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.

AI/ML Overview

This document describes the performance characteristics of the FaStep Marijuana Tests and FaStep Methamphetamine Tests. These are immunochromatographic assays for the qualitative determination of 11-nor-Δ9-THC-9-COOH (Marijuana metabolite) and Methamphetamine in human urine, manufactured by POLYMED THERAPEUTICS, INC. The document presents data to demonstrate that the devices meet acceptance criteria for precision, cut-off verification, interference, specificity, and comparison with a reference method (GC/MS).

Here's a breakdown of the requested information, adapted from the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance of the device in various studies. The core acceptance is accurate qualitative determination (positive/negative) at specific cut-off concentrations, with high correct result percentages and low rates of false positives/negatives, especially near the cut-off.

Overall Performance Summary (Inferred Acceptance Criteria vs. Reported Performance):

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Accurate classification (positive/negative) for samples at various concentrations relative to the cut-off (especially near the cut-off), with minimal misclassifications.	For both THC and MET tests across all formats (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), samples at -100%, -75%, -50%, -25% cut-off consistently showed 50-/0+ results (Negative), indicating 100% agreement with expected negative results. Samples at +25%, +50%, +75%, +100% cut-off uniformly showed 50+/0- results (Positive), indicating 100% agreement with expected positive results. At the exact cut-off concentration, there were a small number of misclassifications (e.g., 1-3 negative results out of 50 tests for expected positive, or 1-3 positive results for expected negative, depending on the lot), demonstrating high accuracy at the analytical threshold.
Cut-off Verification	All samples at and above +25% cut-off should be positive; all samples at and below -25% cut-off should be negative.	All Marijuana and Methamphetamine tests reported "all positive at and above +25% cut-off and all negative at and below -25% cut-off" when tested with three different lots by three different operators. This demonstrates accurate performance with respect to the defined cut-off values (50 ng/mL for THC, 1000 ng/mL for MET).
Interference	No interference from common physiological/pathological substances or specified compounds that would alter the test result.	A wide range of compounds (over 80 for THC, over 90 for MET) at 100 µg/mL concentration showed no interference with test results in both drug-free urine and urine spiked with drugs at +/- 25% of the cut-off. "No differences observed for different formats."
Specificity (Cross-Reactivity)	Low cross-reactivity with structurally similar compounds or metabolites, ensuring the test primarily detects the target analyte. Specificity thresholds are not explicitly stated, but the results demonstrate a controlled level of cross-reactivity where expected (e.g., metabolites).	THC: 11-nor-Δ8-THC-9-COOH and (-)-11-nor-9-carboxy-Δ9-THC showed high cross-reactivity (167%) as expected for similar metabolites. Other related compounds (e.g., Δ8-Tetrahydrocannabinol, Cannabinol) showed very low cross-reactivity (0.05% - 0.3%).MET: 3,4-Methylenedioxymethamphetamine (MDMA) showed high cross-reactivity (200%), which is physiologically relevant for methamphetamine testing. Other compounds showed lower cross-reactivity (e.g., L-Methamphetamine at 10%, Ephedrine at 25%) or were not detected (D-Amphetamine). "No differences observed for different formats."
Comparison Studies (Clinical Samples)	High agreement with GC/MS results, particularly for samples near the cut-off, demonstrating clinical validity. Minimal discordant results.	For both THC and MET tests across all formats, 80 clinical samples (40 negative, 40 positive) were tested. The tables show a high concordance with GC/MS results. Discordant results primarily occurred for samples very close to the cut-off concentration, either false positives slightly below cut-off or false negatives slightly above cut-off (e.g., 1-2 discordant results per viewer for THC and MET strip format, typically within 25% of the cut-off). Overall high agreement was demonstrated.
Lay-User Study	High percentage of correct interpretations by lay users, and clear, easy-to-understand instructions.	Across all formats (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) for both THC and MET, lay users achieved 100% correct results for samples at -100%, -75%, -50% cut-off (negative) and +25%, +50%, +75% cut-off (positive). For samples at -25% cut-off, correct results ranged from 90.2% to 95.2% (some false positives). For samples at +25% cut-off, THC tests showed 100% correct results, while MET tests showed 95.2% to 100% depending on the format. All lay users indicated that the device instructions were easily followed (Flesch-Kincaid Grade Level 7).

