Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, which does not inherently involve AI or ML. There is no mention of any computational analysis or learning algorithms being used to interpret results or improve performance.

Therapeutic

No

This device is for in vitro diagnostic use, intended for qualitative and simultaneous detection of various drugs and drug metabolites in human urine. It is a diagnostic device, not a therapeutic one as it does not treat or directly mitigate a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "It is for in vitro diagnostic use only." and the "Device Description" section describes the devices as "single-use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device is a lateral flow immunochromatographic assay for detecting drugs in urine, which is a hardware-based in vitro diagnostic device. It does not describe any software component that performs a medical device function.

IVD (In Vitro Diagnostic)

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

The document explicitly states multiple times:

"It is for in vitro diagnostic use only."

This statement, along with the description of the device as a test for detecting substances in human urine to provide diagnostic information (even if preliminary), confirms its classification as an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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:

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, 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
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, 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 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 (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 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.

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

DKZ, NFT, DIS, JXM, DJG, PTH, DIO. DJR, NFV. LAF, DJC, LDJ, NGL, NFY, DNK, LCM, PTG, LFG, NGG, NFW, NGI, NGM, QAW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC use, prescription use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Precision Studies:
Samples with predefined concentrations (-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) 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. For each concentration, tests were performed 5 replicates per day for 5 days per device in a randomized order. Results are summarized in tables for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000. Data for other analytes were reported in K182738.

Method Comparison Studies (Clinical Samples):
Method comparison studies 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. Results are presented in tables for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000. Data for other analytes were reported in K182738.

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 by spiking drugs into drug free-pooled urine specimens: negative, +/-75%, +/-50%, +/-25% of the cutoff. 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.

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

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 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.

Precision: (See Description of the test set above for methodology/sample sizes)
The results obtained are summarized in tables provided for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000.
Key Results for new analytes (AMP 1000, COC 300, MET 1000):
For AMP Cup, Lot 1, 2, 3: Cut-off results show 19+/6-, 19+/6-, 20+/5- respectively. All samples at -25% cut-off and below tested negative (25-/0+). All samples at +25% cut-off and above tested positive (25+/0-).
For AMP Panel, Lot 1, 2, 3: Cut-off results show 20+/5-, 19+/6-, 21+/4- respectively. All samples at -25% cut-off and below tested negative (25-/0+). All samples at +25% cut-off and above tested positive (25+/0-).
For COC Cup, Lot 1, 2, 3: Cut-off results show 20+/5-, 19+/6-, 21+/4- respectively. All samples at -25% cut-off and below tested negative (25-/0+). All samples at +25% cut-off and above tested positive (25+/0-).
For COC Panel, Lot 1, 2, 3: Cut-off results show 20+/5-, 20+/5-, 20+/5- respectively. All samples at -25% cut-off and below tested negative (25-/0+). All samples at +25% cut-off and above tested positive (25+/0-).
For MET Cup, Lot 1, 2, 3: Cut-off results show 19+/6-, 19+/6-, 20+/5- respectively. All samples at -25% cut-off and below tested negative (25-/0+). All samples at +25% cut-off and above tested positive (25+/0-).
For MET Panel, Lot 1, 2, 3: Cut-off results show 20+/5-, 21+/4-, 21+/4- respectively. All samples at -25% cut-off and below tested negative (25-/0+). All samples at +25% cut-off and above tested positive (25+/0-).

Linearity: Not applicable.

Stability and Traceability:
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.

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 a table. No differences were observed for different device format, indicating no interference from listed substances.

Specificity (Cross-Reactivity):
Drug metabolites and other structurally related compounds were spiked into negative urine and 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.

Key Specificity Results:
AMP 1000:
d-Amphetamine: 100% Cross-Reactivity at 1000 ng/mL.
d, l-Amphetamine: 100% Cross-Reactivity at 1000 ng/mL.
d,l-3,4-Methylenedioxyamphetamine (MDA): 2000% Cross-Reactivity at 50 ng/mL.
Phentermine: 100% Cross-Reactivity at 1000 ng/mL.

COC 300:
Benzoylecgonine: 100% Cross-Reactivity at 300 ng/mL.
Cocaine: 120% Cross-Reactivity at 250 ng/mL.
Cocaethylene: 60% Cross-Reactivity at 500 ng/mL.

MET 1000:
d-Methamphetamine: 100% Cross-Reactivity at 1000 ng/mL.
d,l-Amphetamine: 200% Cross-Reactivity at 500 ng/mL.
d,l-Methamphetamine: 200% Cross-Reactivity at 500 ng/mL.
3,4- Methylenedioxy-methamphetamine (MDMA): 40% Cross-Reactivity at 2500 ng/mL.
d,l- Methylenedioxyethylamphetamine (MDEA): 8.0% Cross-Reactivity at 12500 ng/mL.

Effect of Urine Specific Gravity and Urine pH:
Urine samples with specific gravity 1.000 to 1.035 or 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.

