(24 days)
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 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 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations 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.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| 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 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
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.
The provided document describes the analytical and user performance of the "AllTest Multi-Drug Rapid Urine Test Cup" and "AllTest Multi-Drug Urine Test Cup" for detecting various drugs in human urine.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or agreement. However, the performance studies demonstrate that the device is designed to correctly identify drug presence/absence relative to a defined cutoff concentration. For qualitative drug tests, a common expectation is high agreement rates for samples significantly above or below the cutoff, with some variability allowed for samples near the cutoff.
The reported device performance can be summarized from the precision and lay person studies. The precision studies show ideal performance at concentrations far from the cutoff (100% agreement), and expected variability (around 50% positive/negative calls) at the cutoff concentration. The lay person study similarly shows very high agreement (typically 90-100%) for samples adequately far from the cutoff concentration.
Since no explicit quantitative acceptance criteria are given in the provided text, the reported performance is presented in relation to the ideal behavior of a qualitative assay around its cutoff.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Summary from studies) |
|---|---|---|
| Precision (at Cutoff) | Expected to be approximately 50% positive and 50% negative calls at the exact cutoff concentration, with 100% agreement for concentrations significantly above or below the cutoff. | Achieved: For all tested drugs (MOP 2000, EDDP, COC 300, TRA, PPX, AMP 1000, MET 1000, 6-MAM), results at the cutoff concentration generally show a mix of positive and negative calls (e.g., 20-30 positive / 30-20 negative out of 50 tests per lot), while concentrations +/- 50-100% from cutoff show 100% agreement. |
| Accuracy (Method Comparison) | High agreement with LC-MS/MS, especially for samples sufficiently above or below the cutoff. Limited discordant results expected primarily near the cutoff. | Achieved: Very high agreement for drug-free, low negative (< -50% cutoff), and high positive (> +50% cutoff) samples (typically 100% agreement). Limited discordant results (<2 per operator per drug type) were primarily observed at or near the cutoff concentrations, as is expected for qualitative tests. |
| Lay Person Readability & Usability | High agreement rate for negative and positive samples. Instructions should be easy to understand and follow, leading to accurate results by lay users. | Achieved: Agreement rates for samples +/- 50-100% from cutoff were generally 90-100%. Agreement rates for samples at -25% cutoff were typically 90-95%, and for +25% cutoff, around 90-95%. All participants surveyed indicated instructions were easy to understand and follow. Flesch-Kincaid Grade Level was 7. |
| Stability | Device to maintain performance over its stated shelf life. | Achieved: Stable at 2-30℃ for 24 months (based on real-time stability study). |
| Analytical Specificity/Interference | No significant cross-reactivity with common drug metabolites or other interfering substances. No interference from variations in pH or specific gravity within physiological ranges. | Achieved: Cross-reactivity data provided for various compounds, demonstrating acceptable specificity. No interference observed with non-structurally related compounds at high concentrations (100µg/mL or specified). No interference observed with pH (4-9) and specific gravity (1.000-1.035). |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Reproducibility: For each drug and each concentration level (total 9 concentrations), 50 tests were performed per lot. With 3 lots, this amounts to 150 tests per concentration level per drug. The total number of precision tests for the 8 reported drugs (MOP 2000, EDDP, COC 300, TRA, PPX, AMP 1000, MET 1000, 6-MAM) and their 9 concentration levels is 8 * 9 * 50 * 3 = 10,800 tests.
- Data Provenance: Samples were "spiked target drug in drug-free urine samples." The concentrations were confirmed by LC-MS/MS. This suggests internally prepared, controlled samples rather than real-world clinical samples, likely conducted within a laboratory setting. No country of origin is explicitly stated, but given the submitter "Hangzhou Alltest Biotech Co.,Ltd", it is likely from China, and the study was "carried out for samples." This is a retrospective analysis of prepared samples.
- Analytical Specificity/Interference: Samples were "spiked into drug-free urine" and tested using three lots of the device. The number of samples per compound is not explicitly stated, but results are given as the "Minimum concentration required to obtain a positive result," implying sufficient testing to determine this.
- Data Provenance: Prepared in-house samples.
