AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

• K Number: K181768
• Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
• Manufacturer: Assure Tech (Hangzhou) Co., Ltd.
• Date Cleared: 2018-08-20 ( 48 days)
• Product Code: NFT , NFV , NFW , NFY , NGG , NGL , NGM , PTG , PTH , QAW , QBF
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: K122809
• Predicate For: K201630 , K243996

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-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	500 ng/mL
Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	50 ng/mL
Methamphetamine	500 ng/mL
Morphine	300 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.

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

AI/ML Overview

The document describes the performance characteristics and studies for the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are qualitative drug detection devices for human urine.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically based on the correct classification of samples, especially around the cutoff concentration. The reported device performance is presented as the percentage of correct results at various concentrations relative to the cutoff. For the purpose of this table, "Acceptance Criteria" will be interpreted as the expectation of high accuracy, particularly at concentrations significantly above or below the cutoff, and reasonable performance around the cutoff. The data provided primarily focuses on the "lay-user study" for all drugs listed.

Drug (Cut-off level)	Test Type	Sample Concentration	Acceptance Criteria (Implied)	Reported Performance (Percentage of correct results)
Amphetamine (AMP - 500 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (132 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (262 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (381 ng/mL)	100% Negative	100% Negative (20/20)
		+25% Cutoff (637 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (765 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (884 ng/mL)	100% Positive	100% Positive (20/20)
Secobarbital (BAR - 300 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (80 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (160 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (229 ng/mL)	100% Negative	90% Negative (18/20)
		+25% Cutoff (368 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (447 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (528 ng/mL)	100% Positive	100% Positive (20/20)
Buprenorphine (BUP - 10 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (2.4 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (4.6 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (7.7 ng/mL)	100% Negative	95% Negative (19/20)
		+25% Cutoff (13.2 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (15.2 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (16.9 ng/mL)	100% Positive	100% Positive (20/20)
Oxazepam (BZO - 300 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (78 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (157 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (220 ng/mL)	100% Negative	100% Negative (20/20)
		+25% Cutoff (382 ng/mL)	100% Positive	100% Positive (20/20)
		+50% Cutoff (461 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (531 ng/mL)	100% Positive	100% Positive (20/20)
Cocaine (COC - 150 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (39 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (80 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (115 ng/mL)	100% Negative	100% Negative (20/20)
		+25% Cutoff (192 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (221 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (268 ng/mL)	100% Positive	100% Positive (20/20)
EDDP (300 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (73 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (154 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (231 ng/mL)	100% Negative	90% Negative (18/20)
		+25% Cutoff (376 ng/mL)	100% Positive	100% Positive (20/20)
		+50% Cutoff (464 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (533 ng/mL)	100% Positive	100% Positive (20/20)
Methylenedioxy-methamphetamine (MDMA - 500 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (122 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (265 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (386 ng/mL)	100% Negative	95% Negative (19/20)
		+25% Cutoff (633 ng/mL)	100% Positive	100% Positive (20/20)
		+50% Cutoff (768 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (890 ng/mL)	100% Positive	100% Positive (20/20)
Methamphetamine (MET - 500 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (134 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (259 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (383 ng/mL)	100% Negative	90% Negative (18/20)
		+25% Cutoff (637 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (771 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (889 ng/mL)	100% Positive	100% Positive (20/20)
Morphine (MOR - 300 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (78 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (154 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (229 ng/mL)	100% Negative	95% Negative (19/20)
		+25% Cutoff (369 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (457 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (530 ng/mL)	100% Positive	100% Positive (20/20)
Methadone (MTD - 300 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (73 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (146 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (232 ng/mL)	100% Negative	90% Negative (18/20)
		+25% Cutoff (379 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (446 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (521 ng/mL)	100% Positive	100% Positive (20/20)
Oxycodone (OXY - 100 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (28 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (48 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (79 ng/mL)	100% Negative	95% Negative (19/20)
		+25% Cutoff (129 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (147 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (179 ng/mL)	100% Positive	100% Positive (20/20)
Phencyclidine (PCP - 25 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (8 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (14 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (21 ng/mL)	100% Negative	90% Negative (18/20)
		+25% Cutoff (30 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (39 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (48 ng/mL)	100% Positive	100% Positive (20/20)
Propoxyphene (PPX - 300 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (71 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (152 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (228 ng/mL)	100% Negative	95% Negative (19/20)
		+25% Cutoff (382 ng/mL)	100% Positive	100% Positive (20/20)
		+50% Cutoff (455 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (522 ng/mL)	100% Positive	100% Positive (20/20)
Nortriptyline (TCA - 1000 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (265 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (514 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (763 ng/mL)	100% Negative	100% Negative (20/20)
		+25% Cutoff (1279 ng/mL)	100% Positive	100% Positive (20/20)
		+50% Cutoff (1531 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (1782 ng/mL)	100% Positive	100% Positive (20/20)
Marijuana (THC - 50 ng/mL)	Lay User	-100% Cutoff (0 ng/mL)	100% Negative	100% Negative (20/20)
		-75% Cutoff (14 ng/mL)	100% Negative	100% Negative (20/20)
		-50% Cutoff (27 ng/mL)	100% Negative	100% Negative (170/170)
		-25% Cutoff (39 ng/mL)	100% Negative	95% Negative (19/20)
		+25% Cutoff (60 ng/mL)	High Positive	95% Positive (19/20)
		+50% Cutoff (78 ng/mL)	100% Positive	100% Positive (40/40)
		+75% Cutoff (84 ng/mL)	100% Positive	100% Positive (20/20)

