First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.

First Sign® Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.

First Sign Multi-Drug Cup Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, and 500 ng/mL, respectively. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.

First Sign® Multi-Drug Dip Card Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, and 500 ng/mL, respectively. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.

Device Description

First Sign Multi-Drug Cup Test, First Sign Multi-Drug Dip Card Test, First Sign Drug of Abuse Cup Test Marijuana, and First Sign Drug of Abuse Dip Card Marijuana are lateral flow, immunochromatographic assays. The First Sign Multi-Drug Cup Test and the First Sign Multi-Drug Dip Card Test are for the qualitative detection of Amphetamine, Cocaine, and Methamphetamine in human urine. First Sign Drug of Abuse Cup Test Marijuana, and First Sign Drug of Abuse Dip Card Marijuana are for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The provided document describes the analytical and user performance of various First Sign® drug tests (Multi-Drug Cup Test, Multi-Drug Dip Card Test, Drug of Abuse Cup Test Marijuana, and Drug of Abuse Dip Card Test Marijuana). These are qualitative lateral flow immunoassays intended for the detection of Amphetamine, Cocaine, Methamphetamine, and Marijuana in human urine. The document does not describe an AI medical device, but rather an in-vitro diagnostic device. Therefore, many of the requested points related to AI/MRMC studies are not applicable.

Here's an attempt to extract relevant information and apply it to the closest possible concepts for an AI device's acceptance criteria and study, based on the provided content:

Device Description:
The devices are lateral flow, immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, and Methamphetamine (Multi-Drug tests) and Marijuana (Drug of Abuse tests) in human urine. They are single-use in vitro diagnostic devices available in Dip Card or Cup formats.

Acceptance Criteria and Device Performance (Interpreted for a diagnostic device):

The acceptance criteria for these devices would typically be established based on their ability to correctly identify positive and negative samples around the defined cut-off concentrations for each drug. The "Precision" and "Lay-user study" data provide the closest insight into this, demonstrating the device's ability to consistently provide correct results across various concentrations relative to the cut-off.

Since this is a qualitative test (positive/negative), the performance is measured by the percentage of correct results at different concentrations, especially near the cut-off.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Performance Metric (Inferred Acceptance Criteria)	Device Performance (Reported)
Precision (All tests, across 3 lots and 3 operators)
-100% Cutoff (Negative Prediction)	100% Negative (e.g., AMP Cup Lot 1: 50-/0+)
-75% Cutoff (Negative Prediction)	100% Negative (e.g., AMP Cup Lot 1: 50-/0+)
-50% Cutoff (Negative Prediction)	100% Negative (e.g., AMP Cup Lot 1: 50-/0+)
-25% Cutoff (Negative Prediction)	100% Negative (e.g., AMP Cup Lot 1: 50-/0+)
Cut-off (Mixed Positive/Negative)	Varies (e.g., AMP Cup Lot 1: 3-/47+ (94% Positive))
+25% Cutoff (Positive Prediction)	100% Positive (e.g., AMP Cup Lot 1: 50+/0-)
+50% Cutoff (Positive Prediction)	100% Positive (e.g., AMP Cup Lot 1: 50+/0-)
+75% Cutoff (Positive Prediction)	100% Positive (e.g., AMP Cup Lot 1: 50+/0-)
+100% Cutoff (Positive Prediction)	100% Positive (e.g., AMP Cup Lot 1: 50+/0-)
Lay-User Study (ACCURACY for over-the-counter and prescription use)
-100% to -25% Cutoff (Negative Prediction)	Generally 100% correct negative results. Some exceptions (e.g., MET DipCard -25% Cutoff: 95% correct, MET Cup -25% Cutoff: 95% correct).
+25% to +100% Cutoff (Positive Prediction)	Generally 100% correct positive results. Some exceptions (e.g., COC DipCard +25% Cutoff: 90% correct, AMP Cup +25% Cutoff: 95% correct, MET Cup +25% Cutoff: 95% correct).
Effect of Urine Specific Gravity and pH	All positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off.

