Dextromethorphan | >100000 | <0.001% | |
| Dihydrocodeine | >100000 | <0.001% | |
| EDDP | >100000 | <0.001% | |
| EMDP | >100000 | <0.001% | |
| Fluoxetine | >100000 | <0.001% | |
| Heroin | >100000 | <0.001% | |
| Hydrocodone | >100000 | <0.001% | |
| Hydromorphone | >100000 | <0.001% | |
| Ketamine | >100000 | <0.001% | |
| Levorphanol | >100000 | <0.001% | |
| Meperidine | >100000 | <0.001% | |
| Methadone | >100000 | <0.001% | |
| Morphine | >100000 | <0.001% | |
| Morphine-3-glucuronide | >100000 | <0.001% | |
| Naloxone | >100000 | <0.001% | |
| Naltrexone | >100000 | <0.001% | |
| Norbuprenorphine | >100000 | <0.001% | |
| Norcodeine | >100000 | <0.001% | |
| Norketamine | >100000 | <0.001% | |
| Normeperidine | >100000 | <0.001% | |
| Normorphine | >100000 | <0.001% | |
| Noroxycodone | >100000 | <0.001% | |
| Oxycodone | >100000 | <0.001% | |
| Oxymorphone | >100000 | <0.001% | |
| Pentazocine (Talwin) | >100000 | <0.001% | |
| Pipamperone | >100000 | <0.001% | |
| Risperidone | >100000 | <0.001% | |
| Tapentadol | >100000 | <0.001% | |
| Thioridazine | >100000 | <0.001% | |
| Tilidine | >100000 | <0.001% | |
| Tramadol | >100000 | <0.001% | |
| Tramadol-O-Desmethyl | >100000 | <0.001% | |
| Tramadol-N-Desmethyl | >100000 | <0.001% |
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
{17}------------------------------------------------
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.
Compounds that show no interference at a concentration of 100μg/mL are summarized in the following table.
| 3-Hydroxytyramine | Digoxin | Nitroglycerin |
|---|---|---|
| Acetaminophen | Diphenhydramine HCl | Nordoxepin |
| Acetone(1000mg/dL) | Disopyramide(except MTD test) | Norethindrone |
| Acetophenetidin | DL-Tryptophan | Norfentanyl |
| Acetylsalicylic acid | DL-Tyrosine | Noscapine |
| Acyclovir | Dopamine HCl | O-Hydroxyhippuric acid |
| Albumin(100mg/dL) | Doxepin(except TCA test) | Octopamine |
| Albuterol sulfate(Proair HFA) | Doxylamine | Olanzapine |
| Alpha Methadol | Duloxetine | Omeprazole |
| Aminophylline | Ecgonine methyl ester | Oxalic acid (100 mg/dL) |
| Aminopyrine | EMDP | Oxolinic acid |
| Amoxicillin | Ephedrine | Oxymetazoline |
| Ampicillin | Erythromycin | Paliperidone |
| Apomorphine | Magnesium(except MTD test) | Papaverine |
| Aripiprazole | Ethanol(1%) | Penicillin-G |
| Ascorbic acid | Fenoprofen | PenicillinV Potassium |
| Aspartame | Fluoxetine Hydrochloride | Perphenazine |
| Aspirin | Fluphenazine | Phenacetin |
| Atomoxetine | Furosemide | Phenelzine |
| Atorvastatin Calcium | Gabapentin | Phenethylamine |
| Atropine | Galactose (10mg/dL) | Phenylpropanolamine |
| Azithromycin | Gamma Globulin (500mg/dL) | Prednisone |
| Benzilic acid | Gatifloxacin | Pregablin |
| Benzocaine | Gentisic acid | Procaine |
| Benzoic acid | Glucose (3000mg/dL) | Promethazine(except TCAtest) |
| Benzphetamine | Hemoglobin | Propoxyphene |
| Bilirubin | Hydralazine | Propranolol |
| Boric Acid (1%) | Hydrochlorothiazide | Pseudoephedrine |
| Bupropion | Hydrocortisone | Quetiapine |
| Caffeine | Hydroxytyramine | Quinine |