- Method Comparison Study: For each drug, 80 clinical urine samples (40 negative, 40 positive). For the 8 drugs reported, this is 8 * 80 = 640 clinical samples.
- Data Provenance: "unaltered urine clinical samples." No country of origin is specified, but the study was "performed in-house." This is a retrospective analysis of acquired clinical samples.
- Lay Person Study: 280 lay persons participated. Each participant tested 7 samples for each drug (7 concentration levels per drug). The number of drug analyses per person or per drug is not explicitly stated in a single count. The results tables show that for each drug and each concentration, 20 tests were performed (e.g., for AMP 1000 at -100% cutoff, "Total" is 20).
- Number of Participants: 280 lay persons.
- Data Provenance: Samples were "prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens." Concentrations confirmed by LC-MS/MS. This indicates internally prepared, controlled samples tested by lay users at "three intended user sites." No country of origin specified for the lay persons, but likely within the operational scope of the manufacturer/sponsor for this type of OTC product validation. This is a prospective study involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: The ground truth for these studies was established by preparing samples with known concentrations of drugs using spiking into drug-free urine, and confirmed by LC-MS/MS. These are analytical methods and do not typically involve human experts for ground truth establishment.
- Method Comparison Study: The ground truth for the clinical samples was established using LC-MS/MS results. LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly sensitive and specific analytical technique considered the gold standard for confirmatory drug testing. Therefore, human experts (e.g., laboratory professionals) in analytical chemistry and toxicology would have been involved in performing and interpreting these LC-MS/MS analyses, though their specific number or qualifications are not detailed in this document.
4. Adjudication Method for the Test Set
- Precision/Reproducibility & Analytical Specificity/Interference: Ground truth was based on known preparations and LC-MS/MS confirmation; therefore, no adjudication by human experts was required for these analytical performance studies.
- Method Comparison Study: The document states that "three operators" ran the test cups. Discrepancies between the test cup result and the LC-MS/MS result are listed as "Discordant" results. There is no explicit mention of an adjudication method for the test cup results, such as a 2+1 reading or a consensus reading. It appears the outcome recorded by each operator was directly compared to the LC-MS/MS ground truth.
- Lay Person Study: Participants were given a device and "the package insert." There's no mention of expert readers adjudicating the lay person's interpretation. The "Agreement (%)" is calculated based on the lay person's result compared to the known spiked concentration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted in the way typically seen for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared.
This device is an in vitro diagnostic (IVD) test cup, not an AI software. The "operators" in the method comparison study were executing the device, but the study was not designed to measure the effect size of human readers improving with AI vs. without AI assistance. Instead, it compared the device's performance (as interpreted by trained operators) against a gold standard (LC-MS/MS). The lay person study assessed the device's usability and accuracy when interpretation was done by untrained individuals following instructions, which is a key part of OTC device validation, but not an MRMC study for AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the analytical performance studies (Precision/Reproducibility, Linearity, Stability, Analytical Specificity/Interference) and the method comparison study can be considered standalone performance studies of the device itself, as evaluated by trained laboratory personnel or against analytical standards.
In the context of IVD devices like this test cup, the "algorithm" is the biochemical reaction and visual line interpretation on the strip. The precision, specificity, and comparison to LC-MS/MS results directly assess the analytical performance of the device without explicit "human-in-the-loop" decision-making, beyond reading the visual output. The "Lay Person study" then evaluates how effectively the intended user (human-in-the-loop) can interpret this standalone performance.
7. The Type of Ground Truth Used
The primary ground truth used for performance evaluation was:
- Known Spiked Concentrations: For precision, stability, analytical specificity, and the lay person study, urine samples were prepared by spiking known concentrations of target drugs into drug-free urine. These concentrations were confirmed by LC-MS/MS.
- LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry): For the method comparison study of clinical samples, LC-MS/MS was used as the reference method (gold standard) to establish the true presence and concentration of drugs in the urine samples.
8. The Sample Size for the Training Set
This document describes a 510(k) premarket notification for a rapid drug test cup, which is an in vitro diagnostic device. These devices are typically developed based on established immunoassay principles and optimized through various analytical and clinical studies.
