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K Number
K191841
Device Name
Accurate Multi Panel Drug Urine Test Cup
Manufacturer
Healstone Biotech Inc
Date Cleared
2019-08-07

(29 days)

Product Code
NFT,NFV,NFW,NFY,NGG,NGL,NGM,PTG,PTH,QAW,QBF
Regulation Number
862.3100
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
K182701
Predicate For
K221871
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)Cut-off
Amphetamine (AMP)1000 ng
Buprenorphine (BUP)10 ng
Secobarbital (BAR)300 ng
Oxazepam (BZO)300 ng
Cocaine (COC)300 ng
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)300 ng
Methamphetamine (MET)1000 ng
Methylenedioxymethamphetamine (MDMA)500 ng
Morphine (MOP 300/OPI 2000)300 ng
Methadone (MTD)300 ng
Oxycodone (OXY)100 ng
Phencyclidine (PCP)25 ng
Propoxyphene (PPX)300 ng
Nortriptyline (TCA)1000 ng
Marijuana (THC 50)50 ng

level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL

Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when 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

Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.

AI/ML Overview

This document describes the performance of the "Accurate Multi Panel Drug Urine Test Cup" for detecting various drugs in human urine.

Here's an analysis based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the results of the "Precision" and "Comparison Studies" sections, demonstrating the device's ability to accurately detect drugs at, above, and below specified cutoff concentrations. The core acceptance criterion for qualitative drug tests like this is often high agreement with a confirmed analytical method (LC/MS or GC/MS) and consistent performance around the cutoff.

Here's a table summarizing the reported device performance, based on the precision study results:

Table of Acceptance Criteria (Implicit) and Reported Device Performance (Precision Study: % Agreement for each concentration across 3 lots where 50 positive and 50 negative results would yield 100%)

The precision studies were performed across three different lots of the device. For each drug, the number of positive (+) and negative (-) results are reported out of 50 tests per concentration per lot.
For ease of understanding the acceptance, I interpret the "0-/50+" and "50-/0+" outcomes as 100% agreement for concentrations far from the cutoff (i.e., always negative for significantly below cutoff, and always positive for significantly above cutoff). The critical region is around the cutoff where some variability is expected and defined by the number of discordant results (mix of positive and negative).

Drug (Cutoff)% of Cutoff (LC/MS Conc. ng/mL)Lot I (Neg/Pos)Lot II (Neg/Pos)Lot III (Neg/Pos)Implied Acceptance Criterion (e.g., all samples below X ng/mL should be Negative, all samples above Y ng/mL should be Positive)Performance (Agreement at each concentration)
BUP (10 ng/mL)+100% (19.1)0-/50+0-/50+0-/50+All positive100% positive
+75% (16.1)0-/50+0-/50+0-/50+All positive100% positive
+50% (15.2)0-/50+0-/50+0-/50+All positive100% positive
+25% (12.9)1-/49+1-/49+2-/48+Predominantly positive (e.g., >80% positive)98%, 98%, 96% positive
Cutoff (9.4)26-/24+22-/28+20-/30+Mix of positive/negative (e.g., ~50% agreement)48%, 56%, 60% positive (for LC/MS 9.4ng/mL)
-25% (7.1)48-/2+49-/1+49-/1+Predominantly negative (e.g., >80% negative)96%, 98%, 98% negative
-50% (5.4)50-/0+50-/0+50-/0+All negative100% negative
-75% (2.4)50-/0+50-/0+50-/0+All negative100% negative
-100% (0)50-/0+50-/0+50-/0+All negative100% negative
PCP (25 ng/mL)+100% (50.3)0-/50+0-/50+0-/50+All positive100% positive
... (similar structure for all 15 drugs)Cutoff (e.g. 25.0 for PCP)Mix of -/+Mix of -/+Mix of -/+Around 50% agreement at LC/MS cutoff concentration is typical for qualitative tests.Consistent with expectations for qualitative assays at cutoff
THC (50 ng/mL)Cutoff (e.g. 50.2 for THC)Mix of -/+Mix of -/+Mix of -/+
OXY (100 ng/mL)Cutoff (e.g. 98.4 for OXY)Mix of -/+Mix of -/+Mix of -/+
BAR (300 ng/mL)Cutoff (e.g. 270.1 for BAR)Mix of -/+Mix of -/+Mix of -/+
BZO (300 ng/mL)Cutoff (e.g. 307.9 for BZO)Mix of -/+Mix of -/+Mix of -/+
EDDP (300 ng/mL)Cutoff (e.g. 300.7 for EDDP)Mix of -/+Mix of -/+Mix of -/+
MTD (300 ng/mL)Cutoff (e.g. 314.6 for MTD)Mix of -/+Mix of -/+Mix of -/+
MOP (300 ng/mL)Cutoff (e.g. 289.0 for MOP)Mix of -/+Mix of -/+Mix of -/+
PPX (300 ng/mL)Cutoff (e.g. 308.6 for PPX)Mix of -/+Mix of -/+Mix of -/+
MDMA (500 ng/mL)Cutoff (e.g. 516.6 for MDMA)Mix of -/+Mix of -/+Mix of -/+
TCA (1000 ng/mL)Cutoff (e.g. 1091.2 for TCA)Mix of -/+Mix of -/+Mix of -/+
OPI (2000 ng/mL)Cutoff (e.g. 2008.3 for OPI)Mix of -/+Mix of -/+Mix of -/+
COC (300 ng/mL)Cutoff (e.g. 303.1 for COC)Mix of -/+Mix of -/+Mix of -/+
AMP (1000 ng/mL)Cutoff (e.g. 1091.8 for AMP)Mix of -/+Mix of -/+Mix of -/+
MET (1000 ng/mL)Cutoff (e.g. 949.7 for MET)Mix of -/+Mix of -/+Mix of -/+

The data consistently shows:

  • 100% agreement (50-/0+ or 0-/50+) for samples significantly below or above the cutoff (e.g., -50% to -100% cutoff, and +50% to +100% cutoff).
  • High agreement (e.g., 47-/3+ or 1-/49+) for samples at -25% and +25% of the cutoff, indicating good performance proximal to the cutoff.
  • A 'mixed' result (e.g., 26-/24+ or 22-/28+) at the exact cutoff concentration. This is expected for qualitative tests designed to distinguish around a specified threshold.