Breakdown of Requested Information (Applying to this non-AI device where possible):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred): For a qualitative drug test, the acceptance criteria are generally that samples below the cut-off should test negative, and samples at or above the cut-off should test positive, with high accuracy at concentrations away from the cut-off, and acceptable accuracy around the cut-off. Specifically, the data shows an expectation of 100% correct results for samples significantly above or below the cut-off (e.g., +/- 50% to +/- 100%) and a tolerance for some misclassification directly at or very close to the cut-off.
- Reported Device Performance: See the table above and the detailed "Precision" and "Lay-user study" results within the document (pages 8-20). For instance, in the precision study, samples at the cut-off typically showed a mix of positive and negative results (e.g., 3-/47+ or 2-/48+ out of 50 tests), indicating the expected performance around the threshold. In the lay-user study, performance at +25% cutoff for COC DipCard was 90% correct, and for AMP Cup and MET Cup at +25% cutoff, it was 95% correct, with near-perfect accuracy further from the cutoff.
Sample sizes used for the test set and the data provenance:
- Precision Study:
  - Sample Size: For each drug and each format (e.g., AMP Cup, COC Dip Card), there were 9 concentration levels tested (from -100% to +100% of cut-off). For each concentration, there were 2 runs per day for 25 days, totalling 50 tests per concentration per lot. Since three lots were tested, this amounts to 150 tests per concentration level per drug per format.
  - Data Provenance: Samples were "prepared by spiking drug in negative urine samples." This suggests laboratory-controlled, prospectively prepared samples. The origin of the negative urine samples (e.g., country) is not specified.
- Method Comparison Studies (Clinical Samples):
  - Sample Size: "80 (40 negative and 40 positive) unaltered clinical samples for each target drug" were used. This means 80 clinical samples per drug per format. (e.g., 80 for AMP Dip Card, 80 for AMP Cup, etc.).
  - Data Provenance: "clinical samples." This implies retrospective (or collected for study), human biological samples. Country of origin is not specified but implied to be in the testing region (likely USA given the FDA submission).
- Lay-user Study:
  - Sample Size: "320 lay persons testing the devices." Urine samples were prepared at 8 concentration levels.
  - Data Provenance: "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." This indicates laboratory-prepared, prospective samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Establishment:
  - For the Precision Study and Lay-user study, the ground truth was established by the precise concentrations of spiked drugs confirmed by GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is considered the "preferred confirmatory method" and the gold standard for drug detection and quantification in urine.
  - For the Method Comparison Studies, the ground truth for clinical samples was established by GC/MS results.
- Experts and Qualifications: The document does not mention human experts establishing the ground truth for the test sets. The ground truth relies on the analytical accuracy of GC/MS. The "three different operators" (or "laboratory assistants") mentioned in the Precision and Method Comparison studies were performing the device tests, not establishing the ground truth. No specific qualifications for these operators are provided beyond their role.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the analytical and method comparison studies, the results of the device were compared directly to the GC/MS ground truth. There was no human adjudication process described for discrepancies in the test results themselves, as the GC/MS is considered definitive. The "discordant results" tables show instances where the viewer disagreed with GC/MS, but there's no mention of a re-adjudication of the GC/MS reference result itself.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This document describes an in-vitro diagnostic device (drug test kit), not an AI medical device. Therefore, no MRMC study involving AI assistance for human readers was conducted or is applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI algorithm. The device itself is a standalone test kit that provides a visual qualitative result (lines appearing on the dip card/cup). The "lay-user study" demonstrates the performance of the device when interpreted by its intended users (without "human-in-the-loop performance" in the AI sense, but rather human-as-user interpretation). The "Method Comparison Studies" also represent standalone performance, where "viewers" (operators) interpret the device results against a gold standard.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used for all performance studies was Gas Chromatography/Mass Spectrometry (GC/MS) results, which is an analytical gold standard for quantifying drug concentrations in urine.
The sample size for the training set:
- N/A. This is not a machine learning/AI device, so there is no "training set" in the computational sense. The device's performance is based on its chemical and biological components, not trained data.
How the ground truth for the training set was established:
- N/A. As there is no training set for an AI model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The overall design is clean and professional, reflecting the organization's role in public health and safety.

February 5, 2018

W.H.P.M., Inc. % Joe Shia Manager LSI Consulting 504E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K171695

Trade/Device Name: First Sign Multi-Drug Dip Card Test First Sign Multi-Drug Cup Test First Sign Drug of Abuse Dip Card Test Marijuana First Sign Drug of Abuse Cup Test Marijuana Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, LDJ, NFY, NGG Dated: December 26, 2017 Received: December 28, 2017

Dear 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. Iisting 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171695

Device Name

First Sign® Drug of Abuse Cup Test Marijuana First Sign® Drug of Abuse Dip Card Test Marijuana

Indications for Use (Describe)

First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL.

