Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on immunochromatographic assays and manual interpretation of results, with no mention of AI or ML for analysis or interpretation.

Therapeutic

No.
The device is an in vitro diagnostic assay used for qualitative and simultaneous detection of various drugs in human urine, which provides preliminary test results and is not intended for treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." Additionally, the "Device Description" identifies the products as "single-use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is an immunochromatographic assay that uses a lateral flow system and comes in the format of Panel Dip Cards or Cups, which are physical hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
Device Description: The "Device Description" section describes the products as "single-use in vitro diagnostic devices".
Nature of the Test: The device performs a test on a biological sample (human urine) to detect the presence of specific substances (drugs). This is a core characteristic of an in vitro diagnostic test.
Intended Use: The intended use is for the qualitative and simultaneous detection of various drugs in human urine, which is a diagnostic purpose.

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, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene 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
EDDP	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	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, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

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

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

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, Methadone, EDDP, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. 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

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For over-the-counter 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:
- Precision: Studies were done with samples at -100%, -75%, -50%, -25%, +25%, +50%, +75%, and +100% cut-off concentrations. Samples were prepared by spiking drug into negative samples, and concentrations were confirmed by LC/MS. Samples were blindly labeled. Tests were performed two runs per day for 25 days per device in a randomized order. Results for EDDP, Nortriptyline (TCA), and Propoxyphene (PPX) were summarized in tables, with most concentrations showing 50-/0+ (negative) or 50+/0- (positive) results, and varying pass/fail rates at the cut-off (e.g., for EDDP Panel Dip, Lot 1 showed 9-/41+ at cut-off).
- Stability: Devices are stable at 4-30 ℃ for 24 months based on accelerated stability study at 45 ℃ and real-time stability determination at both 4 ℃ and 30 ℃.
- Interference: Potential interfering substances (physiological or pathological) were added to drug-free urine and target drug urine (at 25% below and 25% above cut-off). These samples were tested using three batches of each device. Compounds (listed in tables) showed no interference at 100µg/mL (albumin at 100 mg/dL). No differences observed for different devices.
- Specificity: Drug metabolites and other potential interfering components were tested using three batches of each device. The lowest concentration causing a positive result for each compound was listed for EDDP, Nortriptyline (TCA), and Propoxyphene (PPX), along with their cross-reactivity percentages. No differences observed for different devices.
- 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. 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 observed for different devices.
Comparison Studies:
- In-house studies performed with three laboratory assistants for each device.
- Sample Size: 80 (40 negative and 40 positive) unaltered clinical samples for each drug per viewer.
- Data Source: Clinical samples confirmed by LC/MS. Samples were blind labeled.
- **Results for EDDP, Nortriptyline (TCA), and Propoxyphene (PPX) are presented in tables showing: **
  - Panel Dip and Quick Cup results (Positive/Negative counts) for Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, and High Positive by LC/MS.
  - Discordant results tables list specific sample numbers, LC/MS results, and viewer results. For example, for EDDP Panel Dip, one discordant result for Viewer A was Sample 24973 (LC/MS 308, Dip Card Viewer Results Negative).
Lay-user study:
- Sample Size: 310 lay persons for each device format.
- Data Source: Urine samples prepared at concentrations of negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens. Concentrations confirmed by LC/MS. Samples were aliquoted into individual containers and blind-labeled.
- Annotation Protocol: Each participant received the package insert, 1 blind labeled sample, and a device.
- Key Results: Typical results (number of positive/negative, percentage of correct results) are shown for AMP, BAR, COC, BUP, MET, MTD, MOR, OXY, PCP, THC, BZO, MDMA, TCA, EDDP, and PPX. Most concentrations showed 100% correct results, with some at -25% Cutoff and +25% Cutoff showing 90-95% correct results for various analytes (e.g., AMP at -25% Cutoff: 95% correct, +25% Cutoff: 95% correct).
- Lay users found the instructions easy to follow. Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert.

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

Not Found

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.

K153050

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.