The concept of a "training set" is usually associated with machine learning or AI models. Since this device is a competitive binding, lateral flow immunochromatographic assay (a chemical/biological test, not an AI or software algorithm in the conventional sense), there is no explicit "training set" as understood in machine learning.
The development and optimization of the test components (antibodies, membrane, reagents, etc.) would involve extensive internal testing and iteration, but this is part of product development and not typically reported as a "training set" in regulatory submissions for IVDs.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" for this type of IVD device (lateral flow immunoassay) is not applicable in the same way it would be for an AI/ML device. Therefore, the question of how ground truth was established for a training set does not apply to this submission. The development process likely involved iterative testing with known drug concentrations and optimization of reagent formulations to achieve desired performance characteristics.
U.S. Food & Drug Administration FDA 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 4, 2025
Hangzhou Alltest Biotech Co.,Ltd
℅ Jenny Xia
Director
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg, Maryland 20877
Re: K250727
Trade/Device Name: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug 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, QBF, NGM, QAW, NFW
Dated: March 9, 2025
Received: March 11, 2025
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250727 - Jenny Xia Page 2
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 changes to device design and production (21 CFR 820.30 and 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 (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-safety-reporting-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250727 - Jenny Xia Page 3
assistance/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: 2025.04.04 07:32:33 -04'00'
Joseph Kotarek, Ph.D.
Branch Chief
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250727
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, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 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 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations 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.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
Page 5
FORM FDA 3881 (8/23) Page 2 of 2
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| 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 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
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)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 6
510(k) SUMMARY
-
Date: March 26, 2025
-
Submitter: Hangzhou AllTest Biotech Co., Ltd.
Plant Bldg. 3, 4, 5, No. 550 Yinhai Street, Baiyang
Street, Hangzhou ETDZ, Jianggan District -
Contact person: 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
AllTest Multi-Drug Rapid Urine Test Cup -
Classification: Class II
| Product Code | Target Drug | Regulation Section | Panel |
|---|---|---|---|
| NFT | Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTH | Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGL | Buprenorphine (BUP), Fentanyl (FYL), Morphine (MOP/OPI), Oxycodone (OXY), 6-Monoacetylmorphine(6-MAM), Tramadol (TML) | 862.3650, Opiate Test System | Toxicology |
| NFV | Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | Cocaine (COC) | 862.3250, Cocaine and cocaine metabolite test system | Toxicology |
| PTG | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGG | Methylenedioxymethamphetamine (MDMA), Methamphetamine (MET) | 862.3610, Methamphetamine Test System | Toxicology |
| QBF | Propoxyphene(PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| NGM | Phencyclidine (PCP) | Unclassified | Toxicology |
Page 7
| Product Code | Target Drug | Regulation Section | Panel |
|---|---|---|---|
| QAW | Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology |
| NFW | Cannabinoids (THC) | 862.3870, Cannabinoids Test System | Toxicology |
-
Predicate Devices:
AllTest Multi-Drug Rapid Test Cup (K244043) -
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, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 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 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations 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.
Page 8
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, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| 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 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
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.
- 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.
Page 9
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.
- Substantial Equivalence Information
Similarities
| Item | Device | Predicate (K244043) |
|---|---|---|
| Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug and Cut Off Values | Target Drugs Cutoff (ng/mL) SameAmphetamine(AMP) 1000 or 500Secobarbital (BAR) 300Buprenorphine (BUP) 10Oxazepam (BZO) 300Cocaine (COC) 150 or 3002-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300Methylenedioxymethamphetamine (MDMA) 500Methamphetamine (MET) 1000 or 500Morphine (MOP300/OPI2000) 2000 or 300Methadone (MTD) 300Oxycodone (OXY) 100Phencyclidine (PCP) 25Propoxyphene(PPX) 300Nortriptyline (TCA) 1000Cannabinoids (THC) 506-Monoacetylmorphine(6-MAM) 10Fentanyl (FYL) 1Tramadol (TRA) 100 | Same |
| Configurations | Test cup | Cup |
| Test Strips | MET, AMP, MOP/OPI, and TCA strips differ | MET, AMP, MOP/OPI, and TCA strips |
- Standard/Guidance Document Reference (if applicable)
None referenced.
