AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx

Q: Who is the manufacturer of AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx?

Hangzhou AllTest Biotech Co., Ltd. filed the 510(k) submission for AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (K233019).

Q: What is the FDA product code for AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx?

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 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx?

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

Q: Who can help prepare an FDA 510(k) submission like AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx?

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.

K233019 · Hangzhou AllTest Biotech Co., Ltd. · DKZ · Dec 13, 2023 · Clinical Toxicology

Device Facts

Record ID	K233019
Device Name	AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
Applicant	Hangzhou AllTest Biotech Co., Ltd.
Product Code	DKZ · Clinical Toxicology
Decision Date	Dec 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

Intended Use

AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Lateral flow immunochromatographic assay; detects drugs/metabolites in human urine via competitive binding. Urine sample migrates via capillary action; target drugs below cutoff do not saturate monoclonal antibody-coated particles, allowing binding to immobilized drug-conjugate and formation of visible colored test line. Target drugs above cutoff saturate binding sites, preventing test line formation. Control line forms regardless of drug presence. Used in OTC or clinical settings; operated by consumers or healthcare providers. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

No clinical data. Performance established via analytical bench testing (precision, cross-reactivity, interference) and a lay user study (n=560) across three sites. Lay user study confirmed ease of use and performance agreement across various drug concentrations relative to cutoffs. Method comparison against LC/MS performed for select analytes (AMP, COC, MET).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Components: monoclonal mouse antibody-coated particles, immobilized drug-conjugate. Form factor: Test Cup or Test Panel. Sample: human urine. No external energy source required. No specific materials/standards cited.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs/metabolites (Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana) in human urine. Intended for OTC or prescription use. Not intended to distinguish between prescription use and abuse. Requires confirmatory testing (GC/MS or LC/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

Single and Multi-Drug Rapid Test Panel With Adulteration (Urine) (K182738)
Single and Multi-Drug Rapid Test Panel (Urine) (K182738)
Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) (K182738)
Single and Multi-Drug Rapid Test Cup (Urine) (K182738)
Single Drug Rapid Test Dipstick (Urine) (K182738)
Single and Multi-Drug Home Rapid Test Panel (Urine) (K182738)
Single and Multi-Drug Home Rapid Test Cup (Urine) (K182738)
Single Drug Home Rapid Test Dipstick (Urine) (K182738)

Related Devices

K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Feb 28, 2018
K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana · W.H.P.M., Inc. · Feb 5, 2018
K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card · Safecare Biotech (Hangzhou) Co., Ltd. · Mar 24, 2021
K233062 — BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx · Vivachek Biotech (Hangzhou) Co., Ltd. · Nov 2, 2023