Study Details:

  1. A table of acceptance criteria and the reported device performance: See table above.

  2. Sample sized used for the test set and the data provenance:

    • Precision Study (Test Set): For each of the 15 drugs, studies were carried out at 9 different concentrations relative to the cutoff (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). For each concentration, tests were performed two runs per day for 25 days across three different lots of the device. This equates to 50 tests per concentration per lot, meaning 150 tests per concentration across all lots per drug. Given 9 concentrations and 15 drugs, the total number of qualitative tests performed in the precision study is 15 drugs * 9 concentrations * 50 tests/concentration/lot * 3 lots = 20,250 individual qualitative test results. The data provenance is not explicitly stated beyond "performed in-house", but implies controlled laboratory conditions. It is retrospective in the sense that the samples were prepared and then tested.
    • Comparison Studies (Test Set): For each drug, 80 unaltered urine samples (40 negative and 40 positive) were "blind labeled" and compared to LC/MS or GC/MS results. This means 80 test samples were used for performance evaluation against ground truth for each drug. As there are 15 drugs, a total of 15 drugs * 80 samples/drug = 1200 samples were analyzed in the comparison study. The provenance for these samples is "unaltered urine samples," implying they were clinical samples, but specific country of origin or whether they were prospectively or retrospectively collected is not mentioned. Given the context of a 510(k) summary, it's typically retrospective analysis of banked samples.
    • Lay-User Study:
      • Configuration 1 (MOP 300): 184 males and 126 females participated. Urine samples were prepared at 8 concentrations (-100%, +/-75%, +/-25% of the cutoff). Each participant received 1 blind-labeled sample. This means 310 participants (samples) were tested for each characteristic (e.g., Cocaine detection). Given that there are multiple drugs in each configuration, and multiple concentrations per drug, the total number of tests in this section is substantial. For Methamphetamine, for example, there are 8 concentrations, implying 8 x 20 = 160 participants were given samples at specific concentrations, with 170 samples being at -50% cutoff for several drugs (potentially pooled data). It's more likely that 310 total participants each tested one device, which covers multiple drugs simultaneously in one cup. The tables presented show results for each drug at various cutoff percentages, with "Number of samples" referring to the number of individual urine samples prepared at that concentration for a given drug. For instance, for Methamphetamine, 20 samples were prepared at -100% cutoff, 20 at -75%cutoff, etc. The "170" in the "-50% Cutoff" row for several drugs is peculiar – it might indicate cumulative samples for those drugs at that specific concentration across the entire study, or a misprint.
      • Configuration 2 (MOP 2000 (OPI)): 178 males and 132 females participated, similar setup.
      • Data provenance for lay-user study is not stated geographically, but it's a simulated environment with prepared urine samples, likely an in-house study.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • For the Precision Study and Comparison Studies, the ground truth was established by "LC/MS or GC/MS results." These are considered highly accurate analytical methods and are the gold standard for confirming drug concentrations in urine. No human experts are explicitly mentioned for establishing ground truth for these analytical methods themselves, as they are instrumental measurements.
    • For the Lay-User Study: The concentrations were confirmed by LC/MS. Again, LC/MS served as the ground truth.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • For the Precision Study: No adjudication method is described; the quantitative LC/MS results serve as the definitive reference. The qualitative results (positive/negative) from the device are simply compared directly.
    • For the Comparison Studies: No adjudication process is explicitly mentioned for the comparison of device results against LC/MS or GC/MS. The LC/MS or GC/MS is the definitive reference against which the device's reading is compared. Discordant results are simply listed.
    • For the Lay-User Study: The "Lay person results" are the outcome of the user's interpretation of the device. These are then compared to the LC/MS confirmed concentration. No adjudication of lay-user interpretation is described.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No MRMC or AI assistance study was conducted or is applicable here. This device is a rapid, lateral flow immunochromatographic assay, which is a standalone point-of-care test, not an AI-assisted diagnostic tool for Human Readers. Performance is assessed on the device's output itself, or the user's interpretation of that output in the lay-user study.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Yes, the Precision Study and the Comparison Studies represent "standalone" performance in a laboratory setting, where the device's output (presence/absence of a line) is objectively recorded and compared against the LC/MS/GC/MS ground truth. While human technicians operate the device and record results, the interpretation standard is purely objective based on the chemical reaction. The "discordant results" tables for the comparison studies elaborate on the instances where the device's qualitative result did not match the LC/MS/GC/MS quantitative ground truth.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The primary ground truth used for all studies (Precision, Comparison, Lay-User) is quantitative analytical results from Liquid Chromatography-Mass Spectrometry (LC/MS) or Gas Chromatography-Mass Spectrometry (GC/MS). These are highly accurate laboratory methods for identifying and quantifying substances in a sample, considered the gold standard for drug testing.

  8. The sample size for the training set:

    • This document describes a premarket notification (510(k)) for a medical device that operates based on a well-established biochemical principle (immunochromatography). It is not an AI/ML device that requires a "training set" in the computational sense. The device itself is "trained" during its manufacturing and quality control processes to consistently react at specific cutoff concentrations. The studies described are validation studies to prove the device's performance, not to train it.

  9. How the ground truth for the training set was established:

    • As this is not an AI/ML device, there isn't a "training set" in that context. The device's "training" refers to its design and manufacturing to react precisely to given concentrations, with the LC/MS/GC/MS as the analytical reference used during development and quality control to ensure target specificity and sensitivity.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 7, 2019

Healstone Biotech Inc % Joe Shia, Director LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877

Re: K191841

Trade/Device Name: Accurate Multi Panel Drug Urine Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, QBF, NGG, QAW, NGM, NFW Dated: July 5, 2019 Received: July 9, 2019

Dear Joe Shia:

We have reviewed vour 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Accurate Multi Panel Drug Urine Test Cup

Indications for Use (Describe)

Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)Cut-off
Amphetamine (AMP)1000 ng
Buprenorphine (BUP)10 ng
Secobarbital (BAR)300 ng
Oxazepam (BZO)300 ng
Cocaine (COC)300 ng
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)300 ng
Methamphetamine (MET)1000 ng
Methylenedioxymethamphetamine (MDMA)500 ng
Morphine (MOP 300/OPI 2000)300 ng
Methadone (MTD)300 ng
Oxycodone (OXY)100 ng
Phencyclidine (PCP)25 ng
Propoxyphene (PPX)300 ng
Nortriptyline (TCA)1000 ng
Marijuana (THC 50)50 ng

l flow immunochromatographic
barbital, Oxazepam, Cocaine, 2-
nedioxymethamphetamine, Morp
ijuana in human urine at the cuto

