INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)

Q: Who is the manufacturer of INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

Alfa Scientific Designs, Inc. filed the 510(k) submission for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (K173303).

Q: What is the FDA product code for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

DKZ. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

Instant-View Multi-Drug Urine Test Cup (Home Use) (k152122); Instant-View Multi-Drug Urine Test Panel (Home Use) (k152122).

Q: Who can help prepare an FDA 510(k) submission like INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K173303 · Alfa Scientific Designs, Inc. · DKZ · Feb 23, 2018 · Clinical Toxicology

Device Facts

Record ID	K173303
Device Name	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
Applicant	Alfa Scientific Designs, Inc.
Product Code	DKZ · Clinical Toxicology
Decision Date	Feb 23, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

Intended Use

The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: [Table of 13 analytes]. These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method 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. The INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: [Table of 13 analytes]. These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method 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.

Device Story

Lateral flow immunochromatographic urine test cup; detects 13 drugs/metabolites via competitive binding. Input: human urine sample; output: visual burgundy lines on test strips (T-line) and control line (C-line). User urinates directly into cup; sample contacts test strips immediately. Results read visually between 2 and 120 minutes. Used in OTC (home) or prescription (clinical) settings. Provides preliminary results; requires confirmatory testing for clinical decision-making. Benefits: rapid, qualitative screening for drug presence.

Clinical Evidence

Bench testing included precision studies across 10 operators over 10 days using 3 lots, testing concentrations from -75% to +100% of cutoff. A lay user study (n=400) evaluated performance across diverse educational backgrounds and ages (18 to >60), demonstrating high concordance with expected results. Labeling comprehension was also assessed, with the majority of participants finding instructions easy to understand.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: conjugate pad (colloidal gold with anti-drug antibodies), nitrocellulose membrane (drug-protein conjugate test line, control line). Dimensions: cup format with 1-13 test strips. Storage: 15-30°C; 24-month shelf life. No external energy source. No software/algorithm.

Indications for Use

Indicated for rapid, qualitative detection of 13 drugs/metabolites in human urine at specified cutoffs. Intended for both OTC and prescription use. Not for distinguishing between prescription use and abuse. Requires confirmatory testing via chromatography/mass spectrometry.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Instant-View Multi-Drug Urine Test Cup (Home Use) (k152122)
Instant-View Multi-Drug Urine Test Panel (Home Use) (k152122)