2. Sample Size Used for the Test Set and the Data Provenance

• Analytical Performance (Precision, Specificity, Interference, Effect of Urine Specific Gravity and pH):

  • Sample Size: For precision studies, samples were prepared at various concentrations (-100% to +100% cutoff). Each concentration was tested with 3 lots of devices, 2 runs per day for 25 days, resulting in 50 individual tests per concentration per lot (2 runs/day * 25 days = 50). This totals approximately 400 tests per drug per lot per device type (8 concentrations * 50 tests).
  • For Interference, Specificity, and Effect of Urine Specific Gravity/pH studies, urine samples were tested using three lots of each device at 25% below and 25% above Cut-Off levels (and drug-free urine for interference). Specific sample numbers are not explicitly stated for these sub-studies but imply multiple tests per lot.
  • Data Provenance: The analytical studies were performed in-house, meaning within the manufacturer's or an affiliated laboratory. The data is thus prospective for the purpose of these device validations. The "country of origin" is not explicitly stated for the source of base urine samples, but the manufacturer is based in Hangzhou, China. The drugs were "spiked" into negative samples.

• Comparison Studies (with GC/MS):

  • Sample Size: 80 unaltered clinical samples (40 negative and 40 positive) for each drug (AMP500, COC150, MET500) were used for each device (Panel Dip and Quick Cup).
  • Data Provenance: The samples were "unaltered clinical samples," implying these were real-world samples. The study was performed in-house. The country of origin of these clinical samples is not specified, but given the manufacturer's location, they are likely from China or a region where the manufacturer has access to clinical samples. This is a retrospective analysis against a gold standard.

• Lay-user study:

  • Sample Size: 310 lay persons for each device format (Panel Dip and Quick Cup). Urine samples were prepared at various concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of the cutoff). The exact breakdown of how these 310 lay users were distributed across the different concentrations is shown in the tables (e.g., for AMP, 20 samples at -100% Cutoff, 170 at -50% Cutoff, etc., which sums to 310).
  • Data Provenance: The urine samples were "spiked drugs into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared, not unaltered clinical samples. The study was conducted at "three intended user sites," but their location (country) is not specified. This is a prospective study using simulated clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Analytical Performance (Precision, Specificity, Interference): Ground truth established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical chemical method, not by human experts. The drug concentrations in spiked samples were confirmed by LC/MS.
• Comparison Studies (with GC/MS): Ground truth established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the gold standard confirmatory method for drug testing. This is a laboratory-based analytical method, not human expert interpretation.
• Lay-user study: Ground truth established by LC/MS to confirm the drug concentrations in the spiked urine samples.

