Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a lateral flow immunochromatographic assay, which is a chemical and biological test method, not a software-based technology like AI/ML. The description focuses on the biological detection mechanism and performance studies comparing results to LC/MS and expected values, with no mention of computational analysis or algorithms.

Therapeutic

No
This device is an immunochromatographic assay for the qualitative and simultaneous detection of various drugs in human urine. It is used for diagnostic purposes (detection of substances), not for treating or preventing disease or affecting the structure/function of the body.

Diagnostic

Yes

Explanation: The device is described as "competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine". The explicit purpose is "qualitative and simultaneous detection" of these substances, which directly falls under the definition of diagnosis, aimed at identifying the presence of specific conditions or substances.

SaMD (Software as a Medical Device)

No

The device description explicitly states it comprises physical components like a urine collection cup, dip card with a plastic casing, and a quick cup test with a lateral flow device. These are hardware components, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states the device is for the "qualitative and simultaneous detection of [various drugs] in human urine." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of drugs).
Device Description: The description details an "immunochromatographic assay" that uses a "lateral flow system" to detect target analytes in "human urine." This further confirms it's a test performed on a biological sample.
Performance Studies: The document describes "Method comparison studies" and a "lay user study" where the device's results are compared to a reference method (LC/MS) using "clinical samples" and "urine samples." This type of testing and validation is standard for IVD devices.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (K142396) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

The fact that it's intended for both "over-the-counter and for prescription use" also aligns with the scope of IVD devices, which can be regulated for different levels of access.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Cannabinoids	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL or 2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL

Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter and for prescription use.

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

NFT, NFW, NFY, NGG, NGL, NFV, PTH, NGM, PTG

Device Description

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The AssureTech Panel Dip Tests comprise two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device. The AssureTech Quick Cup Tests comprise a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup.

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

for over-the-counter and for 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

Not Found

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

Analytical Performance
a. Precision: Studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative 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 two runs per day for 25 days per device in a randomized order. Results for Oxazepam, Methylenedioxy-methamphetamine and Morphine were summarized, with other data reported in K153465, K151211, K152025 and K161044.
b. Linearity: Not applicable.
c. Stability: The devices are stable at 4-30 degrees Celsius for 24 months based on accelerated stability study at 45 degrees Celsius and real time stability determination at both 4 degrees Celsius and 30 degrees Celsius.
d. Interference: Potential interfering substances found in human urine 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 batches of each device. No interference was observed for compounds at a concentration of 100 micrograms/mL (except for albumin at 100mg/dL).
e. Specificity: Drug metabolites and other components likely to interfere in urine samples were tested using three batches of each device. Lowest concentrations causing a positive result for Oxazepam, Methylenedioxy-methamphetamine, and Morphine were listed. Other data reported in K153465, K151211, K152025, and K161044. No differences observed for different devices.
f. Effect of Urine Specific Gravity and Urine pH: Urine samples with 1.000 to 1.035 specific gravity 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. All results were positive for samples at and above +25% Cut-Off and negative for samples at and below -25% Cut-Off. No differences were observed for different devices.
Comparison Studies
Method comparison studies were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. Samples were blind labeled and compared to LC/MS results. Results for Oxazepam, Methylenedioxy-methamphetamine, and Morphine are presented, with other data reported in K153465, K151211, K152025, and K161044.
Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at various concentrations by spiking drugs into drug-free pooled urine specimens. Concentrations were confirmed by LC/MS. Each participant was provided with the package insert, one blind labeled sample, and a device to test. Lay-users also completed surveys on the ease of understanding the package insert instructions, with all indicating the instructions were easily followed. A Flesch-Kincaid reading analysis showed a reading Grade Level of 7.

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

Discordant results listed for performance studies. Otherwise, individual test results are presented as number of positive/negative readings against LC/MS confirmed concentrations.

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.

K142396

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.

K153465, K151211, K152025, K161044

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2017

ASSURE TECH (HANGZHOU) CO., LTD. C/O JOE SHIA LSI INTERNATIONAL. INC 504 E DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K170049

Trade/Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: NFT, NFW, NFY, NGG, NGL, NFV, PTH, NGM, PTG Dated: March 18, 2017 Received: March 24, 2017

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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

1

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name AssureTech Panel Dip Tests AssureTech Quick Cup Tests

Indications for Use (Describe)

AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Cannabinoids	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL or 2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL

Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

April 21, 2017 1. Date: 2. Submitter: Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030 3. Contact person: Eric Lin Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake
- Economic Zone Hangzhou, China, 310030 Telephone: 510-860-4680 Email: customerservice@assurelabs.com.
1. Device Name: AssureTech Panel Dip Tests AssureTech Quick Cup Tests

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFT
Amphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology
(91)
NFW
Cannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology
(91)
NFY
Cocaine	II	21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System	Toxicology
(91)
NGG
Methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology
(91)
NGL
Morphine	II	21 CFR § 862.3650, Morphine Test System	Toxicology
(91)
NFV
Oxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology
(91)
NGL
Oxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology
(91)
PTH
Secobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology
(91)
NGL
Buprenorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology
(91)
NGG
Methylenedioxy-
methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology
(91)
NGM
Phencyclidine	unclassified	Enzyme Immunoassay
Phencyclidine	Toxicology
(91)
PTG
Methadone	II	21 CFR § 862.3620, Methadone Test System	Toxicology
(91)

1. Predicate Devices: K142396
  The Chemtrue® Multi-Panel Drug Screen Dip Card Tests

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6. Intended Use

AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL or 2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL

Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter and for prescription use.