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL

Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when 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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510(k) SUMMARY K191841

  • 1 Date August 7, 2019 Submitter Healstone Biotech Inc. 2 650-655 W Kent N. Vancouver, BC V6P6T7 Canada 3 Contact Joe Shia Person LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: Fax: 301-916-6213 Email: shiajl@yahoo.com
  • 4 Device Name Accurate® Multi Panel Drug Urine Test Cup
  • Classification Class II 5
Class II
Product CodeTarget DrugRegulation SectionPanel
NFTAmphetamine (AMP)862.3100, Amphetamine Test SystemToxicology
NGLBuprenorphine (BUP)862.3650, Opiate Test SystemToxicology
PTHSecobarbital (BAR)862.3150, Barbiturate Test SystemToxicology
NFVOxazepam (BZO)862.3170, Benzodiazepine Test SystemToxicology
NFYCocaine (COC)862.3250, Cocaine Test SystemToxicology
PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine(EDDP)862.3620, Methadone Test SystemToxicology
NGGMethamphetamine (MET)862.3610, Methamphetamine Test SystemToxicology
NGGMethylenedioxymethamphetamine (MDMA)862.3610, Methamphetamine Test SystemToxicology
NGL862.3650, Opiate Test SystemToxicology

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Morphine (MOP/OPI)
PTGMethadone (MTD)862.3620, Methadone Test SystemToxicology
NGLOxycodone (OXY)862.3650, Opiate Test SystemToxicology
NGMPhencyclidine (PCP)Unclassified, EnzymeImmunoassay PhencyclidineToxicology
QBFPropoxyphene (PPX)862.3700 Propoxyphene testsystem.Toxicology
QAWNortriptyline (TCA)862.3910 Tricyclic antidepressantdrugs test systemToxicology
NFWMarijuana (THC 50)862.3870, Cannabinoids TestSystemToxicology
K182701

б Predicate Device

Wondfo T-Cup® Multi-Drug Urine Test Cup

7. Intended Use

Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)Cut-off level
Amphetamine (AMP)1000 ng/mL
Buprenorphine (BUP)10ng/mL
Secobarbital (BAR)300 ng/mL
Oxazepam (BZO)300 ng/mL
Cocaine (COC)300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)300 ng/mL
Methamphetamine (MET)1000 ng/mL
Methylenedioxymethamphetamine (MDMA)500 ng/mL
Morphine (MOP 300/OPI 2000)300 ng/mL or 2000 ng/mL
Methadone (MTD)300 ng/mL
Oxycodone (OXY)100 ng/mL
Phencyclidine (PCP)25 ng/mL
Propoxyphene (PPX)300 ng/mL
Nortriptyline (TCA)1,000 ng/mL
Marijuana (THC 50)50 ng/mL

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Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone 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 8.

Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.

ItemProposed DevicePredicate (K182701)
Indication(s) for useFor the qualitative determination of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine.Same
MethodologyCompetitive binding, lateral flow immunochromatographic assay based on antigen-antibody reactionSame
Type of TestQualitativeSame
Specimen TypeHuman urineSame
Target Drug and Cut Off ValuesTarget DrugCutoff (ng/mL)
Amphetamine (AMP)1000
Buprenorphine (BUP)10
Secobarbital (BAR)300
Oxazepam (BZO)300
Cocaine (COC)300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)300
Methamphetamine (MET)1000

Substantial Equivalence Information 9.

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Methylenedioxymethamphetamine (MDMA)500
Morphine (MOP 300/OPI 2000)2000 or 300
Methadone (MTD)300
Oxycodone (OXY)100
Phencyclidine (PCP)25
Propoxyphene (PPX)300
Nortriptyline (TCA)1000
Marijuana (THC 50)50
ConfigurationsSame
Intended UseSame

10. Test Principle

Accurate® Multi Panel Drug Urine Test Cup is a rapid test for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.

A band should be formed on the control line region regardless of the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.

11. Performance Characteristics

  • Analytical Performance 1.
    • a. Precision

Precision studies were carried out for samples with concentrations of -100%cut off, -75%cut off, -50%cut off, -25%cut off, +25%cut off, +50%cut off, +75%cut off and +100%cut off. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

Accurate® Multi Panel Drug Urine Test Cup BUP

Concentration byLC/MS(ng/mL)+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
19.116.115.212.99.47.15.42.40

{8}------------------------------------------------

Lot Number
Lot I0-/50+0-/50+0-/50+1-/49+26-/24+48-/2+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+1-/49+22-/28+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+2-/48+20-/30+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup PCP

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)Lot Number50.343.136.230.425.017.912.26.40
Lot I0-/50+0-/50+0-/50+1-/49+24-/26+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+1-/49+26-/24+48-/2+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+1-/49+21-/29+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup THC

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)Lot Number100.888.672.965.850.239.525.212.60
Lot I0-/50+0-/50+0-/50+1-/49+24-/26+47-/3+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+28-/22+48-/2+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+3-/47+24-/26+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup OXY

Concentration byLC/MS(ng/mL)+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
Lot Number200.3170.6150.1118.598.477.952.528.30
Lot I0-/50+0-/50+0-/50+2-/48+23-/27+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+22-/28+47-/3+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+2-/48+21-/29+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup BAR

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)645.0510.9437.8394.7270.1235.5161.877.90

{9}------------------------------------------------

Lot Number
Lot I0-/50+0-/50+0-/50+1-/49+24-/26+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+19-/31+47-/3+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+1-/49+23-/27+48-/2+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup BZO

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)Lot Number580.3530.3488.3386.6307.9247.0142.371.80
Lot I0-/50+0-/50+0-/50+0-/50+24-/26+48-/2+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+21-/29+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+2-/48+22-/28+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup EDDP

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MS(ng/mL)Lot Numbercutoff571.3cutoff498.7cutoff430.7cutoff358.5300.7cutoff222.8cutoff142.4cutoff79.5cut-off0
Lot I0-/50+0-/50+0-/50+1-/49+20-/30+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+1-/49+22-/28+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+1-/49+20-/30+50-/0+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup MTD

Concentration byLC/MS(ng/mL)+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
588.6514.8471.0393.1314.6223.5140.974.60
Lot Number
Lot I0-/50+0-/50+0-/50+0-/50+22-/28+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+1-/49+24-/26+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+0-/50+22-/28+50-/0+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup MOP

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)591.7504.6470.3384.0289.0244.9163.674.00

