FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

• K Number: K142408
• Device Name: FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
• Manufacturer: POLYMED THERAPEUTICS, INC
• Date Cleared: 2014-09-25 ( 28 days)
• Product Code: LDJ LAF
• Regulation Number: 862.3870

Intended Use

FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use. FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

Device Description

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow system for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

Predicate Devices

K052115

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on immunochromatographic assays and do not mention any AI or ML components.

Therapeutic

No.
A therapeutic device is used for treating or curing a disease or medical condition. This device is an in vitro diagnostic (IVD) test, which is used to detect substances like drugs in human urine, providing only preliminary test results. It is not used for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."

SaMD (Software as a Medical Device)

No

The device description clearly states it is an immunochromatographic assay using a lateral flow system with physical components like membranes, antibodies, and gold chloride, which are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).

Here's why:

• Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
• Nature of the Test: The device performs "immunochromatographic assays for the qualitative determination of... in human urine." This describes a test performed on a biological sample (urine) outside of the body to diagnose or provide information about a medical condition (presence of drugs).
• Intended Use: The test is intended to provide preliminary results for the presence of specific drugs in human urine, which is a diagnostic purpose.

Therefore, the device fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Ouick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

Product codes (comma separated list FDA assigned to the subject device)

LDJ, LAF

Device Description

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow system for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Description of the test set: Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cut-off by spiking drugs into drug free-pooled urine specimens.
Sample Size: 147 lay persons
Data Source: Drug-free pooled urine specimens. Samples of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, +25% cut-off, +50% cut-off, +75% cut-off, and +100% cut-off were prepared by spiking drugs in negative samples.
Annotation protocol: The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Analytical Performance:

   • Precision: Precision studies were carried out for samples with concentrations ranging from -100% cut-off to +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. For each concentration, tests were performed two runs per day for 25 days. The results are summarized in tables for THC (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup formats) and MET (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup formats).
   • Linearity: Not applicable.
   • Stability: The devices are stable at 4-30 ℃ for 18 months based on accelerated stability study at 50 ℃ and real time stability determination at both 4 ℃ and 30 °C.
   • 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 all Marijuana and Methamphetamine tests. The verified cut-off values are 50 ng/mL for FaStep Marijuana Test and 1000 ng/mL for FaStep Methamphetamine Test.
   • Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and to urine containing target drugs (11-nor-A9-THC-9-COOH or Methamphetamine) at 25% below and 25% above the cut-off. 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 tables for THC and MET.
   • Specificity: To test 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.
   • Effect of Urine Specific Gravity and Urine pH: Urine samples, with 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 the cut-off level. 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.

2. Comparison Studies:

   • Method Comparison: The method comparison studies for the FaStep Marijuana Test, and the FaStep Methamphetamine Test was performed in-house with three 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. Discordant results were also reported for each format (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) for both THC and MET.
   • Lay-user study: A lay user study was performed at three intended user sites with 147 lay persons. They had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cut-off 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. Correct results percentages were reported for various concentrations across THC and MET for Strip, Panel Dip, Turn-Key Split Cup, and Quick Cup formats. Lay-users were also given surveys on the ease of understanding of 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 scores revealed a reading Grade Level of 7.

3. Clinical Studies: Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Percentages of correct results are provided for the lay-user study:

• -100% cut-off: 100% Correct for both THC and MET.
• -75% cut-off: 100% Correct for both THC and MET.
• -50% cut-off: 100% Correct for both THC and MET.
• -25% cut-off:
  • Strip Format: THC 90.5%, MET 95.2%
  • Panel Dip Format: THC 90.5%, MET 95.2%
  • Turn-Key Split Cup Format: THC 95.2%, MET 95.2%
  • Quick Cup Format: THC 90.2%, MET 95.2%
• +25% cut-off:
  • Strip Format: THC 100%, MET 95.2%
  • Panel Dip Format: THC 100%, MET 100%
  • Turn-Key Split Cup Format: THC 100%, MET 100%
  • Quick Cup Format: THC 100%, MET 100%
• +50% cut-off: 100% Correct for both THC and MET across all formats.
• +75% cut-off: 100% Correct for both THC and MET across all formats.

