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K Number
K142800
Device Name
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
Manufacturer
Co-Innovation Biotech Co., Ltd.
Date Cleared
2014-12-11

(73 days)

Product Code
DKZ,DIO,DIS,DJC,DJG,DJR,DNK,JXM,LCM,LDJ
Regulation Number
862.3100
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
K122809
Predicate For
K153050,K160793
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

TestCalibratorCut-off level
Marijuana (THC)Delta-9-THC-COOH50ng/mL
Cocaine (COC)Benzolecgonine300ng/mL
Amphetamine (AMP)D-Amphetamine1000ng/mL
Methamphetamine (MET)D-Methamphetamine1000ng/mL
Morphine 2000 (MOP)Morphine2000ng/mL
Barbiturates (BAR)Secobarbital300ng/mL
Benzodiazepines (BZO)Oxazepam300ng/mL
Methylenedioxymethamphetamine (MDMA)3,4-Methylenedioxymethamphetamine500ng/mL
Methadone (MTD)Methadone300ng/mL
Oxycodone (OXY)Oxycodone100ng/mL
Phencyclidine (PCP)Phencyclidine25ng/mL

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Rapid Single/Multi-drug Test Cup and Dipcard, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for precision or accuracy studies in a quantitative manner (e.g., "must achieve X% agreement"). However, given the nature of the data presented, the implied acceptance criterion for precision is that the device should reliably identify samples at or above the cutoff as positive, and samples significantly below the cutoff as negative, with a reasonable degree of accuracy for concentrations near the cutoff. For accuracy, the implied acceptance criterion is that the device should demonstrate high agreement with GC/MS analysis. For lay user readability, the implied criterion is high user comprehension.

Let's synthesize the data into a table based on these implied criteria.

Note on "Reported Device Performance": The document provides raw numbers of positive/negative results at different concentration levels for precision and individual count breakdowns for accuracy against GC/MS. To create a concise table, I will report the general trends and highlight key metrics. Specific percentages are primarily for the lay-user study.

Acceptance Criteria CategorySpecific Metric (Implied)Reported Device Performance (Summary)
Precision (for each drug)Reliable detection: - 0% false positives for negative samples - 0% false negatives for high positive samples - Consistent results at +/- 25% cutoff levelsAcross all drugs and lots (single/multi-drug, cup/dipcard formats): - Negative samples (0 ng/mL, -75% & -50% cutoff): Universally reported as 0 positive, 60 negative (100% accurate negative). - High positive samples (+50%, +75%, +100% cutoff): Universally reported as 60 positive, 0 negative (100% accurate positive). - Near Cutoff (-25% & +25% cutoff): Showed variability (e.g., AMP -25% cutoff ranged 4-10 positives out of 60, +25% cutoff ranged 50-58 positives out of 60). This variability near cutoff is expected for qualitative tests.
Accuracy (vs. GC/MS)High agreement between device result and GC/MS for all concentration categories. Minimal discordant results.For clinical specimens: - Drug free, less than half cutoff, and high positive: Generally 100% agreement with GC/MS. - Near Cutoff Negative and Near Cutoff Positive: Showed some mixed results (expected for qualitative tests near cutoff). - Discordant Results: A few specific cases reported where the device result (e.g., positive) did not match GC/MS (e.g., device positive for MET at 867ng/mL vs. 1000ng/mL cutoff, device negative for THC at 61ng/mL vs. 50ng/mL cutoff). These are mostly near the cutoff.
InterferenceNo interference from common substances found in urine at 100µg/mL.None of the tested compounds (listing many common drugs and substances) were shown to interfere with the device's performance when added to drug-free or drug-positive urine.
pH EffectDevice performance unaffected by urinary pH range of 3 to 9.The results demonstrated that varying ranges of pH (3 to 9 in 1 pH unit increments) do not interfere with the test's performance when spiked at 50% below and 50% above cutoff levels.
Specific Gravity EffectDevice performance unaffected by urinary specific gravity range (1.002-1.040).The results demonstrated that varying ranges of urinary specific gravity (1.002, 1.010, 1.020, 1.030, 1.040) do not affect the test result when spiked at 50% below and 50% above cutoff.
Lay User StudyHigh agreement with expected results and high user comprehension for home use.Agreement: For lay users, agreement percentages were high, generally 100% for clear negatives and clear positives, and ranging from 83% to 97% for samples near the +/- 25% cutoff for various drugs and test formats. Readability/Ease of Use: 100% of users felt the test was easy to use and the instructions were easy to understand. The labeling was assessed at a 6th-grade reading level.

2. Sample Sizes Used for the Test Set and Data Provenance

  • Precision Study:
    • Sample Size: 60 determinations per lot per concentration (Total: 9 concentrations * 60 determinations/lot * 3 lots = 1620 observations for each drug type). This was for both single drug and multi-drug formats, and both cup and dipcard.
    • Data Provenance: Not explicitly stated, but based on the overall document, it is likely internal laboratory testing or conducted at the specified Point-of-Care sites, implying prospective. The "nonparticipant" blinding suggests a controlled, prospective design.
  • Accuracy Study (Clinical Urine Specimens):
    • Sample Size: 80 clinical urine specimens for each drug type. These were divided into five categories (drug free, less than half cutoff, near cutoff negative, near cutoff positive, high positive).
    • Data Provenance: "Clinical urine specimens" suggests real-world samples. The study was conducted by nurses at two Point-of-Care sites, indicating prospective, real-world data collection using the device.
  • Home Use Consumer Study:
    • Sample Size: 360 lay users. Urine samples were prepared at various concentrations (0, +/- 50% cutoff, +/- 25% cutoff, +100% cutoff). Each participant performed 1 test on a provided specimen.
    • Data Provenance: Prospective, controlled study with lay users using prepared samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

  • Precision Study: Ground truth was established by spiking known concentrations of drugs into drug-free urine. The concentrations were "confirmed with GC/MS." No human experts were used for ground truth directly for precision.
  • Accuracy Study (Clinical Urine Specimens): The ground truth for the clinical urine specimens was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemistry technique, not human expert interpretation.
  • Home Use Consumer Study: Ground truth was established by spiking known concentrations of drugs into drug-free urine. The concentrations were "confirmed with GC/MS." No human experts were used for ground truth directly for the lay user study's analytical performance.

