Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, with no mention of AI or ML technology for analysis or interpretation.

Therapeutic

No
This device is an in vitro diagnostic test for the qualitative detection of drugs in human urine, not a device for treating a disease or condition.

Diagnostic

Yes

The text explicitly states multiple times that the device is "for in vitro diagnostic use only" and "intended for OTC use," indicating its role in diagnosing the presence of various drugs.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an immunochromatographic assay in a cup format, which is a physical hardware device for testing urine samples.

IVD (In Vitro Diagnostic)

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

The document explicitly states:

"It is for in vitro diagnostic use only."
The intended use describes testing human urine samples, which is an in vitro process.
The device is intended for the qualitative and simultaneous detection of various drugs in human urine, which falls under the definition of an in vitro diagnostic product.

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, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of:
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
Tramadol (TRA) 100 ng/mL
Propoxyphene (PPX) 300 ng/mL
Fentanyl(FYL) 1 ng/mL
6-monoacetylmorphine (6-MAM) 10 ng/mL
AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination 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 when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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 Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

Amphetamine (AMP) Calibrator: d-Amphetamine, Cut-off (ng/mL): 500 or 1000
Buprenorphine (BUP) Calibrator: Buprenorphine, Cut-off (ng/mL): 10
Secobarbital (BAR) Calibrator: Secobarbital, Cut-off (ng/mL): 300
Benzodiazepines (BZO) Calibrator: Oxazepam, Cut-off (ng/mL): 300
Cocaine (COC) Calibrator: Benzoylecgonine, Cut-off (ng/mL): 150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Calibrator: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Cut-off (ng/mL): 300
Methamphetamine (MET) Calibrator: d-Methamphetamine, Cut-off (ng/mL): 500 or 1000
Methylenedioxymethamphetamine (MDMA) Calibrator: d,l-Methylenedioxymethamphetamine, Cut-off (ng/mL): 500
Morphine (MOP/OPI) Calibrator: Morphine, Cut-off (ng/mL): 300 or 2000
Methadone (MTD) Calibrator: Methadone, Cut-off (ng/mL): 300
Oxycodone (OXY) Calibrator: Oxycodone, Cut-off (ng/mL): 100
Phencyclidine (PCP) Calibrator: Phencyclidine, Cut-off (ng/mL): 25
Nortriptyline (TCA) Calibrator: Nortriptyline, Cut-off (ng/mL): 1000
Marijuana (THC) Calibrator: 1-nor-Δ9-THC-9 COOH, Cut-off (ng/mL): 50
Tramadol (TRA) Calibrator: Tramadol, Cut-off (ng/mL): 100
Propoxyphene (PPX) Calibrator: Propoxyphene, Cut-off (ng/mL): 300
Fentanyl(FYL) Calibrator: Fentanyl, Cut-off (ng/mL): 1
6-monoacetylmorphine (6-MAM) Calibrator: 6-monoacetylmorphine, Cut-off (ng/mL): 10

AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs 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)

NFT, PTH, NGL, NFV, NFY, PTG, NGG, QBF, NGM, QAW, NFW, NGI

Device Description

AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC 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

Not Found

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

A. Analytical performance
a. Precision/Reproducibility: Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the table provided for Tramadol (TRA), Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.

b. Linearity/assay reportable range: Not applicable. This device is intended for qualitative use only.

c. Stability: The device is stable at 2-30°C for 24 months based on real time stability study.

d. Analytical specificity/Interference: To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device. The results are summarized for Tramadol (TRA), Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019. Percent cross-reactivity was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. Interference by pH and specific gravity were also evaluated, showing no effect within pH 4-9 and specific gravity 1.000-1.035.

B. Method comparison study
Method comparison studies were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. Results are presented for Tramadol (TRA), Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.

C. Lay person study
A lay user study was performed at three intended user sites with 280 lay persons (121 male, 159 female; age 20->50). Urine samples were prepared at -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens, confirmed by LC-MS/MS. Each participant received a blind labeled sample and a device. The results are summarized in tables for two configurations.
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies: Not applicable.

