Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
Device Facts
| Record ID | K152269 |
|---|---|
| Device Name | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) |
| Applicant | Healgen Scientific,, LLC |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Sep 9, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip 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 Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. The test is available in a Strip 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 Methamphetamine Test is an immunochromatographic assay for the qualitative determination of Methamphetamine 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.
Device Story
Lateral flow immunochromatographic assays for qualitative detection of drugs of abuse (Amphetamine, Benzoylecgonine, Methamphetamine) in human urine. Input: urine specimen; capillary action moves specimen across test strip. Principle: competitive binding; target drug in urine competes with immobilized drug-conjugate for limited antibody-coated particle binding sites. Output: visual colored line in test region indicates negative result (drug below cut-off); absence of line indicates positive result (drug above cut-off). Control line confirms proper test performance. Used in point-of-care or home settings by lay users or clinicians. Results provide preliminary screening; require GC/MS confirmation for clinical decision-making. Benefits: rapid, accessible drug screening.
Clinical Evidence
No clinical studies performed. Evidence consists of bench testing (precision, cut-off verification, interference, specificity) and a lay-user study. Lay-user study included 560 participants per drug type (1680 total) across three sites, comparing device results to GC/MS. Results showed high concordance with GC/MS across all formats and concentrations.
Technological Characteristics
Lateral flow chromatographic immunoassay. Components: test device (strip, cassette, cup, or dip card) and package insert. Detection principle: competitive binding using monoclonal mouse antibodies. No energy source required. Storage: 4-30°C. No software or electronic components.
Indications for Use
Indicated for qualitative detection of Amphetamine (500 ng/mL), Benzoylecgonine (150 ng/mL), and Methamphetamine (500 ng/mL) in human urine. Intended for prescription and over-the-counter use as a preliminary screening tool. Not for definitive diagnosis; requires GC/MS confirmation.
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).
Related Devices
- K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) · Guangzhou Wondfo Biotech Co., Ltd. · Jun 27, 2016
- K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test · W.H.P.M., Inc. · Oct 7, 2014
- K153465 — AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) · Assure Tech. (Hangzhou) Co, Ltd. · Mar 31, 2016
- K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Feb 28, 2018
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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2015
HEALGEN SCIENTIFIC LLC C/O JOE SHIA LSI INTERNATIONAL 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877
Re: K152269
Trade/Device Name: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, DIO, LAF Dated: July 26, 2015
Received: August 11, 2015
Dear Mr. Joe Shia:
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
{1}------------------------------------------------
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known) k152269
#### Device Name
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card) Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card) Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
Indications for Use (Describe)
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip 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 Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. The test is available in a Strip 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 Methamphetamine Test is an immunochromatographic assay for the qualitative determination of Methamphetamine 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
#### 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: September 1, 2015
- 2. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401
- 3. Contact person: Jiangiu 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 Amphetamine Test (Strip, Cassette, Cup, Dip Card) Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card) Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
Classification: Class II
| Product Code | CFR # | Panel |
|--------------|----------------------------------------------|------------|
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| LAF | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |
- 5. Predicate Devices:
K122809
Advin Multi-Drug Screen Test.
- 6. Intended Use / Indications for Use
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine 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 Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 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 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 Methamphetamine Test is an immunochromatographic assay for the qualitative determination of Methamphetamine 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 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 Amphetamine Test, Healgen Cocaine Test and Healgen Methamphetamine Test are immunochromatographic assays for Amphetamine, Cocaine and Methamphetamine. Each assay test is a flow system for the qualitative detection of Amphetamine, Benzoylecgonine lateral and Methamphetamine (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 insert. Each test device is sealed with a desiccant in an aluminum pouch.
- 8. Substantial Equivalence Information
A summary comparison of features of the Healgen Amphetamine Test, Healgen Cocaine Test and Healgen Methamphetamine Test and the predicate device is provided in Table 1, Table 2 and Table 3.