7. Device Description

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The AssureTech Panel Dip Tests comprise two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device. The AssureTech Quick Cup Tests comprise a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup.

8. Substantial Equivalence Information

A summary comparison of features of the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests and the predicate devices is provided in following tables.

Table 1: Features Comparison of AssureTech Panel Dip Tests and the Predicate Devices

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Item	Device	Predicate - K142396
Indication(s)
for Use	For the qualitative determination of drugs of
abuse in human urine.	Same (but the number of
drugs detected is different)
Calibrator and
Cut-Off Values	Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine(COC): 300 ng/ml
Marijuana (THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOR): 300ng/mL or 2000 ng/ml
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-methamphetamine(MDMA):
500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml	Same
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 over-the-counter and prescription uses.	Same
Configurations	Dip Card, Cup	Dip Card

Table 2: Features Comparison of AssureTech Quick Cup Tests and the Predicate Devices

Item	Device	Predicate - K142396
Indication(s)	For the qualitative determination of	Same (but the number of
for Use	drugs of abuse in human urine.	drugs detected is different)

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| Calibrator and Cut-Off
Values | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine(COC): 300 ng/ml
Marijuana (THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOR): 300ng/mL or 2000 ng/ml
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-
methamphetamine(MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml | Same |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 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 over-the-counter and prescription | Same |
| Configurations | Dip Card, Cup | Dip Card |

9. Test Principle

The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone 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 antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative

8

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 two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in K153465, K151211, K152025 and K161044.

Oxazepam

Panel Dip

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off | Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

Methylenedioxy-methamphetamine

Panel Dip

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Morphine (300 ng/mL Cut-off)

Panel Dip

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

9

b. Linearity

Not applicable.

c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

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 batches of each device. Compounds that showed no interference at a concentration of 100µg/mL (except for albumin at 100mg/dL) are summarized in the following tables. There were no differences observed for different devices.

Acetominophen	Ecgonine methyl ester	D,L-Octopamine
Acetophenetidin	EMDP	Oxalic acid
N-Acetylprocainamide	Erythromycin	Oxolinic acid
Acetylsalicylic acid	ẞ-Estradiol	Oxymetazoline
Albumin (100mg/dL)	Fenoprofen	Papaverine
Aminopyrine	Furosemide	Penicillin-G
Amoxicillin	Gentisic acid	Perphenazine
Ampicillin	Hemoglobin	Phenelzine
Apomorphine	Hydralazine	Prednisone
Ascorbic acid	Hydrochlorothiazide	DL-Propranolol
Aspartame	Hydrocortisone	D-Pseudoephedrine
Atropine	O-Hydroxyhippuric acid	Quinine
Benzilic acid	3-Hydroxytyramine	Ranitidine
Benzoic acid	Ibuprofen	Salicylic acid
Bilirubin	D,L-Isoproterenol	Serotonin (5- Hydroxytyramine)
Chloralhydrate	Isoxsuprine	Sulfamethazine
Chloramphenicol	Ketamine	Sulindac
Chlorothiazide	Ketoprofen	Tetrahydrocortisone, 3-acetate
Chlorpromazine	Labetalol	Tetrahydrocortisone 3-(β-
		Dglucuronide)
Cholesterol	Loperamide	Tetrahydrozoline
Clonidine	Maprotiline	Thiamine
Cortisone	Meperidine	Thioridazine
(-) Cotinine	Meprobamate	Triamterene
Creatinine	Methoxyphenamine	DL-Tyrosine
Deoxycorticosterone	Nalidixic acid	Trifluoperazine
Dextromethorphan	Naloxone	Trimethoprim
Diclofenac	Naltrexone	D L-Tryptophan
Diflunisal	Naproxen	Tyramine
Digoxin	Niacinamide	Uric acid
Diphenhydramine	Nifedipine	Verapamil
Disopyramide	Norethindrone	Zomepirac
EDDP	Noscapine

e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere

10

in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in K153465, K151211, K152025 and K161044. There were no differences observed for different devices.