It's important to note that for these in vitro diagnostic devices, the "experts" in establishing ground truth are typically the highly precise analytical instruments (GC/MS, LC/MS) not human readers as would be the case for imaging studies.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Analytical Performance & Lay-user study: No adjudication method explicitly described as the ground truth was an objective measurement by LC/MS. The results are compared directly to the known spiked concentrations confirmed by LC/MS.
• Comparison Studies (with GC/MS): No adjudication method explicitly described. The device results were compared directly against the GC/MS results. The "Viewers" (human operators) for the dip cards/quick cups for AMP, COC, and MET showed some discordant results with GC/MS, but there is no mention of a process to adjudicate these discrepancies among the viewers or with the GC/MS result.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. The device is a rapid test (lateral flow immunoassay) which relies on visual interpretation of lines, not complex image analysis or AI.
• The "Comparison Studies" involved three "laboratory assistants" (referred to as Viewer A, B, C) manually interpreting the device results against GC/MS. This is a multi-reader study, but it's not a comparative effectiveness study of human readers with vs. without AI. It assesses the consistency of human interpretation of the device results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. The devices are qualitative lateral flow immunoassays designed for human visual interpretation. They are not AI algorithms; their performance is intrinsically tied to human reading. The "Performance Characteristics" section covers the analytical performance of the device components themselves, independent of human interpretation to a logical degree (e.g., cross-reactivity, stability).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth used for all performance studies (Analytical Performance, Comparison Studies, and Lay-user study) was analytical confirmation by either LC/MS or GC/MS. These are highly sensitive and specific laboratory methods considered the gold standard for drug detection and quantification in urine.

8. The sample size for the training set

• The document describes the performance of a rapid diagnostic test device (immunoassay), not a machine learning or AI algorithm that typically requires a distinct training set. Therefore, there is no specific "training set" as understood in the context of AI/ML development mentioned for the device itself.
• The device's internal parameters (e.g., antibody binding characteristics) would be developed and optimized by the manufacturer during product development, but this process doesn't constitute a "training set" in the AI sense.

9. How the ground truth for the training set was established

• As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The device's performance is based on its inherent chemical and immunological properties.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 20, 2018

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

Re: K181768

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, NFY, NGG, NFW, NGL, NFV, PTH, NGM, PTG, OAW, OBF Dated: June 29, 2018 Received: July 19, 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. 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 located 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.

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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] 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) K181768

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	500 ng/mL
Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	50 ng/mL
Methamphetamine	500 ng/mL
Morphine	300 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.

{3}------------------------------------------------

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 [e-mail]

"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."

{4}------------------------------------------------

510(k) SUMMARY

• June 29, 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: [phone] Email: [e-mail].
• 4. Device Name: AssureTech Panel Dip Tests AssureTech Quick Cup Tests

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, AmphetamineTest System	Toxicology (91)
NFWCannabinoids	II	21 CFR § 862.3870, CannabinoidsTest System	Toxicology (91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine andCocaine Metabolites Test System	Toxicology (91)
NGGMethamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology (91)
NGLMorphine	II	21 CFR § 862.3650, MorphineTest System	Toxicology (91)
NFVOxazepam	II	21 CFR § 862.3170,Benzodiazepine Test System	Toxicology (91)
NGLOxycodone	II	21 CFR § 862.3650, Opiate TestSystem	Toxicology (91)
PTHSecobarbital	II	21 CFR § 862.3150, BarbiturateTest System	Toxicology (91)
NGLBuprenorphine	II	21 CFR § 862.3650,Opiate Test System	Toxicology (91)
NGGMethylenedioxy-methamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology (91)
NGMPhencyclidine	unclassified	Enzyme ImmunoassayPhencyclidine	Toxicology (91)
PTGMethadone	II	21 CFR § 862.3620, MethadoneTest System	Toxicology (91)

{5}------------------------------------------------

PTG2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP)	II	21 CFR § 862.3620, MethadoneTest System	Toxicology (91)
QAWNortriptyline	II	21 CFR, 862.3910 TricyclicAntidepressant Drugs Test System	Toxicology (91)
QBFPropoxyphene	II	21 CFR, 862.3700 PropoxypheneTest System	Toxicology (91)

5. Predicate Devices: K122809

The Advin Multi-Drug Screen Tests

• 6. 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	500 ng/mL
Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	50 ng/mL
Methamphetamine	500 ng/mL
Morphine	300 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. 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.