| Item | Device | Predicate -<br>k122809 |
|--------------|----------------------------------------------------------------------------|------------------------|
| Intended Use | For the qualitative determination of drugs<br>of abuse in human urine. | Same |
| Drug Analyte | Amphetamine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on | Same |
### Table 1: Features Comparison of Healgen Amphetamine Test and the Predicate Device
{5}------------------------------------------------
| Item | Device | Predicate –<br>k122809 |
|------------------------|-------------------------------------------------------|---------------------------|
| | the principle of antigen antibody<br>immunochemistry. | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 500 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Strip, Cassette, Cup, Dip Card | Cassette, Cup,<br>DipCard |
### Table 2: Features Comparison of Healgen Cocaine Test and the Predicate Device
| Item | Device | Predicate -<br>k122809 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same |
| Drug Analyte | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 150 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Strip, Cassette, Cup, Dip Card | Cassette, Cup,<br>DipCard |
## Table 3: Features Comparison of Healgen Methamphetamine Test and the Predicate Device
| Item | Device | Predicate -<br>k122809 |
|--------------|-----------------------------------------------------------------------------------------------------------------|------------------------|
| Intended Use | For the qualitative determination of drugs<br>of abuse in human urine. | Same |
| Drug Analyte | METHAMPHETAMINE | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody | Same |
{6}------------------------------------------------
| Item | Device | Predicate –<br>k122809 |
|------------------------|------------------------------------------------|---------------------------|
| | immunochemistry. | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 500 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Strip, Cassette, Cup, Dip Card | Cassette, Cup,<br>DipCard |
### 9. Test Principle
Healgen Amphetamine Test, Healgen Cocaine Test and Healgen Methamphetamine Test are rapid tests for the qualitative detection of Amphetamine, Benzoylecgonine and Methamphetamine 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 colored line will not form in the test line region if the target drug level exceeds its cut-off concentration 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 each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:
### Amphe tamine
#### Strip Format
| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
|------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
{7}------------------------------------------------
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 33-/17+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Dip Card Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## CUP Format
| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Cocaine
Strip Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 17-/33+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Cassette Format
| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{8}------------------------------------------------
| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- |
## Dip Card 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# METHAMPHETAMINE
## Strip 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 34-/16+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 33-/17+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### Cassette Format
| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Dip Card 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{9}------------------------------------------------
CUP Format
| | Result | Cut-off | | | | Cut-off | | | |
|-------|--------|---------|--------|--------|--------|---------|--------|--------|--------|
| Drug | | -100% | -75% | -50% | -25% | +25% | +50% | +75% | +100% |
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- |
### b. Linearity
Not applicable.
### c. Stability
The devices are stable at 4-30°C for 24 months based on the accelerated stability study at 45°C 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 Amphetamine, Cocaine and Methamphetamine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off<br>(ng/mL) |
|----------------------|-----------------|--------------------|
| Amphetamine Test | Amphetamine | 500 |
| Cocaine Test | Benzoylecgonine | 150 |
| Methamphetamine Test | Methamphetamine | 500 |
- e. Interference
Potential interfering substances found in human urine of physiological 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 100ug/mL are summarized in the following tables. There were no differences observed for different formats.
#### Amphe tamine
| Acetophenetidin | R(-)-Epinephrine | Pentobarbital |
|-----------------|------------------|---------------|
|-----------------|------------------|---------------|
{10}------------------------------------------------
| N-Acetylprocainamide | Erythromycin | Perphenazine |
|-----------------------------------|-----------------------------------|------------------------------------|
| Acetylsalicylic Acid<br>(Aspirin) | Estrone-3-sulfate | Phencyclidine |
| Alphenal | Ethyl-p-aminobenzoate | Phenelzine |
| Amobarbital | Fenoprofen | Phenobarbital |
| Aminopyrine | Furosemide | Phenylephrine-L |
| Amitriptyline | Gentisic acid | Phenylethylamine |
| Amoxicillin | Hemoglobin | Phenylpropanolamine |
