Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

Q: Who is the manufacturer of Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)?

Healgen Scientific,, LLC filed the 510(k) submission for Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096).

Q: What is the FDA product code for Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)?

LAF. It is classified under 21 CFR 862.3610 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)?

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

Q: Who can help prepare an FDA 510(k) submission like Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)?

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.

K150096 · Healgen Scientific,, LLC · LAF · Mar 4, 2015 · Clinical Toxicology

Device Facts

Record ID	K150096
Device Name	Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
Applicant	Healgen Scientific,, LLC
Product Code	LAF · Clinical Toxicology
Decision Date	Mar 4, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3610
Device Class	Class 2

Intended Use

Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result: GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of MDMA or Phencyclidine in human urine; competitive binding principle using monoclonal mouse antibodies; visual colored line output indicates presence/absence of drug relative to cut-off; used in point-of-care or home settings by lay users or clinicians; provides preliminary results requiring GC/MS confirmation; aids in drug abuse screening; results interpreted visually by user.

Clinical Evidence

Bench testing included precision, interference, specificity, and cut-off verification. Method comparison study (n=80 per format) compared device results to GC/MS. Lay-user study (n=1112) evaluated performance across diverse demographics; results showed high concordance with GC/MS at concentrations near cut-off. No clinical studies required.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; monoclonal mouse antibody; formats: strip, cassette, dip card, cup; storage 4-30°C; shelf life 24 months; no electronic components; no software.

Indications for Use

Indicated for qualitative detection of MDMA (500 ng/mL) or Phencyclidine (25 ng/mL) in human urine. Intended for prescription and over-the-counter use by adults for preliminary drug screening.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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).