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

Precision/Reproducibility:
TRA: At cutoff, Lot 1: 22-/28+, Lot 2: 25-/25+, Lot 3: 24-/26+. For other concentrations, 50-/0+ or 0-/50+.
PPX: At cutoff, Lot 1: 22-/28+, Lot 2: 23-/27+, Lot 3: 20-/30+. For other concentrations, 50-/0+ or 0-/50+ (with one instance of 1-/49+ for Lot 3 at +25% cutoff).
FYL: At cutoff, Lot 1: 25-/25+, Lot 2: 23-/27+, Lot 3: 24-/26+. For other concentrations, results are 50-/0+ or 0-/50+ (with some instances of 48-/2+ and 49-/1+).
6-MAM: At cutoff, Lot 1: 24-/26+, Lot 2: 25-/25+, Lot 3: 23-/27+. For other concentrations, results are 50-/0+ or 0-/50+ (with some instances of 48-/2+ and 49-/1+ and 1-/49+).

Lay person study - Agreement (%):
For Most Drugs (AMP, BAR, EDDP, PCP, TCA, OXY, MDMA, BZO, COC, BUP, MET, MOP, MTD, THC, TRA, PPX, FYL, 6-MAM):
-100% cutoff: 100% Negative Agreement
-75% cutoff: 100% Negative Agreement
-50% cutoff: 100% Negative Agreement
-25% cutoff: Generally 90.0% to 95.0% Negative Agreement (1-2 positive results out of 20 samples)
+25% cutoff: Generally 90.0% to 100.0% Positive Agreement (0-2 negative results out of 20 samples)
+50% cutoff: 100% Positive Agreement
+75% cutoff: 100% Positive Agreement

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.

AllTest Multi-Drug Rapid Test Cup (K233019)

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

February 27, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Hangzhou Alltest Biotech Co., Ltd % Jenny Xia Director LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K244043

Trade/Device Name: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, QBF, NGM, QAW, NFW, NGI Dated: December 28, 2024 Received: December 30, 2024

Dear Jenny Xia:

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.

1

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).

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 QS 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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 mediation-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-regulatory

2

assistance/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,

Digitally signed by Joseph A. Joseph A. Kotarek -S Date: 2025.02.27 Kotarek -S 10:58:43 -05'00'

Joseph Kotarek, Ph.D. 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

Enclosure

3

Indications for Use

EF

510(k) Number (if known) K244043

Device Name

AllTest Multi-Drug Rapid Test Cup : AllTest Multi-Drug Test Cup

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, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine 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
Tramadol (TRA)	100 ng/mL
Propoxyphene (PPX)	300 ng/mL
Fentanyl(FYL)	1 ng/mL
6-monoacetylmorphine (6-MAM)	10 ng/mL
AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination

est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination 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 when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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 Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine 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

4

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)	1-nor-Δ9-THC-9 COOH	50
Tramadol (TRA)	Tramadol	100
Propoxyphene (PPX)	Propoxyphene	300
Fentanyl(FYL)	Fentanyl	1
6-monoacetylmorphine (6-MAM)	6-monoacetylmorphine	10

AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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)

|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."

5

510(k) SUMMARY K244043

December 28, 2024 1. Date: Hangzhou AllTest Biotech Co., Ltd. Submitter: 2. Plant Bldg. 3, 4, 5, No. 550 Yinhai Street, Baiyang Street, Hangzhou ETDZ, Jianggan District 3. Contact person: Jenny Xia LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 301-525-6856 Email: jxia@lsi-consulting.org
Device Name: AllTest Multi-Drug Rapid Test Cup 4. AllTest Multi-Drug Test Cup Classification: Class II ਹੈ.

