First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

K151441 · W.H.P.M., Inc. · DJR · Jun 29, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151441
• Device Name: First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
• Applicant: W.H.P.M., Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Jun 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format. The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone in urine. The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.

Device Story

First Sign™ Drug of Abuse Tests are lateral flow immunochromatographic assays for qualitative detection of Methadone, Phencyclidine, and Oxycodone in human urine. Device formats include single-use Cups or Dip Cards. Principle of operation: competitive binding immunoassay; urine sample migrates via capillary action; drug in sample competes with immobilized drug-conjugate for limited antibody-coated particle binding sites. Absence of colored test line indicates drug concentration above cutoff; presence of line indicates concentration below cutoff. Control line confirms proper flow. Used in point-of-care or home settings by lay users or professionals. Results are visually interpreted by the user. Preliminary positive results require confirmation via Gas Chromatography/Mass Spectrometry (GC/MS). Device aids in identifying potential drug presence to inform clinical or personal decision-making.

Clinical Evidence

Bench testing only. Precision, interference, specificity, and method comparison studies performed. Method comparison against GC/MS using 80 clinical samples per drug/format showed high concordance. Lay-user study (n=280 per drug) confirmed ease of use and performance across diverse demographics (ages 21 to >50). No clinical studies required.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: Test device, desiccant, aluminum pouch, urine cup. Form factor: Cup or Dip Card. Operating temperature: 4-30°C. No electronic components; non-networked. Qualitative visual readout.

Indications for Use

Indicated for qualitative detection of Methadone, Phencyclidine, and Oxycodone in human urine for OTC and prescription use. Intended for preliminary screening; not for distinguishing between prescription use and abuse. Confirmatory testing required.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

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

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

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

June 29, 2015

W.H.P.M., INC. C/O JOE SHIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K151441

Trade/Device Name: First Sign® Drug Of Abuse Cup Test, First Sign® Drug Of Abuse Dip Card Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, LCM, DJG Dated: May 22, 2015 Received: May 29, 2015

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Katherine Serrano -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) k151441

Device Name First Sign® Drug of Abuse Cup Test First Sign® Drug of Abuse Dip Card Test

#### Indications for Use (Describe)

First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.

The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone in urine. The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.

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

| <div> <span>区 Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|--------------------------------------------------------------------------|
| <div> <span>区 Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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### 510(k) SUMMARY k151441

| 1. Date: | June 26, 2015 |
|--------------------|-----------------------------------------------------------------------------------------------------|
| 2. Submitter | W.H.P.M., Inc.<br>5358 Irwindale Ave.<br>Irwindale, CA 91706 |
| 3. Contact person: | John Wan<br>W.H.P.M., Inc.<br>5358 Irwindale Ave.<br>Irwindale, CA 91706<br>Telephone: [phone] |

Fax: [phone] Email: [e-mail]

- 4. Device Name: First Sign® Drug of Abuse Cup Test First Sign® Drug of Abuse Dip Card Test

| Product Code | Class | CFR # | Panel |
|--------------|--------------|----------------------------------------|------------|
| DJR | Class II | 21 CFR, 862.3620 Methadone Test System | Toxicology |
| LCM | Unclassified | Phencyclidine | Toxicology |
| DJG | Class II | 21 CFR, 862.3650 Opiate Test System | Toxicology |

- 5. Predicate Devices: K052115 First Check Multi Drug Cup 12
- 6. Intended Use

First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.

The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment

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should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

### 7. Device Description

First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Methadone, Phencyclidine, and Oxycodone in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample Each test device is sealed with a desiccant in an aluminum pouch. collection.

