Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
Device Facts
| Record ID | K182738 |
|---|---|
| Device Name | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) |
| Applicant | Hangzhou AllTest Biotech Co., Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Mar 27, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated. For Prescription Use.
Device Story
Rapid lateral flow chromatographic immunoassay for qualitative detection of drugs/metabolites in urine. Input: urine sample. Principle: competitive binding immunoassay; drug-protein conjugates compete with drug/metabolites in sample for limited antibody binding sites on colloidal gold conjugate pads. Output: visual color bands on test strip. Absence of color band in test region indicates preliminary positive result; presence of band indicates negative result. Control region confirms proper test performance. Used in clinical settings (prescription) or home (OTC). Results provide preliminary data requiring GC/MS confirmation. Assists healthcare providers in clinical decision-making regarding drug abuse status.
Clinical Evidence
Bench testing only. No clinical data provided. Performance established via analytical verification and validation of cut-off concentrations and cross-reactivity.
Technological Characteristics
Lateral flow chromatographic immunoassay. Materials: drug-protein conjugates, anti-drug antibodies (sheep/mouse), colloidal gold conjugate pads. Format: cup, panel, or dipstick. Principle: competitive binding. No electronic components, software, or external energy source.
Indications for Use
Indicated for qualitative detection of single or multiple drugs and drug metabolites in human urine. Intended for prescription or over-the-counter use to provide preliminary analytical results. Requires confirmatory testing via GC/MS.
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 plus Multi-Drug of Abuse Urine Test (k173303)
Related Devices
- K121166 — WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL · Guangzhou Wondfo Biotech Co., Ltd. · May 8, 2012
- K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests · Chemtron Biotech, Inc. · Oct 9, 2014
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name in blue text, with the word "FDA" in a blue square.
March 27, 2019
Hangzhou AllTest Biotech Co., Ltd % Feng-Yu Lee, Principal Regulatory Consultant IVDD Regulatory Consultant 29222 Rancho Viejo Rd., Suite 218 San Juan Capistrano, CA 92675
| Trade/Device Name: | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)<br>Single and Multi-Drug Rapid Test Panel (Urine)<br>Single and Multi-Drug Rapid Test Cup With Adulteration (Urine)<br>Single and Multi-Drug Rapid Test Cup (Urine)<br>Single Drug Rapid Test Dipstick (Urine)<br>Single and Multi-Drug Home Rapid Test Panel (Urine)<br>Single and Multi-Drug Home Rapid Test Cup (Urine)<br>Single Drug Home Rapid Test Dipstick (Urine) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 862.3100 |
| Regulation Name: | Amphetamine test system |
| Regulatory Class: | Class II |
| Product Code: | DKZ, NFT, DIS, PTH, JXM, NFV, DJG, NGL, DIO, NFY, DJR, PTG, DJC, NGG, LDJ,<br>NFW, LAF, DNK, NGI, LCM, NGM, LFG, QAW |
| Dated: | February 18, 2019 |
| Received: | February 19, 2019 |
Dear Feng-Yu Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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
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510(k) Number (if known) k182738
#### Device Name
Single and Multi-Drug Rapid Test Cup With Adulteration (Urine)
#### Indications for Use (Describe)
The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
{3}------------------------------------------------
510(k) Number (if known) k182738
Device Name Single and Multi-Drug Rapid Test Cup (Urine)
#### Indications for Use (Describe)
The Single and Multi-Drug Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.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
{4}------------------------------------------------
510(k) Number (if known) k182738
#### Device Name
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)
#### Indications for Use (Describe)
The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <span style="display:inline-block; margin-right: 5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; margin-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
{5}------------------------------------------------
510(k) Number (if known) k182738
#### Device Name
Single and Multi-Drug Rapid Test Panel (Urine)
#### Indications for Use (Describe)
The Single and Multi-Drug Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
Type of Use (*Select one or both, as applicable*)
| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
{6}------------------------------------------------
510(k) Number (if known) k182738
Device Name Single Drug Rapid Test Dipstick (Urine)
#### Indications for Use (Describe)
The Single Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine
150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
{7}------------------------------------------------
510(k) Number (if known) k182738
#### Device Name
Single and Multi-Drug Home Rapid Test Cup (Urine)
#### Indications for Use (Describe)
The Single and Multi-Drug Home Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Over-The-Counter Use.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="white-space: nowrap;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
{8}------------------------------------------------
510(k) Number (if known) k182738
#### Device Name
Single and Multi-Drug Home Rapid Test Panel (Urine)
#### Indications for Use (Describe)
The Single and Multi-Drug Home Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Over-The-Counter Use.
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) |
|----------------------------------------------|---------------------------------------------|
| <div style="text-align: center;">☐</div> | <div style="text-align: center;">☑</div> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
{9}------------------------------------------------
510(k) Number (if known) k182738
Device Name Single Drug Home Rapid Test Dipstick (Urine)
#### Indications for Use (Describe)
The Single Drug Home Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Over-The-Counter Use.
| 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.