Method Comparison Studies (Clinical Samples): (See Description of the test set above for methodology/sample sizes)
Sample Size: 80 clinical samples (40 negative, 40 positive) for each drug/viewer.
Key Results are provided in tables presenting agreement with LC/MS results for negative, low negative, near cutoff negative, near cutoff positive, and high positive samples. Discordant results are specifically listed for each viewer and drug.

Lay User Study: (See Description of the test set above for methodology/sample sizes)
Sample Size: 560 lay persons.
Key Results: The tables report the number of negative and positive results alongside the agreement percentage for various drug concentrations relative to the cutoff (e.g., -100% cutoff, -75% cutoff, etc., to +75% cutoff) for both low and high cutoff cup and panel formats.
For most analytes across both cup and panel devices and low/high cutoffs, agreement was 100% at -100%, -75%, -50% cutoff concentrations (all negative), and at +50%, +75% cutoff concentrations (all positive). Agreement typically ranged from 90% to 95% at the -25% and +25% cutoff concentrations, indicating some variability around the cutoff.
Lay-users indicated that the device instructions can be easily followed. Flesch-Kincaid reading analysis of the package insert revealed a reading Grade Level of 7.

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

The agreement rates from the lay user study represent a form of sensitivity/specificity around the cutoff values:
Agreement at negative concentrations (e.g., -100% cutoff, -75% cutoff, -50% cutoff) indicates the device's ability to correctly identify negative samples.
Agreement at positive concentrations (e.g., +50% cutoff, +75% cutoff) indicates the device's ability to correctly identify positive samples.
The performance around the cutoff (-25% cutoff and +25% cutoff) shows the device's ability to differentiate between negative and positive results near the threshold. For example, in the low cutoff cup for AMP, at -25% cutoff, 19/20 were negative, and at +25% cutoff, 18/20 were positive, showing 95% and 90% agreement respectively. Similar percentages are observed across other analytes and formats.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182738

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

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

Summary

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

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)

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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.

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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:

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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: shiajl@yahoo.com
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 | |

1. Predicate Devices: K182738
  The AllTest Single and Multi-Drug Rapid Test Cup (Urine)

7

1. 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

1. 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.

1. 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	100000

Results for Low Cutoff Cup
----------------------------	--	--	--	--

Drug	Cutoff (ng/mL)	Results	Concentration
			-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50 % cutoff	+75 % cutoff
AMP	500	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
BAR	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
BZO	300	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
BUP	10	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%

		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
COC	150	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
MDMA	500	Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
MET	500	Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
MOP	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
MTD	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
OXY	100	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
PCP	25	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
TCA	1000	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
THC	50	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%

19

20

Results for High Cutoff Cup

			Concentration
	Cutoff		-100%
cutoff	-75%
cutoff	-50%
cutoff	-25%
cutoff	+25%
cutoff	+50
%
cutoff	+75
%
cutoff
Drug	(ng/mL)	Results						f	f
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
AMP	1000	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
BAR	300	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
BZO	300	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
BUP	10	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
COC	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
MDMA	500	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	19	1	0	0
MET	1000	Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	95%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
OPI	2000	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
		(%)
MTD	300	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	95%	95%	100%	100%
OXY	100	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
PCP	25	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	95%	90%	100%	100%
TCA	1000	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%
THC	50	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	95%	90%	100%	100%

21

Results for Low Cutoff Panel

			Concentration
Drug	Cutoff
(ng/mL)	Results	-100%
cutoff	-75%
cutoff	-50%
cutoff	-25%
cutoff	+25%
cutoff	+50
%
cutoff	+75
%
cutoff
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
AMP	500	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
BAR	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
BZO	300	Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
BUP	10	Positive	0	0	0	2	18	20	20
			Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
COC	150	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
MDMA	500	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
		Negative	20	20	20	18	1	0	0
	500	Positive	0	0	0	2	19	20	20
MET		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
MOP		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
	300	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
MTD		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
OXY	100	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
PCP	25	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
	1000	Total	20	20	20	20	20	20	20
TCA		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
THC	50	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement
(%)	100%	100%	100%	90%	90%	100%	100%

22

23

Results for High Cutoff Panel

| Drug | Cutoff
(ng/mL) | Results | Concentration | |------|-------------------|--------- | | | cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff |
| | | | AMP | 1000 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | BAR | 300 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | BZO | 300 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | BUP | 10 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | COC | 300 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | EDDP | 300 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | MDMA | 500 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | MET | 1000 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | OPI | 2000 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | MTD | 300 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | OXY | 100 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | PCP | 25 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | TCA | 1000 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | THC | 50 | Negative | | | Positive | | | Total | | | Agreement (%) | 100% | | | | | |
------|-----------------|----------------|----------------|----------------|----------------|----------------|----------------|
| -100%
| | | | | | | |
| 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 100% | 100% | 100% |
| 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 95% | 95% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 95% | 90% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 95% | 90% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 95% | 95% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 95% | 95% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 90% | 90% | 100% | 100% |
| 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| 100% | 100% | 95% | 90% | 100% | 100% |

24

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

1. Clinical Studies
  Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are substantially equivalent to the predicate.