| Cannabidiol | Ibuprofen | Ranitidine |
| Captopril | Isoproterenol | Riboflavin (10mg/dL) |
| Carbamazepine | Isoxsuprine | Rifampicin |
| Carfentanil(except FYL test) | Ketamine | Risperidone |
| Cefradine | Ketoprofen | Salicylic acid |
| Cephalexin | L-Ephedrine | Serotonin (5-Hydroxytyramine) |
| Chloralhydrate | L-Epinephrine | Sertraline |
| Chloramphenicol | L-phenylephrine | Sildenafil Citrate |
| Chloroquine(except MET test) | LAAM HCl | Simvastatin |
| Chlorothiazide | Labetalol | Sulfamethazine |
| Chlorpheniramine | Levofloxacin Hydrochloride | Sulindac |
| Chlorpromazine | Levonorgestrel | Telmisartan |
| Cholesterol | Levothyroxine Sodium | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Ciprofloxacin Hydrochloride | Lidocaine Hydrochloride | Tetrahydrocortisone, 3-acetate |
| Citalopram | Lisinopril | Tetrahydrozoline |
| Clarithromycin | Loperamide | Theophylline |
| Clonidine | Loratadine | Thiamine |
| Clozapine | Magnesium | Thioridazine |
| Conjugated Estrogens | Maprotiline | Tramadol Hydrochloride |
| Cortisone | Meperidine | Triamterene |
| Cotinine | Meprobamate | Trifluoperazine |
| Creatinine | Methapyrilene | Trimethobenzamide |
| Cyclobenzaprine | Methaqualone | Trimethoprim |
| Methoxyphenamine (except | ||
| D-Pseudoephedrine | AMP/MET test) | Tyramine |
| D,L-Epinephrine | Metoprolol Tartrate | Urea (2000mg/dL) |
| D,L-Isoproterenol | Metronidazole (300ug/ml) | Uric acid |
| D,L-Octopamine | Mifepristone | Valproic acid (250ug/ml) |
| D,L-Propranolol | N-Acetylprocainamide | Venlafaxine HCl |
| D,L-Tryptophan | NaCl (4000mg/dL) | Verapamil |
| D,L-Tyrosine | Nalidixic acid | Vitamin B2 |
| Naloxone | ||
| Delorazepam(except BZOtest) | hydrochloride(except OXYtest) | Vitamin C |
| Deoxycorticosterone | Naltrexone hydrochloride | Zaleplon |
| Desloratadine | Naproxen | Zomepirac |
| Dextromethorphan | Niacinamide | ẞ-Estradiol |
| Diclofenac sodium | Nicotine | |
| Diflunisal | Nifedipine |
{18}------------------------------------------------
{19}------------------------------------------------
Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
B. Method comparison study
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:
| Drugtest | Test DipcardResult | Drug-Free | LowNegative byLC-MS/MS(less than -50%) | Near CutoffNegative byLC-MS/MS(Between -50% and the | Near CutoffPositive byLC-MS/MS(Betweenthe cutoff | High Positiveby LC-MS/MS(greater than+50%) | |
|---|---|---|---|---|---|---|---|
| Cutoff) | and +50%) | ||||||
| AMP | Operator | + | 0 | 0 | 1 | 9 | 30 |
| A | - | 12 | 13 | 14 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 10 | 30 | |
| B | - | 12 | 13 | 14 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 9 | 30 | |
| C | - | 12 | 13 | 15 | 1 | 0 | |
| BAR | Operator | + | 0 | 0 | 1 | 15 | 25 |
| A | - | 12 | 14 | 13 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 14 | 25 | |
| B | - | 12 | 14 | 14 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 14 | 25 | |
| C | - | 12 | 14 | 13 | 1 | 0 | |
| BUP | Operator | + | 0 | 0 | 0 | 10 | 29 |