4. Adjudication Method for the Test Set

  • Precision Study: The samples were "blindly labeled by a nonparticipant" and "randomized prior to testing." Results were qualitative (Positive/Negative) based on the device's output. No explicit multi-reader adjudication method (e.g., 2+1) is mentioned; it appears to be a direct comparison of the device's qualitative result to the known spiked concentration.
  • Accuracy Study (Clinical Urine Specimens): "All samples were blindly labeled by a nonparticipant" and "randomized prior to testing." The device results were compared directly to the GC/MS analysis. No multi-reader adjudication is mentioned for the device's interpretation or the GC/MS results.
  • Home Use Consumer Study: Each participant performed one test and filled out a questionnaire. The device's qualitative result (positive/negative) from the lay user was compared against the known spiked concentration. No explicit multi-reader adjudication is mentioned.

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. This device is a qualitative in-vitro diagnostic (drug test cup/dipcard) that provides a direct positive or negative result, read by an individual (either a healthcare professional or a lay user). It is not an imaging AI device that assists human readers in interpreting complex medical images. Therefore, an MRMC comparative effectiveness study involving AI-assisted human readers is not applicable and was not performed.

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

Yes, in essence. The device itself is a standalone qualitative test. Its performance (producing a positive or negative line) is inherent to the device's chemical assay. While a human physically observes the lines, the "algorithm" is the chemical reaction and visual indicator built into the device. The precision and accuracy studies directly reflect this standalone chemical "algorithm's" performance against known concentrations or GC/MS. The lay user study evaluated the human reading the standalone device.

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

The primary ground truth used for evaluating the performance of the device was known spiked concentrations of drugs (confirmed by GC/MS) for precision and lay user studies, and Gas Chromatography/Mass Spectrometry (GC/MS) analysis for clinical accuracy studies. GC/MS is a highly accurate analytical method considered a gold standard for confirming the presence and concentration of drugs in urine.

8. The sample size for the training set

The document describes performance studies, but it does not mention a "training set" in the context of machine learning or AI models. This device is a lateral flow immunoassay, which does not typically involve training data in the AI sense. The design and validation of this type of device rely on analytical and clinical performance studies, not machine learning model training.

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

As there is no mention of a "training set" for an AI or machine learning model, this question is not applicable to the information provided in the document. The ground truth for the performance evaluation (test sets) was established through spiking known drug concentrations into urine and confirmation via GC/MS, as detailed in point 7.

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

CO-INNOVATION BIOTECH CO., LTD. HONG FENG PRODUCT MANAGER NO. 13, YANYUAN ROAD, TIANHE DISTRICT GUANGZHOU, P.R. CHINA

December 11, 2014

Re: K142800 Trade/Device Name: Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJC, DIS, DIO, JXM, LDJ, DJR, DJG, LCM, DNK Dated: September 26, 2014 Received: September 29, 2014

Dear Hong Feng:

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 (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. 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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142800

Device Name

Rapid Single/Multi-drug test Cup Rapid Single/Multi-drug test Dipcard

Indications for Use (Describe)

Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

TestCalibratorCut-off level
Marijuana (THC)Delta-9-THC-COOH50ng/mL
Cocaine (COC)Benzolecgonine300ng/mL
Amphetamine (AMP)D-Amphetamine1000ng/mL
Methamphetamine (MET)D-Methamphetamine1000ng/mL
Morphine 2000 (MOP)Morphine2000ng/mL
Barbiturates (BAR)Secobarbital300ng/mL
Benzodiazepines (BZO)Oxazepam300ng/mL
Methylenedioxymethamphetamine (MDMA)3,4-Methylenedioxymethamphetamine500ng/mL
Methadone (MTD)Methadone300ng/mL
Oxycodone (OXY)Oxycodone100ng/mL
Phencyclidine (PCP)Phencyclidine25ng/mL

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Section 5 - 510(k) Summary

Date of Summary Preparation: 12/05/2014

1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

2. Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

3. Name of the Device

Proprietary names:

Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard

Recommended classification regulation:

21 CFR 862.3100 Amphetamine test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3250 Cocaine test system 21 CFR 862.3640 Morphine test system 21 CFR 862.3870 Cannabinoid test system 21 CFR 862.3150 Barbiturate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3650 Opiate test system Unclassified, Enzyme immunoassay, phencyclidine test system

Device class: Class II Panel: Toxicology (91) Product code: DKZ,DJC,DIO,LDJ,DNK,DIS,JXM,DJR,DJG,LCM

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4. The Predicate Devices

K122809Advin Multi-Drug Screen Test Dip Card
Advin Multi-Drug Screen Test Cup
Advin Multi-Drug Screen Test Cassette

5. Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

6. Indications for Use

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

TestCalibratorCut-off level
Marijuana (THC)Delta-9-THC-COOH50 ng/mL
Cocaine (COC)Benzoylecgonine300 ng/mL
Amphetamine (AMP)D-Amphetamine1000 ng/mL
Methamphetamine (MET)D-Methamphetamine1000 ng/mL
Morphine 2000 (MOP)Morphine2000 ng/mL
Barbiturates (BAR)Secobarbital300 ng/mL
Benzodiazepines (BZO)Oxazepam300 ng/mL
Methylenedioxymethamphetamine (MDMA)3,4-Methylenedioxymethamphetamine500 ng/mL
Methadone (MTD)Methadone300 ng/mL
Oxycodone (OXY)Oxycodone100 ng/mL
Phencyclidine (PCP)Phencyclidine25 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. The tests are intended for in vitro diagnostics use. They are intended for

{6}------------------------------------------------

prescription use including point of care sites and over-the-counter use.