Specificity: detailed cross-reactivity percentages are provided for various compounds for THC and MET.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K052115

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 25, 2014

POLYMED THERAPEUTICS, INC. C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE., SUITE F GAITHERSBURG MD 20877

Re: K142408

Trade/Device Name: FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup):

FaStep Methamphetamine Test (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, LAF Dated: August 25, 2014 Received: August 28, 2014

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 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

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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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 [phone] or [phone] 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

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Indications for Use

510(k) Number (if known) K142408

Device Name

FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

Indications for Use (Describe)

FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Ouick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Date:	September 23, 2014
2. Submitter:	POLYMED THERAPEUTICS, INC
3040 Post Oak Blvd Ste 1110
Houston, TX 77056
3. Contact person:	Frank Luo
POLYMED THERAPEUTICS, INC
3040 Post Oak Blvd Ste 1110
Houston, TX 77056
Telephone: [phone]
Fax: [phone]
Email: [e-mail]
4. Device Name:	FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup,
Turn-Key Split Cup)
FaStep Methamphetamine Tests (Strip, Panel Dip, Quick
Cup, Turn-Key Split Cup)

Classification:	Class II
Product Code	CFR #	Panel
LDJ	21 CFR, 862.3870 Cannabinoid Test System	Toxicology
LAF	21 CFR, 862.3610 Methamphetamine Test System	Toxicology

• 5. Predicate Devices: K052115 FIRST CHECK DIAGNOSTICS LLC
• 6. Intended Use:

FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off

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concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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 over-the-counter and for prescription use.

• 7. Device Description:
     Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow system for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.
• 8. Substantial Equivalence Information:
     A summary comparison of features of the FaStep Marijuana Test and FaStep Methamphetamine Test and the predicate devices is provided in Table 1 & Table 2.

Item	Device	Predicate -
		K052115
		Same (but the
Indication(s)	For the qualitative determination of	number of drugs
for Use	11-nor-Δ9-THC-9-COOH in human urine.	detected is
		different)
Calibrator	11-nor-Δ9-THC-9-COOH	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative to indicate positive or negative
result	Same
Specimen Type	Human Urine	Same
Cut-Off Values	50 ng/mL	Same
Intended Use	For over-the-counter and prescription
uses.	For
over-the-counter
use.
Configurations	Strip, Panel Dip, Cup, and Turn-Key Split
Cup	Cup

Table 1: Features Comparison of FaStep Marijuana Test and the Predicate Devices

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Table 2: Features Comparison of FaStep Methamphetamine Test and the Predicate Devices

Item	Device	Predicate - K052115
Indication(s)
for Use	For the qualitative determination of
Methamphetamine in human urine.	Same (but the
number of drugs
detected is different)
Calibrator	Methamphetamine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative to indicate positive or
negative result	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
Intended Use	For over-the-counter and prescription
uses.	For over-the-counter
use.
Configurations	Strip, Panel Dip, Cup, and Turn-Key
Split Cup	Cup

9. Test Principle

These are rapid tests for the qualitative detection of 11-nor-Δ9-THC-9-COOH or Methamphetamine in urine samples. These are lateral flow chromatographic immunoassays. 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 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 line should form in the control region of the test devices regardless of the presence of drug in the sample.

10. Performance Characteristics

• 1. Analytical Performance
  • a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, +25% cut-off, +50% 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. For each concentration,

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tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

| | 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: THC1304001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: THC1304002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: THC1304003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

THC Strip Format

THC Panel Dip Format

	Result
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: MSD1305001	50-/0+	50-/0+	50-/0+	50-/0+	1-/49+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: MSD1305002	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: MSD1305003	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-

THC Turn-Key Split Cup Format

Drug	Result
	-100% cut-off	-75% cut-off	-50% cut-off	-25% cut-off	+25% cut-off	+50% cut-off	+75% cut-off	+100% cut-off
Lot: MSCP1305004	50-/0+	50-/0+	50-/0+	50-/0+	1-/49+	50+/0-	50+/0-	50+/0-
Lot: MSCP1305005	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-
Lot: MSCP1305006	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-

THC Quick Cup Format

	Result
Drug	-100% cut-off	-75% cut-off	-50% cut-off	-25% cut-off	+25% cut-off	+50% cut-off	+75% cut-off	+100% cut-off
Lot: MSCP1305007	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-
Lot: MSCP1305008	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-
Lot: MSCP1305009	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-

MET 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: MET1303001	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Drug	Lot: MET1303002	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Drug	Lot: MET1303003	50-/0+	50-/0+	50-/0+	50-/0+	1-/49+	50+/0-	50+/0-	50+/0-	50+/0-

MET Panel Dip 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: MSD1305001	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: MSD1305002	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: MSD1305003	50-/0+	50-/0+	50-/0+	50-/0+	1-/49+	50+/0-	50+/0-	50+/0-	50+/0-

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	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: MSCP1305004	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: MSCP1305005	50-/0+	50-/0+	50-/0+	50-/0+	1-/49+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: MSCP1305006	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-

MET Turn-Key Split Cup Format

MET Quick 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: MSCP1305007 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot: MSCP1305008 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot: MSCP1305009 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

• b. Linearity
  Not applicable.