### 8. Substantial Equivalence Information

A summary comparison of features of the First Sign™ Drug of Abuse Test and the predicate device is provided in Table 1, Table 2 & Table 3.

| Item | Device | Predicate - K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Methadone in human urine. | Same |
| Calibrator | Methadone | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | For over-the-<br>counter use. |
| Configurations | Cup, Dip Card | Cup |

Table 1: Features Comparison of First Sign™ Methadone Test and the Predicate Device

### Table 2: Features Comparison of First Sign™ Phencyclidine Test and the Predicate Device

| Item | Device | Predicate - K052115 |
|--------------------------|-----------------------------------------------------------------------|---------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Phencyclidine in human urine. | Same |
| Calibrator | Phencyclidine | Same |
| Methodology | Competitive binding, lateral flow | Same |

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| Item | Device | Predicate - K052115 |
|------------------------|------------------------------------------------------------------------------------------------|------------------------------|
| | immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 25 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | For over-the-counter<br>use. |
| Configurations | Cup, Dip Card | Cup |

### Table 3: Features Comparison of First Sign™ Oxycodone Test and the Predicate Device

| Item | Device | Predicate - K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Oxycodone in human urine. | Same |
| Calibrator | Oxycodone | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 100 ng/mL | Same |
| Intended | For over-the-counter and prescription | For over-the-counter |
| Population | uses. | use. |
| Configurations | Cup, Dip Card | Cup |

### 9. Test Principle

First Sign™ Drug of Abuse Tests are rapid tests for the qualitative detection of Methadone, Phencyclidine, and Oxycodone in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff 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.

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### 10. Performance Characteristics

### 1. Analytical Performance

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

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 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+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### Methadone Dip Card Format

### Methadone Cup Format

| 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 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |

### Phencyclidine Dip Card Format

| Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 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+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### Phencyclidine Cup Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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| Drug | Result | | | | Cut-off | | | | |
|----------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 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- |
| Oxycodone Cup Format | | | | | | | | | |
| Drug | Result | | | | Cut-off | | | | |
| | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
| Lot 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+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Oxycodone Dip Card Format

### b. Linearity

Not applicable.

### c. Stability

The devices are stable at 4-30°C (39-86°F) 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 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 Methadone, Phencyclidine and Oxycodone. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off (ng/mL) |
|--------------------------------|---------------|-----------------|
| First Sign™ Methadone Test | Methadone | 300 |
| First Sign™ Phencyclidine Test | Phencyclidine | 25 |
| First Sign™ Oxycodone Test | Oxycodone | 100 |

### 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 at 25% below and 25% above cut-off levels. 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.

| Aminopyrine | Ethyl-p-aminobenzoate | Papaverine |
|------------------------|-----------------------------------------------------------|------------------------------------------|
| Amitryptyline | Fenoprofen | Penicillin-G |
| Amobarbital | Furosemide | Pentazocine hydrochloride |
| Amoxicillin | Gentisic acid | Pentobarbital |
| Ampicillin | Hemoglobin | Perphenazine |
| L-Ascorbic acid | Hydralazine | Phencyclidine |
| DL-Amphetamine sulfate | Hydrochlorothiazide | Phenelzine |
| Apomorphine | Hydrocodone | Phenobarbital |
| Aspartame | Hydrocortisone | Phentermine |
| Atropine | O-Hydroxyhippuric acid | L-Phenylephrine |
| Benzilic acid | p-Hydroxyamphetamine | β-Phenylethylamine |
| Benzoic acid | p-Hydroxymethamphetamine | Phenylpropanolamine |
| Benzoylecgonine | 3-Hydroxytyramine | Prednisolone |
| Benzphetamine | Ibuprofen | Prednisone |
| Bilirubin | Imipramine | Procaine |
| Caffeine | Iproniazid | Promazine |
| Cannabidiol | (±) - Isoproterenol | Promethazine |
| Cannabinol | Isoxsuprine | DL-Propranolol |
| Chloralhydrate | Ketamine | D-Propoxyphene |
| Chloramphenicol | Ketoprofen | D-Pseudoephedrine |
| Chlorothiazide | Labetalol | Quinacrine |
| Chlorpromazine | Levorphanol | Quinidine |
| Chlorquine | Loperamide | Quinine |
| Cholesterol | Maprotiline | Ranitidine |
| Clomipramine | Meperidine | Salicylic acid |
| Clonidine | Meprobamate | Secobarbital |
| Cocaethylene | Methamphetamine | Serotonin |
| Temazepam | Methoxyphenamine | Sulfamethazine |
| Cocaine hydrochloride | (±)-3,4-Methylenedioxy- amphetamine hydrochloride | Sulindac |
| Codeine | (±)-3,4-Methylenedioxy- methamphetamine hydrochloride | Tetracycline |
| Cortisone | Morphine-3-β-D glucuronide | Tetrahydrocortisone 3- (β-D-glucuronide) |
| (-) Cotinine | Morphine Sulfate | Tetrahydrozoline |
| Creatinine | Nalidixic acid | Thebaine |
| Deoxycorticosterone | Naloxone | Thiamine |
| Dextromethorphan | Naltrexone | Thioridazine |
| Diazepam | Naproxen | DL-Tyrosine |
| Diclofenac | Niacinamide | Tolbutamide |
| Diflunisal | Nifedipine | Triamterene |
| Digoxin | Norcodein | Trifluoperazine |
| Diphenhydramine | Norethindrone | Trimethoprim |
| Ecgonine hydrochloride | D-Norpropoxyphene | Trimipramine |
| Ecgonine methyl ester | Noscapine | Tryptamine |
| (-) -Ψ -Ephedrine | DL-Octopamine | DL-Tryptophan |
| [1R,2S] (-) Ephedrine | Oxalic acid | Tyramine |
| (L) - Epinephrine | Oxazepam | Uric acid |
| Erythromycin | Oxolinic acid | Verapamil |
| β-Estradiol | Oxycodone | Zomepirac |
| Estrone-3-sulfate | Oxymetazoline | |