- Test Principle
AllTest Multi-Drug Rapid Urine Test Cup or AllTest Multi-Drug Urine Test Cup is a competitive
Page 10
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.
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.
- 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. Other samples were prepared by spiked target drug 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 table for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The precision for the remaining analytes is supported by data in the previously cleared submission K241428.
MOP 2000
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 4211.662 | 3462.759 | 3030.531 | 2431.941 | 2132.487 | 1511.933 | 1015.242 | 515.108 | 0.000 |
| 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+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
EDDP
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| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 587.020 | 517.618 | 487.965 | 355.764 | 294.641 | 223.848 | 157.757 | 81.993 | 0.000 |
| 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+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
COC 300
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 609.678 | 515.747 | 451.622 | 376.434 | 299.386 | 232.496 | 149.316 | 81.012 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 49-/1+ | 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+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
TRA
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 204.718 | 169.671 | 149.969 | 129.661 | 97.564 | 74.650 | 47.592 | 26.174 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 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+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
PPX
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 558.684 | 559.396 | 472.685 | 352.338 | 311.349 | 206.969 | 158.805 | 69.773 | 0.000 |
| 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+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
AMP 1000
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 2025.713 | 1760.840 | 1497.784 | 1226.200 | 1063.069 | 739.120 | 487.230 | 250.343 | 0.000 |
| 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+ | 0-/50+ | 22-/28+ | 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+ |
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MET 1000
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 1976.054 | 1710.253 | 1592.753 | 1244.352 | 1072.277 | 702.076 | 486.231 | 242.057 | 0.000 |
| 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+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
6-MAM
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 21.827 | 16.871 | 15.734 | 12.237 | 10.188 | 7.566 | 4.659 | 2.503 | 0.000 |
| 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+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 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. These urine samples were tested using three lots of the device. The results obtained are summarized in the following table for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The specificity for the remaining analytes is supported by data in the previously cleared submission K241428.
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 | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| MOP 2000 | Morphine | 2000 | 100% |
| Codeine | 5000 | 40% | |
| Codeine-6-β-D-glucuronide | >100000 | <2% |
Page 13
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Hydrocodone | 10000 | 20% | |
| Hydromorphone | 5000 | 40% | |
| Oxycodone | >100000 | <2% | |
| Procaine hydrochloride | >100000 | <2% | |
| Oxymorphone | >100000 | <2% | |
| Normorphine | >100000 | <2% | |
| Ethylmorphine | 500 | 400% | |
| Norcodeine | 50000 | 4% | |
| Thebaine | >100000 | <2% | |
| Acetylcodeine | >100000 | <2% | |
| Dihydrocodeine | 30000 | 6.7% | |
| Nalorphine | 2000 | 100% | |
| Levorphanol tartrate | 10000 | 20% | |
| Morphine-3-β-D-glucuronide | 5000 | 40% | |
| s-Monoacetylmorphine | 10000 | 20% | |
| 6-Monoacetylmorphine (6-MAM) | 10000 | 20% | |
| Norpropoxyphene | >100000 | <2% | |
| Diacetylmorphine (Heroin) | 4000 | 50% | |
| 6-Acetylmorphine | 10000 | 20% | |
| Morphine-6β-D-glucuronide | 5000 | 40% | |
| EDDP | EDDP | 300 | 100% |
| Doxylamine | >100000 | <0.3% | |
| Methadone | >100000 | <0.3% | |
| Methadol | >100000 | <0.3% | |
| COC 300 | Benzoylecogonine | 300 | 100% |
| Cocaethylene | 500 | 60% | |
| Cocaine hydrochloride | 250 | 120% | |