Related Devices

K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE · Alfa Scientific Designs, Inc. · May 7, 2007
K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup · Vivachek Biotech (Hangzhou) Co., Ltd. · Sep 12, 2025
K111322 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD · Chemtron Biotech, Inc. · Sep 14, 2011
K193480 — BIOEASY Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd. · Jan 31, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". February 23, 2018 Alfa Scientific Designs, Inc Naishu Wang CTO 13200 Gregg Street Poway, CA 92064 Re: k173303 Trade/Device Name: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, DJG, JXM, DIO, DJC, DJR, LCM, LFG, LDJ, DNK, NFT, PTH, NFV, NFY, NGG, PTG, NGM, NFW, NGI, NGL, QAW Dated: January 16, 2018 Received: January 22, 2018 Dear Naishu Wang: 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Kellie B. Kelm -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) k173303 #### Device Name INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) #### Indications for Use (Describe) The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: | Analyte | Calibrator | Cutoff (ng/mL) | |------------------------------|-------------------------------|----------------| | Amphetamines | d-Amphetamine | 1000 | | Barbiturates | Secobarbital | 200 | | Buprenorphine | Buprenorphine | 10 | | Benzodiazepines | Oxazepam | 300 | | Cocaine | Benzoylecgonine | 300 | | Methamphetamine | d-Methamphetamine | 1000 | | Methadone | Methadone | 300 | | Phencyclidine | Phencyclidine | 25 | | Tricyclic Antidepressants | Nortriptyline | 1000 | | Cannabinoids | 11-nor-Δ9-THC-9-COOH | 50 | | MDMA | Methylenedioxymethamphetamine | 500 | | Morphine | Morphine | 2000 | | Oxycodone | Oxycodone | 300 | These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ 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." {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known) k173303 #### Device Name INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) #### Indications for Use (Describe) The INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: | Analyte | Calibrator | Cutoff (ng/mL | |-----------------|-------------------------------|---------------| | Amphetamines | d-Amphetamine | 1000 | | Barbiturates | Secobarbital | 200 | | Buprenorphine | Buprenorphine | 10 | | Benzodiazepines | Oxazepam | 300 | | Cocaine | Benzoylecgonine | 300 | | Methamphetamine | d-Methamphetamine | 1000 | | Methadone | Methadone | 300 | | Phencyclidine | Phencyclidine | 25 | | Tricyclic | | | | Antidepressants | Nortriptyline | 1000 | | Cannabinoids | 11-nor-A9-THC-9-COOH | 50 | | MDMA | Methylenedioxymethamphetamine | 500 | | Morphine | Morphine | 2000 | | Oxycodone | Oxycodone | 300 | | | | | These assays may yield positive results when barbiturates, benzodiazenines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {5}------------------------------------------------ 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." {6}------------------------------------------------ # 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: | Naishu Wang, MD, PhD Email: wnss@alfascientific.com | | | | Device Name | Trade Name: | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | | | | | Common Name: | Immunoassay, Drug of Abuse Screening Urine Test | | | | | Classification Name: | Amphetamine Test System, Barbiturate Test System, Benzodiazepine Test System, Cocaine and Cocaine Metabolite Test System, Methamphetamine Test System, Morphine Test System, Cannabinoid Test System, Methadone Test System, Tricyclic Antidepressant Drugs Test System, Phencyclidine Test System, Opiate Test System | | | | | Analyte | Regulation Number | Product code (OTC use) | Product code (prescription use) | | | Amphetamines | 862.3100 | NFT | DKZ | | | Barbiturates | 862.3150 | PTH | DIS | | | Buprenorphine | 862.3650 | NGL | DJG | | | Benzodiazepines | 862.3170 | NFV | JXM | | | Cocaine | 862.3250 | NFY | DIO | | | Methamphetamine | 862.3610 | NGG | DJC | | | Methadone | 862.3620 | PTG | DJR | | | Phencyclidine | unclassified | NGM | LCM | | | Tricyclic Antidepressants | 862.3910 | QAW | LFG | | | Cannabinoids | 862.3870 | NFW | LDJ | | | MDMA | 862.3610 | NGG | DJC | | | Morphine | 862.3640 | NGI | DNK | | | Oxycodone | 862.3650 | NGI | DJG | {7}------------------------------------------------ | Date of Preparation | 02/22/2018 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Devices | k152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | | Device Description | These devices are one-step lateral flow chromatographic immunoassays consisting of any combination of one (1) to thirteen (13) individual test strip(s). 