| A | - | 12 | 17 | 11 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 11 | 29 | |
| B | - | 12 | 17 | 10 | 0 | 0 | |
| Operator | + | 0 | 0 | 1 | 11 | 29 | |
| C | - | 12 | 17 | 10 | 0 | 0 | |
| BZO | Operator | + | 0 | 0 | 1 | 11 | 28 |
| A | - | 12 | 13 | 14 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 12 | 28 | |
| B | - | 12 | 13 | 14 | 0 | 0 | |
| Operator | + | 0 | 0 | 1 | 11 | 28 | |
| C | - | 12 | 13 | 14 | 1 | 0 | |
| COC | Operator | + | 0 | 0 | 0 | 11 | 28 |
| A | - | 12 | 18 | 10 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 12 | 28 | |
| B | - | 12 | 18 | 9 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 11 | 28 | |
| C | - | 12 | 18 | 10 | 1 | 0 | |
| MDMA | Operator | + | 0 | 0 | 1 | 13 | 27 |
| A | - | 12 | 14 | 13 | 0 | 0 | |
| Operator | + | 0 | 0 | 1 | 12 | 27 | |
| B | - | 12 | 14 | 13 | 1 | 0 | |
| Operator | + | 0 | 0 | 0 | 13 | 27 | |
| C | - | 12 | 14 | 14 | 0 | 0 | |
| MET | Operator | + | 0 | 0 | 0 | 11 | 29 |
| A | - | 12 | 16 | 12 | 0 | 0 | |
| Operator | + | 0 | 0 | 1 | 11 | 29 | |
| B | - | 12 | 16 | 11 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 10 | 29 | |
| C | - | 12 | 16 | 12 | 1 | 0 | |
| MOP/OPI | Operator | + | 0 | 0 | 1 | 14 | 26 |
| A | - | 12 | 16 | 11 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 13 | 26 | |
| B | - | 12 | 16 | 12 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 13 | 26 | |
| C | - | 12 | 16 | 11 | 1 | 0 | |
| MTD | Operator | + | 0 | 0 | 1 | 11 | 29 |
| A | - | 12 | 16 | 11 | 0 | 0 | |
| Operator | + | 0 | 0 | 1 | 11 | 29 | |
| B | - | 12 | 16 | 11 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 10 | 29 | |
| C | - | 12 | 16 | 12 | 1 | 0 | |
| OXY | Operator | + | 0 | 0 | 1 | 12 | 28 |
| A | - | 12 | 16 | 11 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 12 | 28 | |
| B | - | 12 | 16 | 12 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 11 | 28 | |
| C | - | 12 | 16 | 12 | 1 | 0 | |
| PCP | Operator | + | 0 | 0 | 0 | 12 | 27 |
| A | - | 12 | 16 | 14 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 12 | 27 | |
| B | - | 12 | 16 | 13 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 12 | 27 | |
| C | - | 12 | 16 | 13 | 1 | 0 | |
| TCA | Operator | + | 0 | 0 | 1 | 10 | 30 |
| A | - | 12 | 15 | 14 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 9 | 30 | |
| B | - | 12 | 15 | 15 | 1 | 0 | |
| Operator | + | 0 | 0 | 1 | 10 | 30 | |
| C | - | 12 | 15 | 14 | 0 | 0 | |
| THC | Operator | + | 0 | 0 | 1 | 10 | 30 |
| A | - | 12 | 17 | 10 | 0 | 0 | |
| Operator | + | 0 | 0 | 0 | 9 | 30 | |
| B | - | 12 | 17 | 11 | 1 | 0 | |
| Operator | + | 0 | 0 | 0 | 9 | 30 | |
| C | - | 12 | 17 | 11 | 1 | 0 | |
| FYL | Operator | + | 0 | 0 | 2 | 22 | 16 |
| A | - | 12 | 13 | 13 | 2 | 0 | |
| OperatorB | + | 0 | 0 | 2 | 22 | 16 | |
| - | 12 | 13 | 13 | 2 | 0 | ||
| OperatorC | + | 0 | 0 | 3 | 22 | 16 | |
| - | 12 | 13 | 12 | 2 | 0 |
{20}------------------------------------------------
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{22}------------------------------------------------
Discordant Results are summarized below.