| Ecgonine | >100000 | <0.3% | |
| Norcocaine | >100000 | <0.3% | |
| Ecgonine methyl ester | >100000 | <0.3% | |
| AMP 1000 | Hydroxyamphetamine | 10000 | 10% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 50 | 2000% | |
| D,L-Amphetamine | 1000 | 100% | |
| D-Amphetamine | 1000 | 100% |
Page 14
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Diethylstilbestrol | >100000 | <1% | |
| L-Amphetamine | 1000 | 100% | |
| Phentermine | 1000 | 100% | |
| β-Phenylethylamine | >100000 | <1% | |
| Tyramine | >100000 | <1% | |
| p-Hydroxynorephedrine | >100000 | <1% | |
| D,L-Norephedrine | >100000 | <1% | |
| p-Hydroxyamphetamine | 10000 | 10% | |
| D-Methamphetamine | >100000 | <1% | |
| L-Methamphetamine | >100000 | <1% | |
| Ephedrine hydrochloride | >100000 | <1% | |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | >100000 | <1% | |
| Phenylpropanolamine | >100000 | <1% | |
| Benzphetamine | >100000 | <1% | |
| L-Ephedrine | >100000 | <1% | |
| L-Epinephrine | >100000 | <1% | |
| D,L-Epinephrine | >100000 | <1% | |
| (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | >100000 | <1% | |
| D,L-Methamphetamine | >100000 | <1% | |
| Pseudoephedrine | >100000 | <1% | |
| MET 1000 | (+/-)3,4-Methylenedioxy-nethylamphetamine(MDEA) | 10000 | 10% |
| (±)-MDMA | 2000 | 50% | |
| D-Methamphetamine | 1000 | 100% | |
| L-Methamphetamine | 20000 | 5% | |
| Fenfluramine | 100000 | 1% | |
| p-Hydroxymethamphetamine | 500 | 200% | |
| D,L-Methamphetamine | 500 | 200% | |
| β-Phenylethylamine | >100000 | <1% | |
| Mephetermine | 50000 | 2% | |
| L-Amphetamine | >100000 | <1% | |
| Methoxyphenamine hydrochloride | >100000 | <1% |
Page 15
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| D-Amphetamine | >100000 | <1% | |
| D,L-Amphetamine | 500 | 200% | |
| Chloroquine | 50000 | 2% | |
| Ephedrine hydrochloride | >100000 | <1% | |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | >100000 | <1% | |
| Trimethobenzamide | >100000 | <1% | |
| L-phenylephrine | >100000 | <1% | |
| (1R,2S)-(-)-Ephedrine | >100000 | <1% | |
| Procaine hydrochloride | >100000 | <1% | |
| Phentermine | >100000 | <1% | |
| Pseudoephedrine | >100000 | <1% | |
| TRA 100 | Tramadol | 100 | 100% |
| N-Desmethyl-cis-tramadol | 200 | 50% | |
| O-Desmethyl-cis-tramadol | 1000 | 10% | |
| Venlafaxine | 100000 | 0.1% | |
| (±)-O-Desmethylvenlafaxine | 100000 | 0.1% | |
| PPX 300 | (+)-Propoxyphene | 300 | 100% |
| (+)-Norpropoxyphene | 500 | 60% | |
| 6-MAM 10 | 6-Monoacetylmorphine | 10 | 100% |
| Hydrocodone | >100000 | <0.01% | |
| Hydromorphone | >100000 | <0.01% | |
| Morphine | >100000 | <0.01% | |
| Oxymorphone | >100000 | <0.01% | |
| Procaine | >100000 | <0.01% | |
| Thebaine | >100000 | <0.01% | |
| Diacetylmorphine (heroin) | 300 | 3.3% | |
| Acetylcodeine | >100000 | <0.01% | |
| Buprenorphine | >100000 | <0.01% | |
| Dihydrocodeine | >100000 | <0.01% | |
| Nalorphine | >100000 | <0.01% | |
| Mitragynine (kratom) | >100000 | <0.01% | |
| Norbuprenorphine | >100000 | <0.01% | |
| s-Monoacetylmorphine | 10 | 100% | |
| Codeine | >100000 | <0.01% |
Page 16
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Ethylmorphine | >100000 | <0.01% | |
| Levorphanol tartrate | >100000 | <0.01% | |
| Morphine-3-β-D-glucuronide | >100000 | <0.01% | |
| Norcodeine | >100000 | <0.01% | |
| Normorphine | >100000 | <0.01% | |
| Oxycodone | >100000 | <0.01% | |
| Dextromethorphan | >100000 | <0.01% | |
| Imipramine hydrochloride | >100000 | <0.01% | |
| Levacetylmethadol (LAAM) | >100000 | <0.01% | |
| Meperidine | >100000 | <0.01% | |
| (±)-Methadone | >100000 | <0.01% | |
| Naloxone hydrochloride | >100000 | <0.01% | |
| Naltrexone hydrochloride | >100000 | <0.01% | |
| Naproxen | >100000 | <0.01% | |
| Noroxycodone HCL | >100000 | <0.01% | |
| Noroxymorphone HCL | >100000 | <0.01% | |
| (+)-Norpropoxyphene maleate | >100000 | <0.01% | |
| Oxymorphone-3β-D-glucuronide | >100000 | <0.01% | |
| Tapentadol HCl | >100000 | <0.01% | |
| Tramadol hydrochloride | >100000 | <0.01% | |
| Chlordiazepoxide | >100000 | <0.01% | |
| Clobazam | >100000 | <0.01% | |
| D-Amphetamine | >100000 | <0.01% | |
| (±)-Amphetamine | >100000 | <0.01% | |
| Morphine-6β-D-glucuronide | >100000 | <0.01% | |
| Norbuprenorphine glucuronide | >100000 | <0.01% | |
| Norhydrocodone HCl | >100000 | <0.01% |
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 or specified concentrations are summarized in the following table.
