Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a simple lateral flow immunoassay, with no mention of AI or ML technologies. The performance evaluation focuses on lay user interpretation of visual results.

Therapeutic

No.
The device is a diagnostic test for the detection of drugs in urine, providing preliminary analytical results. It is not intended for the treatment or prevention of disease.

Diagnostic

Yes

This device is a qualitative immunoassay for the detection of drugs in urine, providing a preliminary analytical test result. While it requires confirmatory testing, its purpose is to provide information regarding the presence or absence of substances, which aligns with the definition of a diagnostic device (used to identify or detect a condition).

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "one-step lateral flow chromatographic immunoassay" consisting of physical components like a "conjugate pad" and "nitrocellulose membrane." This indicates a hardware-based device, not software only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states that the device is for the "detection in human urine of one or more of the cutoff concentrations listed below." This involves testing a biological sample (human urine) in vitro (outside the body) to gain information about a person's health status (presence of drugs or their metabolites).
Device Description: The device description details a "lateral flow chromatographic immunoassay," which is a common type of IVD test. It describes the components and how the test works to detect specific substances in the urine sample.
Anatomical Site: The anatomical site is "human urine," which is a biological specimen used for in vitro testing.
Performance Studies: The document describes performance studies conducted using urine samples, comparing the results to a confirmatory method (GC/MS). This is typical for evaluating the performance of an IVD.
Predicate Device: The mention of a predicate device (K063545; Instant View® Multi-Drug Urine Test) further indicates that this device is being compared to a previously cleared IVD.

The fact that it is intended for "over-the-counter (OTC) consumer use" and is the "first step in a two step process" does not negate its classification as an IVD. It is still performing an in vitro diagnostic test on a biological sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Instant-View@ Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs.

Abbreviation	Test	Calibrator	Cut-off (ng/ml)
AMP	Amphetamine	d-Amphetamine	1000
BAR	Barbiturates	Secobarbital	200
BUP	Buprenorphine	Buprenorphine	10
BZD	Benzodiazepine	Oxazepam	300
COC	Cocaine	Benzoylecgonine	300
MDMA	MDMA or Ecstasy	Methylenedioxy-methamphetamine	500
MET	Methamphetamine	d-Methamphetamine	1000
MTD	Methadone	Methadone	300
MOR	Morphine/Opiate	Morphine	2000
OXY	Oxycodone	Oxycodone	300
PCP	Phencyclidine	Phencyclidine	25
TCA	Tricyclic Antidepressants	Nortriptyline	1000
THC	Marijuana	11-nor-A9-THC-9-COOH	50

These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

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

DKZ, JXM, DIO, LDJ, DJC, LCM, DIS, DJG, DJR, LFG

Device Description

The Instant View® Multi-Drug Urine Test Cup (Home Use) and the Instant View® Multi-Drug Urine Test Panel (Home Use) are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to thirteen individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-counter (OTC) consumer use / Home 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

A lay user study was performed at three intended user sites with 400 lay persons testing cup and panel devices. A total of 210 females and 190 males tested the devices. They had diverse educational and professional backgrounds and ranged in age from 18 to >60 years. The participants had no previous experience with an over the counter (OTC) drug test. Urine samples were prepared at the following concentrations: negative, ± 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 inserts for the test cup and the test panel, 2 different blinded samples, 1 test cup, and 1 test panel. Each participant tested 1 test cup device and 1 test panel device using 2 different blinded samples.

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

Study Type: Lay-user study
Sample Size: 400 lay persons
Key Results:
For the Cup device:

AMP: average = 99.25% agreement
BAR: average = 99.5% agreement
BUP: average = 96.25% agreement
BZD: average = 99.5% agreement
COC: average = 99.25% agreement
MET: average = 99.5% agreement
MTD: average = 99.5% agreement
PCP: average = 99.75% agreement
TCA: average = 99.75% agreement
THC: average = 99.5% agreement
MDMA: average = 99.75% agreement
MOR: average = 99.5% agreement
OXY: average - 99.5% agreement

For the Panel device:

AMP: average = 99.5% agreement
BAR: average = 99.25% agreement
BUP: average = 96.75% agreement
BZD: average = 99.5% agreement
COC: average = 99.5% agreement
MET: average = 99.5% agreement
MTD: average = 99.5% agreement
PCP: average = 99.75% agreement
TCA: average = 99.75% agreement
THC: average = 99.5% agreement
MDMA: average = 99.75% agreement
MOR: average = 99.75% agreement
OXY: average = 99.5% agreement

In both formats, the participants were able to read the results correctly at an average of higher than 96%, and 100% at 150% and above, as well as at 50% and below in this study. Compared with GC/MS results, the lay users are able to obtain similar results with Instant-View® Multi-Drug urine test panel (Home Use) and Instant-View® Multi-Drug urine test cup (Home Use) devices.

Survey Results:

Explanation of intended use of the test: Very easy to understand (41.5%), Easy to understand (54.25%), Understandable w/ some difficulty (4.25%)
Directions to do the test: Very easy to understand (38.5%), Easy to understand (57.75%), Understandable w/ some difficulty (3.75%)
Performing the test: Very easy to understand (44.5%), Easy to understand (50.5%), Understandable w/ some difficulty (5%)
Direction to interpret the results: Very easy to understand (41%), Easy to understand (55.75%), Understandable w/ some difficulty (3.25%)
Actual interpretation of the test results: Very easy to understand (41%), Easy to understand (55%), Understandable w/ some difficulty (4%)

The majority of the participants commented that the devices are very easy to operate and they have no difficulties in interpreting the results.

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

Key metrics are presented as "% of agreement" for correctly interpreted results against GC/MS confirmed concentrations. Specific sensitivity and specificity values are not explicitly stated, but are implied by the agreement percentages at different concentrations relative to the cutoff.

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.

Instant View® Multi-Drug Urine Test (510(k) Number: K063545)

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

§ 862.3100 Amphetamine test system.

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

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

June 24, 2016

ALFA SCIENTIFIC DESIGNS, INC. JIMMY JING DIRECTOR OF REGULATORY AFFAIRS 13200 GREGG ST. POWAY CA 92064

Re: K152122

Trade/Device Name: Instant-View Multi-Drug Urine Test Cup (Home Use). Instant-View Multi-Drug Urine Test Panel (Home Use) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, JXM, DIO, LDJ, DJC, LCM, DIS, DJG, DJR, LFG Dated: May 20, 2016 Received: May 24, 2016

Dear Dr. Jing:

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 (OS) 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,

Courtney H. Lias -S

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

Enclosure

2

Indications for Use

510(k) Number (if known) K152122

Device Name

Instant-View® Multi-Drug Urine Test Cup (Home Use) Instant-View@ Multi-Drug Urine Test Panel (Home Use)

Indications for Use (Describe)

The Instant-View@ Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs.

Abbreviation	Test	Calibrator	Cut-off (ng/ml)
AMP	Amphetamine	d-Amphetamine	1000
BAR	Barbiturates	Secobarbital	200
BUP	Buprenorphine	Buprenorphine	10
BZD	Benzodiazepine	Oxazepam	300
COC	Cocaine	Benzoylecgonine	300
MDMA	MDMA or Ecstasy	Methylenedioxy-methamphetamine	500
MET	Methamphetamine	d-Methamphetamine	1000
MTD	Methadone	Methadone	300
MOR	Morphine/Opiate	Morphine	2000
OXY	Oxycodone	Oxycodone	300
РСР	Phencyclidine	Phencyclidine	25
TCA	Tricyclic Antidepressants	Nortriptyline	1000
THC	Marijuana	11-nor-A9-THC-9-COOH	50

These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo includes the company name and address, which is 13200 Gregg Street, Poway, CA 92064, USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.