{6}------------------------------------------------

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, 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

• 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.

Item	Device	Predicate - K122809
Indication(s)for Use	For the qualitative determination of drugs ofabuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator andCut-Off Values	Amphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 150 ng/mlMarijuana (THC):50 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOR): 300ng/mL or 2000 ng/mlOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlBuprenorphine (BUP): 10 ng/mlMethylenedioxy-methamphetamine(MDMA):500 ng/mlPhencyclidine (PCP): 25 ng/mlMethadone (MTD): 300 ng/ml2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP): 300 ng/mlNortriptyline (TCA): 1000 ng/mlPropoxyphene (PPX): 300 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Dip Card	Same

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

{7}------------------------------------------------

Item	Device	Predicate - K122809
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator and Cut-OffValues	Amphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 150 ng/mlMarijuana (THC):50 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOR): 300ng/mL or 2000 ng/mlOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlBuprenorphine (BUP): 10 ng/mlMethylenedioxy-methamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlMethadone (MTD): 300 ng/ml2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP): 300 ng/mlNortriptyline (TCA): 1000 ng/mlPropoxyphene (PPX): 300 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Cup	Same

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

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 drug-conjugate and a visible colored line will show up in the test line region. The colored line

{8}------------------------------------------------

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 Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500). The rest data were reported in the K180349.

AMP500

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+	8-/42+	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+	9-/41+	50+/0-	50+/0-	50+/0-	50+/0-

Quick Cup

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	7-/43+	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	9-/41+	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	8-/42+	50+/0-	50+/0-	50+/0-

COC150

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+	13-/37+	50+/0-	50+/0-	50+/0-	50+/0-

LotNumber	-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+	7-/43+	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-

MET500

Panel Dip

{9}------------------------------------------------

Lot	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	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+	12-/38+	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-
Quick Cup
Lot	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	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+	13-/37+	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 lots of each device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL) are summarized in the following table. 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 lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500). The rest data were reported in the K180349. There were no differences observed for different devices.

AMP500	Result	% Cross-Reactivity
(Cut-off=500 ng/mL)	Positive at (ng/mL)
D - Amphetamine	500	100%
L - Amphetamine	10000	5%
DL - Amphetamine	1200	42%
Phentermine	15000	3.3%
Hydroxyamphetamine	4000	12.5%
Methylenedioxyamphetamine (MDA)	500	100%
d-Methamphetamine	>100000	<0.5%
1-Methamphetamine	>100000	<0.5%
Ephedrine	>100000	<0.5%
Methylenedioxyethylamphetamine (MDE)	>100000	<0.5%
3,4-methylenedioxy-methamphetamine (MDMA)	>100000	<0.5%

Cocaine(Cut-off=150 ng/mL)	ResultPositive at (ng/mL)	% Cross-Reactivity
Benzoylecgonine	150	100%
Cocaine HCl	500	30%
Cocaethylene	7500	2%
Ecgonine	15000	1%
Norcocaine	50000	0.3%

Methamphetamine(Cut-off=500 ng/mL)	ResultPositive at (ng/ml)	% Cross-Reactivity
D(+)-Methamphetamine	500	100%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	5000	10%
D/L-Methamphetamine	500	100%
p-Hydroxymethamphetamine	5000	10%
D-Amphetamine	>100000	<0.5%
L-Amphetamine	>100000	<0.5%
Chloroquine	40000	1.25%
(+/-)-Ephedrine	2000	25%
L-Methamphetamine	5000	10%
(+/-)3,4-Methylenedioxyamphetamine (MDA)	>100000	<0.5%
(+/-)3,4-methylenedioxymethamphetamine (MDMA)	5000	10%
β -Phenylethylamine	4000	12.5%
Trimethobenzamide	10000	5%

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of

{11}------------------------------------------------

each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

2. Comparison Studies

Method comparison studies for the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests 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. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below for Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500). The rest data were reported in the K180349.