2. Sample Size and Data Provenance

Precision Studies:
- Sample Size: For each drug (THC, MET), each concentration level (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), across 3 different lots of the device, 50 tests were performed (2 runs per day for 25 days). This means for each drug and each format, 9 concentrations x 3 lots x 50 tests = 1350 data points per format were generated for precision, although only summarized frequency counts are provided.
- Data Provenance: Not explicitly stated, but implied to be laboratory-controlled samples prepared by spiking drugs into negative samples. The concentration was confirmed by GC/MS. This suggests a retrospective controlled laboratory study, likely conducted in the US (given the FDA submission).
Cut-off Verification:
- Sample Size: 150 samples equally distributed at concentrations of -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off. These were tested using three different lots of each device.
- Data Provenance: Laboratory-controlled spiked samples.
Interference & Specificity:
- Sample Size: Concentrations of various compounds were tested in drug-free urine and in urine containing target drugs at 25% below and 25% above the cut-off. Tested using three batches (lots) of each device for all formats.
- Data Provenance: Laboratory-controlled spiked samples.
Comparison Studies (Clinical Samples):
- Sample Size: 80 unaltered clinical samples per drug (40 negative and 40 positive, categorized based on GC/MS). These samples were used for each of the four device formats (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup).
- Data Provenance: "In-house with three laboratory assistants." Samples were "unaltered clinical samples." The country of origin is not specified but is implicitly the US for an FDA submission. This was a retrospective study using existing clinical samples.
Lay-User Study:
- Sample Size: 147 lay persons. Urine samples were prepared at 7 concentration levels (negative, +/- 75%, +/- 50%, +/- 25% of the cut-off). Each participant was provided with 1 blind-labeled sample (implying each individual participant tested one sample concentration per drug type and format, making the overall sample count for analysis 21 samples per concentration level per drug type - 7 concentrations x 21 participants = 147 tests. Since both THC and MET were tested per participant per format, this would be 147 x 2 = 294 tests per format (or total if formats were varied).
- Data Provenance: "Performed at three intended user sites." Controlled spiked samples, blind-labeled. This was a prospective study with lay users.

3. Number of Experts and Qualifications for Ground Truth

Expert Establishment of Ground Truth: The ground truth for all analytical and clinical comparison studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted "gold standard" method for confirming drug concentrations in urine.
Qualifications of Experts: The document does not specify the number or detailed qualifications of the individuals who performed the GC/MS analysis (e.g., "radiologist with 10 years of experience"). However, GC/MS is a laboratory analytical method, and it is assumed that the personnel operating such sophisticated equipment are qualified laboratory technicians/scientists with appropriate training and experience in analytical chemistry. For the comparison studies, three laboratory assistants performed the device readings. Their specific qualifications beyond "laboratory assistants" are not detailed.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is explicitly described for the individual readings of the rapid tests in the comparison studies.
For the comparison studies, three laboratory assistants ("Viewers A, B, C") independently read the results of the 80 clinical samples for each device format. Their individual readings were then compared against the GC/MS ground truth. The discordant results are individually listed for each viewer against the GC/MS result. This implies independent assessment rather than a consensus or adjudication process among the viewers themselves for the final study result.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance.
- This device is a rapid diagnostic test (lateral flow immunoassay) for drug screening, not an "AI-assisted" diagnostic imaging device (e.g., for radiology). Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable here.
- The "human readers" in the comparison studies were laboratory assistants reading the strip/panel for a visible line, and lay users following instructions. There is no AI component involved in the interpretation of these tests according to the documentation provided.

6. Standalone (Algorithm Only) Performance

Not applicable. As stated above, this is a chemical immunoassay, not an algorithm-only device. The test itself performs the "detection" by the presence or absence of a colored line, which is then interpreted by a human user. There is no software algorithm that provides a standalone diagnostic output without human involvement.

7. Type of Ground Truth Used

The primary and definitive ground truth for all analytical and comparison studies was GC/MS (Gas Chromatography/Mass Spectrometry) results. GC/MS is a highly precise and accurate analytical method used to identify and quantify substances, making it a robust form of outcomes data or a highly regarded reference standard for determining the true concentration of drug metabolites in urine.

8. Sample Size for the Training Set

Not applicable. This device is a biochemical immunoassay, not an AI/machine learning model that requires a "training set" of data. The manufacturing process and reagent formulations are established through traditional laboratory development and quality control, not through data-driven model training.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/machine learning model, there is no ground truth to be established for such a set. The "ground truth" (i.e., known concentrations of analytes) used in the analytical performance studies (precision, cut-off, interference, specificity) was established by carefully prepared spiked samples with concentrations confirmed by GC/MS.

Summary

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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 (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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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)

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, INC3040 Post Oak Blvd Ste 1110Houston, TX 77056
3. Contact person:	Frank LuoPOLYMED THERAPEUTICS, INC3040 Post Oak Blvd Ste 1110Houston, TX 77056Telephone: 713-777-7088Fax: 713-777-7091Email: frank.luo@polymedt.com
4. Device Name:	FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup,Turn-Key Split Cup)FaStep Methamphetamine Tests (Strip, Panel Dip, QuickCup, 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

1. Predicate Devices: K052115 FIRST CHECK DIAGNOSTICS LLC
1. Intended Use:

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.

