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

Device Description

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

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

AI/ML Overview

The provided text describes the performance characteristics and acceptance criteria for the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are qualitative drug screening devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically defined by the performance at and around the cutoff concentration. The data presented shows excellent performance for samples well below and well above the cutoff, with some expected variability around the cutoff.

The tables provide the raw results rather than a single aggregated performance metric (like accuracy, sensitivity, or specificity relative to a cutoff for the entire dataset). However, we can infer the performance based on these results. For samples significantly below the cutoff, the device should consistently report negative results. For samples significantly above the cutoff, it should consistently report positive results. Near the cutoff, there's a transition zone where both positive and negative results are expected, and the reported numbers reflect this.

Let's illustrate with an example for Oxazepam (-25% cutoff, which is 225 ng/mL). The "Panel Dip" table shows for Lot 1: 9-/41+ (9 negative, 41 positive out of 50 samples). This means 41 samples with concentrations at 225 ng/mL were correctly identified as positive (or transitioning to positive). Similarly, for +25% cut off (375 ng/mL), it's 50+/0- (50 positive, 0 negative), indicating consistent positive detection.

Here's a summary table derived from the provided precision data for Oxazepam, Methylenedioxy-methamphetamine, and Morphine, illustrating the device performance relative to the acceptance criteria (consistent results at extremes, transition near cutoff). The "acceptance criteria" for these qualitative tests at different concentration levels are implied by the expected outcome (all negative for greatly reduced concentrations, all positive for greatly increased concentrations, and a mix near the cutoff).

Inferred Acceptance Criteria vs. Reported Performance (from Precision Studies)

Drug Analyte	Concentration Relative to Cut-off	Inferred Acceptance Criteria (Expected Outcome)	Reported Performance (Combined Across 3 Lots, Sample Size 150)
Oxazepam	-100% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-75% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-50% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-25% cut off	Predominantly Negative, some Positive (Transition Zone)	Panel Dip: 29-/121+Quick Cup: 28-/122+
	+25% cut off	Predominantly Positive, some Negative (Transition Zone)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+50% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+75% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+100% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
Methylenedioxy-methamphetamine	-100% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-75% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-50% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-25% cut off	Predominantly Negative, some Positive (Transition Zone)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	Cut off (0%)	Transition Zone	Panel Dip: 35-/115+Quick Cup: 32-/118+
	+25% cut off	Predominantly Positive, some Negative (Transition Zone)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+50% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+75% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+100% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
Morphine (300 ng/mL Cut-off)	-100% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-75% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-50% cut off	100% Negative (150-/0+)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	-25% cut off	Predominantly Negative, some Positive (Transition Zone)	Panel Dip: 150-/0+Quick Cup: 150-/0+
	Cut off (0%)	Transition Zone	Panel Dip: 33-/117+Quick Cup: 26-/114+
	+25% cut off	Predominantly Positive, some Negative (Transition Zone)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+50% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+75% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-
	+100% cut off	100% Positive (150+/0-)	Panel Dip: 150+/0-Quick Cup: 150+/0-

Note on Acceptance Criteria: For qualitative tests like these, the acceptance criteria are generally that samples significantly below the cutoff (e.g., -50% to -100% of cutoff) should consistently yield negative results and samples significantly above the cutoff (e.g., +50% to +100% of cutoff) should consistently yield positive results. Around the cutoff (e.g., +/- 25% of cutoff), a mix of positive and negative results is expected, demonstrating the device's ability to discriminate at the threshold. The reported data generally supports this behavior.

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

Precision Studies (Test Set):
- For each drug and each concentration point (-100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% cut off), and for each device (Panel Dip, Quick Cup), 50 samples per lot (2 runs per day for 25 days) for 3 lots were tested.
- Total samples per drug/concentration point/device: 50 samples/lot * 3 lots = 150 samples.
- Data Provenance: Samples were prepared by spiking drug in negative urine samples, and concentrations were confirmed by LC/MS. "In-house" studies are mentioned for comparison studies, suggesting the data was generated within the company or a collaborating lab. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though the precision studies appear prospective due to the controlled spiking and testing regimen.
Comparison Studies (Test Set):
- For each drug and each device (Panel Dip, Quick Cup): 80 unaltered clinical samples (40 negative and 40 positive).
- Data Provenance: "In-house" studies. Samples were "unaltered clinical samples", meaning they were real patient samples, and were blind labeled. The origin (country/retrospective/prospective) is not explicitly stated.
Lay-user Study (Test Set):
- For each device format (Panel Dip, Quick Cup): 280 lay persons per device format participated.
- Urine samples were prepared at various concentrations (-100% Cutoff, -75% Cutoff, -50% Cutoff, -25% Cutoff, +25% Cutoff, +50% Cutoff, +75% Cutoff). The sample count varies for each concentration, but the total across all concentrations sums to 280 (e.g., 20+20+140+20+20+40+20 = 280) for each drug.
- Data Provenance: "Lay users" at "three intended user sites." The data was generated in a controlled manner (spiking drugs into pooled urine, blind labeling, LC/MS confirmation). The document does not specify country.