| Acetaminophen | D-Pseudoephedrine | Norfentanyl |
|---|---|---|
| Acetone (1000mg/dL) | Duloxetine | Noscapine |
| Acetophenetidin | 4-Dimethyl-aminoantipyrine | (+)-Naproxen |
| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | 19-Norethindrone |
Page 17
| Acyclovir | Ecgonine methyl ester | Octopamine |
|---|---|---|
| Albumin (100mg/dL) | EMDP | O-Hydroxyhippuric acid |
| Albuterol sulfate (Proair HFA) | Ephedrine | Olanzapine |
| Alpha Methadol | Erythromycin | Omeprazole |
| Aminophylline | Esomeprazole Magnesium (except MTD test) | Oxalic acid (100 mg/dL) |
| Aminopyrine | Estradiol | Oxolinic acid |
| Amoxicillin | Estrone | Oxymetazoline |
| Ampicillin | Ethanol (1%) | Paliperidone |
| Aripiprazole | Fenofibrate | Papaverine |
| Aspartame | Fenoprofen | Penicillin-G |
| Aspirin | Fentanyl(except FYL test) | PenicillinV Potassium |
| Atomoxetine | Fluoxetine Hydrochloride | Perphenazine |
| Atorvastatin Calcium | Fluphenazine | Phenacetin |
| Atropine | Fotemustine | Phenelzine |
| Azithromycin | Furosemide | Phenethylamine |
| Baclofen | Gabapentin | Phenylethylamine |
| Benzilic acid | Galactose(10mg/dL) | Phenylpropanolamine |
| Benzocaine | Gamma Globulin(500mg/dL) | Prednisone |
| Benzoic Acid | Gatifloxacin | Pregablin |
| Benzphetamine | Gemfibrozil | Procaine |
| Bilirubin | Gentisic acid | Promazine |
| Boric Acid (1%) | Glucose(3000mg/dL) | Promethazine |
| Bupropion | Guaiacol glyceryl ether | Propoxyphene (except PPX test) |
| Caffeine | Hemoglobin | Propranolol |
| Cannabidiol | Hydralazine | Pseudoephedrine |
| Captopril | Hydrochlorothiazide | Pyridoxine |
| Carbamazepine | Hydrocortisone | Pyrilamine |
| Carfentanil (except FYL test) | 3-Hydroxytyramine | Pyrogallol |
| Carisoprodol | Ibuprofen | Quetiapine |
| Cefradine | Isoxsuprine | Quinine |
| Cephalexin | (+/-)-Isoproterenol | Quinolinic Acid |
| Chloralhydrate | Ketamine | R-(-)-Apomorphine |
| Chloramphenicol | Ketoprofen | Ranitidine |
| Chlordiazepoxide (except BZO test) | LAAM HCl | Riboflavin (10mg/dL) |
| Chloroquine (except MET test) | Labetalol | Rifampicin |
| Chlorothiazide | L-Ascorbic Acid | Risperidone |
| Chlorpromazine | L-Ephedrine | Salicylic Acid |
| Cholesterol | L-Epinephrine | Serotonin(5- Hydroxytyramine) |
| Ciprofloxacin Hydrochloride | Levofloxacin Hydrochloride | Sertraline |
| Citalopram | Levonorgestrel | Sildenafil Citrate |
| Clarithromycin | Levothyroxine Sodium | Simvastatin |
| Clonidine | Lidocaine Hydrochloride | Sulfamethazine |
| Clozapine | Lisinopril | Sulindac |
| Conjugated Estrogens | Loperamide | Telmisartan |
| Cortisone | Loratadine | Tetracycline |
| Creatine Hydrate | L-phenylephrine | Tetrahydrocortisone 3-(βDglucuronide) |
| Creatinine | Magnesium | Tetrahydrocortisone, 3-acetate |
| Cyclobenzaprine | Maprotiline | Tetrahydrozoline |
| Cyclodextrin | Meperidine | Theophylline |
| (-)-Cotinine | Meprobamate | Thiamine |
| (+)-Chlorpheniramine | Methapyrilene | Thioridazine |
| D,L-Epinephrine | Methaqualone | Tramadol (except TRA test) |
Page 18
| D,L-Octopamine | Methoxyphenamine (except AMP/MET test) | Triamterene |
|---|---|---|
| d,l-Propranolol | Methylphenidate | Trifluoperazine |
| D,L-Tryptophan | Metoprolol Tartrate | Trimethobenzamide |
| D,L-Tyrosine | Metronidazole (300ug/ml) | Trimethoprim |
| Delorazepam (except BZO test) | Mifepristone | Tryptamine |
| Deoxycorticosterone | N-Acetylprocainamide | Tyramine |