Product Code	Regulation Section	Panel
Target Drug
NFT
Amphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
PTH
Secobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NGL
Buprenorphine (BUP)
Fentanyl (FYL)
Morphine (MOP/OPI)
Oxycodone (OXY)
6-Monoacetylmorphine(6-MAM)
Tramadol (TML)	862.3650, Opiate Test System	Toxicology
NGI
Morphine (MOP/OPI)	862.3640, Morphine Test System	Toxicology
NFV
Oxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
NFY
Cocaine (COC)	862.3250, Cocaine and cocaine
metabolite test system	Toxicology
PTG
2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP)
Methadone (MTD)	862.3620, Methadone Test System	Toxicology
NGG
Methylenedioxymethamphetamine
(MDMA)	862.3610,
Methamphetamine Test System	Toxicology

6

Methamphetamine (MET)
QBF	862.3700 Propoxyphene test system.	Toxicology
Propoxyphene(PPX)
NGM	Unclassified	Toxicology
Phencyclidine (PCP)
QAW	862.3910 Tricyclic antidepressant drugs
test system	Toxicology
Nortriptyline (TCA)
NFW	862.3870, Cannabinoids Test System	Toxicology
Cannabinoids (THC)

6. Predicate Devices:

AllTest Multi-Drug Rapid Test Cup (K233019)

Intended Use 7.

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, Marijuana, Tramadol , Propoxyphene , Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off (ng/mL)
Amphetamine (AMP)	500 or 1000
Buprenorphine (BUP)	10
Secobarbital (BAR)	300
Benzodiazepines (BZO)	300
Cocaine (COC)	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300
Methamphetamine (MET)	500 or 1000
Methylenedioxymethamphetamine (MDMA)	500
Morphine (MOP/OPI)	300 or 2000
Methadone (MTD)	300
Oxycodone (OXY)	100
Phencyclidine (PCP)	25
Nortriptyline (TCA)	1000
Marijuana (THC)	50
Tramadol (TRA)	100
Propoxyphene (PPX)	300
Fentanyl (FYL)	1
6-monoacetylmorphine (6-MAM)	10

AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

7

The tests may yield positive results for the prescription drugs 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 is the recommended confirmatory method.

AllTest Multi-Drug 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, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine 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
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
Tramadol (TRA)	Tramadol	100
Propoxyphene (PPX)	Propoxyphene	300
Fentanyl (FYL)	Fentanyl	1
6-monoacetylmorphine (6-MAM)	6-monoacetylmorphine	10

AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs 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 is the recommended confirmatory method.

8

8. Device Description

AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

9. Substantial Equivalence Information

Similarities
Item	Device	Predicate (K233019)
Intended use	Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use	Same.
Methodology	Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drug and Cut Off Values	Target Drugs	Cutoff (ng/mL)	Same except that no
	Amphetamine(AMP)	1000 or 500	FYL
	Secobarbital (BAR)	300	TRA
	Buprenorphine (BUP)	10	6-MAAM
	Oxazepam (BZO)	300	PPX
	Cocaine (COC)	150
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300
	Methylenedioxymethamphetamine (MDMA)	500
	Methamphetamine (MET)	1000 or 500
	Morphine (MOP300/OPI2000)	2000 or 300
	Methadone (MTD)	300
	Oxycodone (OXY)	100
	Phencyclidine (PCP)	25
	Propoxyphene(PPX)	300
	Nortriptyline (TCA)	1000
	Cannabinoids (THC)	50
	6-Monoacetylmorphine(6-MAM)	10
	Fentanyl (FYL)	1
	Tramadol (TRA)	100
Differences
Configurations	Test cup		Test cup & Test Dip Card

9

10. Standard/Guidance Document Reference (if applicable)

None referenced.

11. Test Principle

AllTest Multi-Drug Rapid Test Cup or AllTest Multi-Drug Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.

When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.

12. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following table for Tramadol (TRA), Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.