| Ampicinine(Ampicillin) | Hydralazine | Prednisolone Acetate |
| Aprobarbital | (+/-)-4-Hydroxyamphetamine<br>HCL | Prednisone |
| Apomorphine | Hydrochlorothiazide | Procaine (Novocaine) |
| L-Ascorbic Acid | Hydrocodone | Promazine |
| Aspartame | Hydrocortisone | Promethazine |
| Atropine | a -Hydroxyhippuric acid | Propoxyphene,d- |
| Butabarbital | p-Hydroxymethamphetamine | Propranolol |
| Butalbital | Ibuprofen | Pseudoephedrine HCL |
| Butethal | Imipramine | Quinidine |
| Benzilic acid | Isoxsuprine | Quinine |
| Benzphetamine | Isoproterenol-(+/-) | Ranitidine(Zantac) |
| Bezoic Acid | Ketamine | Salicylic Acid |
| Bilirubin | Labetalol | Secobarbital |
| Caffeine | Levorphanol | Serotonin |
| Chloramphenicol | Loperamide | Sulfamethazine |
| Chlordiazepoxide HCL | Maprotiline | Sulindac |
| Chloroquine | Meprobamate | Temazepam |
| Chlorothiazide | Methadone | 11-Nor-△9-Tetrahydrocannab<br>inol |
| Chlorpheniramine | Methoxyphenamine | Tetracycline |
| Chlorpromazine | Methylphenidate | Tetrahydrozoline |
| Cholesterol | Nalbuphine | Thiamine |
| Clomipramine | Nalidixic acid | L-Thyroxine |
| Clonidine hydrochloride | Naloxone hydrochloride | ThioridazineHydrochloride |
| Cortisone | Naltrexone hydrochloride | Triamterene |
| Cotinine(-) | Naproxen | Triflupromazine<br>Hydrochloride |
| Creatinine | Niacinamide | Trimethoprim |
| Cyclopentobarbita1 | Nifedipine | Trimipramine |
| Deoxyepinephrine | Norethindrone | Tryptamine |
| Dextromethorphan | Norpropoxyphene | DL-Tryptophan |
| Diazepam | Noscapine | Tyramine |
| Diflunisal | Oxazepam | D/L-Tyrosine |
| Digoxin | Oxymetazoline | Uric Acid |
| Doxylamine | Papaverine | Verapamil |
| Ecgonine methylester | Penicillin | Zomepirac |
{11}------------------------------------------------
Cocaine
| Acetophenetidin | Doxylamine | Phentermine |
|-----------------------------------|-----------------------------------|--------------------------------|
| N-Acetylprocainamide | R(-)-Epinephrine | Pentobarbital |
| Acetylsalicylic Acid<br>(Aspirin) | Erythromycin | Perphenazine |
| Alphenal | Estrone-3-sulfate | Phencyclidine |
| Amobarbital | Ethyl-p-aminobenzoate | Phenelzine |
| Aminopyrine | Fenoprofen | Phenobarbital |
| Amitriptyline | Furosemide | Phenylephrine-L |
| Amoxicillin | Gentisic acid | Phenylethylamine |
| Amphetamine Sulfate | Hemoglobin | Phenylpropanolamine |
| Ampicinine(Ampicillin) | Hydralazine | Prednisolone Acetate |
| Aprobarbital | (+/-)-4-Hydroxyamphetamine<br>HCL | Prednisone |
| Apomorphine | Hydrochlorothiazide | Procaine (Novocaine) |
| d-amphetamine | Hydrocodone | Promazine |
| D,l-amphetamine | Hydrocortisone | Promethazine |
| l-amphetamine | a -Hydroxyhippuric acid | Propoxyphene,d- |
| L-Ascorbic Acid | p-Hydroxymethamphetamine | Propranolol |
| Aspartame | Ibuprofen | Pseudoephedrine HCL |
| Atropine | Imipramine | Quinidine |
| Butabarbital | Isoxsuprine | Quinine |
| Butalbital | Isoproterenol-(+/-) | Ranitidine (Zantac) |
| Butethal | Ketamine | Salicylic Acid |
| Benzilic acid | Labetalol | Secobarbital |
| Benzphetamine | Levorphanol | Serotonin |
| Bezoic Acid | Loperamide | Sulfamethazine |
| Bilirubin | Maprotiline | Sulindac |
| Caffeine | Meprobamate | Temazepam |
| Chloramphenicol | Methadone | 11-Nor-△9-Tetrahydrocannabinol |
| Chlordiazepoxide HCL | Methoxyphenamine | Tetracycline |
| Chloroquine | Methylphenidate | Tetrahydrozoline |
{12}------------------------------------------------
| Chlorothiazide | (+/-)-Methylenedioxyampheta<br>mine (MDA) | Thiamine |
|-------------------------|-------------------------------------------|----------------------------------|
| Chlorpheniramine | Nalbuphine | L-Thyroxine |
| Chlorpromazine | Nalidixic acid | ThioridazineHydrochloride |
| Cholesterol | Naloxone hydrochloride | Triamterene |
| Clomipramine | Naltrexone hydrochloride | Triflupromazine<br>Hydrochloride |
| Clonidine hydrochloride | Naproxen | Trimethoprim |
| Cortisone | Niacinamide | Trimipramine |
| Cotinine(-) | Nifedipine | Tryptamine |
| Creatinine | Norethindrone | DL-Tryptophan |
| Cyclopentobarbital | Norpropoxyphene | Tyramine |
| Deoxyepinephrine | Noscapine | D/L-Tyrosine |
| Dextromethorphan | Oxazepam | Uric Acid |
| Diazepam | Oxymetazoline | Verapamil |
| Diflunisal | Papaverine | Zomepirac |
| Digoxin | Penicillin | |
# METHAMPHETAMINE
| Acetophenetidin | R(-)-Epinephrine | Pentobarbital |
|-----------------------------------|-----------------------------------|----------------------|
| N-Acetylprocainamide | Erythromycin | Perphenazine |
| Acetylsalicylic Acid<br>(Aspirin) | Estrone-3-sulfate | Phencyclidine |
| Alphenal | Ethyl-p-aminobenzoate | Phenelzine |
| Amobarbital | Fenoprofen | Phenobarbital |
| Aminopyrine | Furosemide | Phenylpropanolamine |
| Amitriptyline | Gentisic acid | Prednisolone Acetate |
| Amoxicillin | Hemoglobin | Prednisone |
| Ampicinine(Ampicillin) | Hydralazine | Procaine(Novocaine) |
| Aprobarbital | (+/-)-4-Hydroxyamphetamine<br>HCL | Promazine |
| Apomorphine | Hydrochlorothiazide | Promethazine |
| L-Ascorbic Acid | Hydrocodone | Propoxyphene,d- |
| Aspartame | Hydrocortisone | Propranolol |
| Atropine | a -Hydroxyhippuric acid | Pseudoephedrine HCL |
| Butabarbital | Ibuprofen | Quinidine |
| Butalbital | Imipramine | Quinine |
| Butethal | Isoxsuprine | Ranitidine(Zantac) |
| Benzilic acid | Isoproterenol-(+/-) | Salicylic Acid |
| Benzphetamine | Ketamine | Secobarbital |
{13}------------------------------------------------
| Bezoic Acid | Labetalol | Serotonin |
|-------------------------|--------------------------|--------------------------------|
