AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, 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.
Configuration of the AssureTech DOA Dipstick Screen Panel 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.

AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, 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.
Configuration of the AssureTech Cup Tests can consist of any combination of the above listed drug analytes.

For in vitro diagnostic use only.

Device Description

The AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 6-Monoacetylmorphine, 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 DOA Dipstick Screen Panel 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 provided text describes the performance characteristics of the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests, which are in vitro diagnostic devices for detecting drugs of abuse in human urine.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by the satisfactory performance in the analytical studies (precision, interference, specificity, effect of urine specific gravity and pH) and method comparison studies. The goal is for the device to correctly identify positive and negative samples, especially around the established cutoff concentrations.

A formal table of explicit acceptance criteria (e.g., minimum sensitivity/specificity percentages) is not provided directly in the text as such for "acceptance criteria." However, the reported device performance in the precision study demonstrates that the device performs as expected. For samples with drug concentrations further away from the cutoff (e.g., -100%, -75%, -50% for negative; +25%, +50%, +75%, +100% for positive), the device consistently yields the correct result (100% agreement: 30-/0+ for negative ranges and 30+/0- for positive ranges). Around the cutoff, there is some variability, which is expected for qualitative tests. For instance, at the cutoff, the positive results range from 22+/8- to 29+/1- out of 30 tests, meaning 22 to 29 out of 30 tests correctly identified as positive, and the remaining were negative. Conversely, for samples at -25% of the cutoff, all 30 tests were negative, and for samples at +25% of the cutoff, all 30 tests were positive.

For the purpose of this request, I will synthesize the implied acceptance criteria from the study design and report the performance based on the precision study across all evaluated drugs and device types, focusing on the key ranges around the cutoff.

Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance (Consolidated from Precision Study)
Precision (Accuracy)	Consistent and accurate results for samples significantly below and above the cutoff concentration. Acceptable variability at the cutoff concentration. Specifically, high agreement for all samples at -50% cutoff and +50% cutoff, and a reasonable proportion of correct results at +/- 25% and at the cutoff itself (while recognizing qualitative nature).	Consistent Performance: All samples at -100%, -75%, -50% of cutoff consistently yielded negative results (30-/0+ across all drugs and lots). All samples at +25%, +50%, +75%, +100% of cutoff consistently yielded positive results (30+/0- across all drugs and lots).Performance at Cutoff: At the cutoff concentration, the number of positive results out of 30 varied by drug and lot, ranging from 22+/8- (e.g., COC, MDMA, THC) to 29+/1- (BZO). This indicates generally good, though not perfect, agreement with the cutoff.Performance at -25% Cutoff: All samples at -25% of cutoff consistently yielded negative results (30-/0+ across all drugs and lots).
Specificity	No interference from common physiological/pathological substances or non-target drugs/metabolites at specified concentrations.	Interference: Over 100 common substances (e.g., acetaminophen, ethanol, hemoglobin, ibuprofen) showed no interference at 100ug/mL (or 1% for ethanol, 100 mg/dL for albumin).Cross-Reactivity (6-MAM): Only 6-acetylmorphine showed 100% cross-reactivity at the cutoff. Diacetylmorphine (heroin precursor) showed 1% cross-reactivity at 1000 ng/mL, Hydromorphone and Nalorphine showed 0.2% cross-reactivity at 5000 ng/mL, and Morphine showed 0.1% at 10000 ng/mL. Most other listed substances showed <0.1% or <0.01% cross-reactivity at high concentrations (e.g., >10000 ng/mL).Cross-Reactivity (THC): 11-nor-D*-THC-9 COOH and 11-nor-D8-THC-9 COOH showed 100% cross-reactivity. Other tested cannabinoids showed <0.25% cross-reactivity at >10000 ng/mL.
Stability	Device remains stable for a specified shelf-life under defined storage conditions.	Devices are stable at 4-30 ℃ for 24 months based on accelerated stability at 45 °C and real-time stability at 4 °C and 30 °C.
Effect of Urine SG/pH	Device performance should not be significantly affected by variations in urine specific gravity (SG) or pH within physiological ranges.	For urine samples with SG 1.000-1.035 and pH 4-9, results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. This indicates no significant effect.