The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The test is intended for prescription use.

First Sign® Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL.

For in vitro diagnostic use only. The test is intended for prescription use.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known) K171695

Device Name First Sign® Multi-Drug Cup Test First Sign® Multi-Drug Dip Card Test

Indications for Use (Describe)

For in vitro diagnostic use only. The tests are intended for over-the-counter use.

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

☐ Prescription Use (Part 21 CFR 801 Subpart D)	☒ Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------	-------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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1. Date: February 2, 2018
1. Submitter W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706
1. Contact person: John Wan W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706 Telephone: 626-443-8480 Fax: 626-443-8065 Email: johnwan@whpm.com
First Sign® Multi-Drug Cup Test 4. Device Name: First Sign® Multi-Drug Dip Card Test First Sign® Drug of Abuse Cup Test Marijuana First Sign® Drug of Abuse Dip Card Test Marijuana

Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, Amphetamine TestSystem	Toxicology(91)
LDJCannabinoids	II	21 CFR § 862.3870, Cannabinoids TestSystem	Toxicology(91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine and CocaineMetabolites Test System	Toxicology(91)
NGGMethamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology(91)

1. Predicate Devices: K122809, Advin Multi-Drug Screen Test
1. Intended Use

First Sign® Multi-Drug Cup Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500ng/mL, 150 ng/mL, and 500 ng/mL, respectively.

The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred

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confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.

The tests provide only preliminary test results. A more specific alternative method must to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.

First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL.

First Sign® Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ne/mL.

7. Device Description

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1. Substantial Equivalence Information
  A summary comparison of features of the candidate device and the predicate device is provided in following tables

	Candidate Device	Predicate Device (K122809)
Item	First Sign® Multi-Drug Cup Test
Indication(s)for Use	For the qualitative determination ofAmphetamine, Cocaine, andMethamphetamine in human urine.	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human urine	Same
Cut-Off Values	Amphetamine 500 ng/mLCocaine 150 ng/mlMethamphetamine 500 ng/ml	Amphetamine 500 ng/mLCocaine 150 ng/mlMethamphetamine 500 ng/ml
IntendedPopulation	For over-the-counter use.	Same
Configurations	Cup	Same

Table 1: Features Comparison of First Sign® Multi-Drug Cup Test and the Predicate Device

Table 2: Features Comparison of First Sign® Multi-Drug Dip Card Test and the Predicate Device

Item	Candidate DeviceFirst Sign® Multi-Drug Dip Card Test	Predicate Device (K122809)
Indication(s)for Use	For the qualitative determination ofAmphetamine, Cocaine, andMethamphetamine in human urine.	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human urine	Same
Cut-Off Values	Amphetamine 500 ng/mLCocaine 150 ng/mlMethamphetamine 500 ng/ml	Amphetamine 500 ng/mLCocaine 150 ng/mlMethamphetamine 500 ng/ml
IntendedPopulation	For over-the-counter use.	Same
Configurations	Dip Card	Same

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Table 3: Features Comparison of First Sign® Drug of Abuse Cup Test Marijuana and the Predicate Device

Item	Candidate DeviceFirst Sign® Drug of Abuse Cup TestMarijuana	Predicate Device (K122809)
Indication(s)for Use	For the qualitative determination ofMarijuana in human urine.	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human urine	Same
Cut-Off Values	Marijuana 20 ng/ml	Marijuana 50 ng/ml
IntendedPopulation	For prescription use.	Same
Configurations	Cup	Same

Table 4: Features Comparison of First Sign® Drug of Abuse Dip Card Test Marijuana and the
Predicate Device
Item	Candidate DeviceFirst Sign® Drug of Abuse Dip Card TestMarijuana	Predicate Device (K122809)
Indication(s) for Use	For the qualitative determination ofMarijuana in human urine.	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human urine	Same
Cut-Off Values	Marijuana 20 ng/ml	Marijuana 50 ng/ml
Intended Population	For prescription use.	Same
Configurations	Dip Card	Same

9. Test Principle

Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug

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conjugate and a visible colored line will show up in the test line region. The will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample.