The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

7. Comparison to Predicate Devices:

A summary comparison of features of the Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table:

ItemDevice(K122809)Predicate
Indication for useQualitative detection ofSame( but the number of
drugs-of-abuse in urinedrugs detected different)
( Cocaine ,Morphine,
Methamphetamine, Amphetamine,
Marijuana, Barbiturates,
Benzodiazepines,
Methylenedioxymethamphetamine,
Methadone, Oxycodone, Phencyclidine)
Intended UsersOver the Counter (OTC) Use andSame
Prescription Use
SpecimenUrineSame
CutoffCocaine:300 ng/mLCocaine:150 ng/mL
Methamphetamine:1000 ng/mLMethamphetamine:500 ng/mL
Amphetamine:1000 ng/mLAmphetamine:500 ng/mL
Morphine:2000 ng/mLMorphine:300 ng/mL
Marijuana:50 ng/mLMarijuana:50 ng/mL
Barbiturates:300 ng/mLBarbiturates:300 ng/mL
Benzodiazepines:300 ng/mLBenzodiazepines:300 ng/mL
Methylenedioxymethamphetamine:500Methylenedioxymethamphetamin
ng/mLe:500 ng/mL
Methadone:300 ng/mLMethadone:300 ng/mL
Oxycodone:100 ng/mLOxycodone:100 ng/mL
Phencyclidine:25 ng/mLPhencyclidine:25 ng/mL
Read time5 minutesSame

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ResultsQualitativeSame
MethodologyCompetitive binding, Lateral flowimmunochromatographic assay basedon the principle of antigen antibodyimmunochemistrySame
ConfigurationDipcard and CupCassette,Dip Card and Cup

8. Performance Data:

8.1 Cross-reactivity with structurally similar compounds

To test the cross reactivity of the test, 2 lots of test Dipcard and one lot of test Cup was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using 3 lots of Test Cup and Test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below.

Amphetamine (AMP)LowestConcentration(ng/mL)% Cross-reactivityBenzodiazepines (BZO)LowestConcentration(ng/mL)% Cross-reactivity
d-Amphetamine1,000100%Oxazepam300100%
d,l-Amphetamine2,50040%Alprazolam200150%
1-Amphetamine50,0002%α-Hydroxyalprazolam110027.3%
3,4-Methylenedioxyamphetamine(MDA)2,00050%Bromazepam100030%
d-methamphetamine>100,000NotdetectedChlordiazepoxide200015%
l-methamphetamine>100,000NotdetectedClobazam100300%
3,4-Methylenedioxumethamphetamine(MDMA)>100,000NotdetectedClonazepam80037.5%
Methylenedioxyethylamphetamine(MDEA)>100,000NotdetectedClorazepate200150%
Cannabinoids (THC)Delorazepam160018.8%
11-nor-Δ9-THC-9-COOH50100%Desalkylflurazepam40075%
11-nor-Δ8-THC-9-COOH50100%Diazepam200150%
Δ8- Tetrahydrocannabinol10,0000.5%Estazolam100030%
Δ9- Tetrahydrocannabinol15,0000.3%Flunitrazepam35085.7%
Cannabinol20,0000.3%Lorazepam120025%
Cannabidiol>100,000NotdetectedMidazolam250012%
Cocaine (COC)Nitrazepam100300%
Benzoylecgonine300100%Nordiazepam40075%
Cocaine80037.5%Temazepam120250%
Cocaethylene12,5002.4%Triazolam100030%
Ecgonine HCl35,0000.9%Methylenedioxymethamphetamine (MDMA)
Methamphetamine (MET)D-Amphetamine>100000Not

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detected
D(+)-Methamphetamine1,000100%(+/-)3,4-Methylenedioxymethamphetamine (MDMA)50060%
L(-)-Methamphetamine8,00012.5%3,4-Methylenedioxyamphetamine (MDA)220013.6%
(+/-)3,4-Methylenedioxumethamphetamine(MDMA)2,00050%3,4-Methylenedioxyethylamphetamine (MDEA)240125%
p-hydroxymethamphetamine30,0003.3%D-methamphetamine(MAMP)1000000.3%
3,4-Methylenedioxyethylamphetamine(MDEA)50,0002%L-Amphetamine>100000Notdetected
d-Amphetamine>100,000NotdetectedL-Methamphetamine>100000Notdetected
1-Amphetamine>100,000NotdetectedMethadone (MTD)
3,4-methylenedioxyamphetamine(MDA)>100,000NotdetectedMethadone300100%
Morphine 2000 (MOP)(±)2-Ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium500000.6%
Morphine2,000100%Doxylamine500000.6%
Codeine2,000100%Oxycodone (OXY)
Hydrocodone15,00013.3%Oxycodone100100%
Hydromorphine10,00020%Naloxone500000.2%
6-Monoacetylmorphine5,00040%Naltrexone500000.2%
Morphine 3-b-D-glucuronide2,000100%Morphine3-β-D-glucuronide500000.2%
Oxycodone>1000002%Hydrocodone30003.3%
Hydromorphone10,00020%Hydromorphone750000.1%
Barbiturates (BAR)Oxymorphone100010%
Secobarbital300100%Phencyclidine (PCP)
Amobarbital50060%Phencyclidine25100%
Alphenol150200%4-Hydroxyphencyclidine150000.2%
Aprobarbital200150%
Butabarbital75400%
Butalbital1,50020%
Butethal100300%
Cyclopentobarbital60050%
Pentobarbital70042.9%
Phenobarbital300100%

8.2 Interference

Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing AMP, THC, COC, MET, MOP, BAR, BZO, MDMA, MTD, OXY, or PCP with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100µg/mL (All concentrations of the drugs were confirmed with GC/MS). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. None of the compounds listed below were shown to interfere.

AcetaminophenEstrone-3-sulfated,l-Octopamine
AcetophenetidinEthyl-p-aminobenzoateOxalic acid

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AmoxicillinErythromycinOxolinic acid
AmpicillinFenoprofenOxymetazoline
AspirinFlucloxacillinOxytetracycline
AtenololFluoxetinePapaverine
AtorvastatinFurosemidePenicillin-G
AzlocillinGentisic acidPentazocine
Benzilic acidHemoglobinPerphenazine
BenzylpenicillinHydralazinePhenelzine
Benzoic acidHydrochlorothiazidePrednisolone
BilirubinHydrocortisonePrednisone
Benzydamineo-Hydroxyhippuric acidd,l-Propanolol
Caffeinep-Hydroxytyramined-Pseudoephedrine
CarbamazepineIbuprofenQuinacrine
CephalexinIndomethacinQuinine
ChloralhydrateIproniazidQuindine
Chloramphenicold,l-IsoproterenolRanitidine
ChlorothiazideIsoxsuprineSalicylic acid
ChlorpheniramineKetamineSerotonin
d,1-ChlorpromazineKetoprofenSulfamethazine
CholesterolLabetalolSulindac
ClonidineLisinoprilTetracycline
CimetidineLoperamideTetrahydrozoline
CitalopramMeperidineThiamine
CortisoneMeprobamateThioridazine
CreatinineMethoxyphenamined, 1-Thyroxine
DeoxycorticosteroneMethylphenidateTolbutamine
DexamethasoneNadololTolbutamide
DextromethorphanNalidixic acidTrifluoperazine
DiclofenacNaproxenTryptamine
DiflunisalNiacinamideUric acid
DigoxinNicotineVerapamil
DiphenhydramineNifedipineZomepirac
EphedrineNorethindrone
ß-EstradiolNoscapine

8.3 Effect of urinary pH

The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.