TRA

| Concentration
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| Lot Number | 193 | 175.0 | 152.5 | 129.1 | 101.5 | 74.3 | 49.2 | 25.6 | 0 |

10

Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+
Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+

PPX

Concentration	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
(ng/mL)	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
Lot Number	613.3	528.7	435.4	371.3	304.6	229.7	146.9	79.9	0
Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	20-/30+	50-/0+	50-/0+	50-/0+	50-/0+

FYL

| Concentration
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | 2.05 | 1.79 | 1.53 | 1.21 | 0.96 | 0.71 | 0.48 | 0.26 | 0 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |

6-MAM

Concentration	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
(ng/mL)	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
Lot Number	20.6	17.0	15.3	12.2	9.8	7.0	5.3	2.6	0
Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+

b. Linearity/assay reportable range:

Not applicable. This device is intended for qualitative use only.

c. Stability:

The device is stable at 2-30°C for 24 months based on real time stability study.

d. Analytical specificity/Interference:

To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device. The results obtained are summarized in the following table for Tramadol (TRA),

11

Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.

Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. If no cross-reactivity was observed, the highest concentration tested is shown.

| Drug/Cutoff | Compound | Minimum
concentration
required to obtain
a positive result
(ng/mL) | % Cross-
Reactivity |
|--------------------------------|------------------------------|--------------------------------------------------------------------------------|------------------------|
| TRA 100 | Tramadol | 100 | 100% |
| TRA 100 | N-Desmethyl-cis-tramadol | 200 | 50% |
| TRA 100 | O-Desmethyl-cis-tramadol | 1000 | 10% |
| TRA 100 | Venlafaxine | 100000 | 0.1% |
| TRA 100 | (±)-O-Desmethylvenlafaxine | 100000 | 0.1% |
| PPX 300 | (+)-Propoxyphene | 300 | 100% |
| PPX 300 | (+)-Norpropoxyphene | 500 | 60% |
| 6-MAM 10 | 6-Monoacetylmorphine | 10 | 100% |
| 6-MAM 10 | Hydrocodone | >100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 100000 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug freepooled urine specimens. The concentrations of the samples were confirmed by LC-MS/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. The results are summarized below.