10. Performance Characteristics

Analytical Performance

a. Precision
Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind-labeled and randomized by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:

Result	-100%	-75%	-50%	-25%	Cut-off	+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
AMP Cup Format
Result	-100%	-75%	-50%	-25%	Cut-off	+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off
Lot 4	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 5	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 6	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
COC Dip Card Format
Result	-100%	-75%	-50%	-25%	Cut-off	+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
COC Cup Format
Result	-100%	-75%	-50%	-25%	Cut-off	+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off
Lot 4	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 5	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 6	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-

AMP Dip Card Format

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Result	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Drug	Cut-off		Cut-off Cut-off	Cut-off	Cut-off		Cut-off Cut-off	Cut-off	Cut-off
Lot 1	50-10+	50-10+	50-10+	50-10+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-10+	50-10+	50-10+	4-/46+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-10+	50-10+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
MET Cup Format
Result	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off		Cut-off Cut-off Cut-off		Cut-off
Lot 4	50-/0+	50-10+	50-10+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 5	50-/0+	50-/0+	50-10+	50-10+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 6	50-/0+	50-10+	50-10+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
THC Dip Card Format
Result	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off Cut-off Cut-off			Cut-off		Cut-off Cut-off Cut-off		Cut-off
Lot 1	50-/0+	50-10+	50-10+	50-10+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-10+	50-10+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-10+	50-10+	50-10+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
THC Cup Format
Result	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Drug	Cut-off	Cut-off	Cut-off	Cut-off	Cut-off		Cut-off Cut-off	Cut-off	Cut-off
Lot 4	50-/0+	50-10+	50-10+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 5	50-/0+	50-10+	50-10+	50-10+	4-/46+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 6	50-/0+	50-10+	50-10+	50-10+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-

MET Dip Card Format

b. Linearity

Not applicable.

c. Stability

The devices are stable at 860F (4-30°C) for 24 months based on the accelerated stability study at 50°C. Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% cut-off; cutoff; +25% cut-off; +50% cut-off of each target drug 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 the four target drugs. The following cut-off values for the test devices have been verified.

{10}------------------------------------------------

Target Drug	Calibrator	Cut-off (ng/mL)
Amphetamine	d-Amphetamine	500
Cocaine	Benzoylecgonine	150
Methamphetamine	d-Methamphetamine	500
Marijuana	Marijuana	20

e. Interference
Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and to urine containing target drugs at 25% below and 25% above cut-off levels. These urine samples were tested using three lots of each device for all formats.

Compounds that showed no interference at a concentration of 100µg/mL (except of specified) are summarized in the following table. There were no differences observed for different formats.

Acetaminophen (4-Acetamidophenol)	Erythromycin	Oxalic acid
Acetophenetidin	β-Estradiol	Oxazepam
N-Acetylprocainamide	Fenoprofen	Oxolinic acid
Acetylsalicylic acid	Furosemide	Oxymetazoline
Albumin (1mg/mL)	Gentisic acid	Papaverine
Aminopyrine	Hemoglobin (1mg/mL)	Penicillin-G
D-Amphetamine	Hydralazine	Pentobarbital
Amoxicillin	Hydrochlorothiazide	Perphenazine
Ampicillin	Hydrocodone	Phenelzine
Apomorphine	Hydrocortisone	Phencyclidine
L-Ascorbic acid	O-Hydroxyhippuric acid	Prednisone
Aspartame	3-Hydroxytyramine	Procaine
Atropine	Ibuprofen	DL-Propranolol
Benzilic acid	D,L-Isoproterenol	D-Propoxyphene
Benzoic acid	Isoxsuprine	D-Pseudoephedrine
Benzoylecgonine	Ketamine	Quinine
Bilirubin	Ketoprofen	Ranitidine
Cannabidiol	Labetalol	Salicylic acid
Chloralhydrate	Loperamide	Secobarbital
Chloramphenicol	Maprotiline	Serotonin (5- Hydroxytyramine)
Chlorothiazide	Meperidine	Sulfamethazine
Chlorpromazine	Meprobamate	Sulindac
Chloroquine	Methadone	Tetrahydrocortisone3-(β-D-glucuronide)
Cholesterol	Methamphetamine	Tetrahydrozoline

{11}------------------------------------------------

Clonidine	Methoxyphenamine	Thiamine
Codeine	Morphinie-3-β-d-glucuronide	Thioridazine
Cortisone	Nalidixic acid	Triamterene
(-) Cotinine	Naloxone	DL-Tyrosine
Creatinine	Naltrexone	Trifluoperazine
Deoxycorticosterone	Naproxen	Trimethoprim
Dextromethorphan	Niacinamide	D L-Tryptophan
Diclofenac	Nifedipine	Tyramine
Diflunisal	Norcodeine	Uric acid
Digoxin	Norethindrone	Verapamil
Diphenhydramine	D-Norpropoxyphene	Zomepirac
Ecgonine methyl ester	Noscapine
EMDP	D,L-Octopamine

f. Specificity
To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three lots of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.