• c. Stability
  The devices are stable at 4-30 ℃ for 18 months based on the accelerated stability study at 50 ℃ and real time stability determination at both 4 ℃ and 30 °C.

• 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 all Marijuana and Methamphetamine tests. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off
(ng/mL) |
|-----------------------------|----------------------|--------------------|
| FaStep Marijuana Test | 11-nor-Δ9-THC-9-COOH | 20 |
| FaStep Methamphetamine Test | Methamphetamine | 1000 |

• e. Interference
  Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and to urine containing target drugs (11-nor-A9-THC-9-COOH or Methamphetamine) at 25% below and 25% above the cut-off. These urine samples were tested using three batches of each device for all formats.

8

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.

THC:

4-Acetamidophenol	Erythromycin	Papaverine
Acetone	β-Estradiol	Penicillin-G
Acetophenetidin	Estrone-3-sulfate	Pentazocine
N-Acetylprocainamide	Ethanol	Pentobarbital
Acetylsalicylic acid	Ethyl-p-aminobenzoate	Perphenazine
Albumin	Fenoprofen	Phencyclidine
Aminopyrine	Furosemide	Phenelzine
Amitryptyline	Gentisic acid	Pheniramine
Amobarbital	Glucose	Phenobarbital
Amoxicillin	Guaiacol Glyceryl Ether	Phentermine
Ampicillin	Hemoglobin	L-Phenylephrine
Ascorbic acid	Hydralazine	β-Phenylethylamine
D,L-Amphetamine	Hydrochlorothiazide	β-Phenylethylamine
L-Amphetamine	Hydrocodone	Phenylpropanolamine
Apomorphine	Hydrocortisone	Prednisolone
Aspartame	O-Hydroxyhippuric acid	Prednisone
Atropine	3-Hydroxytyramine	Procaine
Benzilic acid	Ibuprofen	Promazine
Benzocaine	Imipramine	Promethazine
Benzoic acid	Iproniazid	D,L-Propanolol
Benzoylecgonine	(-) Isoproterenol	D-Propoxyphene
Benzphetamine	Isoxsuprine	D-Pseudoephedrine
Bilirubin	Ketamine	Quinidine
Brompheniramine	Ketoprofen	Quinine
Caffeine	Labetalol	Ranitidine
Chloralhydrate	Levorphanol	Riboflavin
Chloramphenicol	Loperamide	Salicylic acid
Chlordiazepoxide	Maprotiline	Secobarbital
Chlorothiazide	Meprobamate	Serotonin
(5-Hydroxytyramine)
(+) Chlorpheniramine	Methadone	Sodium Chloride
(±) Chlorpheniramine	Methoxyphenamine	Sulfamethazine
Chlorpromazine	(+)3,4-Methylenedioxyamphetamine	Sulindac
Chlorquine	(+)3,4-Methylenedioxymethamphetamine	Temazepam
Cholesterol	Methylphenidate	Tetracycline
Clomipramine	Methyprylon	Tetrahydrocortisone, 3 Acetate
Clonidine	Morphine-3-β-Dglucuronide	Tetrahydrocortisone3
(5-Dglucuronide)
Cocaine hydrochloride	Nalorphine	Tetrahydrozoline
Codeine	Naloxone	Thebaine
Cortisone	Nalidixic acid	Theophylline
(-) Cotinine	Naltrexone	Thiamine
Creatine	Naproxen	Thioridazine
Creatinine	Niacinamide	D, L-Thyroxine
Deoxycorticosterone	Nicotine	Tolbutamine
Dexbrompheniramine	Nifedipine	Triamterene
Dextromethorphan	Norcodein	Trifluoperazine
Diazepam	(+)-Norephedrine	Trimethoprim
Diclofenac	Norethindrone	Trimipramine
Diflunisal	D-Norpropoxyphene	Tryptamine
Digoxin	Noscapine	D, L-Tryptophan
4-Dimethilaminoantipyrine	D,L-Octopamine	Tyramine
Diphenhydramine	Oxalic acid	D, L-Tyrosine
Dopamine	Oxazepam	Uric acid
Doxylamine	Oxolinic acid	Verapamil
Ecgonine hydrochloride	Oxycodone	Zomepirac
Ecgonine methylester	Oxymetazoline
(-) Y Ephedrine	p-Hydroxymethamphetamine