K170049

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

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April 5, 2018

Assure Tech (Hangzhou) Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave, Suite I Gaithersburg, MD 20877

Re: K180349

Trade/Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGL, NFV, PTH, NGM, PTG, QAW, QBF Dated: February 5, 2018 Received: February 8, 2018

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 Part 801 and Part 809); medical device 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

1

Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Kellie B. Kelm -S

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

Enclosure

2

Indications for Use

510(k) Number (if known) K180349

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, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene 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
EDDP	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	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, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

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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K180349 510(k) SUMMARY

Email: customerservice@assurelabs.com.

March 13, 2018 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
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)

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| PTG
2-ethylidene-1, 5-
dimethyl-3, 3-
diphenylpyrrolidine
(EDDP) | II | 21 CFR § 862.3620, Methadone
Test System | Toxicology (91) |
|------------------------------------------------------------------------------|----|----------------------------------------------------------------|-----------------|
| QAW
Nortriptyline | II | 21 CFR, 862.3910 Tricyclic
Antidepressant Drugs Test System | Toxicology (91) |
| QBF
Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene
Test System | Toxicology (91) |

1. Predicate Devices: K153050
  The CO-INNOVATION BIOTECH Rapid Multi-Drug Test Dip Card and Rapid Multi-Drug Test Cup
1. 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, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene 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
EDDP	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	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 vield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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. For in vitro diagnostic use only.

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1. 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, Methadone, EDDP, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
1. 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.

Item	Device	Predicate - K153050
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
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 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	Same

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

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Configurations	Dip Card	Same
----------------	----------	------

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

Item	Device	Predicate - K153050
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
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 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	Same
Configurations	Cup	Same

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, Methadone, EDDP, Nortriptyline and Propoxyphene 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

8

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
- Precision 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. The results obtained are summarized in the following tables for 2ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), Nortriptyline (TCA) and Propoxyphene (PPX). The rest data were reported in the K170049.

EDDP

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+ | 9-/41+ | 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- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 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+ | 10-/40+ | 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- |

Nortriptyline

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+ | 10-/40+ | 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+ | 10-/40+ | 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+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Propoxyphene

Panel Dip

9

| 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+ | 12-/38+ | 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+ | 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+ | 8-/42+ | 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- |

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 (albumin was tested at 100 mg/dL) are summarized in the following tables. There were no differences observed for different devices.

Acetaminophen	β-Estradiol	Oxalic acid
Acetophenetidin	Erythromycin	Oxolinic acid
N-Acetylprocainamide	Fenoprofen	Oxymetazoline
Acetylsalicylic acid	Furosemide	Papaverine
Albumin (100 mg/dL)	Gentisic acid	Penicillin G
Aminopyrine	Hemoglobin	Perphenazine
Amoxicillin	Hydralazine	Phenelzine
Ampicillin	Hydrochlorothiazide	Prednisone
Apomorphine	Hydrocortisone	(±)-Propranolol
Ascorbic acid	O-Hydroxyhippuric acid	Pseudoephedrine
Aspartame	3-Hydroxytyramine	Quinine
Atropine	Ibuprofen	Ranitidine
Benzilic acid	Isoproterenol	Salicylic acid
Benzoic acid	Isoxsuprine	Serotonin (5- Hydroxytyramine)
Bilirubin	Ketamine	Sulfamethazine
Chloral hydrate	Ketoprofen	Sulindac
Chloramphenicol	Labetalol	Tetrahydrocortisone 3-(β-
Dglucuronide)
Chlorothiazide	Loperamide	Tetrahydrocortisone 3-acetate
Chlorpromazine	Meperidine	Tetrahydrozoline
Cholesterol	Meprobamate	Thiamine
Clonidine	Methoxyphenamine	Thioridazine
Cortisone	Nalidixic acid	Triamterene
(-)-Cotinine	Naloxone	Trifluoperazine
Creatinine	Naltrexone	Trimethoprim
Deoxycorticosterone	Naproxen	DL-Tryptophan
Dextromethorphan	Niacinamide	Tyramine

