Predicate Devices

K052115 First Check Multi Drug Cup 12

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is described as an immunochromatographic assay (lateral flow system) for qualitative detection, which is a traditional biochemical method and does not involve AI/ML. The summary does not mention any computational analysis or algorithms beyond the visual interpretation of the test lines.

Therapeutic

No
Explanation: The device is an in vitro diagnostic test for the qualitative determination of certain drugs in human urine. It is not designed to treat or prevent a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." and the "Device Description" section describes the products as "single-use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device is described as immunochromatographic assays in Dip Card and Cup formats, which are physical, in vitro diagnostic devices. The description includes hardware components like the test device, package insert, and urine cup.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
Device Description: The "Device Description" section also states: "The products are single-use in vitro diagnostic devices..."
Nature of the Test: The device performs an "immunochromatographic assay for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine." This is a test performed on a biological sample (urine) outside of the body to provide information about a person's health status (presence of certain drugs). This aligns with the definition of an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

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

DJR, LCM, DJG

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 collection. Each test device is sealed with a desiccant in an aluminum pouch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

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

Not Found

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

The method comparison studies for the First Sign™ Drug Tests (Cup and Dip Card) for Methadone, Phencyclidine, and Oxycodone were performed in-house. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results.

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 individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.

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

Analytical Performance:
- 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. 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.
- Linearity: Not applicable.
- Stability: The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C.
- 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.
- 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. No interference was observed for listed compounds at 100µg/mL.
- 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 lowest detectable concentration was used to calculate the cross-reactivity.
- 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. No differences were observed for different formats.
Comparison Studies:
- Method Comparison (Professional User): Performed in-house with three different laboratory assistants for each format (Cup and Dip Card). 80 unaltered clinical samples (40 negative and 40 positive) for each drug were tested. Samples were blind labeled and compared to GC/MS results. Tables of discordant results are provided for Methadone, Phencyclidine, and Oxycodone for both Dip Card and Cup formats.
- Lay-user study: Performed at three sites with 280 lay persons for each drug (Methadone, Phencyclidine, Oxycodone).
  - Sample Size: 20 samples per concentration level for Methadone, Phencyclidine, and Oxycodone for both DipCard and Cup formats.
  - Key Results: The percentage of correct results for Methadone, Phencyclidine, and Oxycodone were generally high (100% or 95%) at most concentrations for both DipCard and Cup formats, with some exceptions at -25% cutoff and +25% cutoff where results were 90% or 95%.
  - Ease of Use: All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid reading analysis showed a reading Grade Level of 7 for the package insert.
Clinical Studies: Not applicable.

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

Key metrics are presented in tables as "No. of Positive" and "No. of Negative" results relative to the "Number of samples" for different concentration levels compared to GC/MS, and the "The percentage of correct results (%)" in the lay-user study. Exact sensitivity, specificity, PPV, NPV values are not explicitly calculated or presented.

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

K052115 First Check Multi Drug Cup 12

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

Not Found

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

Not Found

Regulation Number and Section

§ 862.3620 Methadone test system.

(a)
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.(b)
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).

Summary

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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.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/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 (800) 638-2041 or (301) 796-7100 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)
-------------------------------------------------

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

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510(k) SUMMARY K151441

1. Date:	June 26, 2015
2. Submitter	W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale, CA 91706
3. 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

1. 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

1. Predicate Devices: K052115 First Check Multi Drug Cup 12
1. 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)
for Use	For the qualitative determination of
Methadone in human urine.	Same
Calibrator	Methadone	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
Intended
Population	For over-the-counter and prescription
uses.	For over-the-
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)
for Use	For the qualitative determination of
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
on the principle of antigen antibody
immunochemistry.
Specimen Type	Human Urine	Same
Cut-Off Values	25 ng/mL	Same
Intended
Population	For over-the-counter and prescription
uses.	For over-the-counter
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)
for Use	For the qualitative determination of
Oxycodone in human urine.	Same
Calibrator	Oxycodone	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
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%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot 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%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | |
| Lot 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%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 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%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off		+25%
Cut-off	+50%
Cut-off	+75%
Cut-off	+100%
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%
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-	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

9

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

10

Chloralhydrate	Labetalol	Ranitidine
Chloramphenicol	Loperamide	Salicylic acid
Chlordiazepoxide	Maprotiline	Secobarbital
Chlorothiazide	Meperidine	Serotonin (5-
Hydroxytyramine)
(+) Chlorpheniramine	Meprobamate	Sulfamethazine
Chlorpromazine	Methadone	Sulindac
Chlorquine	Methoxyphenamine	Temazepam
Cholesterol	(+) 3,4-Methylenedioxy-
amphetamine	Tetracycline
Clomipramine	(+)3,4-Methylenedioxy-
methamphetamine	Tetrahydrocortisone3 (β-D
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

11

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

12

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

| Phencyclidine
Cut-off=25 ng/mL) | Result | % Cross-
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

13

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
format		Negative	Low
Negative
by GC/MS
(less than -
50%)	Near Cutoff
Negative by
GC/MS
(Between -
50% and
cut-off)	Near
Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%)	High
Positive by
GC/MS
(greater
than +50%)
Viewer A	Positive	0	0	0	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
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
format | | Negative | Low
Negative
by GC/MS
(less than -
50%) | Near Cutoff
Negative by
GC/MS
(Between -
50% and
cut-off) | Near
Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than +50%) |
|---------------|----------|----------|-----------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| | | | | | | |
| Viewer A | Positive | 0 | 0 | 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

14

| Viewer | Sample Number | GC/MS Result | Cup Format
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
format | | Negative | Low
Negative
by GC/MS
(less than -
50%) | Near Cutoff
Negative by
GC/MS
(Between -
50% and
cut-off) | Near
Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than +50%) |
|--------------------|----------|----------|-----------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 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
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 |

---------------	--	----------	-----------------------------------------------------	--------------------------------------------------------------------------	----------------------------------------	--------------------------------------------------------

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| | | | | | (Between
the cut-off
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
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
format | | Negative | Low
Negative
by GC/MS
(less than -
50%) | Near Cutoff
Negative by
GC/MS
(Between -
50% and cut-
off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|-------------------|----------|----------|-----------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| | Viewer A | Positive | 0 | 0 | 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
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
(less than - 50%) | Near Cutoff Negative by GC/MS
(Between - 50% and cut-off) | Near Cutoff Positive by GC/MS
(Between the cut-off and +50%) | High Positive by GC/MS
(greater than +50%) |
|------------|----------|----------|--------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------|
| Viewer A | Positive | 0 | 0 | 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
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
of
samples | Methadone
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 | 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
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|--------------|---------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | of
samples | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -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
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------|----------------------------------------------------|--------------------|----|------------------------------------------------|
| -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
Oxycodone | | Lay person results | The | |
|-------------|---------------------|-----------------------------------|--------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| % of Cutoff | of
samples | Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -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
of
samples | Oxycodone
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 | 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.

1. Clinical Studies Not applicable.
1. 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.