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# Phencyclidine

| Acetaminophen | (+) Ephedrine | Oxycodone |
|----------------------|--------------------------|---------------------------|
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N-Acetylprocainamide | β-Estradiol | Papaverine |
| Acetylsalicylic acid | Estrone-3-sulfate | Penicillin-G |
| Aminopyrine | Ethyl-p-aminobenzoate | Pentazocine hydrochloride |
| Amitryptyline | Fenoprofen | Pentobarbital |
| Amobarbital | Furosemide | Perphenazine |
| Amoxicillin | Gentisic acid | Phenelzine |
| Ampicillin | Hemoglobin | Phenobarbital |
| Ascorbic acid | Hydralazine | Phentermine |
| D,L-Amphetamine | Hydrochlorothiazide | L-Phenylephrine |
| Apomorphine acid | Hydrocodone | β-Phenylethylamine |
| Aspartame | Hydrocortisone | Phenylpropanolamine |
| Atropine | O-Hydroxyhippuric | Prednisolone |
| Benzilic acid | p-Hydroxymethamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | Procaine |
| Benzoylecgonine | Ibuprofen | Promazine |
| Benzphetamine | Imipramine | Promethazine |
| Bilirubin | Iproniazid | D,L-Propanolol |
| Brompheniramine | (±) - Isoproterenol | D-Propoxyphene |
| Caffeine | Isoxsuprine | D-Pseudoephedrine |
| Cannabidiol | Ketamine | Quinidine |
| Cannabinol | Ketoprofen | Quinine |

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| Chloralhydrate | Labetalol | Ranitidine |
|------------------------|-------------------------------------------|-------------------------------------------|
| Chloramphenicol | Loperamide | Salicylic acid |
| Chlordiazepoxide | Maprotiline | Secobarbital |
| Chlorothiazide | Meperidine | Serotonin (5-<br>Hydroxytyramine) |
| (+) Chlorpheniramine | Meprobamate | Sulfamethazine |
| Chlorpromazine | Methadone | Sulindac |
| Chlorquine | Methoxyphenamine | Temazepam |
| Cholesterol | (+) 3,4-Methylenedioxy-<br>amphetamine | Tetracycline |
| Clomipramine | (+)3,4-Methylenedioxy-<br>methamphetamine | Tetrahydrocortisone3 (β-D<br>glucuronide) |
| Clonidine | Morphine-3-β-D glucuronide | Tetrahydrozoline |
| Cocaine hydrochloride | Morphine Sulfate | Thiamine |
| Codeine | Nalidixic acid | Thioridazine |
| Cortisone | Naloxone | D, L-Tyrosine |
| (-) Cotinine | Naltrexone | Tolbutamide |
| Creatinine | Naproxen | Triamterene |
| Deoxycorticosterone | Niacinamide | Trifluoperazine |
| Dextromethorphan | Nifedipine | Trimethoprim |
| Diazepam | Norcodein | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
| Ecgonine hydrochloride | Oxazepam | Zomepirac |
| Ecgonine methylester | Oxolinic acid | |