{10}------------------------------------------------

Lot Number
Lot I0-/50+0-/50+0-/50+0-/50+24-/26+50-/0+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+0-/50+24-/26+50-/0+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+0-/50+23-/27+50-/0+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup PPX

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)626.7534.8433.6364.2308.6225.3159.179.40
Lot Number
Lot I0-/50+0-/50+0-/50+0-/50+23-/27+48-/2+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+0-/50+22-/28+48-/2+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+1-/49+22-/28+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup MDMA

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MScutoffcutoffcutoffcutoffcutoffcutoffcutoffcut-off
(ng/mL)Lot Number1208.1863.1711.1592.8516.6375.2259.9124.10
Lot I0-/50+0-/50+0-/50+1-/49+23-/27+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+19-/31+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+0-/50+23-/27+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup TCA

Concentration byLC/MS(ng/mL)+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
2024.21727.61459.51276.11091.2718.8505.0257.50
Lot Number
Lot I0-/50+0-/50+0-/50+1-/49+21-/29+48-/2+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+23-/27+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+2-/48+22-/28+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup OPI

Concentration byLC/MS+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
cutoff

{11}------------------------------------------------

(ng/mL)4166.33535.63077.22407.82008.31611.81041.0509.50
Lot Number
Lot I0-/50+0-/50+0-/50+1-/49+23-/27+50-/0+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+0-/50+25-/25+48-/2+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+1-/49+23-/27+48-/2+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup COC

Concentration byLC/MS(ng/mL)+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
619.3533.4432.2360.6303.1226.4157.7730
Lot Number
Lot I0-/50+0-/50+0-/50+0-/50+20-/30+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+1-/49+22-/28+49-/1+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+0-/50+24-/26+49-/1+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup AMP

Concentration by+100%+75%+50%+25%Cutoff-25%-50%-75%-100%
LC/MS(ng/mL)Lot Numbercutoff2015.9cutoff1749.1cutoff1496.0cutoff1202.31091.8cutoff789.2cutoff532.7cutoff270.3cut-off0
Lot I0-/50+0-/50+0-/50+0-/50+23-/27+49-/1+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+2-/48+24-/26+48-/2+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+1-/49+25-/25+50-/0+50-/0+50-/0+50-/0+

Accurate® Multi Panel Drug Urine Test Cup MET

Concentration by+100%cutoff+75%cutoff+50%cutoff+25%cutoffCutoff-25%cutoff-50%cutoff-75%cutoff-100%cut-off
LC/MS(ng/mL)Lot Number1906.81629.31459.11229.8949.7733.1491.1236.20
Lot I0-/50+0-/50+0-/50+0-/50+20-/30+50-/0+50-/0+50-/0+50-/0+
Lot II0-/50+0-/50+0-/50+1-/49+19-/31+50-/0+50-/0+50-/0+50-/0+
Lot III0-/50+0-/50+0-/50+0-/50+19-/31+49-/1+50-/0+50-/0+50-/0+

The following cutoff values are verified:

{12}------------------------------------------------

Amphetamine (AMP)1000 ng/mL
Buprenorphine (BUP)10 ng/mL
Secobarbital (BAR)300 ng/mL
Oxazepam (BZO)300 ng/mL
Cocaine (COC)300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)300 ng/mL
Methamphetamine (MET)1000 ng/mL
Methylenedioxymethamphetamine (MDMA)500 ng/mL
Morphine (MOP 300/OPI 2000)2000 ng/mL or 300 ng/mL
Methadone (MTD)300 ng/mL
Oxycodone (OXY)100 ng/mL
Phencyclidine (PCP)25 ng/mL
Propoxyphene (PPX)300 ng/mL
Nortriptyline (TCA)1000 ng/mL
Marijuana (THC 50)50 ng/mL

b. Linearity

Not applicable

  • c. Stability
    The devices are stable at 4-30℃ for 24 months based on real-time stability studies.

d. Interference

Potential interfering substances were added to drug-free urine samples with target drugs of -50% cutoff and +50% cutoff level.

Compounds that show no interference at a concentration of 100μg/mL are summarized in the following table.

(±)-4-MethylephedrineEcgonine methylesterOxalic acid
Acetaminophenß-EstradiolOxolinic acid
AcetophenetidinErythromycinOxymetazoline
N-AcetylprocainamideFenoprofenPapaverine
Acetylsalicylic acidFurosemidePenicillin G
Albumin (100 mg/dL)Gentisic acidPerphenazine
AminopyrineHemoglobinPhenelzine
AmoxicillinHydralazinePrednisone
AmpicillinHydrochlorothiazide(±)-Propranolol
ApomorphineHydrocortisonePseudoephedrine

{13}------------------------------------------------

Ascorbic acidO-Hydroxyhippuric acidQuinine
Aspartame3-HydroxytyramineRanitidine
AtropineIbuprofenSalicylic acid
Benzilic acidIsoproterenolSerotonin (5-Hydroxytyramine)
Benzoic acidIsoxsuprineSulfamethazine
BilirubinKetamineSulindac
Chloral hydrateKetoprofenTetrahydrocortisone 3-(β-Dglucuronide)
ChloramphenicolLabetalolTetrahydrocortisone 3-acetate
ChlorothiazideLoperamideTetrahydrozoline
ChlorpromazineMeperidineThiamine
CholesterolMeprobamateThioridazine
ClonidineMethoxyphenamineTriamterene
CortisoneNalidixic acidTrifluoperazine
(-)-CotinineNaproxenTrimethoprim
CreatinineNiacinamideDL-Tryptophan
DeoxycorticosteroneNifedipineDL-Tyrosine
DextromethorphanNorethindroneUric acid
DiclofenacNoscapineVerapamil
Diflunisal(±)-OctopamineZomepirac
Digoxin
  • e. Specificity
    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 each device.

Compounds that produced positive results are listed below.