2. Sample Sizes and Data Provenance

Test Set Sample Size (Precision Study): For each drug and each of the two device types (Dipstick Screen Panel and Integrated Cup), three different lots were tested. For each lot, 9 different drug concentrations (from -100% to +100% of cutoff) were evaluated. Each concentration was tested 30 times (1 run per lot per day for 10 days, across three POC sites, implying 30 tests per concentration per lot).
- Therefore, for a single drug and a single device type: 3 lots * 9 concentrations * (implied 1 test per concentration per run * 10 days * 3 sites / 3 lots) = 3 lots * 9 concentrations * 30 tests = 810 tests.
- For the two device types and 16 drugs: 2 * 16 * 810 = 25,920 individual qualitative test results (excluding controls).
Test Set Sample Size (Method Comparison Study): For each drug (6-MAM and THC20 explicitly detailed, with a note that "the rest data were reported in the K181768"), a total of 80 unaltered clinical urine samples were tested. These 80 samples consisted of 40 negative samples and 40 positive samples. The positive samples were further categorized into "Near Cutoff Positive" (15 samples) and "High Positive" (25 samples). The negative samples were categorized into "Negative" (10 samples), "Low Negative" (20 samples), and "Near Cutoff Negative" (10 samples).
- These 80 samples were tested for each of the two device types (Dipstick Screen Panel and Integrated Cup).
- Each sample result was reviewed by 3 "Viewers" (human readers). So, for one drug and one device type, it's 80 samples * 3 viewers = 240 observations.
Data Provenance:
- Precision Study: Samples were "prepared by spiking drug in negative samples." The text doesn't specify the origin of the "negative samples." The study was conducted in a controlled lab setting, essentially creating a prospective dataset.
- Method Comparison Study: "Unaltered clinical samples" were used. The country of origin is not explicitly stated. The study design of using "clinical samples" retrospectively analyzed against a gold standard (LC/MS) suggests these were real-world samples.

3. Number of Experts (Viewers) and Qualifications for Ground Truth in Test Set

Ground Truth for Precision Study: The ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical chemical method considered the gold standard for drug detection and quantification in urine. No human experts were involved in establishing the ground truth for this part of the study.
Ground Truth for Method Comparison Study: The ground truth for the clinical samples was established by LC/MS.
Human Readers (Viewers): While not establishing ground truth, the method comparison study mentions "Viewer A," "Viewer B," and "Viewer C" who ran and interpreted the tests. Their qualifications are not explicitly stated in the provided text. It's implied they were trained operators at the POC (Point of Care) testing sites.

4. Adjudication Method for the Test Set

For the precision study, results were either positive or negative based on visual interpretation, directly compared to the known spiked concentration relative to the cutoff. No explicit adjudication method is mentioned as the results are discrete (positive/negative based on line presence at a known concentration).
For the method comparison study, the results for each sample were recorded by "Viewer A," "Viewer B," and "Viewer C." The tables show individual viewer results, implying no formal adjudication process (like 2+1 or 3+1 consensus) was applied between the viewers. Each viewer's interpretation was directly compared against the LC/MS ground truth. Discordant results highlight instances where a viewer's reading differed from the LC/MS.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text to assess how much human readers improve with AI vs. without AI assistance. The study evaluates the standalone performance of the rapid diagnostic device (Dipstick/Cup) and human interpretation of those devices against LC/MS, not human performance with or without AI assistance. The devices themselves are the "AI" analog (the automated detection method).

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are described as "competitive binding, lateral flow immunochromatographic assays." These are point-of-care devices that produce a visual result (a colored line) indicating presence or absence of a drug. While human interpretation is involved, the device itself is the "algorithm" that produces the result. The precision and specificity studies directly evaluate the performance of these devices in a controlled, standalone manner, where the output is a qualitative visual signal. The method comparison study further tests this standalone device performance with human interpretation against a golden standard.

7. Type of Ground Truth Used

The primary ground truth used in both the precision and method comparison studies was LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and quantitative analytical method used to confirm and quantify drug concentrations in urine samples.

8. Sample Size for the Training Set

The provided document is a 510(k) summary for a rapid diagnostic test (lateral flow immunoassay). These types of devices are typically developed and optimized through iterative design and testing processes that involve numerous samples during the research and development phase. However, the 510(k) summary focuses on the validation studies demonstrating the device's performance for regulatory clearance. It does not explicitly describe a "training set" in the context of machine learning. The studies described are performance evaluation studies, not algorithm training studies.

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

Since a "training set" for an AI algorithm is not explicitly mentioned or relevant to the nature of these immunoassay devices, there is no information provided on how ground truth for such a set would have been established. The ground truth for the performance evaluation (test set) samples was established using LC/MS.