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other. March 4, 2015 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 HEALGEN SCIENTIFIC LLC C/O JOE XIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877 Re: K150096 Trade/Device Name: Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, LCM Dated: January 12, 2015 Received: January 20, 2015 Dear Mr. Xia: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 -A 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) k150096 Device Name Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card) Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) #### Indications for Use (Describe) Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result: GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED.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." {3}------------------------------------------------ - 1. Date: February 26, 2015 - 2. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401 - 3. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com - 4. Device Name: Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card) Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) Classification: | Product Code | CFR # | Panel | |--------------|----------------------------------------------|------------| | LCM | This device has not been classified. | | | LAF | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology | - 5. Predicate Devices: K052115 First Check Multi Drug Cup 12 - 6. Intended Use / Indications for Use Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. {4}------------------------------------------------ Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. - 7. Device Description Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are immunochromatographic assays for Methylenedioxymethamphetamine and Phencyclidine. Each assay test is a lateral flow system for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package Each test device is sealed with a desiccant in an aluminum pouch. insert. ### 8. Substantial Equivalence Information A summary comparison of features of the Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test and the predicate device is provided in Table 1 & Table 2. | Item | Device | Predicate - K052115 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same | | Drug Analyte | Methylenedioxymethamphetamine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Specimen Type | Human Urine | Same | | Cut-Off Values | 500 ng/mL | Same | | Intended Population | For over-the-counter and prescription uses. | For over-the-counter use. | | Configurations | Strip, Cassette, Cup, Dip Card | Cup | #### Table 1: Features Comparison of Healgen MDMA (Ecstasy) Test and the Predicate Device Table 2: Features Comparison of Healgen Phencyclidine Test and the Predicate Device {5}------------------------------------------------ | Item | Device | Predicate - K052115 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same | | Drug Analyte | Phencyclidine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Specimen Type | Human Urine | Same | | Cut-Off Values | 25 ng/mL | Same | | Intended Population | For over-the-counter and prescription uses. | For over-the-counter use. | | Configurations | Strip, Cassette, Cup, Dip Card | Cup | ### 9. Test Principle Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are rapid tests for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The will not form in the test line region if the target drug level exceeds its cut-offconcentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the test has been performed properly. ### 10. Performance Characteristics - 1. Analytical Performance - a. Precision Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind labeled and randomized by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for {6}------------------------------------------------ each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables: ## MDMA (Ecstasy) | | Result | | | | | Cut-off | | | | |-----------------|---------------|--------------|--------------|--------------|---------|--------------|--------------|--------------|---------------| | Drug | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | | Lot:MDMA1201001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Cassette Format | Drug | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | |-----------------|--------|---------------|--------------|--------------|--------------|---------|--------------|--------------|--------------|---------------| | Lot:MDMA1201004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ### Dip Card Format | | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | |-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Drug | | | | | | | | | | | | Lot:MDMA1201007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ### CUP Format | Drug | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | |-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot:MDMA1201010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:MDMA1201012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## Phencyclidine Strip Format | | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | |----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Drug | | | | | | | | | | | | Lot:PCP1111001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:PCP1111002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot:PCP1111003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | {7}------------------------------------------------ ### Cassette