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

8.4 Effect of Urinary specific gravity

The specific gravity studies were conducted on different specific gravity including 1.002,1.010, 1.020, 1.030, 1.040 specimens with drug free urine containing AMP, THC, COC, MET, MOP, BAR, BZO, MDMA, MTD, OXY, or PCP at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.

8.5 Precision

Precision studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±25% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test precision studies each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format. There were 1620 observations by 3 sites at 9 concentrations.

DrugtestApproximateNumber ofResult
concentrationof sample% of cutoffdeterminations per lotLot 1Lot 2Lot 3
AMP0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50% cutoff60060060060
750ng/ml-25%cutoff60654852852
1000ng/mlcutoff60342636243228
1250ng/ml+25%cutoff60528528546
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
COC0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25% cutoff60852654456
300ng/mlcutoff60362434263822
375ng/ml+25%cutoff60564546528
450ng/ml+50% cutoff60600600600
525ng/ml+75% cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
250ng/ml-75% cutoff60060060060
500ng/ml-50% cutoff60060060060
750ng/ml-25% cutoff60456852654
MET1000ng/mlcutoff60342636243822
1250ng/ml+25% cutoff60546564582
1500ng/ml+50% cutoff60600600600
1750ng/ml+75% cutoff60600600600
2000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
500ng/ml-75% cutoff60060060060
1000ng/ml-50% cutoff60060060060
1500ng/ml-25% cutoff608521050852
MOP2000ng/mlcutoff60421844164416
2500ng/ml+25% cutoff60546564564
3000ng/ml+50% cutoff60600600600
3500ng/ml+75% cutoff60600600600
4000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
12.5ng/ml-75% cutoff60060060060
25ng/ml-50% cutoff60060060060
37.5ng/ml-25% cutoff60852654654
THC50ng/mlcutoff60362438223624
62.5ng/ml+25% cutoff60528564546
75ng/ml+50% cutoff60600600600
87.5ng/ml+75%cutoff60600600600
100ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60456654456
BAR300ng/mlcutoff60382238223624
375ng/ml+25% cutoff60546564582
450ng/ml+50% cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60654456654
BZO75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml25% cutoff60654456654
300ng/mlcutoff60382236243426
375ng/ml+25% cutoff60564546528
450ng/ml+50% cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
125ng/ml-75% cutoff60060060060
250ng/ml-50% cutoff60060060060
375ng/ml-25% cutoff60852654654
MDMA500ng/mlcutoff60362434263624
625ng/ml+25% cutoff60528546564
750ng/ml+50% cutoff60600600600
875ng/ml+75% cutoff60600600600
1000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60654456456
MTD300ng/mlcutoff60342638223624
375ng/ml+25% cutoff60546582564
450ng/ml+50% cutoff60600600600
525ng/ml+75% cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
25ng/ml-75% cutoff60060060060
50ng/ml-50% cutoff60060060060
75ng/ml-25% cutoff60654456852
OXY100ng/mlcutoff60362438223426
125ng/ml+25% cutoff60564564582
150ng/ml+50% cutoff60600600600
175ng/ml+75%cutoff60600600600
200ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
6.3ng/ml-75% cutoff60060060060
12.5ng/ml-50% cutoff60060060060
18.8ng/ml-25% cutoff60456456654
PCP25ng/mlcutoff60362438223426
31.3ng/ml+25% cutoff60546564564
37.5ng/ml+50% cutoff60600600600
43.8ng/ml+75% cutoff60600600600
50ng/ml+100% cutoff60600600600
Drug testApproximateconcentrationof sample% of cutoffNumber ofdeterminationsper lotLot 1Lot 2Lot 3
PositiveNegativePositiveNegativePositiveNegative
AMP0ng/mlNegative60060060060
250ng/ml-75% cutoff60060060060
500ng/ml-50% cutoff60060060060
750ng/ml-25% cutoff60654654852
1000ng/mlcutoff60342638223624
1250ng/ml+25% cutoff60546582564
1500ng/ml+50% cutoff60600600600
1750ng/ml+75% cutoff60600600600
2000ng/ml+100% cutoff60600600600
COC0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60654456654
300ng/mlcutoff60342636243426
375ng/ml+25% cutoff60546564564
450ng/ml+50% cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
MET0ng/mlNegative60060060060
250ng/ml-75% cutoff60060060060
500ng/ml-50% cutoff60060060060
750ng/ml-25% cutoff60456654654
1000ng/mlcutoff60342638223624
1250ng/ml+25% cutoff60564582582
1500ng/ml+50% cutoff60600600600
1750ng/ml+75% cutoff60600600600
2000ng/ml+100% cutoff60600600600
MOP0ng/mlNegative60060060060
500ng/ml-75% cutoff60060060060
1000ng/ml-50% cutoff60060060060
1500ng/ml-25% cutoff606548521050
2000ng/mlcutoff60402044164218
2500ng/ml+25% cutoff60564546546
3000ng/ml+50% cutoff60600600600
3500ng/ml+75%cutoff60600600600
4000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
12.5ng/ml-75% cutoff60060060060
25ng/ml-50% cutoff60060060060
37.5ng/ml-25% cutoff60654852456
THC50ng/mlcutoff60382236243624
62.5ng/ml+25% cutoff60528564546
75ng/ml+50% cutoff60600600600
87.5ng/ml+75% cutoff60600600600
100ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60654258456
BAR300ng/mlcutoff60382236243426
375ng/ml+25% cutoff60582546564
450ng/ml+50% cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60852456654
BZO300ng/mlcutoff60362436243822
375ng/ml+25% cutoff60528546564
450ng/ml+50% cutoff60600600600
525ng/ml+75% cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
125ng/ml-75% cutoff60060060060
250ng/ml-50% cutoff60060060060
375ng/ml-25% cutoff608521050654
MDMA500ng/mlcutoff60322834263624
625ng/ml+25% cutoff60564546528
750ng/ml+50% cutoff60600600600
875ng/ml+75% cutoff60600600600
1000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60258456456
MTD300ng/mlcutoff60382234263624
375ng/ml+25% cutoff60582546564
450ng/ml+50% cutoff60600600600
525ng/ml+75% cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
25ng/ml-75% cutoff60060060060
OXY50ng/ml-50% cutoff60060060060
75ng/ml-25%cutoff60654852456
100ng/mlcutoff60342636243822
125ng/ml+25% cutoff60546582564
150ng/ml+50% cutoff60600600600
175ng/ml+75%cutoff60600600600
200ng/ml+100% cutoff60600600600
0ng/mlNegative600600600
6.3ng/ml-75%cutoff60060060060
12.5ng/ml-50% cutoff60060060060
18.8ng/ml-25%cutoff60456456654
PCP25ng/mlcutoff60382236243426
31.3ng/ml+25%cutoff60564546528
37.5ng/ml+50%cutoff60600600600
43.8ng/ml+75%cutoff60600600600
50ng/ml+100%cutoff60600600600