510(k) Summary

Safety and effectiveness as required by 21 CFR 807.92

| Manufacturer

and Submitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg Street
Poway, CA 92064
Telephone: 858-513-3888
Fax: 858-513-8388
	Contact
Person:	Jimmy Jing, Ph.D.
Email: jjing@alfascientific.com
858-413-1279 (direct)
Device Name	Trade Name:	Instant View® Multi-Drug Urine Test Cup (Home Use)
Instant View® Multi-Drug Urine Test Panel (Home Use)
	Common Name:	Immunoassay, Drug of Abuse Screening Urine Test
	Classification Name:	Amphetamine Test System, Barbiturate Test System, Buprenorphine Tes
System, Benzodiazepine Test System, Cocaine and Cocaine Metabolite
Test System, Methamphetamine Test System, Opiate/ Morphine Test
System, Cannabinoid Test System, Methadone Test System, Tricyclic
Antidepressant Drugs Test System, Phencyclidine Test System
	Product Code:	DKZ (21 CFR 862.3100), DIS (21 CFR 862.3150), JXM (21 CFR
862.3170), DIO (21 CFR 862.3250), DJC (21 CFR 862.3610), DJG (21
CFR 862.3650), DJR (21 CFR 862.3620), LCM (21 CFR 862.3100),
LFG (21 CFR 862.3910), LDJ (21 CFR 862.3870)
Date of
Summary
Preparation	6/23/2016
Predicate
Devices	Instant View® Multi-Drug Urine Test (510(k) Number: K063545)
Made by Alfa Scientific Designs, Inc
Device
Description	The Instant View® Multi-Drug Urine Test Cup (Home Use) and the
Instant View® Multi-Drug Urine Test Panel (Home Use) are one-step
lateral flow chromatographic immunoassays. Each device consists of any
combination of one to thirteen individual test strip(s) for the analyte(s)
being tested. Each test strip in the device consists of 1) a conjugate pad
containing colloidal gold coupled with the anti-drug antibodies and 2)
nitrocellulose membrane containing a test line (T line) coated with the
conjugated drug antigen and a control line (C line). The C line serves as
an internal quality control of the system and appears as a burgundy-
colored band during the test regardless of the presence of the drug.
Intended Use	Instant View® Multi-Drug Urine Test Cup (Home Use)
Instant View® Multi-Drug Urine Test Panel (Home Use)

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Image /page/5/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features the word "ALFA" in a stylized font. The address is listed as 13200 Gregg Street, Poway, CA 92064 – USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.

judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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Image /page/6/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs Inc. The logo features the word "ALFA" in a stylized font. The address is listed as 13200 Gregg Street, Poway, CA 92064, USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Tests for prescription drugs will vield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

Similarity to Predicate Devices

· Devices are one-step lateral-flow chromatographic immunoassays.
· Devices are intended to provide qualitative detection of drug abuse.
Devices have built-in quality control feature, C line, to indicate that an adequate volume of specimen is applied and the liquid flow occurred properly.
· Devices consist test strips, each for one analyte.

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Image /page/7/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo includes the company name and address, which is 13200 Gregg Street, Poway, CA 92064 – USA. The image also includes the company's telephone number, which is 858-513-3888, and fax number, which is 858-513-8388.

Performance Characteristics

The proposed multi-drug urine test devices use the same technology and formulations for the detection of the drugs as individual test devices.

The performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of this drug of abuse test are the same as the predicate device.

Lay-user study:

A lay user study was performed at three intended user sites with 400 lay persons testing cup and panel devices. A total of 210 females and 190 males tested the devices. They had diverse educational and professional backgrounds and ranged in age from 18 to >60 years. The participants had no previous experience with an over the counter (OTC) drug test. Urine samples were prepared at the following concentrations: negative, ± 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 inserts for the test cup and the test panel, 2 different blinded samples, 1 test cup, and 1 test panel. Each participant tested 1 test cup device and 1 test panel device using 2 different blinded samples.