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 The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: | Analyte | Calibrator | Cutoff (ng/mL) | |---------------------------|--------------------------------|----------------| | Amphetamines | d-Amphetamine | 1000 | | Barbiturates | Secobarbital | 200 | | Buprenorphine | Buprenorphine | 10 | | Benzodiazepines | Oxazepam | 300 | | Cocaine | Benzoylecgonine | 300 | | Methamphetamine | d-Methamphetamine | 1000 | | Methadone | Methadone | 300 | | Phencyclidine | Phencyclidine | 25 | | Tricyclic Antidepressants | Nortriptyline | 1000 | | Cannabinoids | 11-nor-Δ9-THC-9-COOH | 50 | | MDMA | Methylenedioxy-methamphetamine | 500 | | Morphine | Morphine | 2000 | | Oxycodone | Oxycodone | 300 | These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical {8}------------------------------------------------ consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: | Analyte | Calibrator | Cutoff (ng/mL) | |---------------------------|--------------------------------|----------------| | Amphetamines | d-Amphetamine | 1000 | | Barbiturates | Secobarbital | 200 | | Buprenorphine | Buprenorphine | 10 | | Benzodiazepines | Oxazepam | 300 | | Cocaine | Benzoylecgonine | 300 | | Methamphetamine | d-Methamphetamine | 1000 | | Methadone | Methadone | 300 | | Phencyclidine | Phencyclidine | 25 | | Tricyclic Antidepressants | Nortriptyline | 1000 | | Cannabinoids | 11-nor-Δ9-THC-9-COOH | 50 | | MDMA | Methylenedioxy-methamphetamine | 500 | | Morphine | Morphine | 2000 | | Oxycodone | Oxycodone | 300 | These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method 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. {9}------------------------------------------------ # Comparison to Predicate Devices | Similarities | | | | | |-----------------------------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Item | Device | Predicate | | | | Intended Use | Same | Qualitative detection of drugs of abuse in urine | | | | Test Principle | Same | Lateral flow immunochromatographic | | | | Matrix | Same | Urine | | | | Number of strips per device | Same | 1 – 13 depending upon configuration | | | | Analyte cutoffs (ng/mL) | Same | AMP - 1000 BAR – 200 BUP – 10 BZD – 300 COC - 300 MDMA - 500 MET – 1000 MTD – 300 MOR – 2000 OXY - 300 PCP – 25 TCA - 1000 THC – 50 | | | | Shelf life | Same | 24 months | | | | Differences | | | |------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Device | Predicate | | Sample application procedure | User urinates into cup and urine contacts the test strips immediately. | User urinates into cup, but the urine sample does not contact test strips until a knob is pushed, allowing the sample to flow to the bottom of the cup. | | Storage conditions | Same | 15° – 30° C | {10}------------------------------------------------ #### Performance Characteristics To assess precision, each analyte was tested at the following concentrations: Negative, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, and +100% of the cutoff for each analyte. The panels were blinded and randomized prior to testing. Testing was performed using three lots of test strips and was performed by 10 operators over ten non- consecutive days, and the results of this testing are summarized as follows for each analyte. Amphetamines | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 250 | -75% | 50/0 | 50/0 | 50/0 | | 500 | -50% | 50/0 | 50/0 | 50/0 | | 750 | -25% | 50/0 | 50/0 | 50/0 | | 1000 | cutoff | 2/48 | 1/49 | 1/49 | | 1250 | +25% | 0/50 | 0/50 | 0/50 | | 1500 | +50% | 0/50 | 0/50 | 0/50 | | 1750 | +75% | 0/50 | 0/50 | 0/50 | | 2000 | +100% | 0/50 | 0/50 | 0/50 | Barbiturates | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 50 | -75% | 50/0 | 50/0 | 50/0 | | 100 | -50% | 50/0 | 50/0 | 50/0 | | 150 | -25% | 50/0 | 50/0 | 50/0 | | 200 | cutoff | 1/49 | 3/47 | 2/48 | | 250 | +25% | 0/50 | 0/50 | 0/50 | | 300 | +50% | 0/50 | 0/50 | 0/50 | | 350 | +75% | 0/50 | 0/50 | 0/50 | | 400 | +100% | 0/50 | 0/50 | 0/50 | {11}------------------------------------------------ # Buprenorphine | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 2.5 | -75% | 50/0 | 50/0 | 50/0 | | 5 | -50% | 50/0 | 50/0 | 50/0 | | 7.5 | -25% | 50/0 | 50/0 | 50/0 | | 10 | cutoff | 1/49 | 2/48 | 2/48 | | 12.5 | +25% | 0/50 | 0/50 | 0/50 | | 15 | +50% | 0/50 | 0/50 | 0/50 | | 17.5 | +75% | 0/50 | 0/50 | 0/50 | | 20 | +100% | 0/50 | 0/50 | 0/50 | # Benzodiazepines | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 75 | -75% | 50/0 | 50/0 | 50/0 | | 150 | -50% | 50/0 | 50/0 | 50/0 | | 225 | -25% | 50/0 | 50/0 | 50/0 | | 300 | cutoff | 2/48 | 2/48 | 2/48 | | 375 | +25% | 0/50 | 0/50 | 0/50 | | 450 | +50% | 0/50 | 0/50 | 0/50 | | 525 | +75% | 0/50 | 0/50 | 0/50 | | 600 | +100% | 0/50 | 0/50 | 0/50 | # Cocaine | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 75 | -75% | 50/0 | 50/0 | 50/0 | | 150 | -50% | 50/0 | 50/0 | 50/0 | | 225 | -25% | 50/0 | 50/0 | 50/0 | | 300 | cutoff | 1/49 | 2/48 | 1/49 | | 375 | +25% | 0/50 | 0/50 | 0/50 | | 525 | +75% | 0/50 | 0/50 | 0/50 | | 600 | +100% | 0/50 | 0/50 | 0/50 | {12}------------------------------------------------ Methamphetamine | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 250 | -75% | 50/0 | 50/0 | 50/0 | | 500 | -50% | 50/0 | 50/0 | 50/0 | | 750 | -25% | 50/0 | 50/0 | 50/0 | | 1000 | cutoff | 1/49 | 2/48 | 1/49 | | 1250 | +25% | 0/50 | 0/50 | 0/50 | | 1500 | +50% | 0/50 | 0/50 | 0/50 | | 1750 | +75% | 0/50 | 0/50 | 0/50 | | 2000 | +100% | 0/50 | 0/50 | 0/50 | ## Methadone | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 75 | -75% | 50/0 | 50/0 | 50/0 | | 150 | -50% | 50/0 | 50/0 | 50/0 | | 225 | -25% | 50/0 | 50/0 | 50/0 | | 300 | cutoff | 2/48 | 2/48 | 2/48 | | 375 | +25% | 0/50 | 0/50 | 0/50 | | 450 | +50% | 0/50 | 0/50 | 0/50 | | 525 | +75% | 0/50 | 0/50 | 0/50 | | 600 | +100% | 0/50 | 0/50 | 0/50 | # Phencyclidine | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 6.25 | -75% | 50/0 | 50/0 | 50/0 | | 12.5 | -50% | 50/0 | 50/0 | 50/0 | | 18.75 | -25% | 50/0 | 50/0 | 50/0 | | 25 | cutoff | 1/49 | 2/48 | 2/48 | | 31.25 | +25% | 0/50 | 0/50 | 0/50 | | 37.5 | +50% | 0/50 | 0/50 | 0/50 | | 43.75 | +75% | 0/50 | 0/50 | 0/50 | | 50 | +100% | 0/50 | 0/50 | 0/50 | {13}------------------------------------------------ Tricyclic Antidepressants | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 250 | -75% | 50/0 | 50/0 | 50/0 | | 500 | -50% | 50/0 | 50/0 | 50/0 | | 750 | -25% | 50/0 | 50/0 | 50/0 | | 1000 | cutoff | 3/47 | 2/48 | 1/49 | | 1250 | +25% | 0/50 | 0/50 | 0/50 | | 1500 | +50% | 0/50 | 0/50 | 0/50 | | 1750 | +75% | 0/50 | 0/50 | 0/50 | | 2000 | +100% | 0/50 | 0/50 | 0/50 | Cannabinoids | Cannabinoids | | | | | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | | 0 | 0 | 50/0 | 50/0 | 50/0 | | 12.5 | -75% | 50/0 | 50/0 | 50/0 | | 25 | -50% | 50/0 | 50/0 | 50/0 | | 37.5 | -25% | 50/0 | 50/0 | 50/0 | | 50 | cutoff | 1/49 | 1/49 | 1/49 | | 62.5 | +25% | 0/50 | 0/50 | 0/50 | | 75 | +50% | 0/50 | 0/50 | 0/50 | | 87.5 | +75% | 0/50 | 0/50 | 0/50 | | 100 | +100% | 0/50 | 0/50 | 0/50 | # MDMA | MDMA | | | | | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | | 0 | 0 | 50/0 | 50/0 | 50/0 | | 125 | -75% | 50/0 | 50/0 | 50/0 | | 250 | -50% | 50/0 | 50/0 | 50/0 | | 375 | -25% | 50/0 | 50/0 | 50/0 | | 500 | cutoff | 3/47 | 2/48 | 2/48 | | 625 | +25% | 0/50 | 0/50 | 0/50 | | 750 | +50% | 0/50 | 0/50 | 0/50 | | 875 | +75% | 0/50 | 0/50 | 0/50 | | 1000 | +100% | 0/50 | 0/50 | 0/50 | {14}------------------------------------------------ | Morphine | |----------| | | | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 500 | -75% | 50/0 | 50/0 | 50/0 | | 1000 | -50% | 50/0 | 50/0 | 50/0 | | 1500 | -25% | 50/0 | 50/0 | 50/0 | | 2000 | cutoff | 2/48 | 1/49 | 2/48 | | 2500 | +25% | 0/50 | 0/50 | 0/50 | | 3000 | +50% | 0/50 | 