Amphetamine	Result	%Cross-Reactivity
(D-Amphetamine, Cutoff = 500 ng/mL)	Positive at 500 ng/mL	100%
L-Amphetamine	Positive at 60000 ng/mL	0.8%
D,L - Amphetamine	Positive at 1000 ng/mL	50%
Methylenedioxyamphetamine (MDA)	Positive at 600 ng/mL	83%
R-(-)-Apomorphine	Positive at 13000 ng/mL	4%
β-Phenylethylamine	Positive at 8000 ng/mL	6%
Tyramine	Positive at 5000 ng/mL	10%
Tryptamine	Positive at 100000 ng/mL	0.5%
Hydroxyamphetamine	Positive at 600 ng/mL	83%
D-Pseudoephedrine	Negative at ≥ 105 ng/mL	<0.5%
D-Methamphetamine	Negative at ≥ 105 ng/mL	<0.5%
L-Methamphetamine	Negative at ≥ 105 ng/mL	<0.5%
(±)-Methamphetamine	Negative at ≥ 105 ng/mL	<0.5%
Ephedrine	Negative at ≥ 105 ng/mL	<0.5%
Methylenedioxyethylamphetamine (MDE)	Negative at ≥ 105 ng/mL	<0.5%
3,4-Methylenedioxymethamphetamine (MDMA)	Negative at ≥ 105 ng/mL	<0.5%
Phentermine	Negative at ≥ 105 ng/mL	<0.5%

Cocaine	Result	%Cross-Reactivity
(Benzoylecgonine, Cutoff = 150 ng/mL)	Positive at 150 ng/mL	100%

{12}------------------------------------------------

Cocaine HCL	Positive at 3000 ng/mL	5%
Norcocaine	Negative at ≥ 105 ng/mL	<0.15%
Cocaethylene	Negative at ≥ 105 ng/mL	<0.15%
Ecgonine	Negative at ≥ 105 ng/mL	<0.15%

Methamphetamine	Result	%Cross-Reactivity
(D-Methamphetamine, Cutoff = 500 ng/mL)	Positive at 500 ng/mL	100%
(±)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	Positive at 20000 ng/mL	2.5%
(±)-Methamphetamine	Positive at 1000 ng/mL	50%
P-Hydroxymethamphetamine	Positive at 16000 ng/mL	3%
(±)3,4-MDMA	Positive at 2000 ng/mL	25%
L-Methamphetamine	Positive at 5000 ng/mL	10%
Fenfluramine	Positive at 40000 ng/mL	1.3%
L-Amphetamine	Positive at 60000 ng/mL	0.8%
D-Pseudoephedrine	Negative at ≥ 105 ng/mL	<0.5%
Trimethobenzamide	Negative at ≥ 105 ng/mL	<0.5%
Chloroquine	Negative at ≥ 105 ng/mL	<0.5%
Ephedrine	Negative at ≥ 105 ng/mL	<0.5%
Procaine (Novocaine)	Negative at ≥ 105 ng/mL	<0.5%
Ranitidine (Zantac)	Negative at ≥ 105 ng/mL	<0.5%
D-Amphetamine	Negative at ≥ 105 ng/mL	<0.5%
Oxazepam	Negative at ≥ 105 ng/mL	<0.5%
Morphine	Negative at ≥ 105 ng/mL	<0.5%
(+/-) 3,4-MDA	Negative at ≥ 105 ng/mL	<0.5%