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
{10}------------------------------------------------
### 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: k182738
#### 1. Submitter's Identification:
Hangzhou AllTest Biotech Co., Ltd #550, Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou 310018, P.R. China
c/o IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928 Date Summary Prepared: March 27, 2019
#### Name of the Device: 2.
### For Prescription Use
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)
Single and Multi-Drug Rapid Test Panel (Urine)
Single and Multi-Drug Rapid Test Cup With Adulteration (Urine)
Single and Multi-Drug Rapid Test Cup (Urine)
Single Drug Rapid Test Dipstick (Urine)
{11}------------------------------------------------
## For Over-the-Counter
Single and Multi-Drug Home Rapid Test Panel (Urine)
Single and Multi-Drug Home Rapid Test Cup (Urine)
Single Drug Home Rapid Test Dipstick (Urine)
#### 3. Common or Usual Name: Drugs of Abuse Test
Panel: Toxicology
| Analyte | Product<br>Code<br>Professional /<br>OTC | Regulation Section |
|-------------------------------------------------------|------------------------------------------|---------------------------------------------------------|
| Amphetamine | DKZ / NFT | 21CFR 862.3100,<br>Amphetamine Test System |
| Secobarbital | DIS / PTH | 21 CFR 862.3150,<br>Barbiturates Test System |
| Benzodiazepines | JXM / NFV | 21 CFR 862.3170,<br>Benzodiazepines Test System |
| Buprenorphine | DJG / NGL | 21CFR 862.3650, Opiate<br>Test System |
| Cocaine | DIO / NFY | 21 CFR 862.3250, Cocaine<br>and metabolites Test System |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | DJR / PTG | 21 CFR 862.3620,<br>Methadone Test System |
| Methylenedioxymethamphetamine | DJC / NGG | 21 CFR 862.3610,<br>Methamphetamine Test |
| Marijuana | LDJ / NFW | 21 CFR 862.3870,<br>Cannabinoids Test System |
| Methadone | DJR / PTG | 21 CFR 862.3620,<br>Methadone Test System |
| Methamphetamine | LAF / NGG | 21 CFR 862.3610,<br>Methamphetamine Test |
| Morphine (300 and 2000) | DNK / NGI | 21 CFR 862.3640,<br>Morphine Test System |
{12}------------------------------------------------
| Oxycodone | DJG / NGL | 21 CFR 862.3650, Opiate<br>Test System |
|---------------|-----------|-------------------------------------------------------------------|
| Phencyclidine | LCM / NGM | Unclassified, Enzyme<br>Immunoassay Phencyclidine |
| Nortriptyline | LFG / QAW | 21 CFR 862.3910,<br>Tricyclic Antidepressant<br>Drugs Test System |
#### 4. Device Description:
The Candidate Drug Screen Tests are rapid lateral flow immunoassays in which drugprotein conjugates in the test device compete with drugs or drug metabolites that may be present in urine.
On each test strip, a drug-protein conjugate is added to the test band of the membrane known as the test region (T), and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. Anti-drug antibodies derived from sheep and/or mice are used on the candidate tests. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody- gold conjugates then complexes with the drug-protein conjugates to form visible lines.
Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.
#### ട്. Intended Use:
### (I) For Prescription Use
### - Single and Multi-Drug Rapid Test Cup With Adulteration (Urine)
The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL.
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Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL. Nortriptyline 1.000ng/mL. Oxycodone 100ng/mL. and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
### - Single and Multi-Drug Rapid Test Cup (Urine)
The Single and Multi-Drug Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
## - Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)
The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
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This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
### - Single and Multi-Drug Rapid Test Panel (Urine)
The Single and Multi-Drug Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Prescription Use.
## - Single Drug Rapid Test Dipstick (Urine)
The Single Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following concentrations: cut-off 300ng/mL. Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana Methadone 50ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
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For Prescription Use.
## (II) For Over-the-Counter
## - Single and Multi-Drug Home Rapid Test Cup (Urine)
The Single and Multi-Drug Home Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL. Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Over-The-Counter use.
## - Single and Multi-Drug Home Rapid Test Panel (Urine)
The Single and Multi-Drug Home Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, 50ng/mL, Methadone 300ng/mL, Methamphetamine Mariiuana 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Over-The-Counter use.
## - Single Drug Home Rapid Test Dipstick (Urine)
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The Single Drug Home Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, 50ng/mL. Methadone Marijuana 500ng/mL. Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1.5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 indicated.
For Over-The-Counter use.
#### 6. Predicate Device Information:
The subject devices are substantially equivalent to the following 510(k) cleared device noted below.
| | Device Company: |
|----------------|----------------------------------------------------|
| 510(K) Number: | GUANGZHOU WONDFO BIOTECH CO., LTD.; and<br>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)
- 7. Comparison to Predicate Devices (Substantial Equivalence Comparison):
| Similarities and Differences | | |
|------------------------------|---------------------|-------------------------------------------------------------|
| Item | Candidate Device(s) | Predicate Device(s) |
| Intended Use | Same | For the qualitative detection of<br>drugs of abuse in human |
| Results | Same | Qualitative |
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| Methodology | Same | Lateral flow, competitive binding<br>immunoassay based on the principle<br>of antigen and antibody |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Users | Same | Prescription and over the counter<br>users |
| Cutoff<br>Levels<br>(ng/mL) | Amphetamine – 500<br>Secobarbital - 300<br>Benzodiazepines – 300<br>Buprenorphine – 10<br>Cocaine - 150<br>Marijuana - 50<br>Methadone - 300<br>Methamphetamine – 500<br>Methylenedioxymethamphetamine<br>– 500<br>Morphine - 300 and 2000<br>Phencyclidine – 25<br>Nortriptyline - 1,000<br>Oxycodone - 100<br>2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine – 300 | Amphetamine – 500<br>Barbiturates – 300<br>Benzodiazepines – 300<br>Buprenorphine – 10<br>Cocaine - 150<br>EDDP - 300<br>Ecstasy (MDMA) – 500<br>Marijuana - 50<br>Methadone – 300<br>Methamphetamine – 500<br>Morphine - 300<br>Opiates - 2000<br>Oxycodone - 100<br>Phencyclidine – 25<br>Tricyclic Antidepressants – 1000 |
| Format | Cup, Panel / Dipstick | Cup, Panel / Dip Card, Cassette,<br>and Dipstick |
#### Conclusions from Verification and Validation Activities: 8.
The results of all verification and validation activities demonstrate that the candidate device is substantially equivalent to the cleared predicate devices.