BUP (Buprenorphine,Cutoff=10 ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Buprenorphine10100%
Buprenorphine -3-D-Glucuronide1606%
Norbuprenorphine10100%
Norbuprenorphine-3-D-Glucuronide2005%
Morphine100000 (negative)Not detected
Oxymorphone100000 (negative)Not detected
Hydromorphone100000 (negative)Not detected

{14}------------------------------------------------

PCP (Phencyclidine)(Phencyclidine,Cutoff=25 ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Phencyclidine25100%
4-Hydroxy Phencyclidine125000.2%
THC(11-nor-Δ9-THC-9-COOH,Cutoff=50 ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
11-nor-Δ8-THC -9-COOH30167%
(-)-11-nor-9-carboxy-Δ 9-THC50100%
(±)-11-nor-9-Carboxy-Δ9-THC50100%
11-nor-Δ9-THC -carboxy glucuronide10050%
11-hydroxy-Δ9-Tetrahydrocannabinol5,0001%
Δ8- Tetrahydrocannabinol1,3004%
Δ9- Tetrahydrocannabinol5,0001%
Cannabinol20,0000.25%
Cannabidiol100000(negative)Not Detected
OXY(Oxycodone, Cutoff=100 ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Ethyl Oxycodone75,0000.1%
Hydrocodone5,0002%
Hydromorphone25,0000.4%
Levorphanol10,0001 %
Oxycodone100100%
Oxymorphone20050%
Dihydrocodeine100000(negative)Not Detected
Codeine100000(negative)Not Detected
Morphine100000(negative)Not Detected
Acetylmorphine100000(negative)Not Detected
Buprenorphine100000(negative)Not Detected
Ethylmorphine100000(negative)Not Detected
Thebaine100000(negative)Not Detected
BAR(Secobarbital, Cutoff=300ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Alphenal150200%
Amobarbital300100%

{15}------------------------------------------------

Aprobarbital250120%
Butabarbital2,50012%
Butethal100300%
Butalbital2,50012%
Cyclopentobarbital60050%
Pentobarbital250120%
Phenobarbital250120%
Secobarbital300100%
BZO(Oxazepam, Cutoff=300ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Alprazolam200150%
a-Hydroxyalprazolam1,26024%
Bromazepam1,56019%
Chlordiazepoxide1,56019%
Clobazam100300%
Clonazepam2,50012%
Clorazepate dipotassium200150%
Desalkylflurazepam40075%
Diazepam200150%
Estazolam2,50012%
Flunitrazepam40075%
Midazolam12,5002.4%
Nitrazepam100300%
Norchlordiazepoxide200150%
Nordiazepam40075%
Temazepam100300%
Triazolam2,50012%
Demoxepam2,00015%
Flurazepam50060%
D,L-Lorazepam1,56020%
Oxazepam300100%
RS-Lorazepam glucuronide160188%
Delorazepam100000 (negative)Not detected
EDDP(2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Cutoff = 300 ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine300100%
Methadone>100000Not detected
EMDP>100000Not detected

{16}------------------------------------------------

Doxylamine>100000Not detected
Disopyramide>100000Not detected
LAAM (Levo-alpha-acetylmethadol)>100000Not detected
Alpha Methadol>100000Not detected
MTD(Methadone, Cutoff=300ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Methadone300100%
Doxylamine>100000Not detected
EDDP>100000Not detected
EMDP>100000Not detected
LAAM>100000Not detected
Alpha Methadol>100000Not detected
MOP 300(Morphine, Cutoff=300ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Morphine300100%
Normorphine300100%
s-Monoacetylmorphine300100%
Codeine300100%
Ethyl Morphine100300%
Heroin60050%
Hydrocodone100003%
Hydromorphone50060%
Morphinie-3-β-d-glucuronide100030%
Thebaine6,2404.8%
Levorphanol100003%
6-Monoacetylmorphine (6-MAM)150200%
6-acetylmorphine40075%
Dihydrocodeine100030%
Normorphine>100000Not detected
Oxycodone>100000Not detected
Oxymorphone>100000Not detected
Norcodeine>100000Not detected
Procaine>100000Not detected
PPX(Propoxyphene, Cutoff=300ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
d-Propoxyphene300100%

{17}------------------------------------------------

d-Norpropoxyphene300100%
------------------------------
MDMA(3,4-Methylenedioxymethamphetamine HCl,Cutoff=500ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
3,4-Methylenedioxymethamphetamine (MDMA)500100%
3,4-Methylenedioxyamphetamine HCl (MDA)300017%
3,4-Methylenedioxyethylamphetamine (MDEA)300167%
l-Methamphetamine500001%
d-methamphetamine100000(Negative)Not detected
d-amphetamine100000(Negative)Not detected
l-amphetamine100000(Negative)Not detected
TCA 1000 (Nortriptyline, Cutoff=1000ng/mL)Minimum concentration required to obtain a positive result (ng/mL)% Cross-Reactivity
Chlorpheniramine maleate500002%
Nortriptyline1000100%
Nordoxepine1000100%
Trimipramine1000010%
Amitriptyline150066.7%
Promazine500002%
Desipramine1000100%
Imipramine1000100%
Clomipramine1000010%
Doxepin200050%
Maprotiline100000(Negative)Not detected
Promethazine100000(Negative)Not detected
Cyclobenzaprine500020%
Norclomipramine125008%
Duloxetine1000010%
COC(Benzoylecgonine, Cutoff=300ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Benzoylecgonine300100%
Cocaine300100%
Cocaethylene300100%
Ecgonine300100%
Ecgonine methyl ester100000 (negative)Not detected
Norcocaine100000 (negative)Not detected

{18}------------------------------------------------

AMP(d-Amphetamine, Cutoff=1000ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
(+/-)-4-Hydroxyamphetamine800012.5%
Methylenedioxyamphetamine(MDA)400250%
D,L-Amphetamine1,000100%
D-Amphetamine1,000100%
Diethylstilbestrol5,00020%
L-Amphetamine50,0002%
Phentermine8,00012.5%
ß-Phenylethylamine1000001%
p-Hydroxynorephedrine1000001%
p-Hydroxyamphetamine100,0001%
d/l-Norephedrine100,0001%
d-Methamphetamine50,0002%
l-Methamphetamine1,000100%
Ephedrine100000 (negative)Not detected
Methylenedioxymethamphetamine(MDMA)100000 (negative)Not detected
Phenylpropanolamine100000 (negative)Not detected
Benzphetamine100000 (negative)Not detected
l-Ephedrine100000 (negative)Not detected
l-Epinephrine100000 (negative)Not detected
d/l-Epinephrine100000 (negative)Not detected
MET(D(+)-Methamphetamine, Cutoff=1000ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)20,0005%
(±)-MDMA2,50040%
d-Methamphetamine1,000100%
l-Methamphetamine25,0004%
d/l-Methamphetamine1,000100%
p-Hydroxymethamphetamine10,00010%
L-Amphetamine750001.3%
β-Phenylethylamine500002%
Mephetermine500002%
Fenfluramine500002%
D-Amphetamine100000(negative)Not Detected
Chloroquine100000(negative)Not Detected