9

MET

4-Acetamidophenol	(IR,2S)-(-)-Ephedrine	Papaverine
Acetone	L-Ephedrine	Penicillin-G
Acetophenetidin	(-) Y Ephedrine	Pentazocaine
N-Acetylprocainamide	Erythromycin	Pentobarbital
Acetylsalicylic acid	β-Estradiol	Perphenazine
Albumin	Estrone-3-sulfate	Phencyclidine
Aminopyrine	Ethanol	Phenelzine
Amitriptyline	Ethyl-p-aminobenzoate	Phendimetrazine
Amobarbital	Fenfluramine	Pheniramine
Amoxicillin	Fenoprofen	Phenobarbital
Ampicillin	Furosemide	Phenytoin
Ascorbic acid	Gentisic acid	L-Phenylephrine
Apomorphine	Glucose	β-Phenylethlamine
Aspartame	Guaiacol Glyceryl Ether	Phenylpropanolamine
Atropine	Hemoglobin	Prednisolone
Benzilic acid	Hydralazine	Prednisone
Benzocaine	Hydrochlorothiazide	Procaine
Benzoic acid	Hydrocodone	Promazine
Benzoylecgonine	Hydrocortisone	Promethazine
Bilirubin	O-Hydroxyhippuric acid	D.L-Propanolol

10

Brompheniramine	3-Hydroxytyramine	Propiomazine
Caffeine	Ibuprofen	D-Propoxyphene
Cannabidiol	Imipramine	Quinidine
Cannabinol	(-) Isoproterenol	Quinine
Chloralhydrate	Isoxsuprine	Ranitidine
Chloramphenicol	Ketamine	Riboflavin
Chlordiazepoxide	Ketoprofen	Salicylic acid
Chlorothiazide	Labetalol	Secobarbital
(+)-Chlorpheniramine	Levorphanol	Serotonin
(±) Chlorpheniramine	Loperamide	Sodium Chloride
Chlorpromazine	Maprotiline	Sulfamethazine
Chlorquine	Meperidine	Sulindac
Cholesterol	Meprobamate	Temazepam
Clomipramine	Methadone	Tetracycline
Clonidine	Methylphenidate	Tetrahydrocortisone
Cocaine hydrochloride	Morphine-3-Dglucuronide	Tetrahydrozoline
Codeine	Nalidixic acid	Δ9-THC-COOH
Cortisone	Naloxone	Thebaine
(-) Cotinine	Naltrexone	Theophylline
Creatine	Naproxen	Thiamine
Creatinine	Niacinamide	Thioridazine
Deoxycorticosterone	Nicotine	D,L-Thyroxine
Dexbrompheniramine	Nifedipine	Tolbutamine
Dextromethorphan	Norcodein	Triamterene
Diazepam	(+)-Norephedrine	Trifluoperazine
Diclofenac	Norethindrone	Trimethoprim
Diflunisal	D-Norpropoxyphene	Trimipramine
Digoxin	Noscapine	Tryptamine
4-Dimethylaminoantipyrine	D,L-Octopamine	Tyramine
Diphenhydramine	Oxalic acid	D, L-Tyrosine
Dopamine	Oxazepam	Uric acid
Doxylamine	Oxolinic acid	Verapamil
Ecgonine hydrochloride	Oxycodone	Zomepirac
Ecgonine methylester	Oxymetazoline

• f. Specificity
  To test 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.

11

| THC
(11-nor-Δ9-THC-9-COOH,
ng/mL) | Result
Cut-off=50 | %
Cross-Reactivity |
|-----------------------------------------|--------------------------|-----------------------|
| 11-nor-Δ8-THC-9-COOH | Positive at 30 ng/mL | 167% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | Positive at 50 ng/mL | 100% |
| Δ8- Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.3% |
| Δ9- Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.3% |
| Cannabinol | Positive at 20000 ng/mL | 0.25% |
| Cannabidiol | Positive at 100000 ng/mL | 0.05% |
| 11-nor- Δ 9-THC-carboxy glucuronide | Positive at 25000 ng/mL | 0.2% |
| (-)-11-nor-9-carboxy-Δ 9-THC | Positive at 30 ng/mL | 167% |