| Desloratadine | NaCl(4000mg/dL) | Urea (2000mg/dL) |
| Dextromethorphan | Nalidixic Acid | Uric Acid |
| Diclofenac | Naloxone hydrochloride (except OXY test) | Valproic acid (250ug/ml) |
| Diflunisal | Naltrexone | Venlafaxine HCl (except TRA test) |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine HCl | Nicotine | Vitamin B2 |
| Disopyramide (except MTD test) | Nicotinic Acid | Vitamin C |
| Dopamine HCl | Nifedipine | Zaleplon |
| Doxepin | Nitroglycerin | Zomepirac sodium salt |
| Doxylamine | Nordoxepin |
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 for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The method comparison for the remaining analytes is supported by data in the previously cleared submission K241428.
| Drug test | Test Cup Result | Drug-Free | Low Negative by LC-MS/MS (less than -50%) | Near Cutoff Negative by LC-MS/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC-MS/MS (Between the cutoff and +50%) | High Positive by LC-MS/MS (greater than +50%) |
|---|---|---|---|---|---|---|
| MOP 2000 | Operator A | + | 0 | 0 | 0 | 13 |
| - | 12 | 15 | 13 | 0 | ||
| Operator B | + | 0 | 0 | 0 | 12 | |
| - | 12 | 15 | 13 | 1 | ||
| Operator C | + | 0 | 0 | 1 | 13 | |
| - | 12 | 15 | 12 | 0 | ||
| Operator | + | 0 | 0 | 0 | 13 |
Page 19
| Drug test | Test Cup Result | Drug-Free | Low Negative by LC-MS/MS (less than -50%) | Near Cutoff Negative by LC-MS/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC-MS/MS (Between the cutoff and +50%) | High Positive by LC-MS/MS (greater than +50%) |
|---|---|---|---|---|---|---|
| AMP 1000 | A | - | 12 | 12 | 16 | 1 |
| Operator B | + | 0 | 0 | 1 | 13 | |
| - | 12 | 12 | 15 | 1 | ||
| Operator C | + | 0 | 0 | 1 | 14 | |
| - | 12 | 12 | 15 | 0 | ||
| MET 1000 | Operator A | + | 0 | 0 | 0 | 10 |
| - | 12 | 11 | 17 | 1 | ||
| Operator B | + | 0 | 0 | 1 | 11 | |
| - | 12 | 11 | 16 | 0 | ||
| Operator C | + | 0 | 0 | 1 | 10 | |
| - | 12 | 11 | 16 | 1 | ||
| COC 300 | Operator A | + | 0 | 0 | 1 | 10 |
| - | 12 | 10 | 17 | 0 | ||
| Operator B | + | 0 | 0 | 0 | 9 | |
| - | 12 | 10 | 18 | 1 | ||
| Operator C | + | 0 | 0 | 1 | 9 | |
| - | 12 | 10 | 17 | 1 | ||
| EDDP | Operator A | + | 0 | 0 | 1 | 12 |
| - | 12 | 15 | 12 | 1 | ||
| Operator B | + | 0 | 0 | 1 | 13 | |
| - | 12 | 15 | 12 | 0 | ||
| Operator C | + | 0 | 0 | 0 | 13 | |
| - | 12 | 15 | 13 | 0 | ||
| TRA | Operator A | + | 0 | 0 | 1 | 10 |
| - | 12 | 14 | 13 | 1 | ||
| Operator B | + | 0 | 0 | 1 | 11 | |
| - | 12 | 14 | 13 | 0 | ||
| Operator C | + | 0 | 0 | 0 | 10 | |
| - | 12 | 14 | 14 | 1 | ||
| PPX | Operator A | + | 0 | 0 | 1 | 10 |
| - | 12 | 13 | 14 | 0 | ||
| Operator B | + | 0 | 0 | 0 | 10 | |
| - | 12 | 13 | 15 | 0 | ||
| Operator C | + | 0 | 0 | 1 | 9 | |
| - | 12 | 13 | 14 | 1 | ||
| 6-MAM | Operator A | + | 0 | 0 | 1 | 13 |
| - | 12 | 11 | 16 | 1 | ||
| Operator B | + | 0 | 0 | 1 | 14 | |
| - | 12 | 11 | 16 | 0 | ||
| Operator C | + | 0 | 0 | 1 | 13 | |
| - | 12 | 11 | 16 | 1 |
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Discordant |
Page 20
| Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Device Result |
|---|---|---|---|---|
| MOP 2000 | B | S1854 | 2061.2 | - |
| C | S1836 | 1853.5 | + | |
| AMP 1000 | A | S1667 | 1070.8 | - |
| B | S1636 | 1058.2 | - | |
| B | S1610 | 923.0 | + | |
| C | S1642 | 987.8 | + | |
| MET 1000 | B, C | S1732 | 974.6 | + |
| A, C | S1744 | 1102.9 | - | |