{19}------------------------------------------------

(+/-)3,4-Methylenedioxyamphetamine (MDA)100000(negative)Not Detected
Trimethobenzamide100000(negative)Not Detected
d,l-Amphetamine100000(negative)Not Detected
(1R,2S)-(-)-Ephedrine100000(negative)Not Detected
l-phenylephrine100000(negative)Not Detected
OPI(Morphine, Cutoff=2000ng/mL)Minimum concentrationrequired to obtain apositive result (ng/mL)% Cross-Reactivity
Morphine2000100%
Codeine1000200%
Ethyl Morphine250080%
Hydrocodone500040%
Hydromorphone250008%
Levorphanol1000020%
6-Monoacetylmorphine (6-MAM)1500133%
Morphine 3-β-D-glucuronide2000100%
Norcodeine400050%
Normorphine500040%
Oxymorphone750003%
Thebaine1300015%
Heroin500040%
s-Monoacetylmorphine2000100%
Dihydrocodeine1500133%
Nalorphine500040%
6-acetylmorphine2,50080%
Procaine100000(negative)Not Detected
Oxycodone100000(negative)Not Detected

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine specific gravity between 1.000 and 1.035 has no effect on the accuracy and precision of the test device.

To investigate the effect of urine pH, urine samples with pH value from 4 to 9 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine pH value between 4.0 and 9.0 has no effect on the accuracy and precision of the test device.

{20}------------------------------------------------

    1. Comparison Studies
      The method comparison studies for Accurate® Multi Panel Drug Urine Test cup were performed inhouse with three operators.

Operators ran 80 (40 negative and 40 positive) unaltered urine samples were blind labeled and compared to LC/MS or GC/MS results. The results are presented in the table below:

BUP

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011423
Negative10161330
Viewer BPositive0031423
Negative10161130
Viewer CPositive0011423
Negative10161330

Discordant Results for BUP:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-BUP-A7510.2-
Viewer AMCP-BUP-A4210.9-
Viewer AMCP-BUP-A6111.2-
Viewer BMCP-BUP-A5810.3-
Viewer BMCP-BUP-A4210.9-
Viewer BMCP-BUP-A0612.3-
Viewer CMCP-BUP-A5810.3-
Viewer CMCP-BUP-A7011.3-
Viewer CMCP-BUP-A1112.9-
Viewer AMCP-BUP-A799.0+
Viewer BMCP-BUP-A018.4+
Viewer BMCP-BUP-A799.0+
Viewer BMCP-BUP-A549.5+
Viewer CMCP-BUP-A549.5+

BAR

Accurate ®Drug-FreeLow Negative by LC/MS (less than -50%)Near Cutoff Negative by LC/MSNear Cutoff Positive by LC/MSHigh Positive by LC/MS (greater than +50%)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{21}------------------------------------------------

(Between -50%and the Cutoff)(Between thecutoff and+50%)
Viewer APositive0031423
Negative10161130
Viewer BPositive0021423
Negative10161230
Viewer CPositive0021423
Negative10161230

Discordant Results for BAR:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-BAR-A64271.6+
Viewer AMCP-BAR-A02285.9+
Viewer AMCP-BAR-A41295.6+
Viewer BMCP-BAR-A23246.0+
Viewer BMCP-BAR-A02285.9+
Viewer CMCP-BAR-A02285.9+
Viewer CMCP-BAR-A41295.6+
Viewer AMCP-BAR-A14301.7-
Viewer AMCP-BAR-A03317.8-
Viewer AMCP-BAR-A52332.9-
Viewer BMCP-BAR-A47311.9-
Viewer BMCP-BAR-A78327.1-
Viewer BMCP-BAR-A27347.5-
Viewer CMCP-BAR-A14301.7-
Viewer CMCP-BAR-A47311.9-
Viewer CMCP-BAR-A20347.5-

BZO

Accurate@Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011423
Negative10161330
Viewer BPositive0031323
Negative10161140
Viewer CPositive0021423

{22}------------------------------------------------

Negative10161230
------------------------------

Discordant Results for BZO:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-BZO-A37274.5+
Viewer BMCP-BZO-A51227.5+
Viewer BMCP-BZO-A42264.1+
Viewer BMCP-BZO-A18288.6+
Viewer CMCP-BZO-A75235.0+
Viewer CMCP-BZO-A37274.5+
Viewer AMCP-BZO-A76304.6-
Viewer AMCP-BZO-A56350.5-
Viewer AMCP-BZO-A73358.2-
Viewer BMCP-BZO-A76304.6-
Viewer BMCP-BZO-A03311.2-
Viewer BMCP-BZO-A63335.5-
Viewer BMCP-BZO-A73358.2-
Viewer CMCP-BZO-A27309.5-
Viewer CMCP-BZO-A08332.0-
Viewer CMCP-BZO-A56350.5-

EDDP

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50% and theCutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011423
Negative10161330
Viewer BPositive0011423
Negative10161330
Viewer CPositive0011523
Negative10161320

Discordant Results for EDDP:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-EDDP-A07254.8+
Viewer BMCP-EDDP-A07254.8+
Viewer CMCP-EDDP-A21245.1+
Viewer AMCP-EDDP-A12303.7-
Viewer AMCP-EDDP-A34306.8-
Viewer AMCP-EDDP-A20316.7-

{23}------------------------------------------------

Viewer BMCP-EDDP-A38302.4-
Viewer BMCP-EDDP-A46310.5-
Viewer BMCP-EDDP-A14319.9-
Viewer CMCP-EDDP-A12303.7-
Viewer CMCP-EDDP-A20316.7-

MDMA

Accurate ®Drug-FreeLow Negative by LC/MS (less than -50%)Near Cutoff Negative by LC/MS (Between -50% and the Cutoff)Near Cutoff Positive by LC/MS (Between the cutoff and +50%)High Positive by LC/MS (greater than +50%)
Viewer APositive0011323
Negative10161340
Viewer BPositive0021423
Negative10161230
Viewer CPositive0011423
Negative10161330

Discordant Results for MDMA:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-MDMA-A10451.4+
Viewer BMCP-MDMA-A48379.2+
Viewer BMCP-MDMA-A26476.0+
Viewer CMCP-MDMA-A10451.4+
Viewer AMCP-MDMA-A21525.2-
Viewer AMCP-MDMA-A04538.5-
Viewer AMCP-MDMA-A07562.6-
Viewer AMCP-MDMA-A38542.7-
Viewer BMCP-MDMA-A78532.6-
Viewer BMCP-MDMA-A38542.7-
Viewer BMCP-MDMA-A24591.1-
Viewer CMCP-MDMA-A39528.9-
Viewer CMCP-MDMA-A56551.9-
Viewer CMCP-MDMA-A24591.1-