| Discordant Results are summarized below. | ||||
|---|---|---|---|---|
| Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Accurate Result |
| AMP | A | N0949 | 491.559 | + |
| A | N0966 | 619.861 | - | |
| B | N0949 | 491.559 | + | |
| C | N0966 | 619.861 | - | |
| BAR | A | N0728 | 271.093 | + |
| B | N0756 | 304.564 | - | |
| C | N0728 | 271.093 | + | |
| C | N0756 | 304.564 | - | |
| BUP | A | N1328 | 11.971 | - |
| B | N1353 | 9.149 | + | |
| C | N1353 | 9.149 | + | |
| BZO | A | N0825 | 297.539 | + |
| A | N0840 | 306.319 | - | |
| B | N0825 | 297.539 | + | |
| C | N0818 | 261.170 | + | |
| C | N0840 | 306.319 | - | |
| COC | A | N0557 | 151.609 | - |
| B | N0538 | 122.809 | + | |
| C | N0557 | 151.609 | - | |
| MDMA | A | N0254 | 412.537 | + |
| B | N0220 | 503.780 | - | |
| B | N0254 | 412.537 | + | |
| MET | B | N1066 | 482.955 | + |
| C | N1032 | 514.414 | - | |
| MOP/OPI | A | N0113 | 281.983 | + |
| B | N0129 | 337.839 | - | |
| C | N0113 | 281.983 | + | |
| C | N0129 | 337.839 | - | |
| MTD | A | N0618 | 295.461 | + |
| B | N0618 | 295.461 | + | |
| C | N0630 | 306.162 | - | |
| OXY | A | N0356 | 98.859 | + |
| C | N0309 | 104.534 | - | |
| PCP | A | N0459 | 25.355 | - |
| B | N0441 | 25.891 | - |
{23}------------------------------------------------
| B | N0456 | 22.017 | + | |
|---|---|---|---|---|
| C | N0456 | 22.017 | + | |
| C | N0459 | 25.355 | - | |
| TCA | A | N1140 | 981.903 | + |
| B | N1123 | 1038.965 | - | |
| C | N1140 | 981.903 | + | |
| THC | A | N1222 | 45.970 | + |
| B | N1236 | 50.876 | - | |
| C | N1236 | 50.876 | - | |
| FYL | A | N1402 | 0.917 | + |
| A | N1422 | 1.079 | - | |
| A | N1447 | 1.013 | - | |
| A | N1465 | 0.920 | + | |
| B | N1425 | 1.024 | - | |
| B | N1439 | 1.015 | - | |
| B | N1442 | 0.906 | + | |
| B | N1453 | 0.822 | + | |
| C | N1402 | 0.917 | + | |
| C | N1420 | 0.872 | + | |
| C | N1425 | 1.024 | - | |
| C | N1442 | 0.906 | + | |
| C | N1447 | 1.013 | - |
C. Lay person study
A lay user study was performed at three intended user sites with 140 lay persons. 51 male and 89 female tested AllTest Multi-Drug Urine Test Cup. They had diverse educational and professional backgrounds and their age range from 20 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug freepooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| Drug | Cutoff(ng/mL) | Concentration | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Results | -100%cutoff | -75%cutoff | -50%cutoff | -25%cutoff | +25%cutoff | +50%cutoff | +75%cutoff | ||
| AMP | 500 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | ||
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 | ||
| BZO | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | ||
| BUP | 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | ||
| COC | 150 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | ||
| MDMA | 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| MET | 500 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | ||
| 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | |
| MOP | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| MTD | 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| OXY | 100 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| PCP | 25 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| TCA | 1000 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | ||
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | ||
| FYL | 1 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90.0% | 100.0% | 100% | 100% |
Result of AllTest Multi-Drug Urine Test Cup:
{24}------------------------------------------------
{25}------------------------------------------------
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
Clinical Studies: Not applicable.
13. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are substantially equivalent to the predicate device.
§ 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).