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

K142800 · Co-Innovation Biotech Co., Ltd. · DKZ · Dec 11, 2014 · Clinical Toxicology

Device Facts

Record IDK142800
Device NameRapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
ApplicantCo-Innovation Biotech Co., Ltd.
Product CodeDKZ · Clinical Toxicology
Decision DateDec 11, 2014
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.3100
Device ClassClass 2

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 drugs and drug metabolites in human urine at the following cut-off concentrations: Marijuana (THC) 50ng/mL, Cocaine (COC) 300ng/mL, Amphetamine (AMP) 1000ng/mL, Methamphetamine (MET) 1000ng/mL, Morphine 2000 (MOP) 2000ng/mL, Barbiturates (BAR) 300ng/mL, Benzodiazepines (BZO) 300ng/mL, Methylenedioxymethamphetamine (MDMA) 500ng/mL, Methadone (MTD) 300ng/mL, Oxycodone (OXY) 100ng/mL, Phencyclidine (PCP) 25ng/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 Story

Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine; competitive binding principle; monoclonal antibody-coated particles; drug-specific conjugate; visual read-out; no instrumentation required; single-use; available as Test Cup or Test Dipcard; used at point-of-care or home; provides preliminary results; requires GC/MS confirmation; aids clinical decision-making.

Clinical Evidence

Bench testing only. Accuracy evaluated by comparing device results to GC/MS analysis using 80 clinical urine specimens per drug. Precision and accuracy studies conducted at point-of-care sites by nurses. Home-use consumer study included 360 lay users (ages 18-65) to validate ease of use and instruction comprehension. No clinical prospective/retrospective trials required for this immunoassay type.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; monoclonal antibody (mouse) coated particles; qualitative visual read-out; no instrumentation; shelf-life 24 months at 4-30°C.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites in human urine for prescription, point-of-care, and over-the-counter use.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {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, # 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 {2}------------------------------------------------ ### 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: | Test | Calibrator | Cut-off level | |--------------------------------------|-----------------------------------|---------------| | Marijuana (THC) | Delta-9-THC-COOH | 50ng/mL | | Cocaine (COC) | Benzolecgonine | 300ng/mL | | Amphetamine (AMP) | D-Amphetamine | 1000ng/mL | | Methamphetamine (MET) | D-Methamphetamine | 1000ng/mL | | Morphine 2000 (MOP) | Morphine | 2000ng/mL | | Barbiturates (BAR) | Secobarbital | 300ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300ng/mL | | Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500ng/mL | | Methadone (MTD) | Methadone | 300ng/mL | | Oxycodone (OXY) | Oxycodone | 100ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25ng/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) | <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px;">☑</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {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: 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 {5}------------------------------------------------ ### 4. The Predicate Devices | K122809 | Advin 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: | 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 | | Methylenedioxymethampheta<br>mine (MDMA) | 3,4-Methylenedioxymetha<br>mphetamine | 500 ng/mL | | Methadone (MTD) | Methadone | 300 ng/mL | | Oxycodone (OXY) | Oxycodone | 100 ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25 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: | Item | Device | (K122809)<br>Predicate | |--------------------|--------------------------------------|------------------------------| | Indication for use | Qualitative detection of | Same<br>( but the number of | | | drugs-of-abuse in urine | drugs detected different) | | | ( Cocaine ,Morphine, | | | | Methamphetamine, Amphetamine, | | | | Marijuana, Barbiturates, | | | | Benzodiazepines, | | | | Methylenedioxymethamphetamine, | | | | Methadone, Oxycodone, Phencyclidine) | | | Intended Users | Over the Counter (OTC) Use and | Same | | | Prescription Use | | | Specimen | Urine | Same | | Cutoff | Cocaine:300 ng/mL | Cocaine:150 ng/mL | | | Methamphetamine:1000 ng/mL | Methamphetamine:500 ng/mL | | | Amphetamine:1000 ng/mL | Amphetamine:500 ng/mL | | | Morphine:2000 ng/mL | Morphine:300 ng/mL | | | Marijuana:50 ng/mL | Marijuana:50 ng/mL | | | Barbiturates:300 ng/mL | Barbiturates:300 ng/mL | | | Benzodiazepines:300 ng/mL | Benzodiazepines:300 ng/mL | | | Methylenedioxymethamphetamine:500 | Methylenedioxymethamphetamin | | | ng/mL | e:500 ng/mL | | | Methadone:300 ng/mL | Methadone:300 ng/mL | | | Oxycodone:100 ng/mL | Oxycodone:100 ng/mL | | | Phencyclidine:25 ng/mL | Phencyclidine:25 ng/mL | | Read time | 5 minutes | Same | {7}------------------------------------------------ | Results | Qualitative | Same | |---------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Methodology | Competitive binding, Lateral flow<br>immunochromatographic assay based<br>on the principle of antigen antibody<br>immunochemistry | Same | | Configuration | Dipcard and Cup | Cassette,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) | Lowest<br>Concentrat<br>ion<br>(ng/mL) | % Cross-react<br>ivity | Benzodiazepines (BZO) | Lowest<br>Concentrat<br>ion<br>(ng/mL) | % Cross-react<br>ivity | |---------------------------------------------|----------------------------------------|------------------------|--------------------------------------|----------------------------------------|------------------------| | d-Amphetamine | 1,000 | 100% | Oxazepam | 300 | 100% | | d,l-Amphetamine | 2,500 | 40% | Alprazolam | 200 | 150% | | 1-Amphetamine | 50,000 | 2% | α-Hydroxyalprazolam | 1100 | 27.3% | | 3,4-Methylenedioxyamphetamine<br>(MDA) | 2,000 | 50% | Bromazepam | 1000 | 30% | | d-methamphetamine | >100,000 | Not<br>detected | Chlordiazepoxide | 2000 | 15% | | l-methamphetamine | >100,000 | Not<br>detected | Clobazam | 100 | 300% | | 3,4-Methylenedioxumethamphetamine<br>(MDMA) | >100,000 | Not<br>detected | Clonazepam | 800 | 37.5% | | Methylenedioxyethylamphetamine<br>(MDEA) | >100,000 | Not<br>detected | Clorazepate | 200 | 150% | | Cannabinoids (THC) | | | Delorazepam | 1600 | 18.8% | | 11-nor-Δ9-THC-9-COOH | 50 | 100% | Desalkylflurazepam | 400 | 75% | | 11-nor-Δ8-THC-9-COOH | 50 | 100% | Diazepam | 200 | 150% | | Δ8- Tetrahydrocannabinol | 10,000 | 0.5% | Estazolam | 1000 | 30% | | Δ9- Tetrahydrocannabinol | 15,000 | 0.3% | Flunitrazepam | 350 | 85.7% | | Cannabinol | 20,000 | 0.3% | Lorazepam | 1200 | 25% | | Cannabidiol | >100,000 | Not<br>detected | Midazolam | 2500 | 12% | | Cocaine (COC) | | | Nitrazepam | 100 | 300% | | Benzoylecgonine | 300 | 100% | Nordiazepam | 400 | 75% | | Cocaine | 800 | 37.5% | Temazepam | 120 | 250% | | Cocaethylene | 12,500 | 2.4% | Triazolam | 1000 | 30% | | Ecgonine HCl | 35,000 | 0.9% | Methylenedioxymethamphetamine (MDMA) | | | | Methamphetamine (MET) | | | D-Amphetamine | >100000 | Not | {8}------------------------------------------------ | | | | | | detected | |--------------------------------------------------|----------|-----------------|-----------------------------------------------------|---------|-----------------| | D(+)-Methamphetamine | 1,000 | 100% | (+/-)3,4-Methylenedioxymet<br>hamphetamine (MDMA) | 500 | 60% | | L(-)-Methamphetamine | 8,000 | 12.5% | 3,4-Methylenedioxyampheta<br>mine (MDA) | 2200 | 13.6% | | (+/-)3,4-Methylenedioxumethampheta<br>mine(MDMA) | 2,000 | 50% | 3,4-Methylenedioxyethylam<br>phetamine (MDEA) | 240 | 125% | | p-hydroxymethamphetamine | 30,000 | 3.3% | D-methamphetamine(MAM<br>P) | 100000 | 0.3% | | 3,4-<br>Methylenedioxyethylamphetamine(M<br>DEA) | 50,000 | 2% | L-Amphetamine | >100000 | Not<br>detected | | d-Amphetamine | >100,000 | Not<br>detected | L-Methamphetamine | >100000 | Not<br>detected | | 1-Amphetamine | >100,000 | Not<br>detected | Methadone (MTD) | | | | 3,4-methylenedioxyamphetamine<br>(MDA) | >100,000 | Not<br>detected | Methadone | 300 | 100% | | Morphine 2000 (MOP) | | | (±)2-Ethyl-1,5-dimethyl-3,<br>3-diphenylpyrrolinium | 50000 | 0.6% | | Morphine | 2,000 | 100% | Doxylamine | 50000 | 0.6% | | Codeine | 2,000 | 100% | Oxycodone (OXY) | | | | Hydrocodone | 15,000 | 13.3% | Oxycodone | 100 | 100% | | Hydromorphine | 10,000 | 20% | Naloxone | 50000 | 0.2% | | 6-Monoacetylmorphine | 5,000 | 40% | Naltrexone | 50000 | 0.2% | | Morphine 3-b-D-glucuronide | 2,000 | 100% | Morphine<br>3-β-D-glucuronide | 50000 | 0.2% | | Oxycodone | >100000 | 2% | Hydrocodone | 3000 | 3.3% | | Hydromorphone | 10,000 | 20% | Hydromorphone | 75000 | 0.1% | | Barbiturates (BAR) | | | Oxymorphone | 1000 | 10% | | Secobarbital | 300 | 100% | Phencyclidine (PCP) | | | | Amobarbital | 500 | 60% | Phencyclidine | 25 | 100% | | Alphenol | 150 | 200% | 4-Hydroxyphencyclidine | 15000 | 0.2% | | Aprobarbital | 200 | 150% | | | | | Butabarbital | 75 | 400% | | | | | Butalbital | 1,500 | 20% | | | | | Butethal | 100 | 300% | | | | | Cyclopentobarbital | 600 | 50% | | | | | Pentobarbital | 700 | 42.9% | | | | | Phenobarbital | 300 | 100% | | | | #### 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. | Acetaminophen | Estrone-3-sulfate | d,l-Octopamine | |-----------------|-----------------------|----------------| | Acetophenetidin | Ethyl-p-aminobenzoate | Oxalic acid | {9}------------------------------------------------ | 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-Propanolol | | Caffeine | p-Hydroxytyramine | d-Pseudoephedrine | | Carbamazepine | Ibuprofen | Quinacrine | | Cephalexin | Indomethacin | Quinine | | Chloralhydrate | Iproniazid | Quindine | | Chloramphenicol | d,l-Isoproterenol | Ranitidine | | Chlorothiazide | Isoxsuprine | Salicylic acid | | Chlorpheniramine | Ketamine | Serotonin | | d,1-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 | | | ß-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). 