10

Diclofenac	Nifedipine	DL-Tyrosine
Diflunisal	Norethindrone	Uric acid
Digoxin	Noscapine	Verapamil
Diphenhydramine	(±)-Octopamine	Zomepirac
Ecgonine methyl ester

e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere 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 2-ethylidene-1. 5dimethyl-3, 3-diphenylpyrrolidine (EDDP), Nortriptyline (TCA) and Propoxyphene (PPX). The rest data were reported in the K170049. There were no differences observed for different devices.

| EDDP
(Cut-off=300 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|-------------------------------------------------------------|-------------------------------|--------------------|
| EDDP(2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine) | 300 | 100% |
| EMDP (2-Ethyl-5-methyl-3,3-
diphenylpyrroline) | >100000 | 100000 | 100000 | 100000 | 100000 | 50 years. Urine samples were prepared at the following concentrations; negative,

14

+/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Typical results are shown below. The results summary for AMP:

% of Cutoff	Number of samples	Drug Concentration by LC/MS (ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	248	0	20	100
-50% Cutoff	170	508	0	170	100
-25% Cutoff	20	752	1	19	95
+25% Cutoff	20	1255	19	1	95
+50% Cutoff	40	1506	40	0	100
+75% Cutoff	20	1748	20	0	100

The results summary for BAR:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 151 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 223 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 378 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 456 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 521 | 20 | 0 | 100 |

The results summary for COC:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|------------------------------------------|-------------------------|--------------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive
0 | No. of
Negative
20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 154 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 222 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 377 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 528 | 20 | 0 | 100 |

The results summary for BUP:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 2.6 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 4.8 | 0 | 170 | 100 |

15

| -25% Cutoff | 20 | С Г
لك ه | | 19 | તેર |
|-------------|----|-------------|----|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| +25% Cutoff | 20 | 12.6 | 19 | | તેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ મુખ્યત્વે આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય |
| +50% Cutoff | 40 | 15.4 | 40 | | 100 |
| +75% Cutoff | 20 | 17.3 | 20 | | 100 |

The results summary for MET:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of
Positive | No. of
Negative | correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 255 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 496 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 757 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1258 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1504 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1744 | 20 | 0 | 100 |

The results summary for MTD:

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	73	0	20	100
-50% Cutoff	170	155	0	170	100
-25% Cutoff	20	228	1	19	95
+25% Cutoff	20	377	19	1	95
+50% Cutoff	40	454	40	0	100
+75% Cutoff	20	528	20	0	100

The results summary for MOR:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of
Positive | No. of
Negative | correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 77 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 155 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 227 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 371 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 521 | 20 | 0 | 100 |

The results summary for OXY:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 20 | 0 | 100 |
| -75% Cutoff | 20 | 23 | 20 | 0 | 100 |
| -50% Cutoff | 170 | 53 | 0 | 170 | 100 |

16

-25% Cutoff	20	72	1	19	95
+25% Cutoff	20	128	19	1	95
+50% Cutoff	40	154	40	0	100
+75% Cutoff	20	171	20	0	100

The results summary for PCP:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 7 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 11 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 18 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 32 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 39 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100 |

The results summary for THC:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 24 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 38 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 64 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 77 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 86 | 20 | 0 | 100 |

The results summary for BZO:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------|
| | | | No. of
Positive | No. of
Negative | correct results (%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 146 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 228 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 377 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 519 | 20 | 0 | 100 |

The results summary for MDMA:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of
Positive | No. of
Negative | correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 121 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 253 | 0 | 170 | 100 |

17

-25% Cutoff	20	371	1	19	95
+25% Cutoff	20	628	19	1	95
+50% Cutoff	40	756	40	0	100
+75% Cutoff	20	879	20	0	100

The results summary for TCA:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results (%) |
|--------------|----------------------|---------------------------------------|--------------------|-----|------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 254 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 505 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 755 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1258 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1508 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1745 | 20 | 0 | 100 |

The results summary for EDDP:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 148 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 228 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 373 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 523 | 20 | 0 | 100 |

The results summary for PPX:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 154 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 228 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 378 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 453 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 523 | 20 | 0 | 100 |

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.

18

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.