AMP500

PanelDip		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	14	26
ViewerA	Negative	10	20	9	0	0
ViewerB	Positive	0	0	1	14	26
ViewerB	Negative	10	20	9	0	0
ViewerC	Positive	0	0	0	14	26
ViewerC	Negative	10	20	10	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip Card Viewer Results
Viewer A	7042	498	Positive
Viewer B	7042	498	Positive

QuickCup		Negative	Low Negative byLC/MS(less than -50%)	Near Cutoff Negative byLC/MS(Between -50% andcutoff)	Near Cutoff Positive byLC/MS(Between thecutoff and +50%)	High Positiveby LC/MS(greater than +50%)
ViewerA	Positive	0	0	0	15	25
ViewerA	Negative	10	20	10	0	0
ViewerB	Positive	0	0	1	14	25
ViewerB	Negative	10	20	9	1	0
ViewerC	Positive	0	0	1	14	25
ViewerC	Negative	10	20	9	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Quick CupViewer Results
--------	---------------	--------------	-----------------------------

{12}------------------------------------------------

Viewer B	7042	498	Positive
Viewer C	7042	498	Positive

COC150

PanelDip		Negative	Low Negative byLC/MS(less than -50%)	Near Cutoff Negative byLC/MS(Between -50% andcutoff)	Near Cutoff Positive byLC/MS(Between the cutoff and+50%)	High Positiveby LC/MS(greater than +50%)
ViewerA	Positive	0	0	0	14	26
	Negative	10	20	10	0	0
ViewerB	Positive	0	0	0	13	26
	Negative	10	20	10	1	0
ViewerC	Positive	0	0	0	14	26
	Negative	10	20	10	0	0

Discordant Results
--------------------	--

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer B	8026	172	Negative

Quick Cup	Viewer	Negative	Low Negative by LC/MS(less than -50%)	Near Cutoff Negative by LC/MS(Between -50% and cutoff)	Near Cutoff Positive by LC/MS(Between the cutoff and +50%)	High Positive by LC/MS(greater than +50%)
A	Positive	0	0	0	14	26
	Negative	10	20	10	0	0
B	Positive	0	0	0	14	26
	Negative	10	20	10	0	0
C	Positive	0	0	0	14	26
	Negative	10	20	10	0	0

MET500

PanelDip		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	0	14	26
	Negative	10	20	10	0	0
Viewer	Positive	0	0	0	13	26

{13}------------------------------------------------

B	Negative	10	20	10	1	0
Viewer	Positive	0	0	0	13	26
C	Negative	10	20	10	1	0

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer B	9072	520	Negative
Viewer C	9036	520	Negative

QuickCup	Negative	Low Negative byLC/MS(less than -50%)	Near Cutoff Negative byLC/MS(Between -50% andcutoff)	Near Cutoff Positive byLC/MS(Between thecutoff and +50%)	High Positiveby LC/MS(greater than +50%)
ViewerA	Positive	0	0	0	13	26
	Negative	10	20	10	1	0
ViewerB	Positive	0	0	0	13	26
	Negative	10	20	10	1	0
ViewerC	Positive	0	0	0	14	26
	Negative	10	20	10	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Quick CupViewer Results
Viewer A	9063	531	Negative
Viewer C	9036	520	Negative

Lay-user study

A lay user study was performed at three intended user sites with 310 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 the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. 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	132	0	20	100
-50% Cutoff	170	262	0	170	100
-25% Cutoff	20	381	0	20	100
+25% Cutoff	20	637	19	1	95
+50% Cutoff	40	765	40	0	100

{14}------------------------------------------------

+75% Cutoff	20	884	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	80	0	20	100
-50% Cutoff	170	160	0	170	100
-25% Cutoff	20	229	2	18	90
+25% Cutoff	20	368	19	1	95
+50% Cutoff	40	447	40	0	100
+75% Cutoff	20	528	20	0	100