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. | Drug<br>test | Approximate | | Number of | Result | | | | | | |--------------|-------------------------------------------|--------------|----------------------------------------|----------|----------|----------|----------|----------|----------| | | concentration<br>of sample | % of cutoff | determinations per lot | Lot 1 | | Lot 2 | | Lot 3 | | | AMP | 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 | 6 | 54 | 8 | 52 | 8 | 52 | | | 1000ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 | | | 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 | | 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 | 8 | 52 | 6 | 54 | 4 | 56 | | | 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 | | | 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 | | | 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 | 4 | 56 | 8 | 52 | 6 | 54 | | MET | 1000ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 38 | 22 | | | 1250ng/ml | +25% cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 | | | 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 | | | 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 | 10 | 50 | 8 | 52 | | MOP | 2000ng/ml | cutoff | 60 | 42 | 18 | 44 | 16 | 44 | 16 | | | 2500ng/ml | +25% cutoff | 60 | 54 | 6 | 56 | 4 | 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 | | | 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 | 8 | 52 | 6 | 54 | 6 | 54 | | THC | 50ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 | | | 62.5ng/ml | +25% cutoff | 60 | 52 | 8 | 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 | | | 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 | 4 | 56 | | BAR | 300ng/ml | cutoff | 60 | 38 | 22 | 38 | 22 | 36 | 24 | | | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 | | | 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 | 4 | 56 | 6 | 54 | | BZO | 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 | 36 | 24 | 34 | 26 | | | 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 | | | 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 | 6 | 54 | | MDMA | 500ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 | | | 625ng/ml | +25% cutoff | 60 | 52 | 8 | 54 | 6 | 56 | 4 | | | 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 | | | 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 | 4 | 56 | | MTD | 300ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 | | | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 58 | 2 | 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 | | | 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 | 6 | 54 | 4 | 56 | 8 | 52 | | OXY | 100ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 | | | 125ng/ml | +25% cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 | | | 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 | 36 | 24 | 38 | 22 | 34 | 26 | | | 31.3ng/ml | +25% cutoff | 60 | 54 | 6 | 56 | 4 | 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 | | Drug test | Approximate<br>concentration<br>of sample | % of cutoff | Number of<br>determinations<br>per lot | Lot 1 | | Lot 2 | | Lot 3 | | | | | | | Positive | Negative | Positive | Negative | Positive | Negative | | AMP | 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 | 6 | 54 | 6 | 54 | 8 | 52 | | | 1000ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 | | | 1250ng/ml | +25% cutoff | 60 | 54 | 6 | 58 | 2 | 56 | 4 | | | 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 | | 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 | 6 | 54 | 4 | 56 | 6 | 54 | | | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 | | | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 56 | 4 | 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 | | 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 | 4 | 56 | 6 | 54 | 6 | 54 | | | 1000ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 | | | 1250ng/ml | +25% cutoff | 60 | 56 | 4 | 58 | 2 | 58 | 2 | | | 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 | 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 | 6 | 54 | 8 | 52 | 10 | 50 | | | 2000ng/ml | cutoff | 60 | 40 | 20 | 44 | 16 | 42 | 18 | | | 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 | | | 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 | 6 | 54 | 8 | 52 | 4 | 56 | | THC | 50ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 | | | 62.5ng/ml | +25% cutoff | 60 | 52 | 8 | 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 | | | 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 | 2 | 58 | 4 | 56 | | BAR | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 | | | 375ng/ml | +25% cutoff | 60 | 58 | 2 | 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 | | | 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 | | BZO | 300ng/ml | cutoff | 60 | 36 | 24 | 36 | 24 | 38 | 22 | | | 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 | | | 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 | 10 | 50 | 6 | 54 | | MDMA | 500ng/ml | cutoff | 60 | 32 | 28 | 34 | 26 | 36 | 24 | | | 625ng/ml | +25% cutoff | 60 | 56 | 4 | 54 | 6 | 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 | | | 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 | 2 | 58 | 4 | 56 | 4 | 56 | | MTD | 300ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 | | | 375ng/ml | +25% cutoff | 60 | 58 | 2 | 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 | | | 25ng/ml | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | OXY | 50ng/ml | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 | | | 100ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 38 | 22 | | | 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 | | | 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 | 36 | 24 | 34 | 26 | | | 31.3ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 | | | 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 | Single drug Test Cup: {11}------------------------------------------------ {12}------------------------------------------------ Multi-drug Test Cup: {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ Single drug Test Dipcard: | Drug<br>test | Approximate<br>concentration<br>of sample | % of cutoff | Number of<br>determinations<br>per lot | Result | | Lot 1 | | Lot 2 | | Lot 3 | | |--------------|-------------------------------------------|-------------|----------------------------------------|----------|----------|----------|----------|----------|----------|-------|--| | | | | | Positive | Negative | Positive | Negative | Positive | Negative | | | | AMP | 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 | 10 | 50 | | | | | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 | | | | | 1250ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 | | | | | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | {16}------------------------------------------------ | | 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 | 6 | 54 | 4 | 56 | 8 | 52 | | COC | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 | | | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 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 | 4 | 56 | 4 | 56 | 6 | 54 | | MET | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 | | | 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 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 | | | 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 | 10 | 50 | 8 | 52 | 6 | 54 | | MOP | 2000ng/ml | cutoff | 60 | 44 | 16 | 42 | 18 | 40 | 20 | | | 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 | | | 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 | 6 | 54 | 4 | 56 | 8 | 52 | | THC | 50ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 | | | 62.5ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 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 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | BAR | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 | | | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 | | | 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 | | | 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 | 4 | 56 | | BZO | 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 | | | 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 | | | 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 | 8 | 52 | 10 | 50 | | MDMA | 500ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 | | | 625ng/ml | +25% cutoff | 60 | 54 | 6 | 56 | 4 | 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 | | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | | 75ng/ml | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | MTD | 225ng/ml | -25% cutoff | 60 | 4 | 56 | 2 | 58 | 6 | 54 | | | 300ng/ml | cutoff | 60 | 32 | 28 | 36 | 24 | 34 | 26 | | | 375ng/ml | +25% cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 | | | 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 | | | 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 | 2 | 58 | 6 | 54 | 4 | 56 | | OXY | 100ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 | | | 125ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 | | | 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…
Innolitics
510(k) Summary
Decision Summary
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100%