0/50 | 0/50 | | 3500 | +75% | 0/50 | 0/50 | 0/50 | | 4000 | +100% | 0/50 | 0/50 | 0/50 | Oxycodone | Conc (ng/mL) | % of cutoff | Results (Neg/Pos) Lot 1 | Results (Neg/Pos) Lot 2 | Results (Neg/Pos) Lot 3 | |-----------------|----------------|-------------------------------|-------------------------------|-------------------------------| | 0 | 0 | 50/0 | 50/0 | 50/0 | | 75 | -75% | 50/0 | 50/0 | 50/0 | | 150 | -50% | 50/0 | 50/0 | 50/0 | | 225 | -25% | 50/0 | 50/0 | 50/0 | | 300 | cutoff | 2/48 | 2/48 | 2/48 | | 375 | +25% | 0/50 | 0/50 | 0/50 | | 450 | +50% | 0/50 | 0/50 | 0/50 | | રુડર | +75% | 0/50 | 0/50 | 0/50 | | 600 | +100% | 0/50 | 0/50 | 0/50 | A lay user study was also performed. A total of four-hundred (400) participants were recruited, and each participant was provided one (1) package insert, one (1) blind labeled test solution, and one (1) test device. Test solutions were randomly picked for participants, one for each. Every participant was requested to read the provided materials, perform the testing, and then filled out the forms. Participants recruited were with diverse educational backgrounds and ranged in age from 18 to >60. Results were as follows: {15}------------------------------------------------ | Drug (cutoff ng/ml) | Cutoff Concentration% (ng/ml) | Number of samples | Negative | Positive | |---------------------------|-------------------------------------|-------------------------|----------|----------| | AMP (1000) | 0% (0) | 350 | 350 | 0 | | | 75% (750) | 10 | 9 | 1 | | | 125% (1250) | 10 | 1 | 9 | | | 150% (1500) | 30 | 0 | 30 | | BAR (200) | 0% (0) | 350 | 350 | 0 | | | 75% (150) | 10 | 9 | 1 | | | 125% (250) | 10 | 1 | 9 | | | 150% (300) | 30 | 0 | 30 | | BUP (10) | 0% (0) | 20 | 20 | 0 | | | 50% (5) | 60 | 60 | 0 | | | 75% (7.5) | 60 | 57 | 3 | | | 125% (12.5) | 120 | 9 | 111 | | | 150% (15) | 140 | 0 | 140 | | BZD (300) | 0% (0) | 350 | 350 | 0 | | | 75% (225) | 10 | 9 | 1 | | | 125% (375) | 10 | 1 | 9 | | | 150% (450) | 30 | 0 | 30 | | COC (300) | 0% (0) | 350 | 350 | 0 | | | 75% (225) | 10 | 9 | 1 | | | 125% (375) | 10 | 0 | 10 | | | 150% (450) | 30 | 0 | 30 | | MET (1000) | 0% (0) | 350 | 350 | 0 | | | 75% (750) | 10 | 9 | 1 | | | 125% (1250) | 10 | 1 | 9 | | | 150% (1500) | 30 | 0 | 30 | | MTD (300) | 0% (0) | 350 | 350 | 0 | | | 75% (225) | 10 | 8 | 2 | | | 125% (375) | 10 | 0 | 10 | | | 150% (450) | 30 | 0 | 30 | | PCP (25) | 0% (0) | 350 | 350 | 0 | | | 75% (18.75) | 10 | 10 | 0 | | | 125% (31.25) | 10 | 1 | 9 | | | 150% (37.5) | 30 | 0 | 30 | | TCA (1000) | 0% (0) | 350 | 350 | 0 | | | 75% (750) | 10 | 9 | 1 | | | 125% (1250) | 10 | 1 | 9 | | | 150% (1500) | 30 | 0 | 30 | | THC (50) | 0% (0) | 350 | 350 | 0 | | | 75% (37.5) | 10 | 10 | 0 | | | 125% (62.5) | 10 | 2 | 8 | | | 150% (75) | 30 | 0 | 30 | | XTC (MDMA) (500) | 0% (0) | 350 | 350 | 0 | | | 75% (37.5) | 10 | 10 | 0 | | | 125% (625) | 10 | 1 | 9 | | | 150% (750) | 30 | 0 | 30 | | MOR (2000) | 0% (0) | 350 | 350 | 0 | | | 75% (1500) | 10 | 10 | 0 | | | 125% (2500) | 10 | 2 | 8 | | | 150% (3000) | 30 | 0 | 30 | | OXY (300) | 0% (0) | 350 | 350 | 0 | | | 75% (225) | 10 | 10 | 0 | | | 125% (375) | 10 | 2 | 8 | | | 150% (450) | 30 | 0 | 30 | {16}------------------------------------------------ # Surveys and labeling assessments | | Very easy to understand | Easy to understand | Understand w/ some difficulty | Difficult or impossible to understand | |----------------------------------------------------|----------------------------|-----------------------|-------------------------------------|---------------------------------------------| | Explanation of intended use of the test | 171 (42.75%) | 215 (53.75%) | 14 (3.5%) | 0 | | Directions to do the test | 226 (59%) | 163 (40.75%) | 11 (2.75%) | 0 | | Performing the test | 186 (46.5%) | 202 (50.5%) | 12 (3%) | 0 | | Direction to interpret the results | 246 (61.5%) | 151 (37.75%) | 13 (3.25%) | 0 | | Actual interpretation of the test results | 182 (45.5%) | 212 (53%) | 16 (4%) | 0 | Conclusion The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) and INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) are substantially equivalent to the predicate device.