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

Precision Studies: Ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical method used for confirming drug concentrations. This is a highly accurate chemical method, not human expert consensus for visual interpretation.
Comparison Studies: Ground truth was established by LC/MS results.
Lay-user Study: Ground truth for sample concentrations was established by LC/MS.

No human experts were used to establish the ground truth in terms of visual interpretation for these studies as the ground truth was based on quantitative chemical analysis.

4. Adjudication Method for the Test Set

Precision, Comparison, and Lay-user Studies: The ground truth for the spiked samples was determined by LC/MS. For the comparison studies, the "unaltered clinical samples" were also compared to "LC/MS results" as the ground truth.
In the comparison studies, three laboratory assistants observed the results. The discordant results (where the viewer's result differed from the LC/MS) are listed in tables.
No explicit "adjudication method" among human viewers (like 2+1 or 3+1 consensus) is described, as the ultimate ground truth was LC/MS. The individual viewer results are presented and compared against this gold standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, a typical MRMC comparative effectiveness study, which usually involves multiple human readers interpreting medical images or data with and without AI assistance to measure improvement, was not performed.
This device is a qualitative drug screening test, where the result is a visible line (or absence of a line). The "readers" in the "Comparison Studies" are "laboratory assistants" observing these lines, not interpreting complex medical images. The study's focus is on the device's accuracy against a chemical gold standard, not human reader performance improvement with AI.

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

Yes, for all studies (Precision, Comparison, Lay-user), the device operates in a standalone manner. The "human-in-the-loop" is simply reading the visual indicator (lines) produced by the device, not an "algorithm" making a diagnostic prediction that is then confirmed or refined by a human. The device itself is the "algorithm" in that it performs the chemical assay. The comparison data shows the device's inherent ability to produce the correct qualitative result based on the chemical content, which is then visually interpreted.

7. The Type of Ground Truth Used

The primary type of ground truth used for all performance evaluations (precision, specificity, interference, comparison, and lay-user studies) was quantitative chemical analysis, specifically Liquid Chromatography/Mass Spectrometry (LC/MS). For the precision studies, concentrations were confirmed by LC/MS, and for the comparison studies, clinical samples were compared to LC/MS results.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a diagnostic device. Such devices are typically developed, manufactured, and validated based on established chemical and immunological principles. They do not involve "training sets" in the context of machine learning or AI models.
The "training" for such devices is in the design, formulation, and manufacturing process to ensure consistent chemical reactivity. There is no explicit "training set" of data points in the same sense as for an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

As stated above, there is no "training set" in the AI/ML sense for this type of device. The "ground truth" for developing the device would involve chemical principles, experimental optimization of reagents and concentrations, and quality control measures during manufacturing. This is a traditional immunoassay, not an AI/ML product.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

May 2, 2017

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

Re: K170049

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

Dear Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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

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

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

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

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

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

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

Sincerely yours,

Courtney H. Lias -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name AssureTech Panel Dip Tests AssureTech Quick Cup Tests

Indications for Use (Describe)

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

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

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{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 PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) SUMMARY

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

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology(91)
NFWCannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology(91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System	Toxicology(91)
NGGMethamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology(91)
NGLMorphine	II	21 CFR § 862.3650, Morphine Test System	Toxicology(91)
NFVOxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology(91)
NGLOxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology(91)
PTHSecobarbital	II	21 CFR § 862.3150, Barbiturate Test 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, Methadone Test System	Toxicology(91)

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

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

6. Intended Use

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

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

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

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

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

7. Device Description

8. Substantial Equivalence Information

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

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

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

Item	Device	Predicate - K142396
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): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/mlMarijuana (THC):50 ng/mlMethamphetamine (MET): 1,000 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/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 and prescription uses.	Same
Configurations	Dip Card, Cup	Dip Card

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

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

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

Calibrator and Cut-OffValues	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/mlMarijuana (THC):50 ng/mlMethamphetamine (MET): 1,000 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/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 and prescription	Same
Configurations	Dip Card, Cup	Dip Card

9. Test Principle

The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

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

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

samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in K153465, K151211, K152025 and K161044.

Oxazepam

Panel Dip

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

Quick Cup

Methylenedioxy-methamphetamine

Panel Dip

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+	13-/37+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	11-/39+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	11-/39+	50+/0-	50+/0-	50+/0-	50+/0-

Quick Cup

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+	9-/41+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	11-/39+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	12-/38+	50+/0-	50+/0-	50+/0-	50+/0-

Morphine (300 ng/mL Cut-off)

Panel Dip

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+	11-/39+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	11-/39+	50+/0-	50+/0-	50+/0-	50+/0-

Quick Cup

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+	8-/42+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	9-/41+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	9-/41+	50+/0-	50+/0-	50+/0-	50+/0-

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

b. Linearity

Not applicable.

c. Stability

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

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL (except for albumin at 100mg/dL) are summarized in the following tables. There were no differences observed for different devices.