Single drug Test Cup:

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

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

Multi-drug Test Cup:

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

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

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

Single drug Test Dipcard:

DrugtestApproximateconcentrationof sample% of cutoffNumber ofdeterminationsper lotResultLot 1Lot 2Lot 3
PositiveNegativePositiveNegativePositiveNegative
AMP0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff608526541050
1000ng/mlcutoff60362434263624
1250ng/ml+25%cutoff605010528546
1500ng/ml+50%cutoff60600600600

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

1750ng/ml+75%cutoff60600600600
2000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60654456852
COC300ng/mlcutoff60342636243426
375ng/ml+25%cutoff60546564564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff60456456654
MET1000ng/mlcutoff60362434263426
1250ng/ml+25%cutoff60564564546
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
500ng/ml-75%cutoff60060060060
1000ng/ml-50%cutoff60060060060
1500ng/ml-25%cutoff601050852654
MOP2000ng/mlcutoff60441642184020
2500ng/ml+25%cutoff60564546546
3000ng/ml+50%cutoff60600600600
3500ng/ml+75%cutoff60600600600
4000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
12.5ng/ml-75%cutoff60060060060
25ng/ml-50%cutoff60060060060
37.5ng/ml-25%cutoff60654456852
THC50ng/mlcutoff60342638223624
62.5ng/ml+25%cutoff605010528546
75ng/ml+50%cutoff60600600600
87.5ng/ml+75%cutoff60600600600
100ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
BAR150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60654456456
300ng/mlcutoff60382236243426
375ng/ml+25%cutoff60564546564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60852654456
BZO300ng/mlcutoff60362438223624
375ng/ml+25% cutoff60546546564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
125ng/ml-75% cutoff60060060060
250ng/ml-50% cutoff60060060060
375ng/ml-25% cutoff606548521050
MDMA500ng/mlcutoff60342636243228
625ng/ml+25% cutoff60546564528
750ng/ml+50% cutoff60600600600
875ng/ml+75%cutoff60600600600
1000ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
150ng/ml-50% cutoff60060060060
75ng/ml-75% cutoff60060060060
MTD225ng/ml-25% cutoff60456258654
300ng/mlcutoff60322836243426
375ng/ml+25% cutoff60564546582
450ng/ml+50% cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
25ng/ml-75%cutoff60060060060
50ng/ml-50%cutoff60060060060
75ng/ml-25%cutoff60258654456
OXY100ng/mlcutoff60342636243426
125ng/ml+25%cutoff60546564582
150ng/ml+50%cutoff60600600600
175ng/ml+75%cutoff60600600600
200ng/ml+100% cutoff60600600600
0ng/mlNegative60060060060
6.3ng/ml-75%cutoff60060060060
12.5ng/ml-50%cutoff60060060060
PCP
18.8ng/ml-25%cutoff60654654456
25ng/mlcutoff60382236243822
31.3ng/ml+25%cutoff60564564582
37.5ng/ml+50%cutoff60600600600
43.8ng/ml+75%cutoff60600600600
50ng/ml+100%cutoff60600600600

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

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

Multi-drug Test Dipcard:

DrugtestApproximateconcentrationof sample% of cutoffNumber ofdeterminationsper lotResultLot 1Lot 2Lot 3
0ng/mlNegative60PositiveNegative060060060
AMP250ng/ml-75% cutoff60060060060
500ng/ml-50% cutoff60060060060
750ng/ml-25% cutoff601050852654
1000ng/mlcutoff60362432283426
1250ng/ml+25% cutoff60564546546
1500ng/ml+50% cutoff60600600600
1750ng/ml+75% cutoff60600600600
2000ng/ml+100% cutoff60600600600
COC0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60852654456
300ng/mlcutoff60342636243228
375ng/ml+25% cutoff60564546528
450ng/ml+50% cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100% cutoff60600600600
MET0ng/mlNegative60060060060
250ng/ml-75% cutoff60060060060
500ng/ml-50% cutoff60060060060
750ng/ml-25% cutoff60654852456
1000ng/mlcutoff60382236243624
1250ng/ml+25% cutoff60546564564
1500ng/ml+50% cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100% cutoff60600600600