Oxazepam	Result	% Cross-Reactivity
(Cut-off=300 ng/mL)	Positive at (ng/mL)
Oxazepam	300	100%
Alprazolam	150	200%
a-Hydroxyalprazolam	1000	30%
Bromazepam	1000	30%
Chiordiazepoxide	63	476.2%
Clonazepam	2500	12%
Clobazam	75	400%
Clorazepate dipotassium	100	300%
Desalkylflurazepam	500	60%
Diazepam	500	60%
Estazolam	500	60%
Flunitrazepam	>50000	50000

The results summary for AMP:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS (ng/mL) | Lay person Results | |
|--------------|----------------------|----------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 248 | 0 | 20 |
| -50% Cutoff | 140 | 508 | 0 | 140 |
| -25% Cutoff | 20 | 752 | 1 | 19 |
| +25% Cutoff | 20 | 1255 | 19 | 1 |
| +50% Cutoff | 40 | 1506 | 40 | 0 |
| +75% Cutoff | 20 | 1748 | 20 | 0 |

The results summary for BAR:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 73 | 0 | 20 |
| -50% Cutoff | 140 | 151 | 0 | 140 |
| -25% Cutoff | 20 | 223 | 1 | 19 |
| +25% Cutoff | 20 | 378 | 20 | 0 |
| +50% Cutoff | 40 | 456 | 40 | 0 |
| +75% Cutoff | 20 | 521 | 20 | 0 |

The results summary for COC:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 76 | 0 | 20 |
| -50% Cutoff | 140 | 154 | 0 | 140 |
| -25% Cutoff | 20 | 222 | 1 | 19 |
| +25% Cutoff | 20 | 377 | 20 | 0 |
| +50% Cutoff | 40 | 452 | 40 | 0 |
| +75% Cutoff | 20 | 528 | 20 | 0 |

The results summary for BUP:

% of Cutoff	Number of	Drug Concentration by	Lay person Results
-------------	-----------	-----------------------	--------------------

15

	samples	LC/MS(ng/mL)	No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20
-75% Cutoff	20	2.6	0	20
-50% Cutoff	140	4.8	0	140
-25% Cutoff	20	7.2	2	18
+25% Cutoff	20	12.6	20	0
+50% Cutoff	40	15.4	40	0
+75% Cutoff	20	17.3	20	0

The results summary for MET:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 255 | 0 | 20 |
| -50% Cutoff | 140 | 496 | 0 | 140 |
| -25% Cutoff | 20 | 757 | 1 | 19 |
| +25% Cutoff | 20 | 1258 | 20 | 0 |
| +50% Cutoff | 40 | 1504 | 40 | 0 |
| +75% Cutoff | 20 | 1744 | 20 | 0 |

The results summary for MTD:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 73 | 0 | 20 |
| -50% Cutoff | 140 | 155 | 0 | 140 |
| -25% Cutoff | 20 | 228 | 0 | 20 |
| +25% Cutoff | 20 | 377 | 19 | 1 |
| +50% Cutoff | 40 | 454 | 40 | 0 |
| +75% Cutoff | 20 | 528 | 20 | 0 |

The results summary for MOR:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 77 | 0 | 20 |
| -50% Cutoff | 140 | 155 | 0 | 140 |
| -25% Cutoff | 20 | 227 | 1 | 19 |
| +25% Cutoff | 20 | 371 | 20 | 0 |
| +50% Cutoff | 40 | 447 | 40 | 0 |
| +75% Cutoff | 20 | 521 | 20 | 0 |

The results summary for OXY:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 20 | 0 |
| -75% Cutoff | 20 | 23 | 20 | 0 |

16

-50% Cutoff	140	53	0	140
-25% Cutoff	20	72	1	19
+25% Cutoff	20	128	19	1
+50% Cutoff	40	154	40	0
+75% Cutoff	20	171	20	0

The results summary for PCP :

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 7 | 0 | 20 |
| -50% Cutoff | 140 | 11 | 0 | 140 |
| -25% Cutoff | 20 | 18 | 2 | 18 |
| +25% Cutoff | 20 | 32 | 20 | 0 |
| +50% Cutoff | 40 | 39 | 40 | 0 |
| +75% Cutoff | 20 | 44 | 20 | 0 |

The results summary for THC:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 13 | 0 | 20 |
| -50% Cutoff | 140 | 24 | 0 | 140 |
| -25% Cutoff | 20 | 38 | 1 | 19 |
| +25% Cutoff | 20 | 64 | 19 | 1 |
| +50% Cutoff | 40 | 77 | 40 | 0 |
| +75% Cutoff | 20 | 86 | 20 | 0 |

The results summary for BZO:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 73 | 0 | 20 |
| -50% Cutoff | 140 | 146 | 0 | 140 |
| -25% Cutoff | 20 | 228 | 1 | 19 |
| +25% Cutoff | 20 | 377 | 20 | 0 |
| +50% Cutoff | 40 | 452 | 40 | 0 |
| +75% Cutoff | 20 | 519 | 20 | 0 |

The results summary for MDMA:

| % of Cutoff | Number of
samples | Drug Concentration by
LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 121 | 0 | 20 |
| -50% Cutoff | 140 | 253 | 0 | 140 |
| -25% Cutoff | 20 | 371 | 0 | 20 |
| +25% Cutoff | 20 | 628 | 19 | 1 |
| +50% Cutoff | 40 | 756 | 40 | 0 |

17

+75% Cutoff	20	879	20	0
-------------	----	-----	----	---

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.

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 AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are substantially equivalent to the predicate.