| Bilirubin | Levorphanol | Sulfamethazine |
| Caffeine | Loperamide | Sulindac |
| Chloramphenicol | Maprotiline | Temazepam |
| Chlordiazepoxide HCL | Meprobamate | 11-Nor-Δ9-Tetrahydrocannabinol |
| Chlorothiazide | Methadone | Tetracycline |
| Chlorpheniramine | Methoxyphenamine | Tetrahydrozoline |
| Chlorpromazine | Methylphenidate | Thiamine |
| Cholesterol | Nalbuphine | L-Thyroxine |
| Clomipramine | Nalidixic acid | Thioridazine Hydrochloride |
| Clonidine hydrochloride | Naloxone hydrochloride | Triamterene |
| Cortisone | Naltrexone hydrochloride | Triflupromazine Hydrochloride |
| Cotinine(-) | Naproxen | Trimethoprim |
| Creatinine | Niacinamide | Trimipramine |
| Cyclopentobarbital | Nifedipine | Tryptamine |
| Deoxyepinephrine | Norethindrone | DL-Tryptophan |
| Dextromethorphan | Norpropoxyphene | Tyramine |
| Diazepam | Noscapine | D/L-Tyrosine |
| Diflunisal | Oxazepam | Uric Acid |
| Digoxin | Oxymetazoline | Verapamil |
| Doxylamine | Papaverine | Zomepirac |
| Ecgonine methylester | Penicillin | |
### 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.
| Amphetamine<br>(Cut-off=500 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|------------------------------------|-------------------------------|--------------------|
| D-Amphetamine | 500 | 100% |
| D,L-Amphetamine | 750 | 67% |
| L-Amphetamine | 16000 | 3% |
| Phentermine | 650 | 77% |
{14}------------------------------------------------
| (+/-)-Methylenedioxyamphetamine<br>(MDA) | 800 | 63% |
|----------------------------------------------|----------|-------|
| d-Methamphetamine | >100,000 | <0.5% |
| 1-Methamphetamine | >100,000 | <0.5% |
| ephedrine | >100,000 | <0.5% |
| 3,4-Methylenedioxyethylamphetamine<br>(MDE) | >100,000 | <0.5% |
| 3,4-methylenedioxy-methamphetamine<br>(MDMA) | >100,000 | <0.5% |
| Cocaine<br>(Cut-off=150 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|--------------------------------|-------------------------------|--------------------|
| Benzoylecogonine | 150 | 100% |
| Cocaethylene | 2500 | 6% |
| Cocaine | 500 | 30% |
| Ecgonine | 12,500 | 1.2% |
| Ecgonine methylester | 50,000 | 0.3% |
| Methamphetamine<br>(Cut-off=500 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|---------------------------------------------|-------------------------------|--------------------|
| d-Methamphetamine | 500 | 100% |
| Methylenedioxyamphetamine<br>(MDA) | 1000 | 50% |
| p-Hydroxymethamphetamine | 15000 | 3% |
| l-Methamphetamine | 4000 | 13% |
| Mephentermine | 25000 | 2% |
| d,l-Amphetamine | 75000 | 0.7% |
| (1R,2S)-(-)-Ephedrine | 50000 | 1% |
| β-Phenylethylamine | 75000 | 0.7% |
| Methylenedioxymethamphetamine<br>(MDMA) | 1000 | 50% |
| Methylenedioxy-n-ethylamphetamine<br>(MDEA) | 20000 | 2.5% |
| d-Amphetamine | 50000 | 1% |
| Chloroquine | 12500 | 4% |
| l-Phenylephrine | 100000 | 0.5% |
### g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, 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%
{15}------------------------------------------------
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 Amphetamine Test, the Cocaine Test and the Methamphetamine 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. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
| Amphetamine | | | | | | |
|-----------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| Strip<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near<br>Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
#### Discordant Results of Amphetamine Strip
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | AMP68 | 531 | Negative |
| Viewer B | AMP68 | 531 | Negative |
| Viewer C | AMP68 | 531 | Negative |
| Viewer C | AMP63 | 504 | Negative |
| Cassette<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near<br>Cutoff<br>Negative<br>by GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
{16}------------------------------------------------
| | 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 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