| COC 300 | A | S1535 | 297.0 | + |
| B, C | S1547 | 313.0 | - | |
| C | S1562 | 294.6 | + | |
| EDDP | A, B | S1927 | 291.3 | + |
| A | S1918 | 300.6 | - | |
| TRA | A, B | S2148 | 91.6 | + |
| A, C | S2157 | 103.0 | - | |
| PPX | A | S2052 | 286.3 | + |
| C | S2017 | 280.6 | + | |
| C | S2024 | 311.3 | - | |
| 6-MAM | C | S2249 | 9.5 | + |
| A, B | S2236 | 9.6 | + | |
| A, C | S2228 | 10.2 | - |
C. Lay person study
A lay user study was performed at three intended user sites with 280 lay persons. 117 male and 163 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 free-pooled 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.
Result of AllTest Multi-Drug Urine Test Cup: Configuration 1
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| AMP | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BAR | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% |
Page 21
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| BZO | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BUP | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| COC | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MDMA | 500 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MET | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MOP | 2000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MTD | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| OXY | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PCP | 25 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TCA | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| THC | 50 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| FYL | 1 | Negative | 20 |
Page 22
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| 6-MAM | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TRA | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PPX | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| EDDP | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% |
Result of AllTest Multi-Drug Urine Test Cup: Configuration 2
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| AMP | 500 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BAR | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BZO | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BUP | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| COC | 150 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MDMA | 500 | Negative | 20 |
Page 23
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MET | 500 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MOP | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MTD | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| OXY | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PCP | 25 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TCA | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| THC | 50 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| FYL | 1 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| 6-MAM | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TRA | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PPX | 300 | Negative | 20 |
| Positive | 0 |
Page 24
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| EDDP | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% |
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.
- 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 Rapid Urine Test Cup and AllTest Multi-Drug 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).