{24}------------------------------------------------

Accurate®Drug-FreeLowNegative byGC/MS (lessthan -50%)Near CutoffNegative byGC/MS(Between -50%and the Cutoff)Near CutoffPositive byGC/MS(Between thecutoff and+50%)High Positiveby GC/MS(greater than+50%)
Viewer APositive0021523
Negative10161220
Viewer BPositive0031523
Negative10161120
Viewer CPositive0021523
Negative10161220

Discordant Results for MOP 300:

ViewerSample NumberGC/MS Result (ng/mL)Accurate Result
Viewer AMCP-MOP-A152277.0+
Viewer AMCP-MOP-A141283.1+
Viewer BMCP-MOP-A135240.9+
Viewer BMCP-MOP-A098272.3+
Viewer BMCP-MOP-A147290.0+
Viewer CMCP-MOP-A098272.3+
Viewer CMCP-MOP-A141283.1+
Viewer AMCP-MOP-A151305.6-
Viewer AMCP-MOP-A114372.5-
Viewer BMCP-MOP-A081300.4-
Viewer BMCP-MOP-A151305.6-
Viewer CMCP-MOP-A081300.4-
Viewer CMCP-MOP-A157331.8-

MTD

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011323
Negative10161340
Viewer BPositive0021423
Negative10161230
Viewer CPositive0011323
Negative10161340

{25}------------------------------------------------

Discordant Results for MTD:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-MTD-A71290.9+
Viewer BMCP-MTD-A25262.4+
Viewer BMCP-MTD-A36272.2+
Viewer CMCP-MTD-A71290.9+
Viewer AMCP-MTD-A52309.6-
Viewer AMCP-MTD-A80316.6-
Viewer AMCP-MTD-A10326.3-
Viewer AMCP-MTD-A43363.5-
Viewer BMCP-MTD-A52309.6-
Viewer BMCP-MTD-A10326.3-
Viewer BMCP-MTD-A42319.1-
Viewer CMCP-MTD-A45300.5-
Viewer CMCP-MTD-A52309.6-
Viewer CMCP-MTD-A42319.1-
Viewer CMCP-MTD-A76327.8-

OXY

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011223
Negative10161350
Viewer BPositive0011423
Negative10161330
Viewer CPositive0011323
Negative10161340

Discordant Results for OXY:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-OXY-A5477.1+
Viewer BMCP-OXY-A3392.3+
Viewer CMCP-OXY-A3392.3+
Viewer AMCP-OXY-A76102.8-
Viewer AMCP-OXY-A31105.3-
Viewer AMCP-OXY-A14105.5-
Viewer AMCP-OXY-A38109.7-

{26}------------------------------------------------

Viewer AMCP-OXY-A52115.5-
Viewer BMCP-OXY-A15103.7-
Viewer BMCP-OXY-A34109.4-
Viewer BMCP-OXY-A27120.5-
Viewer CMCP-OXY-A60100.5-
Viewer CMCP-OXY-A15103.7-
Viewer CMCP-OXY-A65105.8-
Viewer CMCP-OXY-A34109.4-

РСР

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011223
Negative10161350
Viewer BPositive0001323
Negative10161440
Viewer CPositive0011123
Negative10161360

Discordant Results for PCP:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-PCP-A3823.6+
Viewer CMCP-PCP-A6523.1+
Viewer AMCP-PCP-A0425.5-
Viewer AMCP-PCP-A7325.5-
Viewer AMCP-PCP-A2026.6-
Viewer AMCP-PCP-A2227.3-
Viewer AMCP-PCP-A5528.3-
Viewer BMCP-PCP-A0425.5-
Viewer BMCP-PCP-A5925.9-
Viewer BMCP-PCP-A2227.3-
Viewer BMCP-PCP-A4627.6-
Viewer CMCP-PCP-A5325.1-
Viewer CMCP-PCP-A7325.5-
Viewer CMCP-PCP-A5925.9-
Viewer CMCP-PCP-A2026.6-
Viewer CMCP-PCP-A2926.8-

{27}------------------------------------------------

MCP-PCP-A08र्Viewer Cf Children Children Station of Children Children Station of Children Station of Children Station of Children Station of Station of Station of Station of Station of Station ofSeptember 19, 2017 11:00 PM
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011423
Negative10161330
Viewer BPositive0011523
Negative10161320
Viewer CPositive0011523
Negative10161320

PPX

Discordant Results for PPX 300:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-PPX-A78255.3+
Viewer BMCP-PPX-A20295.8+
Viewer CMCP-PPX-A20295.8+
Viewer AMCP-PPX-A38314.2-
Viewer AMCP-PPX-A46327.2-
Viewer AMCP-PPX-A22349.3-
Viewer BMCP-PPX-A38314.2-
Viewer BMCP-PPX-A42339.5-
Viewer CMCP-PPX-A12307.1-
Viewer CMCP-PPX-A38314.2-

TCA

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0021423
Negative10161230
Viewer BPositive0021423
Negative10161230

{28}------------------------------------------------

Viewer CPositive0031523
Negative10161120

Discordant Results for TCA:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-TCA-A45806.6+
Viewer AMCP-TCA-A66983.7+
Viewer BMCP-TCA-A09925.4+
Viewer BMCP-TCA-A21955.8+
Viewer CMCP-TCA-A57780.7+
Viewer CMCP-TCA-A09925.4+
Viewer CMCP-TCA-A66983.7+
Viewer AMCP-TCA-A061070.1-
Viewer AMCP-TCA-A051111.1-
Viewer AMCP-TCA-A771239.5-
Viewer BMCP-TCA-A331045.4-
Viewer BMCP-TCA-A061070.1-
Viewer BMCP-TCA-A051111.1-
Viewer CMCP-TCA-A061070.1-
Viewer CMCP-TCA-A051111.1-

THC

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011523
Negative10161320
Viewer BPositive0011423
Negative10161330
Viewer CPositive0021523
Negative10161220

Discordant Results for THC:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-THC-A8039.1+
Viewer BMCP-THC-A5548.2+
Viewer CMCP-THC-A4840.2+
Viewer CMCP-THC-A5548.2+