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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue. Hangzhou AllTest Biotech Co.,Ltd % Joe Shia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877 ### Re: K233019 Trade/Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Cup Rx, AllTest Multi-Drug Rapid Test Panel, AllTest Multi-Drug Rapid Test Panel Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, NFT, DIS, JXM, DJG, PTH, DIO. DJR, NFV. LAF, DJC, LDJ, NGL, NFY, DNK, LCM, PTG, LFG, NGG, NFW, NGI, NGM, QAW Dated: September 21, 2023 Received: September 22, 2023 Dear Joe Shia: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Joseph A. Digitally signed by Kotarek -S Date: 2023.12.13 Joseph Kotarek, Ph.D. Toxicology Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### k233019 Device Name AllTest Multi-Drug Rapid Test Cup AllTest Multi-Drug Rapid Test Panel #### Indications for Use (Describe) AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Cut-off level ng/mL ng/mL #### Drug (Identifier) | Amphetamine (AMP) | 500 or 1000 ng/mL | |----------------------------------------------------------|-------------------| | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------| | Amphetamine (AMP) | 500 or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | {3}------------------------------------------------ Nortriptyline (TCA) Marijuana (THC) ### 1000 ng/mL 50 ng/mL AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses, It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method. 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 "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." FORM FDA 3881 (6/20) {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### k233019 #### Device Name AllTest Multi-Drug Rapid Test Cup Rx AllTest Multi-Drug Rapid Test Panel Rx #### Indications for Use (Describe) AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-A9-THC-9 COOH | 50 | AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine | d.l-Methylenedioxymethamphetamine | 500 | {5}------------------------------------------------ | (MDMA) | | | |---------------------|----------------------|-------------| | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. 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. 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 K233019 The purpose of this submission is to add analytes Amphetamine 1000, Cocaine 300, Methamphetamine 1000, to previously cleared devices (k182738). These three new analytes were evaluated in this submission. For other analytes, please refer to k182738 for Buprenorphine, Secobarbital, Benzodiazepines, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Nortriptyline and Marijuana. | 1. Date: | November 3, 2023 | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Submitter: | Hangzhou Alltest Biotech Co.,Ltd. #550, Yinhai Street Hangzhou 310018, China | | 3. Contact person: | Joe Shia LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: <a href="mailto:shiajl@yahoo.com">shiajl@yahoo.com</a> | | 4. Device Name: | AllTest Multi-Drug Rapid Test Cup AllTest Multi-Drug Rapid Test Cup Rx AllTest Multi-Drug Rapid Test Panel AllTest Multi-Drug Rapid Test Panel Rx | Classification: Class 2 | Product Codes | Class | Regulation Section | Regulation Name | Panel | |------------------|-------|-----------------------|--------------------------------------------|------------| | DKZ, NFT | II | 862.3100 | Amphetamine Test system | Toxicology | | DIS, PTH | II | 862.3150 | Barbiturate Test system | (91) | | JXM, NFV | II | 862.3170 | Benzodiazepines Test System | | | DIO, NFY | II | 862.3250 | Cocaine and metabolites Test System | | | DJR, PTG | II | 862.3620 | Methadone Test system | | | LAF, DJC, NGG | II | 862.3610 | Methamphetamine Test System | | | LDJ, NFW | II | 862.3870 | Cannabinoids Test System | | | DNK, NGI | II | 862.3640 | Morphine Test System | | | DJG, NGL | II | 862.3650 | Opiate Test System | | | LCM, NGM | II | Unclassified | Enzyme immunoassay Phencyclidine | | | LFG, QAW | II | 862.3910 | Tricyclic Antidepressant Drugs Test System | | - 5. Predicate Devices: K182738 The AllTest Single and Multi-Drug Rapid Test Cup (Urine) {7}------------------------------------------------ - 6. Intended Use AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------| | Amphetamine (AMP) | 500 or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |----------------------------------------------------------|---------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | {8}------------------------------------------------ | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | |-----------------------------------------|-----------------------------------|-------------| | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------| | Amphetamine (AMP) | 500 or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, {9}------------------------------------------------ particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3dipheny|pyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,1-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-A9-THC-9 COOH | 50 | AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. ### 7. Device Description