The lay user study results are summarized in the tables below:

Summary of the Results - Cup
Drug	Cutoff
Concentration%
(ng/ml)	Number of
studies	Correctly
interpreted	Incorrectly
interpreted	% of agreement
AMP	0% (0)	350	350	0	100%
	75% (750)	10	8	2	80%
	125% (1250)	10	9	1	90%
	150% (1500)	30	30	0	100%
					average = 99.25%
BAR	0% (0)	350	350	0	100%
	75% (150)	10	9	1	90%
	125% (250)	10	9	1	90%
	150% (300)	30	30	0	100%
					average = 99.5%
BUP	0% (0)	20	20	0	100%
	50% (5)	60	60	0	100%
	75% (7.5)	60	56	4	93.3%
	125% (12.5)	120	109	11	90.8%
	150% (15)	140	140	0	100%
					average = 96.25%
BZD	0% (0)	350	350	0	100%
	75% (225)	10	9	1	90%
	125% (375)	10	9	1	90%
	150% (450)	30	30	0	100%
					average = 99.5%
	0% (0)	350	350	0	100%
COC	75% (225)	10	9	1	90%
	125% (375)	10	8	2	80%
	150% (450)	30	30	0	100%
					average = 99.25%
	0% (0)	350	350	0	100%
MET	75% (750)	10	9	1	90%
	125% (1250)	10	9	1	90%
	150% (1500)	30	30	0	100%
					average = 99.5%
	0% (0)	350	350	0	100%
	75% (225)	10	8	2	80%
MTD	125% (375)	10	10	0	100%
	150% (450)	30	30	0	100%
					average = 99.5%
PCP	0% (0)	350	350	0	100%
	50% (12.5)	10	10	0	100%
	125% (31.25)	10	9	1	90%
	150% (37.5)	30	30	0	100%
					average = 99.75%
TCA	0% (0)	350	350	0	100%
	50% (500)	10	10	0	100%
	125% (1250)	10	9	1	90%
	150% (1500)	30	30	0	100%
					average = 99.75%
	0% (0)	350	350	0	100%
THC	50% (25)	10	10	0	100%
	125% (62.5)	10	8	2	80%
	150% (75)	30	30	0	100%
					average = 99.5%
	0% (0)	350	350	0	100%
MDMA	50% (250)	10	10	0	100%
	125% (625)	10	9	1	90%
	150% (750)	30	30	0	100%
					average = 99.75%
MOR	0% (0)	350	350	0	100%
	50% (100)	10	10	0	100%
	125% (2500)	10	8	2	80%
	150% (3000)	30	30	0	100%
					average = 99.5%
	0% (0)	350	350	0	100%
OXY	50% (150)	10	10	0	100%
	125% (375)	10	8	2	80%
	150% (450)	30	30	0	100%
					average - 99.5%

Summary of the Results - Cup

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Image /page/8/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features a stylized "A" and "L" intertwined. The address is listed as 13200 Gregg Street, Poway, CA 92064 – USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.

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Image /page/9/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features a stylized "A" and "L" in black and gray. The address is listed as 13200 Gregg Street, Poway, CA 92064, USA, and the telephone number is 858-513-3888, while the fax number is 858-513-8388.