Summary

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August 12, 2021

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

Re: K201630

Trade/Device Name: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DKZ, LDJ, DIO, LAF, JXM, DIS, LCM, DJR, LFG, JXN Dated: September 29, 2020 Received: September 30, 2020

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-Torres. Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201630

Device Name

AssureTech DOA Dipstick Screen Panel Tests AssureTech DOA Integrated Cup Tests

Indications for Use (Describe)

Drug(Identifier)	Cut-off level
6-Monoacetylmorphine	10 ng/mL
Amphetamine	500 ng/mL
Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	20 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 DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes.

Drug(Identifier)	Cut-off level
6-Monoacetylmorphine	10 ng/mL
Amphetamine	500 ng/mL

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Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	20 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 Cup Tests can consist of any combination of the above listed drug analytes.

For in vitro diagnostic use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY K201630

1. Date: September 29, 2020
1. Submitter:

Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030

Joe Shia 3. Contact person: LSI International Inc. 504E Diamond Ave., Suite J Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
1. Device Name: AssureTech DOA Dipstick Screen Panel Tests AssureTech DOA Integrated Cup Tests

Classification:Product Code	Class 2Classification	Regulation Section	Panel
DJGMonoacetylmorphine	II	21 CFR § 862.3650, Morphine Test System	Toxicology (91)
DKZAmphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology (91)
LDJCannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology (91)
DIOCocaine	II	21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System	Toxicology (91)
LAFMethamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
DJGMorphine	II	21 CFR § 862.3650, Morphine Test System	Toxicology (91)
JXMOxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology (91)
DJGOxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
DISSecobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology (91)
DJGBuprenorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
LAFMethylenedioxy-methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
LCMPhencyclidine	unclassified	Enzyme Immunoassay Phencyclidine	Toxicology (91)
DJRMethadone	II	21 CFR § 862.3620, Methadone Test System	Toxicology (91)

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DJR2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP)	II	21 CFR § 862.3620, MethadoneTest System	Toxicology (91)
LFGNortriptyline	II	21 CFR, 862.3910 TricyclicAntidepressant Drugs Test System	Toxicology (91)
	JXNPropoxyphene	II	21 CFR, 862.3700 PropoxypheneTest System

1. Predicate Devices: K181768 & K182123
  AssureTech Panel Dip Tests and AssureTech Quick Cup Tests (K181768) Advin Biotech ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card (K182123)
1. Indications for Use
  AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, 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
6-Monoacetylmorphine	10 ng/mL
Amphetamine	500 ng/mL
Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	20 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 DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes.

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

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analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, 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
6-Monoacetylmorphine	10 ng/mL
Amphetamine	500 ng/mL
Oxazepam	300 ng/mL
Cocaine	150 ng/mL
Marijuana	20 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 DOA Integrated 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.

1. Device Description
  The AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 6-Monoacetylmorphine, 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 DOA Dipstick Screen Panel 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.

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1. Substantial Equivalence Information
  A summary comparison of features of the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests and the predicate devices is provided in following tables.

Item	Device	Predicates - K181768& K182123
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	6-Monoacetylmorphine (6-MAM): 10 ng/mLAmphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 150 ng/mlMarijuana (THC):20 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOR): 300ng/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 as candidate devicewith exclusion of 6-Monoacetylmorphine (6-MAM) 10 ng/mLAnd Marijuana (THC)50 ng/ml
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 prescription	For over-the-counterFor prescription
Configurations	Dip Card	Same

Table 1: Features Comparison of AssureTech DOA Dipstick Screen Panel Tests and the Predicate Devices

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

Item	Device	Predicates - K181768 &K182123
------	--------	-----------------------------------

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Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator andCut-Off Values	6-Monoacetylmorphine (6-MAM): 10 ng/mLAmphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 150 ng/mlMarijuana (THC):20 ng/ml Methamphetamine(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 as candidate device withexclusion of 6-Monoacetylmorphine (6-MAM) 10 ng/mLAnd Marijuana (THC)50 ng/ml
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 prescription	For over-the-counterFor prescription
Configurations	Cup	Same

9. Test Principle

The AssureTech DOA Dipstick Screen Panel Tests, and AssureTech DOA Integrated Cup Tests are rapid tests for the qualitative detection of 6-Monoacetylmorphine, 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 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

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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 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 one run per lot per day for 10 days per device in a randomized order at each testing site. There were total three POC testing sites. The results obtained are summarized in the following tables.