### Oxycodone

| Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine |
|----------------------|-----------------------|---------------------|
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Perphenazine |
| Amoxicillin | Erythromycin | Phenelzine |
| Ampicillin | Fenoprofen | L-Phenylephrine |
| Apomorphine | Furosemide | β-Phenylethylamine |
| Aspartame | Gentisic acid | Phenylpropanolamine |
| Atropine | Hemoglobin | Prednisone |
| Benzilic acid | Hydralazine | Loperamide |

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| Benzoic acid | Hydrochlorothiazide | Quinine |
|-----------------------|------------------------|----------------------------|
| Benzphetamine | Hydrocortisone | Quinidine |
| Bilirubin | O-Hydroxyhippuric acid | Ranitidine |
| Deoxycorticosterone | 3-Hydroxytyramine | Salicylic acid |
| Caffeine | Labetalol | Serotonin |
| Chloralhydrate | D, L-Isoproterenol | Sulfamethazine |
| Chloramphenicol | Meprobamate | Sulindac |
| Chlorothiazide | Methoxyphenamine | Tetracycline |
| D,L-Chlolrpheniramine | Nalidixic acid | Tetrahydrocortisone |
| Chlorpromazine | Naloxone | Morphine-3-β-D-glucuronide |
| Chlorquine | Naltrexone | Tetrahydrozoline |
| Cholesterol | Naproxen | Thiamine |
| Clonidine | Niacinamide | Thioridazine |
| L-Cotinine | Nifedipine | D,L-Tyrosine |
| Cortisone | Isoxsuprine | Tolbutamide |
| Creatinine | D,L-Propanolol | Triamterene |
| D-Pseudoephedrine | Ketoprofen | Trifluoperazine |
| Dextromethorphan | Norethindrone | Trimethoprim |
| Diclofenac | D-Norpropoxyphene | Tyramine |
| Diflunisal | Noscapine | D,L-Tryptophan |
| Digoxin | D,L-Octopamine | Urine acid |
| Diphenhydramine | Oxalic acid | Verapamil |
| L-Ephedrine | Oxolinic acid | Zomepirac |
| Ecgonine methylester | Oxymetazoline | |

### f. Specificity

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

| Methadone<br>Cut-off=300 ng/mL | Result | %<br>Cross-Reactivity |
|--------------------------------|-----------------------|-----------------------|
| Methadone | Positive at 300 ng/mL | 100% |
| LAAM | Positive at 10000 | 3% |
| Alpha Methadol | Negative at 100000 | Not Detected |

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| Doxylamine | Negative at 100000 | Not Detected |
|------------|--------------------|--------------|
| EMDP | Negative at 100000 | Not Detected |
| EDDP | Negative at 100000 | Not Detected |

| Phencyclidine<br>Cut-off=25 ng/mL) | Result | % Cross-<br>Reactivity |
|------------------------------------|-----------------------|------------------------|
| Phencyclidine | Positive at 25 ng/mL | 100% |
| 4-Hydroxyphencyclidine | Positive at 250 ng/mL | 10% |
| Phencyclidine Morpholine | Positive at 625 ng/mL | 4% |

| Oxycodone | Result | % Cross- |
|--------------------------|-------------------------|--------------|
| Cut-off=100 ng/mL | | Reactivity |
| Oxycodone | Positive at 100 ng/mL | 100% |
| Dihydrocodeine | Positive at 50000 ng/mL | 0.2% |
| Hydrocodone | Positive at 10000 ng/mL | 1% |
| Heroin | Negative at 100000 | Not Detected |
| Morphine-3-b-glucuronide | Negative at 100000 | Not Detected |
| Codeine | Negative at 100000 | Not Detected |
| Hydromorphone | Negative at 100000 | Not Detected |
| Morphine | Negative at 100000 | Not Detected |
| Acetylmorphine | Negative at 100000 | Not Detected |
| Buprenorphine | Negative at 100000 | Not Detected |
| Ethylmorphine | Negative at 100000 | Not Detected |