| Drug | Cutoff
Concentration%
(ng/ml) | Number of
studies | Correctly
interpreted | Incorrectly
interpreted | % of
agreement |
|------|-------------------------------------|----------------------|--------------------------|----------------------------|-------------------|
| AMP | 0% (0) | 350 | 350 | 0 | 100% |
| | 75% (750) | 10 | 9 | 1 | 90% |
| | 125% (1250) | 10 | 9 | 1 | 90% |
| | 150% (1500) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |
| BAR | 0% (0) | 350 | 350 | 0 | 100% |
| | 75% (150) | 10 | 9 | 1 | 90% |
| | 125% (250) | 10 | 8 | 2 | 80% |
| | 150% (300) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.25% |
| BUP | 0% (0) | 20 | 20 | 0 | 100% |
| | 50% (5) | 60 | 60 | 0 | 100% |
| | 75% (7.5) | 60 | 55 | 5 | 91.7% |
| | 125% (12.5) | 120 | 112 | 8 | 93.3% |
| | 150% (15) | 140 | 140 | 0 | 100% |
| | | | | | average = 96.75% |
| BZD | 0% (0) | 350 | 350 | 0 | 100% |
| | 75% (225) | 10 | 9 | 1 | 90% |
| | 125% (375) | 10 | 9 | 1 | 90% |
| | 150% (450) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |
| COC | 0% (0) | 350 | 350 | 0 | 100% |
| | 75% (225) | 10 | 9 | 1 | 90% |
| | 125% (375) | 10 | 9 | 1 | 90% |
| | 150% (450) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |
| MET | 0% (0) | 350 | 350 | 0 | 100% |
| | 75% (750) | 10 | 8 | 2 | 80% |
| | 125% (1250) | 10 | 10 | 0 | 100% |
| | 150% (1500) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |
| MTD | 0% (0) | 350 | 350 | 0 | 100% |
| | 75% (225) | 10 | 9 | 1 | 90% |
| | 125% (375) | 10 | 9 | 1 | 90% |
| | 150% (450) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |
| PCP | 0% (0) | 350 | 350 | 0 | 100% |
| | 50% (12.5) | 10 | 10 | 0 | 100% |
| | 125% (31.25) | 10 | 9 | 1 | 90% |
| | 150% (37.5) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.75% |
| TCA | 0% (0) | 350 | 350 | 0 | 100% |
| | 50% (500) | 10 | 10 | 0 | 100% |
| | 125% (1250) | 10 | 9 | 1 | 90% |
| | 150% (1500) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.75% |
| | 0% (0) | 350 | 350 | 0 | 100% |
| THC | 50% (25) | 10 | 10 | 0 | 100% |
| | 125% (62.5) | 10 | 8 | 2 | 80% |
| | 150% (75) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |
| MDMA | 0% (0) | 350 | 350 | 0 | 100% |
| | 50% (250) | 10 | 10 | 0 | 100% |
| | 125% (625) | 10 | 9 | 1 | 90% |
| | 150% (750) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.75% |
| MOR | 0% (0) | 350 | 350 | 0 | 100% |
| | 50% (100) | 10 | 10 | 0 | 100% |
| | 125% (2500) | 10 | 9 | 1 | 90% |
| | 150% (3000) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.75% |
| OXY | 0% (0) | 350 | 350 | 0 | 100% |
| | 50% (150) | 10 | 10 | 0 | 100% |
| | 125% (375) | 10 | 8 | 2 | 80% |
| | 150% (450) | 30 | 30 | 0 | 100% |
| | | | | | average = 99.5% |

Summary of the Results - Panel

10

In both formats, the participants were able to read the results correctly at an average of higher than 96%, and 100% at 150% and above, as well as at 50% and below in this study.

Compared with GC/MS results, the lay users are able to obtain similar results with Instant-View® Multi-Drug urine test panel (Home Use) and Instant-View® Multi-Drug urine test cup (Home Use) devices.

All participants completed questionnaires after they completed the testing. The majority of the participants commented that the devices are very easy to operate and they have no difficulties in interpreting the results.

Summary of Survey and Labeling Assessments
	Very easy to
understand	Easy to
understand	Understandable
w/ some
difficulty	Difficult to
understand	Impossible to
understand	Total
Explanation of
intended use of
the test	166
(41.5%)	217
(54.25%)	17
(4.25%)	0	0	400
Directions to
do the test	154
(38.5%)	231
(57.75%)	15
(3.75%)	0	0	400
Performing the
test	178
(44.5%)	202
(50.5%)	20
(5%)	0	0	400
Direction to
interpret the
results	164
(41%)	223
(55.75%)	13
(3.25%)	0	0	400
Actual
interpretation
of the test
results	164
(41%)	220
(55%)	16
(4%)	0	0	400

Summary of Survey and Labeling Assessments

11

Image /page/11/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features a stylized "A" and the company name in gray text. The address is listed as 13200 Gregg Street, Poway, CA 92064, USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.

Additionally, a Flesh-Kincaid reading analysis revealed that package inserts (cup and panel) had a reading grade level of 7.

Conclusion The proposed test is substantially equivalent to the predicate device.