Marijuana	Result	%Cross-Reactivity
(11-Nor-Δ9- Tetrahydrocannabinol-9-COOH,Cutoff = 20 ng/mL)	Positive at 20 ng/mL	100%
11-Hydroxy-Δ9-Tetrahydrocannabinol	Positive at 8000 ng/mL	0.25%
Δ8-Tetrahydrocannabinol	Positive at 5000 ng/mL	0.4%
Δ9-Tetrahydrocannabinol	Positive at 3000 ng/mL	0.7%
11-Nor-Δ8- Tetrahydrocannabinol-9-COOH	Positive at 30 ng/mL	67%
11-Nor-Δ9-THC-carboxy glucuronide	Positive at 5000 ng/mL	0.4%
Cannabinol	Negative at ≥ 105 ng/mL	<0.02%
Cannabidiol	Negative at ≥ 105 ng/mL	<0.02%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples with a range of 1.000 to 1.035 specific gravity or urine samples with a range of pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three lots of each

{13}------------------------------------------------

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.

h. Comparison Studies
The method comparison studies were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each target drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

AMPDip Cardformat		Negative	Low Negativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer B	Positive	0	0	0	13	26
	Negative	10	10	20	1	0
Viewer C	Positive	0	0	1	13	26
	Negative	10	10	19	1	0

Viewer	Sample Number	GC/MS (ng/mL)Result	Dipcard FormatViewer Results
Viewer A	94912062	496	Positive
Viewer C	94911565	474	Positive
Viewer A	94912145	546	Negative
Viewer B	94912089	528	Negative
Viewer C	94912145	546	Negative

AMPCupformat		Negative	LowNegativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	0	13	26
	Negative	10	10	20	1	0
Viewer B	Positive	0	0	1	13	26

{14}------------------------------------------------

	Negative	10	10	19	1	0
Viewer C	Positive	0	0	1	14	26
	Negative	10	10	19	0	0

Discordant Results
Viewer	Sample Number	GC/MS (ng/mL)Result	Cup FormatViewer Results
Viewer B	94911565	474	Positive
Viewer C	94912058	481	Positive
Viewer A	94912089	528	Negative
Viewer B	94912145	546	Negative

COCDip Cardformat		Negative	Low Negativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	0	13	26
	Negative	10	10	20	1	0
Viewer B	Positive	0	0	0	13	26
	Negative	10	10	20	1	0
Viewer C	Positive	0	0	1	13	26
	Negative	10	10	19	1	0

Viewer	Sample Number	GC/MS (ng/mL)Result	Dipcard FormatViewer Results
Viewer C	94911516	149	Positive
Viewer A	94912178	151	Negative
Viewer B	94911045	168	Negative
Viewer C	94911339	160	Negative

COCCupformat		Negative	LowNegativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	1	14	26

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

	Negative	10	10	19	0	0
Viewer B	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer C	Positive	0	0	0	13	26
	Negative	10	10	20	1	0

Viewer	Sample Number	GC/MS (ng/mL)Result	Cup FormatViewer Results
Viewer A	94911516	149	Positive
Viewer B	94911033	139	Positive
Viewer B	94912178	151	Negative
Viewer C	94911339	160	Negative

METDip Cardformat		Negative	LowNegativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer B	Positive	0	0	0	13	26
	Negative	10	10	20	1	0
Viewer C	Positive	0	0	1	13	26
	Negative	10	10	19	1	0

Viewer	Sample Number	GC/MS (ng/mL)Result	Dipcard FormatViewer Results
Viewer A	94911195	495	Positive
Viewer C	94912082	448	Positive
Viewer A	94912048	514	Negative
Viewer B	94912073	533	Negative
Viewer C	94912048	514	Negative

METCupformat	Negative	Low Negativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS	Near CutoffPositive byGC/MS	High Positive byGC/MS(greater than +50%)
----------------------	----------	----------------------------------------------	-------------------------------------	-------------------------------------	--------------------------------------------------

{16}------------------------------------------------

				(Between -50% andcut-off)	(Betweenthe cut-offand +50%)
Viewer A	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer B	Positive	0	0	0	13	26
	Negative	10	10	20	1	0
Viewer C	Positive	0	0	1	13	26
	Negative	10	10	19	1	0

Viewer	Sample Number	GC/MS (ng/mL)Result	Cup FormatViewer Results
Viewer A	94912072	445	Positive
Viewer C	94912082	448	Positive
Viewer A	94912073	533	Negative
Viewer B	94912073	533	Negative
Viewer C	94912048	514	Negative

THCDip Cardformat		Negative	LowNegativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer B	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer C	Positive	0	0	0	13	26
	Negative	10	10	20	1	0