### 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 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 First Sign™ Drug Tests (Cup and Dip Card) for Methadone, Phencyclidine, and Oxycodone 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

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samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

| | Methadone | | | | | |
|--------------------|-----------|----------|-----------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| Dip Card<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than -<br>50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -<br>50% and<br>cut-off) | Near<br>Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
| Viewer A | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 10 | 20 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |

### Discordant Results of Methadone Dip Card

| Viewer | Sample Number | GC/MS Result | Dipcard Format<br>Viewer Results |
|----------|---------------|--------------|----------------------------------|
| Viewer A | 83001724 | 325 | Negative |
| Viewer A | 83001691 | 337 | Negative |
| Viewer B | 94639074 | 353 | Negative |
| Viewer B | 83001695 | 274 | Positive |
| Viewer C | 83002140 | 366 | Negative |
| Viewer C | 83002176 | 289 | Positive |

| Cup<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than -<br>50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -<br>50% and<br>cut-off) | Near<br>Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|---------------|----------|----------|-----------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| | | | | | | |
| Viewer A | Positive | 0 | 0 | 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 | 1 | 12 | 26 |
| | Negative | 10 | 10 | 19 | 2 | 0 |

Discordant Results of Methadone Cup

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| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | 83001695 | 274 | Positive |
| Viewer A | 83001691 | 337 | Negative |
| Viewer B | 83002176 | 289 | Positive |
| Viewer B | 83001707 | 331 | Negative |
| Viewer C | 83002164 | 242 | Positive |
| Viewer C | 83001724 | 325 | Negative |
| Viewer C | 94639074 | 353 | Negative |

# Phencyclidine

| Dip Card<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than -<br>50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -<br>50% and<br>cut-off) | Near<br>Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|--------------------|----------|----------|-----------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 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 | 12 | 26 |
| | Negative | 10 | 10 | 20 | 2 | 0 |

## Discordant Results of Phencyclidine DipCard

| Viewer | Sample Number | GC/MS Result | DipCard Format<br>Viewer Results |
|----------|---------------|--------------|----------------------------------|
| Viewer A | 83002015 | 20.6 | Positive |
| Viewer A | 83002085 | 27.9 | Negative |
| Viewer B | 83001968 | 21.4 | Positive |
| Viewer B | 83002029 | 28.3 | Negative |
| Viewer C | 83002085 | 27.9 | Negative |
| Viewer C | 83002062 | 28.7 | Negative |

| Cup<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than -<br>50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -<br>50% and<br>cut-off) | Near<br>Cutoff<br>Positive by<br>GC/MS | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|---------------|--|----------|-----------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------|--------------------------------------------------------|
|---------------|--|----------|-----------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------|--------------------------------------------------------|

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| | | | | | (Between<br>the cut-off<br>and +50%) | |
|----------|----------|----|----|----|--------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 2 | 13 | 26 |
| | Negative | 10 | 10 | 18 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 10 | 20 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |

### Discordant Results of Phencyclidine Cup

| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | 83002015 | 20.6 | Positive |
| Viewer A | 83001780 | 21.3 | Positive |
| Viewer A | 83002077 | 29.3 | Negative |
| Viewer B | 83002085 | 27.9 | Negative |
| Viewer B | 83002029 | 28.3 | Negative |
| Viewer C | 83001978 | 27.7 | Negative |

### Oxycodone

| DipCard<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than -<br>50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -<br>50% and cut-<br>off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|-------------------|----------|----------|-----------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| | Viewer A | Positive | 0 | 0 | 2 | 13 |
| Negative | | 10 | 10 | 18 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 10 | 20 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |

# Discordant Results of Oxycodone DipCard

| Viewer | Sample Number | GC/MS Result | DipCard Format<br>Viewer Results |
|----------|---------------|--------------|----------------------------------|
| Viewer A | 83002095 | 89 | Positive |
| Viewer A | 83002040 | 99 | Positive |