Format | | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | |------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Drug | Lot:PCP1111004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | | Lot:PCP1111005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | | Lot:PCP1111006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ### Dip Card Format | | Result -100% -75% | -50% । | -25% | | +25% ' | | +50% +75% +100% | |----------------|----------------------------------------------------------------------------------------|--------|------|---------|--------|--|---------------------------------------| | Drug | Cut-off Cut-off Cut-off Cut-off | | | Cut-off | | | Cut-off Cut-off Cut-off Cut-off | | Lot:PCP1111007 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- 50+/0- | | | | | | | | Lot:PCP1111008 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- | | | | | | | | Lot:PCP1111009 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- | | | | | | | ### CUP Format | | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off | |------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Drug | Lot:PCP1111010 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | | Lot:PCP1111011 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | | Lot:PCP1111012 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | - b. Linearity Not applicable. - c. Stability The devices are stable at 4-30℃ for 24 months based on the accelerated stability study at 45℃ and real time stability determination at both 4 ℃ and 30℃. Control materials are not provided with the device. The labeling provides information on how to obtain control materials. - d. Cut-off A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for both Methylenedioxymethamphetamine and Phencyclidine. The following cut-off values for the test devices have been verified. | Test | Calibrator | Cut-off (ng/mL) | |------|------------|--------------------| | | | | {8}------------------------------------------------ | MDMA (Ecstasy) Test | Methylenedioxymethamphetamine | 500 | |---------------------|-------------------------------|-----| | Phencyclidine Test | Phencyclidine | 25 | - e. Interference Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats. | Acetophenetidin | Ethyl Morphine | Phenelzine | |-----------------------------------|-----------------------------------|------------------------------------| | N-Acetylprocainamide | Ethyl-p-aminobenzoate | Phenobarbital | | Acetylsalicylic Acid (Aspirin) | Fenoprofen | Phentermine | | Aminopyrine | Furosemide | Phenylephrine-L | | Amitriptyline | Gentisic acid | Phenylethylamine | | Amoxicillin | Hemoglobin | Phenylpropanolamine | | Amobarbital | Hydralazine | Prednisolone Acetate | | D-Amphetamine | (+/-)-4-Hydroxyamphetamine HCL | Prednisone | | L-Amphetamine | Hydrochlorothiazide | Procaine(Novocaine) | | Amphetamine Sulfate | Hydrocodone | Promazine | | Ampicinine(Ampicillin) | Hydrocortisone | Promethazine | | Apomorphine | a -Hydroxyhippuric acid | Propoxyphene,d- | | L-Ascorbic Acid | p-Hydroxymethamphetamine | Propranolol | | Aspartame | Ibuprofen | Pseudoephedrine HCL | | Atropine | Imipramine | Quinidine | | Benzilic acid | Isoxsuprine | Quinine | | Benzphetamine | Isoproterenol-(+/-) | Ranitidine(Zantac) | | Bezoic Acid | Ketamine | Salicylic Acid | | Bilirubin | Levorphanol | Secobarbital | | Caffeine | Loperamide | Serotonin | | Chloramphenicol | Maprotiline | Sulfamethazine | | Chlordiazepoxide HCL | Meprobamate | Sulindac | | Chloroquine | Methadone | Temazepam | | Chlorothiazide | Methoxyphenamine | 11-Nor-Δ9-Tetrahydrocannabi nol | ### MDMA (Ecstasy) {9}------------------------------------------------ | Chlorpheniramine | Methylphenidate | Tetracycline | |-------------------------|--------------------------|----------------------------------| | Chlorpromazine | Nalbuphine | Tetrahydrozoline | | Cholesterol | Nalidixic acid | Thebaine | | Clomipramine | Naloxone hydrochloride | Thiamine | | Clonidine hydrochloride | Naltrexone hydrochloride | L-Thyroxine | | Codeine | Naproxen | ThioridazineHydrochloride | | Cortisone | Niacinamide | Triamterene | | Cotinine(-) | Nifedipine | Triflupromazine Hydrochloride | | Creatinine | Norethindrone | Trimethoprim | | Deoxyepinephrine | Norpropoxyphene | Trimipramine | | Dextromethorphan | Noscapine | Tryptamine | | Diazepam | Oxazepam | DL-Tryptophan | | Diflunisal | Oxycodone | Tyramine | | Digoxin | Oxymetazoline | D/L-Tyrosine | | Doxylamine | Papaverine | Uric Acid | | Ecgonine methylester | Penicillin | Verapamil | | R(-)-Epinephrine | Pentobarbital | Zomepirac | | Erythromycin | Perphenazine | | | Estrone-3-sulfate | Phencyclidine | | ## Phencyclidine | Acetophenetidin | Ethyl-p-aminobenzoate | Phenelzine | |-----------------------------------|-----------------------------------|----------------------| | N-Acetylprocainamide | Fenoprofen | Phenobarbital | | Acetylsalicylic Acid (Aspirin) | Furosemide | Phentermine | | Aminopyrine | Gentisic acid | Phenylephrine-L | | Amitriptyline | Hemoglobin | Phenylethylamine | | Amoxicillin | Hydralazine | Phenylpropanolamine | | Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Prednisolone Acetate | | D-Amphetamine | Hydrochlorothiazide | Prednisone | | L-Amphetamine | Hydrocodone | Procaine(Novocaine) | | Amphetamine Sulfate | Hydrocortisone | Promazine | | Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Promethazine | | Apomorphine | p-Hydroxymethamphetamine | Propoxyphene,d- | | L-Ascorbic Acid | Ibuprofen | Propranolol | | Aspartame | Imipramine | Pseudoephedrine HCL | | Atropine | Isoxsuprine | Quinidine | | Benzilic acid | Isoproterenol-(+/-) | Quinine | {10}------------------------------------------------ | Benzphetamine | Ketamine | Ranitidine(Zantac) | |-------------------------|------------------------------------------|------------------------------------| | Bezoic Acid | Labetalol | Salicylic Acid | | Bilirubin | Levorphanol | Secobarbital | | Caffeine | Loperamide | Serotonin | | Chloramphenicol | Maprotiline | Sulfamethazine | | Chlordiazepoxide HCL | Meprobamate | Sulindac | | Chloroquine | Methadone | Temazepam | | Chlorothiazide | Methoxyphenamine | 11-Nor-Δ9-Tetrahydrocannabi nol | | Chlorpheniramine | (+/-)-Methylenedioxyampheta mine(MDA) | Tetracycline | | Chlorpromazine | Methylphenidate | Tetrahydrozoline | | Cholesterol | Nalbuphine | Thebaine | | Clomipramine | Nalidixic acid | Thiamine | | Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine | | Codeine | Naltrexone hydrochloride | ThioridazineHydrochloride | | Cortisone | Naproxen | Triamterene | | Cotinine(-) | Niacinamide | Triflupromazine Hydrochloride | | Creatinine | Nifedipine | Trimethoprim | | Deoxyepinephrine | Norethindrone | Trimipramine | | Dextromethorphan | Norpropoxyphene | Tryptamine | | Diazepam | Noscapine | DL-Tryptophan | | Diflunisal | Oxazepam | Tyramine | | Digoxin | Oxycodone | D/L-Tyrosine | | Doxylamine | Oxymetazoline | Uric Acid | | Ecgonine methylester | Papaverine | Verapamil | | R(-)-Epinephrine | Penicillin | Zomepirac | | Erythromycin | Pentobarbital | | | Estrone-3-sulfate | Perphenazine | | ### f. Specificity To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats. | MDMA | Result | % | |------|--------|---| |------|--------|---| {11}------------------------------------------------ | Methylenedioxymethamphetamine (Cut-off=500 ng/mL) | | Cross-Reactivity | |------------------------------------------------------|------------------------|------------------| | Methylenedioxymethamphetamine | Positive at 500 ng/mL | 100% | | 3,4-Methylenedioxyamphetamine HCl (MDA) | Positive at 3000 ng/mL | 17% | | 3,4-Methylenedioxyethylamphetamine (MDEA) | Positive at 300 ng/mL | 167% | | d-methamphetamine | Positive at 2500 ng/mL | 20% | | d-amphetamine | >100,000 | Not detected | | l-amphetamine | >100,000 | Not detected | | l-methamphetamine | >100,000 | Not detected | | Phencyclidine (Cut-off=25 ng/mL) | Result | % Cross-Reactivity | |-------------------------------------|----------------------|--------------------| | Phencyclidine | Positive at 25 ng/mL | 100% | | 4-Hydroxy Phencyclidine | Positive at 90 ng/mL | 28% | | | | | ### g. Effect of Urine Specific Gravity and Urine pH To investigate the effect of urine specific gravity and urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats. - 2. Comparison Studies The method comparison studies for the MDMA (Ecstasy) Test, and the Phencyclidine Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The results are presented in the tables below: | IVALLA VIZA LEZULO V | | | | | | | |----------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------| | Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | | Viewer A | Positive | 0 | 0 | 0 | 13 | 24 | | | MDMA (Ecstasy) | |--|----------------| |--|----------------| {12}------------------------------------------------ | Viewer B | Negative | 10 | 15 | 15 | 3 | 0 | |----------|----------|----|----|----|----|----| | | Positive | 0 | 0 | 0 | 12 | 24 | | Viewer C | Negative | 10 | 15 | 15 | 4 | 0 | | | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | ## Discordant Results of MDMA (Ecstasy) Strip | Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results | |----------|---------------|--------------|--------------------------------| | Viewer A | 1008 | ર૦તે | Negative | | Viewer A | 1033 | ર૦ર | Negative | | Viewer A | 1076 | 507 | Negative | | Viewer B | 1008 | ર૦તે | Negative | | Viewer B | 1033 | ર૦ર | Negative | | Viewer B | 1076 | 507 | Negative | | Viewer B | 1037 | 211 | Negative | | Viewer C | 1008 | ર૦તે | Negative | | Viewer C | 1033 | ર૦ર | Negative | | Viewer C | 1076 | 507 | Negative | | Cassette format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |-----------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer B | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 14 | 24 | | | Negative | 10 | 15 | 15 | 2 | 0 | ## Discordant Results of MDMA (Ecstasy) Cassette | Cassette Format | | | | |-----------------|---------------|--------------|----------------| | Viewer | Sample Number | GC/MS Result | Viewer Results | | Viewer A | 1008 | 509 | Negative | | Viewer A | 1033 | 505 | Negative | | Viewer A | 1076 | 507 | Negative | | Viewer B | 1033 | 505 | Negative | | Viewer B | 1037 | 511 | Negative | {13}------------------------------------------------ | Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results | |----------|---------------|--------------|-----------------------------------| | Viewer B | 1076 | 507 | Negative | | Viewer C | 1033 | 505 | Negative | | Viewer C | 1076 | 507 | Negative | | Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer B | Positive | 0 | 0 | 0 | 12 | 24 | | | Negative | 10 | 15 | 15 | 4 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | ## Discordant Results of MDMA (Ecstasy) Cup | Viewer | Sample Number | GC/MS Result | Cup Format | | |----------|---------------|--------------|----------------|--| | | | | Viewer Results | | | Viewer A | 