Viewer	Sample Number	GC/MS (ng/mL) Result	Dipcard Format Viewer Results
Viewer A	94912036	18	Positive
Viewer B	94911685	17.8	Positive
Viewer A	94911819	22.6	Negative
Viewer B	94912007	21.3	Negative

{17}------------------------------------------------

Viewer	Sample Number	GC/MS (ng/mL)Result	Dipcard FormatViewer Results
Viewer C	94911788	22	Negative

THCCupformat		Negative	LowNegativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	1	13	26
	Negative	10	10	19	1	0
Viewer B	Positive	0	0	1	14	26
	Negative	10	10	19	0	0
Viewer C	Positive	0	0	1	13	26
	Negative	10	10	19	1	0

Viewer	Sample Number	GC/MS (ng/mL)Result	Cup FormatViewer Results
Viewer A	94911670	19.7	Positive
Viewer B	94911686	17	Positive
Viewer C	94911685	17.8	Positive
Viewer A	94911788	22	Negative
Viewer C	94911819	22.6	Negative

i. Lay-user study

A lay user study was performed at three intended user sites with 320 lay persons testing the devices. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; +/-100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

Comparison between GC/MS and Lay Person Results

AMP DipCard

% of Cutoff	Numberofsamples	Concentration by GC/MS(ng/mL)	Lay person results		The percentageof correctresults(%)
	No. ofPositive		No. ofNegative
-100% Cutoff	20	0	0	20	100%

{18}------------------------------------------------

-75% Cutoff	20	130	0	20	100%
-50% Cutoff	20	245	0	20	100%
-25% Cutoff	20	374		19	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો
+25% Cutoff	20	649	20	0	100%
+50% Cutoff	20	768	20	0	100%
+75% Cutoff	20	857	20	0	100%
+100% Cutoff	20	1019	20	0	100%

COC DipCard

C DipCard
% of Cutoff	Numberofsamples	Concentration by GC/MS(ng/mL)	Lay person results		The percentage
			No. ofPositive	No. ofNegative	of correctresults(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	37	0	20	100%
-50% Cutoff	20	73	0	20	100%
-25% Cutoff	20	109	0	20	100%
+25% Cutoff	20	178	18	2	90%
+50% Cutoff	20	223	20	0	100%
+75% Cutoff	20	258	20	0	100%
+100% Cutoff	20	301	20	0	100%

MET DipCard

% of Cutoff	Number of samples	Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	129	0	20	100%
-50% Cutoff	20	259	0	20	100%
-25% Cutoff	20	393	1	19	95%
+25% Cutoff	20	669	20	0	100%
+50% Cutoff	20	730	20	0	100%
+75% Cutoff	20	930	20	0	100%
+100% Cutoff	20	1028	20	0	100%

AMP Cup

% of Cutoff	Number of samples	Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results
			No. of	No. of

{19}------------------------------------------------

			Positive	Negative	(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	130	0	20	100%
-50% Cutoff	20	245	0	20	100%
-25% Cutoff	20	374	0	20	100%
+25% Cutoff	20	649	19	1	95%
+50% Cutoff	20	768	20	0	100%
+75% Cutoff	20	857	20	0	100%
+100% Cutoff	20	1019	20	0	100%

COC Cup

% of Cutoff	Number of samples	Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	37	0	20	100%
-50% Cutoff	20	73	0	20	100%
-25% Cutoff	20	109	1	19	95%
+25% Cutoff	20	178	20	0	100%
+50% Cutoff	20	223	20	0	100%
+75% Cutoff	20	258	20	0	100%
+100% Cutoff	20	301	20	0	100%

MET Cup

% of Cutoff	Numberofsamples	Concentration by GC/MS(ng/mL)	Lay person results		The percentage
			No. ofPositive	No. ofNegative	of correctresults(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	129	0	20	100%
-50% Cutoff	20	259	0	20	100%
-25% Cutoff	20	393	1	19	તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય
+25% Cutoff	20	ર્ભિતે	19	1	તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય
+50% Cutoff	20	730	20	0	100%
+75% Cutoff	20	930	20	0	100%
+100% Cutoff	20	1028	20	0	100%

{20}------------------------------------------------

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

j. 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 First Sign® Multi-Drug Cup Test, First Sign® Multi-Drug Dip Card Test, First Sign® Drug of Abuse Cup Test Marijuana and First Sign® Drug of Abuse Dip Card Test Marijuana are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).