The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch. {10}------------------------------------------------ - 8. Substantial Equivalence Information A summary comparison of features of the AllTest Multi-Drug Rapid Tests and the predicate devices is provided in following tables. ### Table 1: Features Comparison of AllTest Multi-Drug Rapid Test Cup/Panel and the Predicate Devices | Item | Device | Predicate - K182738 | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same | | Calibrator and Cut-Off Values | Amphetamine (AMP): 500 or 1000 ng/ml Benzodiazepines (BZO):300 ng/ml Cocaine (COC): 150 or 300 ng/ml 11-Nor-△9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml Methamphetamine (MET): 500 or 1000 ng/ml Morphine (MOP/OPI): 300 or 2000 ng/mL Oxycodone(OXY) : 100 ng/ml Secobarbital (BAR): 300 ng/ml Methadone (MTD): 300 ng/ml Buprenorphine (BUP): 10 ng/ml D.L-Methylenedioxymethamphetamine (MDMA): 500 ng/ml Phencyclidine (PCP): 25 ng/ml Nortriptyline (TCA): 1000 ng/ml 2-ethylidene-1.5-dimethyl-3.3- diphenylpyrrolidine (EDDP): 300 ng/ml | Same except AMP 500 MET 500 COC 150 | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human Urine | Same | | Intended Use | For prescription use and over-the-counter | Same | | Configurations | Cup and Panel | Same | ### 9. Test Principle The AllTest Multi-Drug Rapid Test Cup/Panel tests for the qualitative detection of target drug or drug metabolites in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody {11}------------------------------------------------ coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly. - 10. Performance Characteristics - 1. Analytical Performance - a. Precision Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed 5 replicates per day for 5 days per device in a randomized order. The results obtained are summarized in the following tables for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000. The rest data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Benzodiazepines, EDDP, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana were reported in k182738. | AMP Cup | | | | | | | | | | |----------------------------------------------------|----------------------|---------------------|---------------------|---------------------|-------------|---------------------|---------------------|---------------------|-----------------------| | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut- off | -75% Cut- off | -50% Cut- off | -25% Cut- off | Cut- off | Cut- off +25% | Cut- off +50% | Cut- off +75% | Cut- off +100 % | | Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 19+/6- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 19+/6- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100 % | |----------------------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|-------------------| | Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 19+/6- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | #### AMP Panel COC Cup | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut- off | -75% Cut- off | -50% Cut- off | -25% Cut- off | Cut- off | Cut- off +25% | Cut- off +50% | Cut- off +75% | Cut- off +100 % | |----------------------------------------------------|----------------------|---------------------|---------------------|---------------------|-------------|---------------------|---------------------|---------------------|--------------------------| | Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 19+/6- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | {12}------------------------------------------------ | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100 % | |-------------------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|-------------------| | Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | COC Panel | | | | | | | | | | |----------------------------------------------------|----------------------|---------------------|---------------------|---------------------|-------------|---------------------|---------------------|---------------------|--------------------------| | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut- off | -75% Cut- off | -50% Cut- off | -25% Cut- off | Cut- off | Cut- off +25% | Cut- off +50% | Cut- off +75% | Cut- off +100 % | | Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | ## MET Cup | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut- off | -75% Cut- off | -50% Cut- off | -25% Cut- off | Cut- off | Cut- off +25% | Cut- off +50% | Cut- off +75% | Cut- off +100 % | |----------------------------------------------------|----------------------|---------------------|---------------------|---------------------|-------------|---------------------|---------------------|---------------------|--------------------------| | Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 19+/6- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 19+/6- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | ## MET Panel | Concentration by LC/MS (ng/mL) Lot Number | -100% Cut- off | -75% Cut- off | -50% Cut- off | -25% Cut- off | Cut- off | Cut- off +25% | Cut- off +50% | Cut- off +75% | Cut- off +100 % | |----------------------------------------------------|----------------------|---------------------|---------------------|---------------------|-------------|---------------------|---------------------|---------------------|--------------------------| | Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 20+/5- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | | Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- | 25+/0- | ## The following cut-off values are verified. | Drug (Identifier) | Cut-off level | |-----------------------|---------------| | Amphetamine (AMP) | 1000 ng/mL | | Cocaine (COC) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL | ## b. Linearity Not applicable. c. Stability and Traceability {13}------------------------------------------------ The devices are stable at 2-30 ℃ for 24 months based on real time stability studies. All drug calibrators of the device are traceable to available commercial reference materials. #### d. Interference Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. No differences were observed for different device format. | Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | 19-Norethindrone | |----------------------------|-------------------------|-----------------------| | Albumin (100mg/dL) | Erythromycin | Noscapine | | Amoxicillin | Estradiol | Octopamine | | Ampicillin | Estrone | Papaverine | | Aspartame | Ethanol (1%) | Penicillin-G | | Aspirin | Fenofibrate | Perphenazine | | Atropine | Fentanyl | Phenelzine | | Baclofen | Fotemustine | Phenylethylamine | | Benzocaine | Furosemide | Promazine | | Benzoic Acid | Gemfibrozil | Promethazine | | Bilirubin | Gentisic acid | Pyridoxine | | Carisoprodol | Glucose | Pyrilamine | | Chloramphenicol | Guaiacol glyceryl ether | Pyrogallol | | Chlordiazepoxide | Hemoglobin | Quinine | | (+)-Chlorpheniramine | Hydralazine | Quinolinic Acid | | Chlorpromazine | Hydrocortisone | R-(-)-Apomorphine | | Cholesterol | 3-Hydroxytyramine | Ranitidine | | Clonidine | (+/-)-Isoproterenol | Salicylic Acid | | Cortisone | Ketamine | Sulindac | | (-)-Cotinine | L-Ascorbic Acid | Tetracycline | | Creatine Hydrate | Meprobamate | Tetrahydrozoline | | Creatinine | Methylphenidate | Thiamine | | Cyclodextrin | Nalidixic Acid | Thioridazine | | d,l-Propranolol | Naltrexone | Tramadol | | Deoxycorticosterone | (+)-Naproxen | Trifluoperazine | | Dextromethorphan | Niacinamide | Tryptamine | | Diclofenac | Nicotinic Acid | Uric Acid | | 4-Dimethyl-aminoantipyrine | Nifedipine | Zomepirac sodium salt | | | | | #### e. Specificity To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Amphetamine 1000, Cocaine 300, Methamphetamine 1000. No differences were observed for different device format. The rest data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Benzodiazepines, Morphine, Methadone, Oxycodone, Phencyclidine, EDDP, Nortriptyline and Marijuana were reported in k182738. {14}------------------------------------------------ | AMP 1000 | Result | %Cross- | |------------------------------------------------|---------------------|------------| | (Cut-off=1000 ng/mL) | Positive at (ng/ml) | Reactivity | | d-Amphetamine | 1000 | 100% | | Methylenedioxyethylamphetamine (MDEA) | >100000 | <1% | | d,l-Methamphetamine | >100000 | <1% | | Phenylephrine | >100000 | <1% | | d-Methamphetamine | >100000 | <1% | | l-Methamphetamine | >100000 | <1% | | d,l - Methylenedioxy methamphetamine | >100000 | <1% | | l-Amphetamine | 1000 | 100% | | Ephedrine | >100000 | <1% | | Pseudoephedrine | >100000 | <1% | | d, 1-Amphetamine | 1000 | 100% | | d,l-3,4- Methylenedioxyamphetamine (MDA) | 50 | 2000% | | Phentermine | 1000 | 100% | | COC 300 (Cut-off=300 ng/mL) | Result Positive at (ng/ml) | %Cross- Reactivity | |--------------------------------|-------------------------------|-----------------------| | Benzoylecgonine | 300 | 100% | | Cocaine | 250 | 120% | | Cocaethylene | 500 | 60% | | Ecgonine | >100000 | <0.3% | | Norcocaine | >100000 | <0.3% | | MET 1000 (Cut-off=1000 ng/mL) | Result Positive at (ng/ml) | %Cross- Reactivity | |------------------------------------------------|-------------------------------|-----------------------| | d-Methamphetamine | 1000 | 100% | | l-Methamphetamine | 25000 | 4% | | d,l-Amphetamine | 500 | 200% | | Phentermine | >100000 | <1% | | d,l-Methamphetamine | 500 | 200% | | d-Amphetamine | >100000 | <1% | | l-Amphetamine | >100000 | <1% | | Ephedrine | >100000 | <1% | | Phenylephrine | >100000 | <1% | | Pseudoephedrine | >100000 | <1% | | 3,4- Methylenedioxy methamphetamine (MDMA) | 2500 | 40% | | d,l- Methylenedioxy ethylamphetamine (MDEA) | 12500 | 8.0% | | d,l-3,4- Methylenedioxyamphetamine (MDA) | >100000 | <1% | f. Effect of Urine Specific Gravity and Urine pH To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 {15}------------------------------------------------ to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. - 2. Comparison Studies Method comparison studies for the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel were performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000. The rest data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Benzodiazepines, Morphine, Methadone, Oxycodone, Phencyclidine, EDDP, Nortriptyline and Marijuana were reported in k182738. | AMP Cup | | | | | | | |-----------------------------------|----------|----------|----------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------| | AllTest Multi-Drug Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | | Viewer A | Positive | 0 | 0 | 1 | 13 | 26 | | | Negative | 12 | 12 | 15 | 1 | 0 | | Viewer B | Positive | 0 | 0 | 0 | 13 | 26 | | | Negative | 12 | 12 | 16 | 1 | 0 | | Viewer C | Positive | 0 | 0 | 1 | 14 | 26 | | | Negative | 12 | 12 | 15 | 0 | 0 | #### Discordant Results | Viewer | Sample Number | LC/MS Result | Viewer Results | |----------|---------------|--------------|----------------| | Viewer A | SN165 | 896.471 | + | | Viewer A | SN175 | 1070.815 | - | | Viewer B | SN044 | 1149.522 | - | | Viewer C | SN128 | 838.956 | + | #### AMP Panel | AllTest Multi-Drug Test Panel | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |-------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 13 | 26 | | Viewer A | Negative | 12 | 12 | 16 | 1 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 14 | 26 | | Viewer B | Negative | 12 | 12 | 15 | 0 | 0 | {16}------------------------------------------------ | Viewer | Positive | 0 | 0 | 2 | 13 | 26 | |--------|----------|----|----|----|----|----| | C | Negative | 12 | 12 | 14 | 1 | 0 | ## Discordant Results | Viewer | Sample Number | LC/MS Result | Viewer Results | |----------|---------------|--------------|----------------| | Viewer A | SN044 | 1149.522 | - | | Viewer B | SN062 | 833.996 | + | | Viewer C | SN036 | 922.995 | + | | Viewer C | SN120 | 987.795 | + | | Viewer C | SN150 | 1181.731 | - | ## COC Cup | AllTest Multi-Drug Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |-----------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer A | Positive | 0 | 0 | 0 | 9 | 30 | | | Negative | 12 | 10 | 18 | 1 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 10 | 30 | | | Negative | 12 | 10 | 17 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 1 | 10 | 30 | | | Negative | 12 | 10 | 17 | 0 | 0 | ### Discordant Results | Viewer | Sample Number | LC/MS Result | Viewer Results | |----------|---------------|--------------|----------------| | Viewer A | SN174 | 324.6 | - | | Viewer B | SN070 | 297.0 | + | | Viewer C | SN079 | 297.7 | + | # COC Panel | AllTest Multi-Drug Test Panel | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |-------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer A | Positive | 0 | 0 | 1 | 8 | 30 | | | Negative | 12 | 10 | 17 | 2 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 10 | 30 | | | Negative | 12 | 10 | 17 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 0 | 8 | 30 | | | Negative | 12 | 10 | 18 | 2 | 0 | {17}------------------------------------------------ | Discordant Results | | | | |--------------------|---------------|--------------|----------------| | Viewer | Sample Number | LC/MS Result | Viewer Results | | Viewer A | SN079 | 297.7 | + | | Viewer A | SN142 | 352.1 | - | | Viewer A | SN174 | 324.6 | - | | Viewer B | SN012 | 292.7 | + | | Viewer C | SN084 | 312.9 | - | | Viewer C | SN142 | 352.1 | - | ## MET Cup | AllTest Multi-Drug Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |-----------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | | | Viewer | Positive | 0 | 0 | 1 | | | A | Negative | 12 | 11 | 16 | 1 | | | Positive | 0 | 0 | 0 | 10 | 29 | | B | Negative | 12 | 11 | 17 | 1 | 0 | | | Positive | 0 | 0 | 2 | 10 | 29 | | C | Negative | 12 | 11 | 15 | 1 | 0 | # Discordant Results | Viewer | Sample Number | LC/MS Result | Viewer Results | |----------|---------------|--------------|----------------| | Viewer A | SN108 | 974.577 | + | | Viewer A | SN043 | 1194.980 | - | | Viewer B | SN043 | 1194.980 | - | | Viewer C | SN054 | 919.834 | + | | Viewer C | SN188 | 841.261 | + | | Viewer C | SN197 | 1167.315 | - | ## MET Panel | AllTest Multi-Drug Test Panel | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |-------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer A | Positive | 0 | 0 | 1 | 9 | 29 | | Viewer A | Negative | 12 | 11 | 16 | 2 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 10 | 29 | | Viewer B | Negative | 12 | 11 | 16 | 1 | 0 | {18}------------------------------------------------ | Viewer | Positive | 0 | 0 | 0 | 10 | 29 | |--------|----------|----|----|----|----|----| | C | Negative | 12 | 11 | 17 | 1 | 0 | | Viewer | Sample Number | LC/MS Result | Viewer Results | |----------|---------------|--------------|----------------| | Viewer A | SN159 | 882.244 | + | | Viewer A | SN043 | 1194.980 | - | | Viewer A | SN186 | 1138.254 | - | | Viewer B | SN159 | 882.244 | + | | Viewer B | SN186 | 1138.254 | - | | Viewer C | SN197 | 1167.315 | - | ### Discordant Results ### Lay User Study A lay user study was performed at three intended user sites with 560 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Results are shown below. | Results for Low Cutoff Cup | | | | | |----------------------------|--|--|--|--| |----------------------------|--|--|--|--| | Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | | |------|----------------|------------------|---------------|-------------|-------------|-------------|-------------|--------------|--------------| | | | | -100% cutoff | -75% cutoff | -50% c…