1008 | ર09 | Negative | | | Viewer A | 1033 | ર૦ર | Negative | | | Viewer A | 1076 | 507 | Negative | | | Viewer B | 1008 | ર૦તે | Negative | | | Viewer B | 1033 | ૨૦૨ | Negative | | | Viewer B | 1076 | 507 | Negative | | | Viewer B | 1037 | 211 | Negative | | | Viewer C | 1008 | ર૦તે | Negative | | | Viewer C | 1033 | ર૦ર | Negative | | | Viewer C | 1076 | 507 | Negative | | | Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 14 | 24 | {14}------------------------------------------------ | | Negative | 10 | 15 | 15 | 2 | 0 | |----------|----------|----|----|----|----|----| | Viewer B | Positive | 0 | 0 | 0 | 15 | 24 | | | Negative | 10 | 15 | 15 | 1 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | ## Discordant Results of MDMA (Ecstasy) Dip Card | Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results | |----------|---------------|--------------|-----------------------------------| | Viewer A | 1033 | 505 | Negative | | Viewer A | 1076 | 507 | Negative | | Viewer B | 1033 | 505 | Negative | | Viewer C | 1008 | 509 | Negative | | Viewer C | 1033 | 505 | Negative | | Viewer C | 1076 | 507 | Negative | | Phencyclidine | | | | | | | |---------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------| | Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | | Viewer A | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer B | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | ## Discordant Results of Phencyclidine Strip | Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results | |----------|---------------|--------------|--------------------------------| | Viewer A | 774 | 26 | Negative | | Viewer A | 721 | 25 | Negative | | Viewer A | 779 | 27 | Negative | | Viewer B | 774 | 26 | Negative | | Viewer B | 721 | 25 | Negative | | Viewer B | 702 | 27 | Negative | | Viewer C | 721 | 25 | Negative | | Viewer C | 704 | 27 | Negative | {15}------------------------------------------------ | Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results | |----------|---------------|--------------|-----------------------------| | Viewer C | 779 | 27 | Negative | | Cassette format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |-----------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 14 | 24 | | | Negative | 10 | 15 | 15 | 2 | 0 | | Viewer B | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 12 | 24 | | | Negative | 10 | 15 | 15 | 4 | 0 | ## Discordant Results of Phencyclidine Cassette | Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results | |----------|---------------|--------------|--------------------------------| | Viewer A | 774 | 26 | Negative | | Viewer A | 721 | 25 | Negative | | Viewer B | 774 | 26 | Negative | | Viewer B | 721 | 25 | Negative | | Viewer B | 702 | 27 | Negative | | Viewer C | 774 | 26 | Negative | | Viewer C | 721 | 25 | Negative | | Viewer C | 704 | 27 | Negative | | Viewer C | 779 | 27 | Negative | | Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | {16}------------------------------------------------ | Viewer B | Positive | 0 | 0 | 0 | 13 | 24 | |----------|----------|----|----|----|----|----| | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 12 | 24 | | | Negative | 10 | 15 | 15 | 4 | 0 | | Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results | |----------|---------------|--------------|--------------------------------| | Viewer A | 774 | 26 | Negative | | Viewer A | 721 | 25 | Negative | | Viewer A | 779 | 27 | Negative | | Viewer B | 774 | 26 | Negative | | Viewer B | 721 | 25 | Negative | | Viewer B | 702 | 27 | Negative | | Viewer C | 774 | 26 | Negative | | Viewer C | 721 | 25 | Negative | | Viewer C | 779 | 27 | Negative | | Viewer C | 704 | 27 | Negative | ### Discordant Results of Phencyclidine Dip Card | Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |---------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer B | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 13 | 24 | | | Negative | 10 | 15 | 15 | 3 | 0 | Discordant Results of Phencyclidine Cup | Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results | |----------|---------------|--------------|---------------------------| | Viewer A | 774 | 26 | Negative | | Viewer A | 721 | 25 | Negative | | Viewer A | 779 | 27 | Negative | | Viewer B | 774 | 26 | Negative | | Viewer B | 721 | 25 | Negative | {17}------------------------------------------------ | Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results | |----------|---------------|--------------|------------------------------| | Viewer B | 702 | 27 | Negative | | Viewer C | 721 | 25 | Negative | | Viewer C | 779 | 27 | Negative | | Viewer C | 704 | 27 | Negative | Lay-user study A lay user study was performed at three intended user sites with 557 lay persons testing the MDMA(Ecstasy) devices and another set of 555 persons testing the Phencyclidine devices. Total of 1112 individuals performed the study. A total of 230 females and 327 males tested the MDMA(Ecstasy) samples, and 226 females and 329 males tested the Phencyclidine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below. | | Number of samples | MDMA Concentration by GC/MS (ng/mL) | Lay person results | | The | |--------------|-------------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------| | % of Cutoff | | | No. of Positive | No. of Negative | percentage of correct results (%) | | -100% Cutoff | 20 | 0 | 0 | 20 | 100% | | -75% Cutoff | 20 | 125 | 0 | 20 | 100% | | -50% Cutoff | 19 | 250 | 0 | 19 | 100% | | -25% Cutoff | 20 | 375 | 1 | 19 | 95% | | +25% Cutoff | 20 | 625 | 19 | 1 | 95% | | +50% Cutoff | 20 | 750 | 20 | 0 | 100% | | +75% Cutoff | 20 | 875 | 20 | 0 | 100% | Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) Strip) Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) Cassette) | | Number | MDMA Concentration by GC/MS (ng/mL) | Lay person results | | The | |-------------|---------------|-------------------------------------------|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | % of Cutoff | of samples | | No. of Positive | No. of Negative | percentage of correct results (%) | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 19 | 125 | 0 | 19 | 100% | | -50% Cutoff | 20 | 250 | 0 | 20 | 100% | | -25% Cutoff | 20 | 375 | 1 | 19 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય | | +25% Cutoff | 20 | ર્ભ (૧૯૮૮) | 19 | 1 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત | {18}------------------------------------------------ | +50% Cutoff | 20 | 750 | 20 | 0 | 100% | |-------------|----|-----|----|---|------| | +75% Cutoff | 20 | 875 | 20 | 0 | 100% | Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) DipCard) | | Number | MDMA Concentration by | Lay person results | | The | |-------------|---------------|-----------------------|--------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | % of Cutoff | of samples | GC/MS (ng/mL) | No. of Positive | No. of Negative | percentage of correct results (%) | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 20 | 125 | 0 | 20 | 100% | | -50% Cutoff | 20 | 250 | 0 | 20 | 100% | | -25% Cutoff | 20 | 375 | 1 | 19 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | | +25% Cutoff | 20 | ર્ભ (૧૯૮૮) | 19 | 1 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | | +50% Cutoff | 20 | 750 | 20 | 0 | 100% | | +75% Cutoff | 20 | 875 | 20 | 0 | 100% | ### Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) Cup) | % of Cutoff | Number of samples | MDMA Concentration by GC/MS (ng/mL) | Lay person results | | The | |-------------|-------------------------|-------------------------------------------|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | No. of Positive | No. of Negative | percentage of correct results (%) | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 20 | 125 | 0 | 20 | 100% | | -50% Cutoff | 20 | 250 | 0 | 20 | 100% | | -25% Cutoff | 20 | 375 | 1 | 19 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય | | +25% Cutoff | 20 | ર્ભ (૧૯૮૮) | 19 | 1 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય | | +50% Cutoff | 19 | 750 | 19 | 0 | 100% | | +75% Cutoff | 20 | 875 | 20 | 0 | 100% | ### Comparison between GC/MS and Lay Person Results (Phencyclidine Strip) | | Number | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | |-------------|---------------|----------------------------------------------------|--------------------|--------------------|------------------------------------------------| | % of Cutoff | of samples | | No. of Positive | No. of Negative | | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 19 | 6 | 0 | 19 | 100% | | -50% Cutoff | 20 | 12.5 | 0 | 20 | 100% | | -25% Cutoff | 20 | 19 | 1 | 19 | 95% | | +25% Cutoff | 20 | 31 | 19 | 1 | 95% | | +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% | | +75% Cutoff | 20 | 44 | 20 | 0 | 100% | {19}------------------------------------------------ | | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The | |-------------|-------------------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------| | % of Cutoff | | | No. of Positive | No. of Negative | percentage of correct results (%) | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 20 | 6 | 0 | 20 | 100% | | -50% Cutoff | 19 | 12.5 | 0 | 19 | 100% | | -25% Cutoff | 20 | 19 | 1 | 19 | 95% | | +25% Cutoff | 20 | 31 | 19 | 1 | 95% | | +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% | | +75% Cutoff | 20 | 44 | 20 | 0 | 100% | Comparison between GC/MS and Lay Person Results (Phencyclidine Cassette) ## Comparison between GC/MS and Lay Person Results (Phencyclidine DipCard) | | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | |-------------|-------------------------|----------------------------------------------------|--------------------|--------------------|------------------------------------------------| | % of Cutoff | of samples | Phencyclidine Concentration by GC/MS (ng/mL) | No. of Positive | No. of Negative | The percentage of correct results (%) | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 20 | 6 | 0 | 20 | 100% | | -50% Cutoff | 20 | 12.5 | 0 | 20 | 100% | | -25% Cutoff | 20 | 19 | 2 | 18 | 90% | | +25% Cutoff | 20 | 31 | 18 | 2 | 90% | | +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% | | +75% Cutoff | 19 | 44 | 19 | 0 | 100% | ### Comparison between GC/MS and Lay Person Results (Phencyclidine Cup) | % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The | |-------------|-------------------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------| | | | | No. of Positive | No. of Negative | percentage of correct results (%) | | -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | -75%Cutoff | 20 | 6 | 0 | 20 | 100% | | -50% Cutoff | 19 | 12.5 | 0 | 19 | 100% | | -25% Cutoff | 20 | 19 | 2 | 18 | 90% | | +25% Cutoff | 20 | 31 | 19 | 1 | 95% | | +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% | | +75% Cutoff | 19 | 44 | 19 | 0 | 100% | {20}------------------------------------------------ Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the s…