Who is the manufacturer of Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Co-Innovation Biotech Co., Ltd. filed the 510(k) submission for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (K153050).

What is the FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

DJG. It is classified under 21 CFR 862.3650 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

510(k) clearance (submission type: Special).

What are the predicate devices for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

One Step Single/Multi-drug Test Cup (K140748); One Step Single/Multi-drug Test Dipcard (K140748); Rapid Single/Multi-drug Test Cup (K142800); Rapid Single/Multi-drug Test Dipcard (K142800).

Who can help prepare an FDA 510(k) submission like Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K153050 · Co-Innovation Biotech Co., Ltd. · DJG · Apr 26, 2016 · Clinical Toxicology

Device Facts

Record ID	K153050
Device Name	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Applicant	Co-Innovation Biotech Co., Ltd.
Product Code	DJG · Clinical Toxicology
Decision Date	Apr 26, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: [Table of 16 analytes]. The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no uniformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine. This assay provides 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 Story

Competitive binding, lateral flow immunochromatographic assay; detects drugs/metabolites in human urine. Input: urine sample; output: visual qualitative result (presence/absence of drug at cutoff). Used at point-of-care or home; operated by clinicians or lay users. No instrumentation required. Healthcare providers use results as preliminary screening; positive results require GC/MS confirmation. Benefits: rapid, accessible drug screening.

Clinical Evidence

Bench testing only. Accuracy evaluated by comparing 80 clinical urine specimens per drug against GC/MS or HPLC. Precision study conducted at 3 point-of-care sites with 6 operators over 10 days (1620 observations). Lay user study (n=1720) confirmed ease of use and clear labeling (7th-grade reading level). Interference and cross-reactivity studies performed with various compounds and urinary pH/specific gravity ranges.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Test Dipcard. Analyte-specific test strips with identical chemical formulations. No energy source required. Standalone device. Storage: 4-30°C.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites in human urine for prescription and over-the-counter use. Target population includes individuals requiring drug screening. Analytes: Marijuana, Cocaine, Amphetamine, Methamphetamine, Morphine (2000/300), Barbiturates, Benzodiazepines, MDMA, Methadone, Oxycodone, Phencyclidine, Buprenorphine, EDDP, Propoxyphene, TCA.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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).

Predicate Devices

One Step Single/Multi-drug Test Cup (K140748)
One Step Single/Multi-drug Test Dipcard (K140748)
Rapid Single/Multi-drug Test Cup (K142800)
Rapid Single/Multi-drug Test Dipcard (K142800)