| MET
(D-Methamphetamine, Cut-off=1000
ng/mL) | Result
| %
Cross-Reactivity |
|----------------------------------------------------------|-----------------------------|-----------------------|
| (+/-)
3,4-Methylenedioxy-n-ethylamphetamine(
MDEA) | Positive at 10,000
ng/mL | 10% |
| Procaine (Novocaine) | Positive at 60,000
ng/mL | 1.7% |
| Trimethobenzamide | Positive at 20,000
ng/mL | 5% |
| L-Methamphetamine | Positive at 10000
ng/mL | 10% |
| Ranitidine (Zantac) | Positive at 50,000
ng/mL | 2% |
| (+/-)
3,4-Methylenedioxymethamphetamine
(MDMA) | Positive at 500
ng/mL | 200% |
| Chloroquine | Positive at 50,000
ng/mL | 2% |
| Ephedrine | Positive at 4,000
ng/mL | 25% |
| Fenfluramine | Positive at 20,000
ng/mL | 5% |
| p-Hydroxymethamphetamine | Positive at 10,000
ng/mL | 10% |
| D-Amphetamine | >100000 | Not detected |

12

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 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 the cut-off level. 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 FaStep Marijuana Test, and the FaStep Methamphetamine Test was performed in-house with three 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:

THC
Strip format		Negative	Low Negative by GC/MS
(less than -50%)	Near Cut-off Negative by GC/MS
(Between -50% and cut-off)	Near Cut-off Positive by GC/MS
(Between the cut-off and +50%)	High Positive by GC/MS
(greater than +50%)
Viewer A	Positive	0	0	1	15	25
	Negative	10	20	9	0	0
Viewer B	Positive	0	0	1	15	25
	Negative	10	20	9	0	0
Viewer C	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

THC

Discordant Results of THC Strip

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results | |
|----------|---------------|--------------|--------------------------------|--|
| Viewer A | 83698 | 46 | Positive | |
| Viewer B | 83698 | 46 | Positive | |
| Viewer C | 83698 | 46 | Positive | |

| Panel
Dip
format | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cut-off
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cut-off
Positive by
GC/MS
(Between the
cut-off and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|------------------------|----------|----------|----------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer
B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |

13

Viewer		0	0	0	15	25
C	Positive	0	0	0	15	25
C	Negative	10	20	10	0	0

Discordant Results of THC Panel Dip

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 83698 | 46 | Positive |
| Viewer A | 18881 | 53 | Negative |
| Viewer B | 83698 | 46 | Positive |

| Turn-Key
Split Cup
format | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cut-off
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cut-off
Positive by
GC/MS
(Between the
cut-off and
+50%) | High
Positive by
GC/MS
(greater than
+50%) |
|---------------------------------|----------|----------|----------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |

Discordant Results of THC Turn-Key Split Cup

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	83698	46	Positive
Viewer B	18881	53	Negative
Viewer C	83698	46	Positive

| Quick
Cup
format | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cut-off
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cut-off
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 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer
B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer
C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |

Discordant Results of THC Quick Cup

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer B | 37144 | 54 | Negative |
| Viewer C | 83698 | 46 | Positive |

14

MET
Strip
format		Negative	Low Negative by
GC/MS
(less than -50%)	Near Cut-off Negative by
GC/MS
(Between -50% and
cut-off)	Near Cut-off Positive by
GC/MS
(Between the
cut-off and +50%)	High Positive
by GC/MS
(greater than +50%)
Viewer
A	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
Viewer
B	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
Viewer
C	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

Discordant Results of MET Strip

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 17448 | 949 | Positive |
| Viewer A | 13563 | 1099 | Negative |
| Viewer B | 17448 | 949 | Positive |
| Viewer B | 90196 | 1002 | Negative |
| Viewer C | 17448 | 949 | Positive |

| Panel
Dip
format | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cut-off
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cut-off
Positive by
GC/MS
(Between the
cut-off and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|------------------------|----------|----------|----------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 1 | 14 | 25 |
| Viewer
A | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer
B | Positive | 0 | 0 | 1 | 14 | 25 |
| Viewer
B | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer
C | Positive | 0 | 0 | 0 | 15 | 25 |
| Viewer
C | Negative | 10 | 20 | 10 | 0 | 0 |

Discordant Results of MET Panel Dip

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 17448 | 949 | Positive |
| Viewer A | 90196 | 1002 | Negative |
| Viewer B | 17448 | 949 | Positive |
| Viewer B | 90196 | 1002 | Negative |