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

1. 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.
1. 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 flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative to indicate positive or negativeresult	Same
Specimen Type	Human Urine	Same
Cut-Off Values	50 ng/mL	Same
Intended Use	For over-the-counter and prescriptionuses.	Forover-the-counteruse.
Configurations	Strip, Panel Dip, Cup, and Turn-Key SplitCup	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 ofMethamphetamine in human urine.	Same (but thenumber of drugsdetected is different)
Calibrator	Methamphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative to indicate positive ornegative result	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
Intended Use	For over-the-counter and prescriptionuses.	For over-the-counteruse.
Configurations	Strip, Panel Dip, Cup, and Turn-KeySplit 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:

	-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.

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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.

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THC(11-nor-Δ9-THC-9-COOH,ng/mL)	ResultCut-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=1000ng/mL)	Result	%Cross-Reactivity
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	Positive at 10,000ng/mL	10%
Procaine (Novocaine)	Positive at 60,000ng/mL	1.7%
Trimethobenzamide	Positive at 20,000ng/mL	5%
L-Methamphetamine	Positive at 10000ng/mL	10%
Ranitidine (Zantac)	Positive at 50,000ng/mL	2%
(+/-)3,4-Methylenedioxymethamphetamine(MDMA)	Positive at 500ng/mL	200%
Chloroquine	Positive at 50,000ng/mL	2%
Ephedrine	Positive at 4,000ng/mL	25%
Fenfluramine	Positive at 20,000ng/mL	5%
p-Hydroxymethamphetamine	Positive at 10,000ng/mL	10%
D-Amphetamine	>100000	Not detected

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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.

1. 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 FormatViewer Results
Viewer A	83698	46	Positive
Viewer B	83698	46	Positive
Viewer C	83698	46	Positive

PanelDipformat		Negative	LowNegative byGC/MS(less than-50%)	Near Cut-offNegative byGC/MS(Between-50% andcut-off)	Near Cut-offPositive byGC/MS(Between thecut-off and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
ViewerB	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

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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 FormatViewer Results
Viewer A	83698	46	Positive
Viewer A	18881	53	Negative
Viewer B	83698	46	Positive

Turn-KeySplit Cupformat		Negative	LowNegative byGC/MS(less than-50%)	Near Cut-offNegative byGC/MS(Between-50% andcut-off)	Near Cut-offPositive byGC/MS(Between thecut-off and+50%)	HighPositive byGC/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

QuickCupformat		Negative	LowNegative byGC/MS(less than-50%)	Near Cut-offNegative byGC/MS(Between-50% andcut-off)	Near Cut-offPositive byGC/MS(Between thecut-off and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	0	15	25
	Negative	10	20	10	0	0
ViewerB	Positive	0	0	0	14	25
	Negative	10	20	10	1	0
ViewerC	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 FormatViewer Results
Viewer B	37144	54	Negative
Viewer C	83698	46	Positive

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MET
Stripformat		Negative	Low Negative byGC/MS(less than -50%)	Near Cut-off Negative byGC/MS(Between -50% andcut-off)	Near Cut-off Positive byGC/MS(Between thecut-off and +50%)	High Positiveby GC/MS(greater than +50%)
ViewerA	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
ViewerB	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
ViewerC	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

Discordant Results of MET Strip

Viewer	Sample Number	GC/MS Result	Strip FormatViewer 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

PanelDipformat		Negative	LowNegative byGC/MS(less than-50%)	Near Cut-offNegative byGC/MS(Between-50% andcut-off)	Near Cut-offPositive byGC/MS(Between thecut-off and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	14	25
ViewerA	Negative	10	20	9	1	0
ViewerB	Positive	0	0	1	14	25
ViewerB	Negative	10	20	9	1	0
ViewerC	Positive	0	0	0	15	25
ViewerC	Negative	10	20	10	0	0

Discordant Results of MET Panel Dip

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

{15}------------------------------------------------

Turn-KeySplitformat		Negative	LowNegative byGC/MS(less than-50%)	Near Cut-offNegative byGC/MS(Between-50% andcut-off)	Near Cut-offPositive byGC/MS(Between thecut-off and+50%)	HighPositive byGC/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 ofsamples	Concentration byGC/MS(ng/mL)		Lay person results		CorrectResults (%)
		11-nor-Δ9-THC-9-COOH	Methamphetamine	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 byGC/MS(ng/mL)		Lay person results		CorrectResults (%)
	samples	11-nor-△9-THC-9-COOH	Methamphetamine	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 ofsamples	Concentration byGC/MS(ng/mL)		Lay person results		CorrectResults (%)
		11-nor-Δ9-THC-9-COOH	Methamphetamine	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 ofsamples	Concentration byGC/MS(ng/mL)		Lay person results		CorrectResults (%)
		11-nor-Δ9-THC-9-COOH	Methamphetamine	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.

1. 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.

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).