Related Devices

K091612 — UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; · Ucp Biosciences, Inc. · Feb 24, 2010
K152908 — UCP COMPACT DRUG TESTS · Ucp Biosciences, Inc. · May 3, 2016
K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD · Co-Innovation Biotech Co., Ltd. · Jun 16, 2014
K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Feb 28, 2018
K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard · Xenta Biomedical Science Co., Ltd. · May 19, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, stacked on top of each other, forming a stylized wing shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 26, 2016 CO-INNOVATION BIOTECH Co., LTD HONG FENG PRODUCT MANAGER NO. 13, YANYUAN ROAD, TIANHE DISTRICT, GUANGZHOU 510507, CHINA Re: K153050 Trade/Device Name: Rapid Single/multi-drug Test Cup, Rapid Single/multi-drug Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR, JXN Dated: March 28, 2016 Received: March 28, 2016 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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, Courtney H. Lias -S 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K153050 #### Device Name Rapid Single/Multi-drug test Dipcard Rapid Single/Multi-drug test Cup #### Indications for Use (Describe) Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off level | |--------------------------------------|-----------------------------------|---------------| | Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL | | Cocaine (COC) | Benzoylecgonine | 300 ng/mL | | Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL | | Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL | | Morphine 2000 (MOP) | Morphine | 2000 ng/mL | | Barbiturates (BAR) | Secobarbital | 300 ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL | | Methadone (MTD) | Methadone | 300 ng/mL | | Oxycodone (OXY) | Oxycodone | 100 ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25 ng/mL | | Buprenorphine(BUP) | Buprenorphine | 10ng/mL | | 2-ethylidene-1, 5-dimethyl-3, | 2-ethylidene-1, 5-dimethyl-3, | 300 ng/mL | | 3-diphenylpyrrolidine(EDDP) | 3-diphenylpyrrolidine | | | Morphine(MOP300) | Morphine | 300 ng/mL | | Propoxyphene(PPX) | Propoxyphene | 300 ng/mL | | Tri-cyclic Antidepressants (TCA) | Nortriptyline | 1000 ng/mL | The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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 vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine. This assay provides 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) X Prescription Use (Part 21 CFR 801 Subpart D) |× Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### Section 5 - 510(k) Summary Date of Summary Preparation: 26/4/2016 #### 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 Recommended classification regulation: 21 CFR 862.3100 Amphetamine test system 21 CFR 862.3150 Barbiturate test system 21 CFR 862.3650 Opiate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3250 Cocaine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3640 Morphine test system Unclassified, Enzyme immunoassay, phencyclidine test system 21 CFR 862.3700 Propoxyphene test system 21 CFR 862.3910 Tri-cyclic Antidepressants drug test system 21 CFR 862.3870 Cannabinoid test system Device class: Class II Panel: Toxicology (91) Product code: DKZ,DJC.DIO,LDJ,DNK,DIS,JXM,DJR,DJG,LCM,JXN,LFG Common Name: Amphetamine (AMP) Test System Barbiturates (BAR) Test System Buprenorphine(BUP) Test System {5}------------------------------------------------ Benzodiazepines (BZO) Test System Cocaine (COC) Test System 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP) Test System Methylenedioxymethamphetamine (MDMA) Test System Methamphetamine (MET) Test System Morphine (MOP300) Test System Morphine(MOP2000) Test System Methadone (MTD) Test System Oxycodone (OXY) Test System Phencyclidine (PCP) Test System Propoxyphene(PPX) Test System Tri-cyclic Antidepressants (TCA)Test System Cannabinoid (THC) Test System Proprietary names: Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard ### 4. The Predicate Devices | K140748 | One Step Single/Multi-drug Test Cup | |---------|-----------------------------------------| | | One Step Single/Multi-drug Test Dipcard | | K142800 | Rapid Single/Multi-drug Test Cup | | | Rapid Single/Multi-drug Test Dipcard | ### 5. Device Description Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures. #### 6. Intended Use of Device Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test for the qualitatively detection of drugs and drug metabolites in human urine. Drug test cut-off concentrations are listed below: {6}------------------------------------------------ | Test | Calibrator | Cut-off level | |-----------------------------------------------------------|-----------------------------------------------------|---------------| | Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL | | Barbiturates (BAR) | Secobarbital | 300 ng/mL | | Buprenorphine(BUP) | Buprenorphine | 10ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300 ng/mL | | Cocaine (COC) | Benzoylecgonine | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP) | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL | | Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL | | Morphine300(MOP300) | Morphine | 300 ng/mL | | Morphine2000(MOP2000) | Morphine | 2000 ng/mL | | Methadone (MTD) | Methadone | 300 ng/mL | | Oxycodone (OXY) | Oxycodone | 100 ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25 ng/mL | | Propoxyphene(PPX) | Propoxyphene | 300 ng/mL | | Tri-cyclic Antidepressants (TCA) | Nortriptyline | 1000 ng/mL | | Marijuana (THC) | Delta-9-THC-COOH | 50 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 up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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, Buprenorphine, Benzodiazepine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine. This assay provides 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: {7}------------------------------------------------ Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are a modified product format derived from the previously FDA-cleared Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard, One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard. 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. | Item | Device | Predicate (K140748, K142800) | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Indication for use | Qualitative detection of drugs-of-abuse in urine (Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana) | Same (but the number of drugs detected different) | | Intended Users | Over the Counter (OTC) Use and Prescription Use | Same | | Specimen | Urine | Same | | Cutoff | Amphetamine:1000 ng/mL Barbiturates:300 ng/mL Buprenorphine:10 ng/mL Benzodiazepines:300 ng/mL Cocaine:300 ng/mL EDDP:300 ng/mL Methylenedioxymethamphetamine:500 ng/mL Methamphetamine:1000 ng/mL Morphine:300 ng/mL Morphine:2000 ng/mL Methadone:300 ng/mL Oxycodone:100 ng/mL Phencyclidine:25 ng/mL Propoxyphene:300 ng/mL Tri-cyclic Antidepressants:1000 ng/mL Marijuana:50 ng/mL | Same | | Read time | 5 minutes | Same | | Storage | 4 ~ 30 °C | Same | | Results | Qualitative | Same | | Methodology | Competitive binding, Lateral flow | Same | | | immunochromatographic assay based on | | | | the principle of antigen antibody | | | | immunochemistry | | | Configuration | Dipcard and Cup | Same | {8}------------------------------------------------ Remark: - 1、The subject devices have all features of the predicate device except the number of drugs detected. These differences do not affect the performance characteristics of the subject devices. ### 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) | Lowest Concentration (ng/mL) | % Cross- reactivity | Methamphetamine (MET) | Lowest Concentratio n (ng/mL) | % Cross- reactivity | |---------------------------------------------------------------|------------------------------------|------------------------|-----------------------------------------------------|-------------------------------------|------------------------| | d-Amphetamine | 1,000 | 100% | 3,4- Methylenedioxyethyl amphetamine(MDEA) | 50,000 | 2% | | d.l-Amphetamine | 2,500 | 40% | d-Amphetamine | > 100,000 | Not detected | | 1-Amphetamine | 50,000 | 2% | l-Amphetamine | > 100,000 | Not detected | | 3,4-Methylenedioxyamphetamine (MDA) | 2,000 | 50% | 3,4-methylenedioxyampheta mine (MDA) | > 100,000 | Not detected | | d-methamphetamine | > 100,000 | Not detected | Morphine300(MOP300) | | | | l-methamphetamine | > 100,000 | Not detected | Morphine | 300 | 100% | | 3,4-Methylenedioxumethamphetamin e(MDMA) | > 100,000 | Not detected | Codeine | 300 | 100% | | Methylenedioxyethylamphetamine (MDEA) | > 100,000 | Not detected | Hydrocodone | 2000 | 15% | | Barbiturates (BAR) | | | Hydromorphone | 1500 | 20% | | Secobarbital | 300 | 100% | 6-Monoacetylmorphine (6-MAM ) | 750 | 40% | | Amobarbital | 500 | 60% | Morphine 3-b-D-glucuronide | 300 | 100% | | Alphenal | 150 | 200% | Ethylmorphine | 3500 | 8.6% | | Aprobarbital | 200 | 150% | Levorphanol | 5000 | 6% | | Butabarbital | 75 | 400% | Heroin | 300 | 100% | | Butalbital | 1,500 | 20% | Norcodeine | 7500 | 4% | | Butethal | 100 | 300% | Oxycodone | 100000 | 0.3% | | Cyclopentobarbital | 600 | 50% | Thebain | 8000 | 3.8% | | Pentobarbital | 700 | 42.9% | Morphine2000(MOP2000) | | | | Phenobarbital | 300 | 100% | Morphine | 2,000 | 100% | | Buprenorphine(BUP) | | | Codeine | 2,000 | 100% | | Buprenorphine | 10 | 100% | Hydrocodone | 15,000 | 13.3% | | Norbuprenorphine | 20 | 50% | Hydromorphone | 10,000 | 20% | | Buprenorphine 3-D-glucuronide | 15 | 66.7% | 6-Monoacetylmorphine | 5,000 | 40% | | Norbuprenorphine 3-D-glucuronide | 200 | 5% | Morphine 3-b-D-glucuronide | 2,000 | 100% | | Benzodiazepines (BZO) | | | Oxycodone | >100000 | 2% | | Oxazepam | 300 | 100% | Methadone (MTD) | | | | Alprazolam | 200 | 150% | Methadone | 300 | 100% | | α-Hydroxyalprazolam | 1100 | 27.3% | (±)2-Ethy1-1,5-dimethy1-3,3- diphenylpyrrolinium | 50000 | 0.6% | | Bromazepam | 1000 | 30% | Doxylamine | 50000 | 0.6% | | Chlordiazepoxide | 2000 | 15% | Oxycodone (OXY) | | | | Clobazam | 100 | 300% | Oxycodone | 100 | 100% | | Clonazepam | 800 | 37.5% | Naloxone | 50000 | 0.2% | | Clorazepate | 200 | 150% | Naltrexone | 50000 | 0.2% | | Delorazepam | 1600 | 18.8% | Morphine 3-β-D-glucuronide | 50000 | 0.2% | | Desalkylflurazepam | 400 | 75% | Hydrocodone | 3000 | 3.3% | | Diazepam | 200 | 150% | Hydromorphone | 75000 | 0.1% | | Estazolam | 1000 | 30% | Oxymorphone | 1000 | 10% | | Flunitrazepam | 350 | 85.7% | Phencyclidine (PCP) | | | | Lorazepam | 1200 | 25% | Phencyclidine | 25 | 100% | | Midazolam | 2500 | 12% | 4-Hydroxyphencyclidine | 15000 | 0.2% | | Nitrazepam | 100 | 300% | Propoxyphene (PPX) | | | | Nordiazepam | 400 | 75% | d-Propoxyphene | 300 | 100% | | Temazepam | 120 | 250% | d-Norpropoxyphene | 300 | 100% | | Triazolam | 1000 | 30% | Tri-cyclic Antidepressants (TCA) | | | | Cocaine (COC) | | | Nortriptyline | 1000 | 100% | | Benzoylecgonine | 300 | 100% | Nordoxepin | 1000 | 100% | | Cocaine | 800 | 37.5% | Trimipramine | 5000 | 20% | | Cocaethylene | 12,500 | 2.4% | Promazine | 3000 | 33.3% | | Ecgonine HCI | 35,000 | 0.9% | Desipramine | 1000 | 100% | | 2-ethylidene-1, 5-dimethyl-3,3- diphenylpyrrolidine (EDDP) | | | Imipramine | 1000 | 100% | | EDDP | 300 | 100% | Clomipramine | 12500 | 8% | | Methylenedioxymethamphetamine (MDMA) | | | Doxepin | 2000 | 50% | | (+/-)3,4-Methylenedioxymeth amphetamine (MDMA) | 500 | 100% | Maprotiline | 2000 | 50% | | 3,4-Methylenedioxyamphetamine (MDA) | 2200 | 22.7% | Amitriptyline | 1000 | 100% | | 3,4-Methylenedioxyethyl amphetamine (MDEA) | 240 | 208% | Promethazine | 25000 | 4% | | D-methamphetamine(MAMP) | 100000 | 0.5% | Cannabinoids (THC) | | | | D-Amphetamine | >100000 | Not detected | 11-nor-Δ9-THC-9-COOH | 50 | 100% | | L-Amphetamine | >100000 | Not detected | 11-nor-Δ8-THC-9-COOH | 50 | 100% | | L-Methamphetamine | >100000 | Not detected | Δ8- Tetrahydrocannabinol | 10,000 | 0.5% | | Methamphetamine (MET) | | | Δ9- Tetrahydrocannabinol | 15,000 | 0.3% | | 3,4- Methylenedioxyethyl amphetamine(MDEA) | 50,000 | 2% | Cannabinol | 20,000 | 0.3% | | L(-)-Methamphetamine | 8,000 | 12.5% | Cannabidiol | > 100,000 | Not detected | | (+/-)3,4-Methylenedioxumeth amphetamine(MDMA) | 2,000 | 50% | | | | | p-hydroxymethamphetamine | 30,000 | 3.3% | | | | {9}------------------------------------------------ #### 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, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC 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, or LC/MS,HPLC). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. {10}------------------------------------------------ None of the compounds listed below were shown to interfere. | Acetaminophen | Estrone-3-sulfate | d,l-Octopamine | |---------------------|------------------------|-------------------| | Acetophenetidin | Ethyl-p-aminobenzoate | Oxalic acid | | Amoxicillin | Erythromycin | Oxolinic acid | | Ampicillin | Fenoprofen | Oxymetazoline | | Aspirin | Flucloxacillin | Oxytetracycline | | Atenolol | Fluoxetine | Papaverine | | Atorvastatin | Furosemide | Penicillin-G | | Azlocillin | Gentisic acid | Pentazocine | | Benzilic acid | Hemoglobin | Perphenazine | | Benzylpenicillin | Hydralazine | Phenelzine | | Benzoic acid | Hydrochlorothiazide | Prednisolone | | Bilirubin | Hydrocortisone | Prednisone | | Benzydamine | o-Hydroxyhippuric acid | d,l-Propranolol | | Caffeine | p-Hydroxytyramine | d-Pseudoephedrine | | Carbamazepine | Ibuprofen | Quinacrine | | Cephalexin | Indomethacin | Quinine | | Chloralhydrate | Iproniazid | Quinidine | | Chloramphenicol | d,l-Isoproterenol | Ranitidine | | Chlorothiazide | Isoxsuprine | Salicylic acid | | Chlorpheniramine | Ketamine | Serotonin | | d,l-Chlorpromazine | Ketoprofen | Sulfamethazine | | Cholesterol | Labetalol | Sulindac | | Clonidine | Lisinopril | Tetracycline | | Cimetidine | Loperamide | Tetrahydrozoline | | Citalopram | Meperidine | Thiamine | | Cortisone | Meprobamate | Thioridazine | | Creatinine | Methoxyphenamine | d, 1-Thyroxine | | Deoxycorticosterone | Methylphenidate | Tolbutamine | | Dexamethasone | Nadolol | Tolbutamide | | Dextromethorphan | Nalidixic acid | Trifluoperazine | | Diclofenac | Naproxen | Tryptamine | | Diflunisal | Niacinamide | Uric acid | | Digoxin | Nicotine | Verapamil | | Diphenhydramine | Nifedipine | Zomepirac | | Ephedrine | Norethindrone | | | β-Estradiol | Noscapine | | #### 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, or LC/MS, HPLC). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results {11}------------------------------------------------ demonstrate that varying ranges of pH do not interfere with the performance of the test. #### 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, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS, or LC/MS, HPLC). 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 multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff and +100% cutoff of The concentrations of the target drugs were confirmed with GC/MS, or LC/MS, drug. HPLC. Each concentration of the urine specimen was then 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. | Drug test | Approximate | % of cutoff | Number of | Result | | | | | | |--------------|---------------|-------------|-------------|----------|----------|----------|----------|----------|----------| | | concentration | | determinati | Lot 1 | | Lot 2 | | Lot 3 | | | | of sample | | ons per lot | Positive | Negative | Positive | Negative | Positive | Negative | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | AMP | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 750ng/ml | -25%cutoff | 60 | 8 | 52 | 8 | 52 | 10 | 50 | | | 1000ng/ml | cutoff | 60 | 34 | 26 | 34 | 26 | 32 | 28 | | | 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 50 | 10 | 54 | 6 | | | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | BAR | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 10 | 50 | | | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 | | | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 54 | 6 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 2.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 7.5ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 6 | 54 | | BUP | 10ng/ml | cutoff | 60 | 34 | 26 | 32 | 28 | 34 | 26 | | | 12.5ng/ml | +25%cutoff | 60 | 50 | 10 | 48 | 12 | 50 | 10 | | | 15ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 17.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 20ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 8 | 52 | | BZO | 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 | | | 375ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 52 | 8 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 6 | 54 | | COC | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 52 | 8 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | EDDP | 225ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 | | | 300ng/ml | cutoff | 60 | 36 | 24 | 36 | 24 | 38 | 22 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 52 | 8 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | MDMA | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 375ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 | | | 500ng/ml | cutoff | 60 | 32 | 28 | 34 | 26 | 34 | 26 | | | 625ng/ml | +25%cutoff | 60 | 52 | 8 | 48 | 12 | 50 | 10 | | | 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 750ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 8 | 52 | | MET | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 | | | 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 50 | 10 | | | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 10 | 50 | 10 | 50 | 12 | 48 | | MOP | 300ng/ml | cutoff | 60 | 38 | 22 | 40 | 20 | 38 | 22 | | 300 | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 56 | 4 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 500ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 1000ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | MOP | 1500ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 | | 2000 | 2000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 32 | 28 | | | 2500ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 | | | 3000ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 3500ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 4000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | MTD | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 8 | 52 | 4 | 56 | 6 | 54 | | | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 | | | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | OXY | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 25ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 6 | 54 | | | 100ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 | | | 125ng/ml | +25%cutoff | 60 | 54 | 6 | 58 | 2 | 56 | 4 | | | 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 6.3ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 | | PCP | 25ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 34 | 26 | | | 31.3ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 56 | 4 | | | 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 6 | 54 | | PPX | 300ng/ml | cutoff | 60 | 34 | 26 | 32 | 28 | 32 | 28 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 56 | 4 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 750ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 | | TCA | 1000ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 36 | 24 | | | 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 50 | 10 | 54 | 6 | | | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | THC | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 37.5ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 6 | 54 | | | 50ng/ml | cutoff | 60 | 38 | 22 | 38 | 22 | 36 | 24 | | | 62.5ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 54 | 6 | | 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | Multi-drug Test Cup: {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ Multi-drug Test Dipcard: | | Approximate | | Number of | Result | | Lot 2 | | Lot 3 | | |-------------|---------------|-------------|-------------|----------|----------|----------|----------|----------|----------| | Drug | concentration | % of cutoff | determinati | Lot 1 | | | | | | | test | of sample | | ons per lot | Positive | Negative | Positive | Negative | Positive | Negative | | AMP | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 750ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 6 | 54 | | | 1000ng/ml | cutoff | 60 | 32 | 28 | 34 | 26 | 36 | 24 | | | 1250ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 50 | 10 | | | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | BAR | 225ng/ml | -25%cutoff | 60 | 10 | 50 | 8 | 52 | 10 | 50 | | | 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 | | | 375ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 56 | 4 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 2.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 7.5ng/ml | -25%cutoff | 60 | 4 | 56 | 8 | 52 | 6 | 54 | | BUP | 10ng/ml | cutoff | 60 | 32 | 28 | 32 | 28 | 34 | 26 | | | 12.5ng/ml | +25%cutoff | 60 | 52 | 8 | 50 | 10 | 48 | 12 | | | 15ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 17.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 20ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | BZO | 225ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 | | | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 50 | 10 | 52 | 8 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | COC | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 8 | 52 | | | 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 52 | 8 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | EDDP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 6 | 54 | | | 300ng/ml | cutoff | 60 | 38 | 22 | 38 | 22 | 36 | 24 | | | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | MDMA | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 375ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 8 | 52 | | | 500ng/ml | cutoff | 60 | 34 | 26 | 32 | 28 | 32 | 28 | | | 625ng/ml | +25%cutoff | 60 | 50 | 10 | 48 | 12 | 52 | 8 | | | 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | MET | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 750ng/ml | -25%cutoff | 60 | 10 | 50 | 8 | 52 | 6 | 54 | | | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 | | | 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 52 | 8 | 54 | 6 | | | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | MOP 300 | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 12 | 48 | 10 | 50 | 8 | 52 | | | 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 40 | 20 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 54 | 6 | 56 | 4 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | MOP 2000 | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 500ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 1000ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 1500ng/ml | -25%cutoff | 60 | 8 | 52 | 8 | 52 | 6 | 54 | | | 2000ng/ml | cutoff | 60 | 34 | 26 | 32 | 28 | 34 | 26 | | | 2500ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 56 | 4 | | | 3000ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 3500ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 4000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | MTD | 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 8 | 52 | | | 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 | | | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 54 | 6 | | | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 25ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | OXY | 75ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 | | | 100ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 | | | 125ng/ml | +25%cutoff | 60 | 54 | 6 | 54 | 6 | 56 | 4 | | | 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 6.3ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 2 | 58 | | PCP | 25ng/ml…