Result of AllTest Multi-Drug Rapid Test Cup: Configuration 1

Drug	Cutoff	Results	Concentration
------	--------	---------	---------------

18

	(ng/mL)		-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff
AMP	1000	Negative	20	20	20	19	1	0	0
	1000	Positive	0	0	0	1	19	20	20
	1000	Total	20	20	20	20	20	20	20
	1000	Agreement (%)	100%	100%	100%	95.0%	95.0%	100%	100%
BAR	300	Negative	20	20	20	19	1	0	0
	300	Positive	0	0	0	1	19	20	20
	300	Total	20	20	20	20	20	20	20
	300	Agreement (%)	100%	100%	100%	95.0%	95.0%	100%	100%
BZO	300	Negative	20	20	20	19	2	0	0
	300	Positive	0	0	0	1	18	20	20
	300	Total	20	20	20	20	20	20	20
	300	Agreement (%)	100%	100%	100%	95.0%	90.0%	100%	100%
BUP	10	Negative	20	20	20	19	2	0	0
	10	Positive	0	0	0	1	18	20	20
	10	Total	20	20	20	20	20	20	20
	10	Agreement (%)	100%	100%	100%	95.0%	90.0%	100%	100%
COC	300	Negative	20	20	20	19	1	0	0
	300	Positive	0	0	0	1	19	20	20
	300	Total	20	20	20	20	20	20	20
	300	Agreement (%)	100%	100%	100%	95.0%	95.0%	100%	100%
EDDP	300	Negative	20	20	20	19	1	0	0
	300	Positive	0	0	0	1	19	20	20
	300	Total	20	20	20	20	20	20	20
	300	Agreement (%)	100%	100%	100%	95.0%	95.0%	100%	100%
MDMA	500	Negative	20	20	20	19	2	0	0
	500	Positive	0	0	0	1	18	20	20
	500	Total	20	20	20	20	20	20	20
	500	Agreement (%)	100%	100%	100%	95.0%	90.0%	100%	100%
MET	1000	Negative	20	20	20	18	1	0	0
	1000	Positive	0	0	0	2	19	20	20
	1000	Total	20	20	20	20	20	20	20
	1000	Agreement (%)	100%	100%	100%	90.0%	95.0%	100%	100%
MOP	2000	Negative	20	20	20	18	1	0	0
	2000	Positive	0	0	0	2	19	20	20
	2000	Total	20	20	20	20	20	20	20
	2000	Agreement (%)	100%	100%	100%	90.0%	95.0%	100%	100%
MTD	300	Negative	20	20	20	18	1	0	0
	300	Positive	0	0	0	2	19	20	20
	300	Total	20	20	20	20	20	20	20
	300	Agreement (%)	100%	100%	100%	90.0%	95.0%	100%	100%
OXY	100	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%	95.0%	90.0%	100%	100%
	Negative	20	20	20	18	1	0	0
PCP	Positive	0	0	0	2	19	20	20
25	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90.0%	95.0%	100%	100%
	Negative	20	20	20	19	1	0	0
TCA	Positive	0	0	0	1	19	20	20
1000	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95.0%	95.0%	100%	100%
	Negative	20	20	20	18	1	0	0
THC	Positive	0	0	0	2	19	20	20
50	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90.0%	95.0%	100%	100%
	Negative	20	20	20	18	1	0	0
TRA	Positive	0	0	0	2	19	20	20
100	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90.0%	95.0%	100%	100%
	Negative	20	20	20	19	2	0	0
PPX	Positive	0	0	0	1	18	20	20
300	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95.0%	90.0%	100%	100%
	Negative	20	20	20	17	0	0	0
FYL	Positive	0	0	0	3	20	20	20
1	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	85.0%	100.0%	100%	100%
	Negative	20	20	20	18	2	0	0
6-MAM	Positive	0	0	0	2	18	20	20
10	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90.0%	90.0%	100%	100%
		Concentration
		Result of AllTest Multi-Drug Rapid Test Cup: Configuration 2

19

| Drug | Cutoff
(ng/mL) | Concentration | |---------------| | | cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff | |
| | | Positive | 0 | Total | 20 | Agreement (%) | 100% | BAR | 300 | | | | | | | | | | | BZO | 300 | | | | | | | BUP | 10 | | | | | | | COC | 150 | | | | | | | EDDP | 300 | | | | | | | MDMA | 500 | | | | | | | MET | 500 | | | | | | | MOP | 300 | | | | | | | MTD | 300 | | | | | | | OXY | 100 | | | | | | | PCP | 25 | | | | | | | TCA | | | THC | 50 | | | | | | | TRA | 100 | | | | | | | PPX | 300 | | | | | | | FYL | 1 | | | | | | | 6-MAM | 10 | | | | | | | | | | | | | |
-------------------|---------------|-----------------|----------------|----------------|----------------|----------------|----------------|----------------|---|
| Results | -100%
| | AMP | 500 | Negative | 20 | 20 | 20 | 18 | |
| 0 | | | 0 | 2 | 19 | 20 | 20 | |
| 20 | | | 20 | 20 | 20 | 20 | 20 | |
| 100% | | | 100% | 90.0% | 95.0% | 100% | 100% | |
| 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% | 95.0% | 90.0% | 100% | 100% | |
| | 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% | 95.0% | 95.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |
| 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% | 95.0% | 90.0% | 100% | 100% | |
| 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% | 95.0% | 90.0% | 100% | 100% | |
| 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% | 95.0% | 95.0% | 100% | 100% | |
| 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% | 95.0% | 95.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |
| 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% | 95.0% | 95.0% | 100% | 100% | |
| 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% | 95.0% | 95.0% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 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 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | |

20

21

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies: Not applicable.

13. Conclusion

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