(128 days)
Not Found
No
The device description and performance studies indicate a standard immunoassay lateral flow test, with no mention of AI/ML components or data processing beyond visual interpretation of lines.
No
The device is described as a rapid, qualitative immunoassay device for the detection of drugs or their metabolites in human urine. It is used for diagnostic purposes (detection of substances), not to treat or cure a disease or condition.
Yes
The device is a rapid, qualitative immunoassay device for the detection of drugs or their metabolites in human urine. Its intended use explicitly states for "detection," which is a diagnostic purpose.
No
The device description clearly states it is a "lateral flow chromatographic immunoassay" consisting of physical test strips with a conjugate pad and nitrocellulose membrane. This indicates a hardware-based diagnostic device, not software only.
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 of one or more drugs or metabolites... in human urine." This clearly indicates that the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting the presence of drugs or metabolites).
- Device Description: The description details a "rapid, qualitative immunoassay device" that uses "lateral flow chromatographic immunoassays." Immunoassays are a common type of in vitro diagnostic test.
- Performance Studies: The document describes performance studies (Precision study, Lay user study) that evaluate the device's ability to accurately detect the target analytes in urine samples. This is a standard requirement for IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a "Predicate Device(s)" with K numbers (K152122) indicates that this device is being compared to previously cleared IVD devices. This is a common regulatory pathway for IVDs.
- Regulatory Context: The mention of "Over-The-Counter Use (21 CFR 801 Subpart C)" and "Prescription Use (Part 21 CFR 801 Subpart D)" refers to regulations governing medical devices, including IVDs, in the United States.
In summary, the device meets the definition of an In Vitro Diagnostic because it is intended for use in vitro (outside the body) to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting drugs or metabolites).
N/A
Intended Use / Indications for 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:
Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic Antidepressants, Cannabinoids, MDMA, Morphine, Oxycodone.
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:
Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic Antidepressants, Cannabinoids, MDMA, Morphine, Oxycodone.
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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, DJG, JXM, DIO, DJC, DJR, LCM, LFG, LDJ, DNK, NFT, PTH, NFV, NFY, NGG, PTG, NGM, NFW, NGI, NGL, QAW
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.
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 Use (21 CFR 801 Subpart C), Prescription Use (Part 21 CFR 801 Subpart D)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Study type: Precision study
Sample size: Each analyte was tested with 3 lots of test strips, performed by 10 operators over 10 non-consecutive days, resulting in 50 tests per concentration per lot.
Key results: For each analyte, testing was done at Negative, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, and +100% of the cutoff. The results show consistent performance across lots with minimal false negatives at the cutoff concentrations and no false positives at negative concentrations. For concentrations above the cutoff, results were consistently positive. For concentrations below the cutoff, results were consistently negative.
Lay user study:
Study type: Lay user study
Sample size: 400 participants
Description: Each participant was provided one package insert, one blind labeled test solution, and one test device. Test solutions were randomly picked for participants. 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.
Key results: The study reported the number of negative and positive results for various analytes at different percentages of cutoff concentration. For example, for Amphetamines (1000 ng/mL cutoff), at 0% concentration (0 ng/mL), there were 350 negative results out of 350 samples. At 150% concentration (1500 ng/mL), there were 30 positive results out of 30 samples. For Buprenorphine (10 ng/mL cutoff), at 75% (7.5 ng/mL), 57 negative and 3 positive results out of 60 samples were observed, and at 125% (12.5 ng/mL), 9 negative and 111 positive results out of 120 samples.
Surveys and labeling assessments:
Study type: Survey
Description: Participants evaluated the ease of understanding of various aspects of the device, including explanation of intended use, directions to do the test, performing the test, directions to interpret results, and actual interpretation of test results.
Key results: High percentages of participants found each aspect "Very easy to understand" or "Easy to understand". For example, 96.5% found "Explanation of intended use of the test" easy to understand, and 99.75% found "Directions to do the test" easy to understand.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Raw data for positive/negative counts at different concentrations are provided, from which these metrics could be calculated, but the metrics themselves are not explicitly stated).
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.
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
§ 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).
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.