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

e. Specificity

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

{10}------------------------------------------------

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

Oxazepam	Result	% Cross-Reactivity
(Cut-off=300 ng/mL)	Positive at (ng/mL)
Oxazepam	300	100%
Alprazolam	150	200%
a-Hydroxyalprazolam	1000	30%
Bromazepam	1000	30%
Chiordiazepoxide	63	476.2%
Clonazepam	2500	12%
Clobazam	75	400%
Clorazepate dipotassium	100	300%
Desalkylflurazepam	500	60%
Diazepam	500	60%
Estazolam	500	60%
Flunitrazepam	>50000	<0.6%
D,L-Lorazepam	10000	3%
Midazolam	10000	3%
Nitrazepam	75	400%
Norchiordiazepoxide	62.5	480%
Nordiazepam	125	240%
Temazepam	75	400%
Trazolam	1000	30%

Ecstasy	ResultPositive at(ng/ml)	% Cross-Reactivity
(Cut-off=500 ng/mL)
Methylenedioxymethamphetamine (MDMA)	500	100%
3,4-Methylenedioxyamphetamine (MDA)	5,000	10%
3,4-Methylenedioxyethylamphetamine (MDEA)	300	166.7%
d-methamphetamine	>50000	<1%
d-amphetamine	>50000	<1%
l-amphetamine	>50000	<1%
l-methamphetamine	>50000	<1%

Morphine	Result	% Cross-Reactivity
(Cut-off=300 ng/mL)	Positive at(ng/ml)
Morphine	300	100%
Codeine	300	100%
Ethylmorphine	310	96.8%
Hydrocodone	25000	1.2%
Hydromorphine	10000	3%
Levorphanol	>100000	<0.3%
6-Acetylmorphine	250	120%
Morphine 3- β -D-glucuronide	10000	3%
Normorphine	100000	0.3%
Oxycodone	>100000	<0.3%
Oxymorphone	>100000	<0.3%
Procaine	>100000	<0.3%
Thebaine	>100000	<0.3%
Heroine	500	60%

f. Effect of Urine Specific Gravity and Urine pH

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

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 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.

1. 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 LC/MS results. The results are presented in the tables below for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in K153465, K151211, K152025 and K161044.

Oxazepam

PanelDip		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	14	25
	Negative	10	20	10	1	0
ViewerB	Positive	0	0	0	14	25
	Negative	10	20	10	1	0
ViewerC	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer C	41261	289.61	Positive
Viewer A	35578	310.69	Negative
Viewer B	35578	310.69	Negative

QuickCup		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	25
	Negative	10	20	10	1	0
ViewerB	Positive	0	0	0	14	25
	Negative	10	20	10	1	0
Viewer	Positive	0	0	1	15	25

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

C	Negative	10	20	9	0	0
Discordant Results

Viewer	Sample Number	LC/MS Result	Quick Cup Viewer Results
Viewer C	41261	289.6	Positive
Viewer A	73291	311.7	Negative
Viewer B	35578	310.6	Negative

Methylenedioxy-methamphetamine

Panel Dip		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%)
Viewer A	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
Viewer B	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
Viewer C	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	37623	491.17	Positive
Viewer B	37623	491.17	Positive
Viewer C	37623	491.17	Positive
Viewer A	61074	508.34	Negative
Viewer B	61074	508.34	Negative

QuickCup		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	1	14	25
	Negative	10	20	9	1	0
ViewerB	Positive	0	0	1	15	25
	Negative	10	20	9	0	0
ViewerC	Positive	0	0	1	14	25
	Negative	10	20	9	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Quick CupViewer Results

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

Viewer A	37623	491.17	Positive
Viewer B	37623	491.17	Positive
Viewer C	37623	491.17	Positive
Viewer A	61074	508.34	Negative
Viewer C	61074	508.34	Negative

Morphine

Panel Dip		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	1	14	25
	Negative	10	20	9	1	0
ViewerB	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
ViewerC	Positive	0	0	0	14	25
	Negative	10	20	10	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	90003	278.16	Positive
Viewer B	80161	280.75	Positive
Viewer A	59386	322.85	Negative
Viewer B	98199	306.08	Negative
Viewer C	98199	306.08	Negative

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

Discordant Results

Viewer	Sample Number	LC/MS Result	Quick Cup Viewer Results
Viewer A	80161	280.75	Positive
Viewer B	80161	280.75	Positive

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

Viewer B	59386	322.85	Negative
----------	-------	--------	----------

Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at 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 was tested. Typical results are shown below.

The results summary for AMP:

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

The results summary for BAR:

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

The results summary for COC:

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

The results summary for BUP:

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

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

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

The results summary for MET:

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

The results summary for MTD:

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

The results summary for MOR:

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

The results summary for OXY:

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

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

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

The results summary for PCP :

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

The results summary for THC:

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

The results summary for BZO:

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

The results summary for MDMA:

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

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

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

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

Clinical Studies

Not applicable.

11. Conclusion

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

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).