15

| Turn-Key
Split
format | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cut-off
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cut-off
Positive by
GC/MS
(Between the
cut-off and
+50%) | High
Positive by
GC/MS
(greater than
+50%) |
|-----------------------------|----------|----------|----------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |

Discordant Results of MET Turn-Key Split Cup

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	17448	949	Positive
Viewer A	90196	1002	Negative
Viewer B	17448	949	Positive
Viewer C	17448	949	Positive
Viewer C	90196	1002	Negative

Quick Cup format		Negative	Low Negative by GC/MS (less than -50%)	Near Cut-off Negative by GC/MS (Between -50% and cut-off)	Near Cut-off 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	25
Viewer A	Negative	10	20	10	0	0
Viewer B	Positive	0	0	1	15	25
Viewer B	Negative	10	20	9	0	0
Viewer C	Positive	0	0	0	14	25
Viewer C	Negative	10	20	10	1	0

Discordant Results of MET Quick Cup

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer B	17448	949	Positive
Viewer C	90196	1002	Negative

Lay-user study

A lay user study was performed at three intended user sites with 147 lay persons. They had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cut-off by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into

16

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:

| % Cut-off | No of
samples | Concentration by
GC/MS(ng/mL) | | Lay person results | | Correct
Results (%) | |
|-----------|------------------|----------------------------------|---------------------|--------------------|--------|------------------------|------|
| | | 11-nor-Δ9-
THC-9-COOH | Methamphe
tamine | THC | MET | THC | MET |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 12 | 250 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 25 | 500 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 37 | 750 | 2+/19- | 1+/20- | 90.5 | 95.2 |
| +25% | 21 | 63 | 1250 | 21+/0- | 20+/1- | 100 | 95.2 |
| +50% | 21 | 75 | 1500 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 88 | 1750 | 21+/0- | 21+/0- | 100 | 100 |

Comparison of GC/MS and Lay Person Results for THC and MET Strip Formats

Comparison of GC/MS and Lay Person Results for THC and MET Panel Dip Formats

| % Cut-off | No of | Concentration by
GC/MS(ng/mL) | | Lay person results | | Correct
Results (%) | |
|-----------|---------|----------------------------------|---------------------|--------------------|--------|------------------------|------|
| | samples | 11-nor-△9-
THC-9-COOH | Methamphe
tamine | THC | MET | THC | MET |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 12 | 250 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 25 | 500 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 37 | 750 | 2+/19- | 1+/20- | 90.5 | 95.2 |
| +25% | 21 | 63 | 1250 | 21+/0- | 21+/0- | 100 | 100 |
| +50% | 21 | 75 | 1500 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 88 | 1750 | 21+/0- | 21+/0- | 100 | 100 |

Comparison of GC/MS and Lay Person Results for THC and MET Turn-Key Split Cup Formats

| % Cut-off | No of
samples | Concentration by
GC/MS(ng/mL) | | Lay person results | | Correct
Results (%) | |
|-----------|------------------|----------------------------------|---------------------|--------------------|--------|------------------------|------|
| | | 11-nor-Δ9-
THC-9-COOH | Methamphe
tamine | THC | MET | THC | MET |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 12 | 250 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 25 | 500 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 37 | 750 | 1+/20- | 1+/20- | 95.2 | 95.2 |
| +25% | 21 | 63 | 1250 | 21+/0- | 21+/0- | 100 | 100 |
| +50% | 21 | 75 | 1500 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 88 | 1750 | 21+/0- | 21+/0- | 100 | 100 |

Comparison of GC/MS and Lay Person Results for THC and MET Quick Cup Formats

| % Cut-off | No of
samples | Concentration by
GC/MS(ng/mL) | | Lay person results | | Correct
Results (%) | |
|-----------|------------------|----------------------------------|---------------------|--------------------|--------|------------------------|-----|
| | | 11-nor-Δ9-
THC-9-COOH | Methamphe
tamine | THC | MET | THC | MET |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |

17

-75%	21	12	250	0+/21-	0+/21-	100	100
-50%	21	25	500	0+/21-	0+/21-	100	100
-25%	21	37	750	2+/19-	1+/20-	90.2	95.2
+25%	21	63	1250	21+/0-	21+/0-	100	100
+50%	21	75	1500	21+/0-	21+/0-	100	100
+75%	21	88	1750	21+/0-	21+/0-	100	100

Lay-users were also given surveys on the ease of understanding of 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 scores revealed a reading Grade Level of 7.

• 3. Clinical Studies Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the FaStep Marijuana Test, and the FaStep Methamphetamine Test are substantially equivalent to the predicate.