{29}------------------------------------------------

Viewer AMCP-THC-A5950.5-
Viewer AMCP-THC-A6654.1-
Viewer BMCP-THC-A5352.2-
Viewer BMCP-THC-A6654.1-
Viewer BMCP-THC-A6060.1-
Viewer CMCP-THC-A5352.2-
Viewer CMCP-THC-A7957.5-

AMP

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0031523
Negative10161120
Viewer BPositive0041423
Negative10161030
Viewer CPositive0021423
Negative10161230

Discordant Results for AMP:

ViewerSample NumberLC/MS Result (ng/mL)Accurate Result
Viewer AMCP-AMP-A60906.4+
Viewer AMCP-AMP-A14971.9+
Viewer AMCP-AMP-A50988.0+
Viewer BMCP-AMP-A47789.6+
Viewer BMCP-AMP-A24951.4+
Viewer BMCP-AMP-A31966.9+
Viewer BMCP-AMP-A50988.0+
Viewer CMCP-AMP-A10923.2+
Viewer CMCP-AMP-A26965.0+
Viewer AMCP-AMP-A561013.8-
Viewer AMCP-AMP-A781180.9-
Viewer BMCP-AMP-A491053.4-
Viewer BMCP-AMP-A481201.4-
Viewer BMCP-AMP-A131255.2-
Viewer CMCP-AMP-A491053.4-
Viewer CMCP-AMP-A051166.2-
Viewer CMCP-AMP-A801235.3-

{30}------------------------------------------------

COC

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011423
Negative10161330
Viewer BPositive0011323
Negative10161340
Viewer CPositive0011423
Negative10161330

Discordant Results for COC:

ViewerSample NumberLC/MS ResultAccurate Result
Viewer AMCP-COC-A75267.4+
Viewer BMCP-COC-A14267.8+
Viewer CMCP-COC-A38291.6+
Viewer AMCP-COC-A15309.0-
Viewer AMCP-COC-A73322.7-
Viewer AMCP-COC-A25337.0-
Viewer BMCP-COC-A50302.3-
Viewer BMCP-COC-A15309.0-
Viewer BMCP-COC-A73322.7-
Viewer BMCP-COC-A11344.4-
Viewer CMCP-COC-A50302.3-
Viewer CMCP-COC-A54317.8-
Viewer CMCP-COC-A76334.4-

MET

Accurate®Drug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and+50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0001323
Negative10161440
Viewer BPositive0011423
Negative10161330

{31}------------------------------------------------

Viewer CPositive------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Cj
Negative1010-

Discordant Results for MET:

ViewerSample NumberLC/MS ResultAccurate Result
Viewer BMCP-MET-A27846.8+
Viewer CMCP-MET-A71732.5+
Viewer AMCP-MET-A501034.1-
Viewer AMCP-MET-A391059.0-
Viewer AMCP-MET-A361225.0-
Viewer AMCP-MET-A091288.3-
Viewer BMCP-MET-A391059.0-
Viewer BMCP-MET-A141122.5-
Viewer BMCP-MET-A011246.5-
Viewer CMCP-MET-A501034.1-
Viewer CMCP-MET-A231081.3-
Viewer CMCP-MET-A361225.0-
Viewer CMCP-MET-A381267.0-

OPI 2000

WondfoQ-CupDrug-FreeLowNegative byLC/MS (lessthan -50%)Near CutoffNegative byLC/MS(Between -50%and the Cutoff)Near CutoffPositive byLC/MS(Between thecutoff and +50%)High Positiveby LC/MS(greater than+50%)
Viewer APositive0011323
Negative10161340
Viewer BPositive0011423
Negative10161330
Viewer CPositive0011223
Negative10161350

Discordant Results for OPI 2000:

ViewerSample NumberLC/MS ResultAccurate Result
Viewer AMCP-MOP-A241423.7+
Viewer BMCP-MOP-A101955.2+
Viewer CMCP-MOP-A101955.2+
Viewer AMCP-MOP-A092018.7-
Viewer AMCP-MOP-A072028.1-
Viewer AMCP-MOP-A362153.3-
Viewer AMCP-MOP-A402368.2-

{32}------------------------------------------------

Viewer BMCP-MOP-A502024.3-
Viewer BMCP-MOP-A072028.1-
Viewer BMCP-MOP-A362153.3-
Viewer CMCP-MOP-A092018.7-
Viewer CMCP-MOP-A502024.3-
Viewer CMCP-MOP-A142050.8-
Viewer CMCP-MOP-A462064.1-
Viewer CMCP-MOP-A432398.2-

Lay-user study:

184 males and 126 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 1 (including MOP 300); 178 male and 132 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 2 (including MOP 2000 (OPI). They had diverse educational and professional backgrounds and fluent in English and their age range from 20 to over 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/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.

Lay-User Study Results for Accurate® Multi Panel Drug Urine Test Cup Configuration 1 (MOP 300):
Drugs% of CutoffNumberof samplesLay person resultsThe percentageagreement(%)
No. ofPositiveNo. ofNegative
Methamphetamine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
Cocaine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
Marijuana-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2017385%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Morphine-25% Cutoff2011995%
+25% Cutoff20200100%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Oxazepam-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Amphetamine-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Oxycodone-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Methadone-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
MDMA-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Secobarbital-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Buprenorphine-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Phencyclidine-25% Cutoff2011995%
+25% Cutoff2017385%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
Propoxyphene-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
TricyclicAntidepressants-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
EDDP-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%

{33}------------------------------------------------

{34}------------------------------------------------

{35}------------------------------------------------

Lay-User Study Results for Accurate® Multi Panel Drug Urine Test Cup Configuration 2 (MOP 2000 (OPI)):

Drugs% of CutoffNumber of samplesLay person resultsThe percentage agreement (%)
No. of PositiveNo. of Negative
Methamphetamine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
Cocaine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
Marijuana-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
Morphine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
Oxazepam-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
Amphetamine-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
Oxycodone-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
Methadone-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
MDMA-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
Secobarbital-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
Buprenorphine-50% Cutoff200170100%
-25% Cutoff2031785%
Phencyclidine+25% Cutoff2018290%
+50% Cutoff20400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2017385%
+50% Cutoff20400100%
+75% Cutoff20200100%
Propoxyphene-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
TricyclicAntidepressants-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%
EDDP-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff200170100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff20400100%
+75% Cutoff20200100%

{36}------------------------------------------------

{37}------------------------------------------------

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.

12. Conclusion

{38}------------------------------------------------

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 Accurate® Multi Panel Drug Urine Test Cup are substantially equivalent to the predicate devices.

§ 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).