The results summary for BUP:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	2.4	0	20	100
-50% Cutoff	170	4.6	0	170	100
-25% Cutoff	20	7.7	1	19	95
+25% Cutoff	20	13.2	19	1	95
+50% Cutoff	40	15.2	40	0	100
+75% Cutoff	20	16.9	20	0	100

The results summary for BZO:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	78	0	20	100
-50% Cutoff	170	157	0	170	100
-25% Cutoff	20	220	0	20	100
+25% Cutoff	20	382	20	0	100
+50% Cutoff	40	461	40	0	100
+75% Cutoff	20	531	20	0	100

The results summary for COC:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	39	0	20	100
-50% Cutoff	170	80	0	170	100
-25% Cutoff	20	115	0	20	100
+25% Cutoff	20	192	19	1	95
+50% Cutoff	40	221	40	0	100

{15}------------------------------------------------

+75% Cutoff	20	268	20	0	100
The results summary for EDDP:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	73	0	20	100
-50% Cutoff	170	154	0	170	100
-25% Cutoff	20	231	2	18	90
+25% Cutoff	20	376	20	0	100
+50% Cutoff	40	464	40	0	100
+75% Cutoff	20	533	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 correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	122	0	20	100
-50% Cutoff	170	265	0	170	100
-25% Cutoff	20	386	1	19	95
+25% Cutoff	20	633	20	0	100
+50% Cutoff	40	768	40	0	100
+75% Cutoff	20	890	20	0	100

The results summary for MET:

% of Cutoff	Number of samples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	134	0	20	100
-50% Cutoff	170	259	0	170	100
-25% Cutoff	20	383	0	20	90
+25% Cutoff	20	637	19	1	95
+50% Cutoff	40	771	40	0	100
+75% Cutoff	20	889	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 correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	78	0	20	100
-50% Cutoff	170	154	0	170	100
-25% Cutoff	20	229	1	19	95
+25% Cutoff	20	369	19	1	95
+50% Cutoff	40	457	40	0	100

{16}------------------------------------------------

+75% Cutoff	20	530	20	0	100
The results summary for MTD:

% of Cutoff	Number of samples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	73	0	20	100
-50% Cutoff	170	146	0	170	100
-25% Cutoff	20	232	0	20	90
+25% Cutoff	20	379	19	1	95
+50% Cutoff	40	446	40	0	100
+75% Cutoff	20	521	20	0	100

The results summary for OXY:

% of Cutoff	Number of samples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	20	0	100
-75% Cutoff	20	28	20	0	100
-50% Cutoff	170	48	0	170	100
-25% Cutoff	20	79	1	19	95
+25% Cutoff	20	129	19	1	95
+50% Cutoff	40	147	40	0	100
+75% Cutoff	20	179	20	0	100

The results summary for PCP:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
-100% Cutoff	20	0	No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	8	0	20	100
-50% Cutoff	170	14	0	170	100
-25% Cutoff	20	21	2	18	90
+25% Cutoff	20	30	19	1	95
+50% Cutoff	40	39	40	0	100
+75% Cutoff	20	48	20	0	100

The results summary for PPX:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentage
			No. ofPositive	No. ofNegative	of correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	71	0	20	100
-50% Cutoff	170	152	0	170	100
-25% Cutoff	20	228	1	19	95
+25% Cutoff	20	382	20	0	100
+50% Cutoff	40	455	40	0	100

{17}------------------------------------------------

+75% Cutoff	20	522	20	0	100
The results summary for TCA:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentage
			No. ofPositive	No. ofNegative	of correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	265	0	20	100
-50% Cutoff	170	514	0	170	100
-25% Cutoff	20	763	0	20	100
+25% Cutoff	20	1279	20	0	100
+50% Cutoff	40	1531	40	0	100
+75% Cutoff	20	1782	20	0	100

The results summary for THC:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	14	0	20	100
-50% Cutoff	170	27	0	170	100
-25% Cutoff	20	39	1	19	95
+25% Cutoff	20	60	19	1	95
+50% Cutoff	40	78	40	0	100
+75% Cutoff	20	84	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.

3. 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.

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).