# Discordant Results of Amphetamine Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | AMP68 | 531 | Negative |
| Viewer A | AMP63 | 504 | Negative |
| Viewer B | AMP68 | 531 | Negative |
| Viewer C | AMP68 | 531 | 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 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
## Discordant Results of Amphetamine Cup
| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | AMP68 | 531 | Negative |
| Viewer A | AMP63 | 504 | Negative |
| Viewer B | AMP68 | 531 | Negative |
| Viewer B | AMP63 | 504 | Negative |
| Viewer C | AMP68 | 531 | Negative |
| Dip Card<br>format | | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| | Negative | | | | |
{17}------------------------------------------------
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
|----------|----------|----|----|----|----|----|
| | 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 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
## Discordant Results of Amphetamine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | AMP68 | 531 | Negative |
| Viewer A | AMP63 | 504 | Negative |
| Viewer B | AMP68 | 531 | Negative |
| Viewer C | AMP68 | 531 | Negative |
| Viewer C | AMP63 | 504 | Negative |
| Strip<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|-----------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
## Discordant Results of Cocaine Strip
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | COC68 | 171 | Negative |
| Viewer A | COC69 | 164 | Negative |
| Viewer B | COC68 | 171 | Negative |
| Viewer B | COC71 | 187 | Negative |
| Viewer C | COC69 | 164 | Negative |
{18}------------------------------------------------
| Cassette<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
## Discordant Results of Cocaine Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | COC69 | 164 | Negative |
| Viewer B | COC68 | 171 | Negative |
| Viewer C | COC68 | 171 | Negative |
| Viewer C | COC69 | 164 | 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 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
## Discordant Results of Cocaine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | COC68 | 171 | Negative |
| Viewer A | COC69 | 164 | Negative |
| Viewer B | COC68 | 171 | Negative |
| Viewer B | COC03 | 182 | Negative |
{19}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer C | COC68 | 171 | Negative |
| Viewer C | COC69 | 164 | 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 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
## Discordant Results of Cocaine Cup
| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | COC68 | 171 | Negative |
| Viewer B | COC68 | 171 | Negative |
| Viewer C | COC69 | 164 | Negative |
## Me thamphe tamine
| Strip<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|-----------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
## Discordant Results of Methamphetamine Strip
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|--------|---------------|--------------|--------------------------------|
|--------|---------------|--------------|--------------------------------|
{20}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | MET64 | 501 | Negative |
| Viewer B | MET64 | 501 | Negative |
| Viewer C | MET64 | 501 | Negative |
| Viewer C | MET62 | 504 | Negative |
| Cassette<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
## Discordant Results of Methamphetamine Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | MET64 | 501 | Negative |
| Viewer B | MET64 | 501 | Negative |
| Viewer C | MET64 | 501 | Negative |
| Viewer C | MET62 | 504 | Negative |
| Dip Card<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
{21}------------------------------------------------
| Discordant Results of Methamphetamine Dip Card | | | |
|------------------------------------------------|---------------|--------------|--------------------------------|
| Viewer | Sample Number | GC/MS Result | Dip Card Form…