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

| Viewer A | 83001639 | 120 | Negative |
|----------|----------|-----|----------|
| Viewer B | 83001639 | 120 | Negative |
| Viewer B | 83002092 | 116 | Negative |
| Viewer C | 94639011 | 85 | Positive |
| Viewer C | 83002092 | 116 | Negative |

| Cup format | | Negative | Low Negative by GC/MS<br>(less than - 50%) | Near Cutoff Negative by GC/MS<br>(Between - 50% and cut-off) | Near Cutoff Positive by GC/MS<br>(Between the cut-off and +50%) | High Positive by GC/MS<br>(greater than +50%) |
|------------|----------|----------|--------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 12 | 26 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 13 | 26 |
| | Negative | 10 | 10 | 18 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 10 | 20 | 2 | 0 |

#### Discordant Results of Oxycodone Cup

| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | 83002095 | 89 | Positive |
| Viewer A | 83001639 | 120 | Negative |
| Viewer A | 83002092 | 116 | Negative |
| Viewer B | 83002096 | 85 | Positive |
| Viewer B | 83002040 | 99 | Positive |
| Viewer B | 83001638 | 117 | Negative |
| Viewer C | 83001639 | 120 | Negative |
| Viewer C | 83001638 | 117 | Negative |

#### Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons testing the Methadone devices, 280 lay persons testing the Phencyclidine devices and 280 lay persons testing the Oxycodone devices. A total of 136 females and 144 males tested the Methadone samples, 141 females and 139 males tested Phencyclidine samples, and 141 females and 139 males tested the Oxycodone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into

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

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.

| % of Cutoff | Number<br>of<br>samples | Methadone<br>Concentration by GC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|--------------|-------------------------|------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 74 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 148 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 222 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 378 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 452 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 530 | 20 | 0 | 100% |

### Comparison between GC/MS and Lay Person Results (Methadone DipCard)

## Comparison between GC/MS and Lay Person Results (Methadone Cup)

| % of Cutoff | Number of samples | Methadone Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|--------------|-------------------|------------------------------------------|--------------------|--------------------|---------------------------------------|
| -100% Cutoff | 20 | 0 | No. of Positive 0 | No. of Negative 20 | 100% |
| -75% Cutoff | 20 | 74 | No. of Positive 0 | No. of Negative 20 | 100% |
| -50% Cutoff | 20 | 148 | No. of Positive 0 | No. of Negative 20 | 100% |
| -25% Cutoff | 20 | 222 | No. of Positive 1 | No. of Negative 19 | 95% |
| +25% Cutoff | 20 | 378 | No. of Positive 19 | No. of Negative 1 | 95% |
| +50% Cutoff | 20 | 452 | No. of Positive 20 | No. of Negative 0 | 100% |
| +75% Cutoff | 20 | 530 | No. of Positive 20 | No. of Negative 0 | 100% |

### Comparison between GC/MS and Lay Person Results (Phencyclidine DipCard)

| | Number | Phencyclidine<br>Concentration by GC/MS<br>(ng/mL) | Lay person results | | The |
|--------------|---------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | of<br>samples | | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 12.2 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 19 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 31.3 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 37 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100% |

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

| % of Cutoff | Number of samples | Phencyclidine<br>Concentration by GC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|--------------|-------------------|----------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 12.2 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 19 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 31.3 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 37 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100% |

Comparison between GC/MS and Lay Person Results (Phencyclidine Cup)

### Comparison between GC/MS and Lay Person Results (Oxycodone DipCard)

| | Number<br>Oxycodone | | Lay person results | The | |
|-------------|---------------------|-----------------------------------|--------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| % of Cutoff | of<br>samples | Concentration by GC/MS<br>(ng/mL) | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br>(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 24 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 49 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 74 | 1 | 19 | તે તે જેવી 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 | 124 | 19 | 1 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી ત |
| +50% Cutoff | 20 | 148 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 173 | 20 | 0 | 100% |

### Comparison between GC/MS and Lay Person Results (Oxycodone Cup)

| % of Cutoff | Number<br>of<br>samples | Oxycodone<br>Concentration by GC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|--------------|-------------------------|------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 24 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 49 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 74 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 124 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 148 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 173 | 20 | 0 | 100% |

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

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.

- 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 First Sign™ Drug of Abuse Dip Card Test and First Sign™ Drug of Abuse Cup Test are substantially equivalent to the predicate.