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

MOP0ng/mlNegative60060060060
500ng/ml-75% cutoff60060060060
1000ng/ml-50% cutoff60060060060
1500ng/ml-25% cutoff608521050852
2000ng/mlcutoff60421840204416
2500ng/ml+25% cutoff60546564564
3000ng/ml+50% cutoff60600600600
3500ng/ml+75% cutoff60600600600
4000ng/ml+100% cutoff60600600600
THC0ng/mlNegative60060060060
12.5ng/ml-75% cutoff60060060060
25ng/ml-50% cutoff60060060060
37.5ng/ml-25% cutoff60852456654
50ng/mlcutoff60362434263822
62.5ng/ml+25% cutoff605010528546
75ng/ml+50% cutoff60600600600
87.5ng/ml+75%cutoff60600600600
100ng/ml+100% cutoff60600600600
BAR0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60456654852
300ng/mlcutoff60362434263822
375ng/ml+25% cutoff60564546546
450ng/ml+50% cutoff60600600600
525ng/ml+75% cutoff60600600600
600ng/ml+100% cutoff60600600600
BZO0ng/mlNegative60060060060
75ng/ml-75% cutoff60060060060
150ng/ml-50% cutoff60060060060
225ng/ml-25% cutoff60654456654
300ng/mlcutoff60382234263624
375ng/ml+25% cutoff60564546564
450ng/ml+50% cutoff60600600600
525ng/ml+75% cutoff60600600600
600ng/ml+100% cutoff60600600600
MDMA0ng/mlNegative60060060060
125ng/ml-75% cutoff60060060060
250ng/ml-50% cutoff60060060060
375ng/ml-25%cutoff601050654852
500ng/mlcutoff60362434263426
625ng/ml+25%cutoff60528564546
750ng/ml+50%cutoff60600600600
875ng/ml+75%cutoff60600600600
1000ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
MTD150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60654456258
300ng/mlcutoff60362434263624
375ng/ml+25%cutoff60564582564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
OXY0ng/mlNegative60060060060
25ng/ml-75%cutoff60060060060
50ng/ml-50%cutoff60060060060
75ng/ml-25%cutoff60852456654
100ng/mlcutoff60382236243426
125ng/ml+25%cutoff60564582546
150ng/ml+50%cutoff60600600600
175ng/ml+75%cutoff60600600600
200ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
6.3ng/ml-75%cutoff60060060060
12.5ng/ml-50%cutoff60060060060
18.8ng/ml-25%cutoff60258456654
PCP25ng/mlcutoff60362438223426
31.3ng/ml+25%cutoff60582564546
37.5ng/ml+50%cutoff60600600600
43.8ng/ml+75%cutoff60600600600
50ng/ml+100%cutoff60600600600

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

8.6 Accuracy

80 clinical urine specimens for each drug were analyzed by GC/MS and by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. Samples were divided by

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

concentration into five categories: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. All samples were blindly labeled by a nonparticipant. Separate sets of the blind coded were assigned. Samples were also randomized prior to testing. The study was conducted by 4 nurses at two Point-of-Care sites. The test dipcard format was performed at one site and the test cup format at the second site. Each operator only performed one test format and different nurses tested each format. Results were as follows:

Single drug Test Cup:

DrugTestCo-InnovationResultDrug freebyGC/MSanalysisLess than half thecutoffconcentration byGC/MS analysisNear CutoffNegative (Between50% below thecutoff and the cutoffconcentration)Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration)High Positive(greater than 50%above the cutoffconcentration)Total
+00063480
AMP-332500
+00053580
COC-331600
+00153580
MET-303600
MOP2000+00163480
-304500
THC+00063380
-341510
+000634
BAR-33070080
+001733
BZO-31080080
+000534
MDMA-32351080
+001535
MTD-32250080
+000634
OXY-35050080
+001535
PCP-35040080

Analysis of Discordant Results with Rapid Single drug Test Cup

Rapid Single drug Test CupGC/MS Analysis
Drug TestCutoff(ng/mL)Test ResultDrug Concentration (ng/mL)Drug in Urine
MET1000Positive867Methamphetamine
MOP20002000Positive1742Morphine
THC50Negative6111-nor-Δ9--THC-9-COOH
BZO300Positive188Oxazepam
MDMA500Negative7153,4-Methylenedioxymethamphetamine
MTD300Positive209Methadone
PCP25Positive23Phencyclidine

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

Multi-drug Test Cup:

DrugTestCo-InnovationResultDrug freebyGC/MSanalysisLess than half thecutoffconcentration byGC/MS analysisNear CutoffNegative (Between50% below thecutoff and the cutoffconcentration)Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration)High Positive(greater than 50%above the cutoffconcentration)Total
AMP+00063480
AMP-332500
COC+00053580
COC-331600
MET+00153580
MET-303600
MOP2000+00163480
MOP2000-304500
THC+00063380
THC-341510
BAR+00063480
BAR-330700
BZO+00173380
BZO-310800
MDMA+00053480
MDMA-323510
MTD+00153580
MTD-322500
OXY+00063480
OXY-350500
PCP+00153580
PCP-350400

Analysis of Discordant Results with Rapid Multi-drug Test Cup

Rapid Multi-drug Test CupGC/MS Analysis
Drug TestCutoff(ng/mL)Test ResultDrugConcentration(ng/mL)Drug in Urine
MET1000Positive867Methamphetamine
MOP20002000Positive1742Morphine
THC50Negative6111-nor-Δ9--THC-9-COOH
BZO300Positive188Oxazepam
MDMA500Negative7153,4-Methylenedioxymethamphetamine
MTD300Positive209Methadone
PCP25Positive23Phencyclidine

Single drug Test Dipcard:

DrugTestCo-InnovationResultDrug freebyGC/MSanalysisLess than half thecutoffconcentration byGC/MS analysisNear CutoffNegative (Between50% below thecutoff and the cutoffconcentration)Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration)High Positive(greater than 50%above the cutoffconcentration)Total
AMP+00063480
-332500
COC+00053580
-331600
MET+00153580
-303600

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

MOP2000+00163480
MOP2000-304500
THC+000633
THC-34151080
BAR+00063480
BAR-330700
BZO+001733
BZO-31080080
MDMA+00053480
MDMA-323510
MTD+001535
MTD-32250080
OXY+000634
OXY-35050080
PCP+001535
PCP-35040080

Analysis of Discordant Results with Rapid Single drug Test Dipcard

Rapid Single drug Test DipcardGC/MS Analysis
Drug TestCutoff(ng/mL)Test ResultDrug Concentration (ng/mL)Drug in Urine
MET1000Positive867Methamphetamine
MOP20002000Positive1742Morphine
THC50Negative6111-nor-Δ9--THC-9-COOH
BZO300Positive188Oxazepam
MDMA500Negative7153,4-Methylenedioxymethamphetamine
MTD300Positive209Methadone
PCP25Positive23Phencyclidine

Multi-drug Test Dipcard:

DrugTestCo-InnovationResultDrug freebyGC/MSanalysisLess than half thecutoffconcentration byGC/MS analysisNear CutoffNegative (Between50% below thecutoff and the cutoffconcentration)Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration)High Positivegreater than 50%above the cutoffconcentration)Total
+000б3480
AMP-332500
COC+0005રેર80
-331б00
+00l5રેરે80
MET-303б00
MOP2000+00lб3480
-304500
THC+000б3380
-341510
+000б34
BAR-33070080
+001733
BZO-31080080
+000534
MDMA-3235l080
MTD+0015રેર
-32250080
+000б34
OXY-રેરે050080

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

PCP+00153580
-350400
Rapid Multi-drug Test DipcardGC/MS Analysis
Drug TestCutoff(ng/mL)Test ResultDrug Concentration (ng/mL)Drug in Urine
MET1000Positive867Methamphetamine
MOP20002000Positive1742Morphine
THC50Negative6111-nor-Δ9--THC-9-COOH
BZO300Positive188Oxazepam
MDMA500Negative7153,4-Methylenedioxymethamphetamine
MTD300Positive209Methadone
PCP25Positive23Phencyclidine

Analysis of Discordant Results with Rapid Multi-drug Test Dipcard

8.7 Home Use Consumer Study

360 lay users from age 18 to 65 years participated in the study. Urine samples were prepared at the following concentrations: 0, +/- 50% cutoff,+/- 25% cutoff and +100% cutoff by spiking drug into drug free urine specimens. The concentrations of target drugs were confirmed with GC/MS. Each participant performed only 1 test on provided specimen with one format of Rapid Single/Multidrug Test (Dipcard, Cup) using the English package insert as guide to perform the test. They were asked to fill out an English questionnaire after finishing the test. Results were as follows:

Single drug Test Cup:

Drug testApproximateconcentrationof sample% of cutoffNumber ofdeterminationsLayer user ResultsAgreement(%)
PositiveNegative
AMP0ng/mlNegative60060100%
500ng/ml-50% cutoff60060100%
750ng/ml-25% cutoff6075388%
1250ng/ml+25% cutoff60501083%
1500ng/ml+50% cutoff60600100%
2000ng/ml+100% cutoff60600100%
COC0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6065490%
375ng/ml+25% cutoff6056493%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
MET0ng/mlNegative60060100%
500ng/ml-50% cutoff60060100%
750ng/ml-25% cutoff6045693%
1250ng/ml+25% cutoff6055592%
1500ng/ml+50% cutoff60600100%
2000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
1000ng/ml-50% cutoff60060100%
1500ng/ml-25% cutoff6085287%
MOP20002500ng/ml+25% cutoff6058297%
3000ng/ml+50% cutoff60600100%
4000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
25ng/ml-50% cutoff60060100%
THC37.5ng/ml-25% cutoff6065490%
62.5ng/ml+25% cutoff6052887%
75ng/ml+50% cutoff60600100%
100ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6065490%
BAR375ng/ml+25% cutoff6056493%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
BZO225ng/ml-25% cutoff6085287%
375ng/ml+25% cutoff6055592%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
MDMA250ng/ml-50% cutoff60060100%
375ng/ml-25% cutoff6055592%
625ng/ml+25% cutoff6056493%
750ng/ml+50% cutoff60600100%
1000ng/ml+100% cutoff60600100%
MTD0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6065490%
375ng/ml+25% cutoff6057395%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
50ng/ml-50% cutoff60060100%
75ng/ml-25% cutoff6055592%
OXY125ng/ml+25% cutoff6056493%
150ng/ml+50% cutoff60600100%
200ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
PCP12.5ng/ml-50% cutoff60060100%
18.8ng/ml-25% cutoff6045693%
31.3ng/ml+25% cutoff6056493%
37.5ng/ml+50% cutoff60600100%
50ng/ml+100% cutoff60600100%

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

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

Multi-drug Test Cup:

Drug testApproximateconcentrationof sample% of cutoffNumber ofdeterminationsLayer user ResultsAgreement(%)
PositiveNegative
AMP0ng/mlNegative60060100%
500ng/ml-50%cutoff60060100%
750ng/ml-25%cutoff6095185%
1250ng/ml+25%cutoff6054690%
1500ng/ml+50%cutoff60600100%
2000ng/ml+100%cutoff60600100%
COC0ng/mlNegative60060100%
150ng/ml-50%cutoff60060100%
225ng/ml-25%cutoff6065490%
375ng/ml+25%cutoff6056493%
450ng/ml+50%cutoff60600100%
600ng/ml+100%cutoff60600100%
MET0ng/mlNegative60060100%
500ng/ml-50%cutoff60060100%
750ng/ml-25% cutoff6045693%
1250ng/ml+25% cutoff6058297%
1500ng/ml+50% cutoff60600100%
2000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
1000ng/ml-50% cutoff60060100%
1500ng/ml-25% cutoff6065490%
MOP20002500ng/ml+25% cutoff6055592%
3000ng/ml+50% cutoff60600100%
4000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
25ng/ml-50% cutoff60060100%
37.5ng/ml-25% cutoff6045693%
62.5ng/ml+25% cutoff6054690%
75ng/ml+50% cutoff60600100%
100ng/ml+100% cutoff60600100%
THC0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6055592%
375ng/ml+25% cutoff6054690%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
BAR225ng/ml-25% cutoff6055592%
375ng/ml+25% cutoff6054690%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6055592%
BZO375ng/ml+25% cutoff6056493%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
250ng/ml-50% cutoff60060100%
375ng/ml-25% cutoff6065490%
625ng/ml+25% cutoff6054690%
MDMA750ng/ml+50% cutoff60600100%
1000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
250ng/ml-50% cutoff60060100%
375ng/ml-25% cutoff6065490%
MTD625ng/ml+25% cutoff6054690%
750ng/ml+50% cutoff60600100%
1000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
MTD150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6055592%
375ng/ml+25% cutoff6054690%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
50ng/ml-50% cutoff60060100%
75ng/ml-25% cutoff6045693%
OXY125ng/ml+25% cutoff6056493%
150ng/ml+50% cutoff60600100%
200ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
PCP12.5ng/ml-50% cutoff60060100%
18.8ng/ml-25% cutoff6055592%
31.3ng/ml+25% cutoff6054690%
37.5ng/ml+50% cutoff60600100%
50ng/ml+100% cutoff60600100%

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

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

Single drug Test Dipcard:

Drug testApproximateconcentrationof sample% of cutoffNumber ofdeterminationsLayer user ResultsAgreement(%)
PositiveNegative
AMP0ng/mlNegative60060100%
500ng/ml-50%cutoff60060100%
750ng/ml-25%cutoff6085287%
1250ng/ml+25%cutoff6051985%
1500ng/ml+50%cutoff60600100%
2000ng/ml+100%cutoff60600100%
COC0ng/mlNegative60060100%
150ng/ml-50%cutoff60060100%
225ng/ml-25%cutoff6055592%
375ng/ml+25%cutoff6054690%
450ng/ml+50%cutoff60600100%
600ng/ml+100%cutoff60600100%
MET0ng/mlNegative60060100%
500ng/ml-50%cutoff60060100%
750ng/ml-25%cutoff6065490%
1250ng/ml+25%cutoff6053788%
1500ng/ml+50%cutoff60600100%
2000ng/ml+100%cutoff60600100%
0ng/mlNegative60060100%
1000ng/ml-50%cutoff60060100%
1500ng/ml-25%cutoff6095185%
MOP20002500ng/ml+25%cutoff6056493%
3000ng/ml+50%cutoff60600100%
4000ng/ml+100%cutoff60600100%
0ng/mlNegative60060100%
25ng/ml-50%cutoff60060100%
THC37.5ng/ml-25%cutoff6075388%
62.5ng/ml+25%cutoff60501083%
75ng/ml+50%cutoff60600100%
100ng/ml+100%cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50%cutoff60060100%
BAR225ng/ml-25%cutoff6055592%
375ng/ml+25%cutoff6054690%
450ng/ml+50%cutoff60600100%
600ng/ml+100%cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50%cutoff60060100%
225ng/ml-25%cutoff6075388%
BZO375ng/ml+25%cutoff6056493%
450ng/ml+50%cutoff60600100%
600ng/ml+100%cutoff60600100%
0ng/mlNegative60060100%
250ng/ml-50%cutoff60060100%
MDMA375ng/ml-25%cutoff6065490%
625ng/ml+25%cutoff6053788%
750ng/ml+50%cutoff60600100%
1000ng/ml+100%cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50%cutoff60060100%
225ng/ml-25%cutoff6045693%
MTD375ng/ml+25%cutoff6054690%
450ng/ml+50%cutoff60600100%
600ng/ml+100%cutoff60600100%
OXY0ng/mlNegative60060100%
50ng/ml-50% cutoff60060100%
75ng/ml-25% cutoff6045693%
125ng/ml+25% cutoff6057395%
150ng/ml+50% cutoff60600100%
200ng/ml+100% cutoff60600100%
PCP0ng/mlNegative60060100%
12.5ng/ml-50% cutoff60060100%
18.8ng/ml-25% cutoff6035795%
31.3ng/ml+25% cutoff6054690%
37.5ng/ml+50% cutoff60600100%
50ng/ml+100% cutoff60600100%

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

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

Multi-drug Test Dipcard:

Drug testApproximateconcentrationof sample% of cutoffNumber ofdeterminationsLayer user ResultsAgreement(%)
AMP0ng/mlNegative60060100%
500ng/ml-50%cutoff60060100%
750ng/ml-25%cutoff6065490%
1250ng/ml+25%cutoff6053788%
1500ng/ml+50%cutoff60600100%
2000ng/ml+100%cutoff60600100%
COC0ng/mlNegative60060100%
150ng/ml-50%cutoff60060100%
225ng/ml-25%cutoff6045693%
375ng/ml+25%cutoff6053788%
450ng/ml+50%cutoff60600100%
600ng/ml+100%cutoff60600100%
MET0ng/mlNegative60060100%
500ng/ml-50%cutoff60060100%
750ng/ml-25%cutoff6055592%
1250ng/ml+25%cutoff6054690%
1500ng/ml+50%cutoff60600100%
2000ng/ml+100%cutoff60600100%
MOP20000ng/mlNegative60060100%
1000ng/ml-50% cutoff60060100%
1500ng/ml-25% cutoff6075388%
2500ng/ml+25% cutoff6057395%
3000ng/ml+50% cutoff60600100%
4000ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
25ng/ml-50% cutoff60060100%
37.5ng/ml-25% cutoff6085287%
THC62.5ng/ml+25% cutoff6053788%
75ng/ml+50% cutoff60600100%
100ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
BAR225ng/ml-25% cutoff6045693%
375ng/ml+25% cutoff6057395%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
0ng/mlNegative60060100%
BZO150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6065490%
375ng/ml+25% cutoff6054690%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
MDMA0ng/mlNegative60060100%
250ng/ml-50% cutoff60060100%
375ng/ml-25% cutoff6045693%
625ng/ml+25% cutoff6055592%
750ng/ml+50% cutoff60600100%
1000ng/ml+100% cutoff60600100%
MTD0ng/mlNegative60060100%
150ng/ml-50% cutoff60060100%
225ng/ml-25% cutoff6035795%
375ng/ml+25% cutoff6056493%
450ng/ml+50% cutoff60600100%
600ng/ml+100% cutoff60600100%
OXY0ng/mlNegative60060100%
50ng/ml-50% cutoff60060100%
75ng/ml-25% cutoff6065490%
125ng/ml+25% cutoff6055592%
150ng/ml+50% cutoff60600100%
200ng/ml+100% cutoff60600100%
PCP0ng/mlNegative60060100%
12.5ng/ml-50% cutoff60060100%
18.8ng/ml-25% cutoff6065490%
31.3ng/ml+25% cutoff6057395%
37.5ng/ml+50% cutoff60600100%
50ng/ml+100% cutoff60600100%

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

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

720 questionnaires were distributed and collected. Results from the questionnaires indicated that 100% of users felt the test is easy to use and the test instructions are easy to understand.

Evaluation of the readability of the labeling

The entire package insert readability was assessed. The numbers of polysyllabic words are 12 words. The numbers of total sentences are 156. According to Appendix B the SMOG Readability Formula of "Labeling of Home-Use In Vitro Testing Products: Approved Guideline: GP-14A5", the reading level belong to 6 degree.

9. Conclusion:

The data collected in the performance and accuracy studies demonstrate that the Rapid Single/Multi Drug test cup and dipcard are substantially equivalent to the predicate device.

--- End of this section ---

§ 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).