Result	6-MAM			AMP
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	24+/6	23+/7-	25+/5-	23+/7-	23+/7-	27+/3-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

DOA Dipstick Screen Panel

Result	BAR		BUP
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 1	Lot 2
-100%	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	27+/3-	27+/3-	27+/3-	27+/3-
+25%	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-

Result	BZO			COC
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	28+/2-	28+/2-	27+/3-	22+/8-	25+/5-	23+/7-

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

+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	EDDP			MDMA			Result	MET			MOR
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3	Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	24+/6-	24+/6-	24+/6-	24+/6-	24+/6-	22+/8-	cutoff	25+/5	25+/5-	24+/6-	23+/7-	24+/6-	25+/5-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	MTD			OXY
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	27+/3-	26+/4-	26+/4-	28+/2-	27+/3-	28+/2-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	PCP			PPX
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	25+/5-	25+/5-	24+/6-	25+/5-	25+/5-	26+/4-

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

+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	TCA			THC
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	23+/7-	23+/7-	24+/6-	24+/6-	22+/8-	22+/8-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

DOA Integrated Cup

Result	6-MAM			AMP
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	24+/6-	23+/7-	23+/7-	23+/7-	24+/6-	26+/4-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	BAR		BUP
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 1	Lot 2
-100%	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	28+/2-	26+/4-	28+/2-	28+/2-
+25%	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-

Result	BZO			COC
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+

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

-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	28+/2-	28+/2-	29+/1-	23+/7-	26+/4-	24+/6-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	EDDP			MDMA			Result	MET			MOR
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3	Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	24+/6-	24+/6-	25+/5-	23+/7-	22+/8-	22+/8-	cutoff	23+/7-	27+/3-	23+/7-	22+/8-	24+/6-	23+/7-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	MTD			OXY
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	26+/4-	27+/3-	27+/3-	27+/3-	28+/2-	28+/2-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Result	PCP			PPX
Drug Conc.% of cutoff	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+

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

-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	25+/5-	25+/5-	24+/6-	25+/5-	27+/3-	25+/5-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-

Drug Conc.% of cutoff	TCA			THC
	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
-100%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-75%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-50%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
-25%	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+	30-/0+
cutoff	24+/6-	25+/5-	23+/7-	23+/7-	24+/6-	24+/6-
+25%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+50%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+75%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-
+100%	30+/0-	30+/0-	30+/0-	30+/0-	30+/0-	30+/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 and ethanol at 1%) are summarized in the following table. There were no differences observed for different devices.

Acetaminophen	ß-Estradiol	Oxalic acid
Acetophenetidin	Erythromycin	Oxolinic acid
N-Acetylprocainamide	Ethanol (1%)	Oxymetazoline
Acetylsalicylic acid	Fenoprofen	Papaverine
Albumin (100 mg/dL)	Furosemide	Penicillin G
Aminopyrine	Gentisic acid	Perphenazine
Amoxicillin	Hemoglobin	Phenelzine
Ampicillin	Hydralazine	Prednisone
Apomorphine	Hydrochlorothiazide	(±)-Propranolol
Ascorbic acid	Hydrocortisone	Pseudoephedrine
Aspartame	O-Hydroxyhippuric acid	Quinine
Atropine	3-Hydroxytyramine	Ranitidine
Benzilic acid	Ibuprofen	Salicylic acid
Benzoic acid	Isoproterenol	Serotonin (5- Hydroxytyramine)
Bilirubin	Isoxsuprine	Sulfamethazine
Chloral hydrate	Ketamine	Sulindac
Chloramphenicol	Ketoprofen	Tetrahydrocortisone 3-(ß-Dglucuronide)
Chlorothiazide	Labetalol	Tetrahydrocortisone 3-acetate
Chlorpromazine	Loperamide	Tetrahydrozoline

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

Cholesterol	Meperidine	Thiamine
Clonidine	Meprobamate	Thioridazine
Cortisone	Methoxyphenamine	Triamterene
(-)-Cotinine	Nalidixic acid	Trifluoperazine
Creatinine	Naloxone	Trimethoprim
Deoxycorticosterone	Naltrexone	DL-Tryptophan
Dextromethorphan	Naproxen	Tyramine
Diclofenac	Niacinamide	DL-Tyrosine
Diflunisal	Nifedipine	Uric acid
Digoxin	Norethindrone	Verapamil
Diphenhydramine	Noscapine	Zomepirac
Ecgonine methyl ester	(±)-Octopamine

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 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20). The rest data were reported in the K181768. There were no differences observed for different devices.

6-acetylmorphine(Cut-off=10 ng/mL)	ResultPositive at (ng/mL)	% Cross-Reactivity
6-acetylmorphine	10	100%
Acetylcodeine	>10000	<0.1%
Buprenorphine	>10000	<0.1%
Codeine	>10000	<0.1%
Diacetylmorphine	1000	1%
Dihydrocodeine	>10000	<0.1%
Ethylmorphine	>10000	<0.1%
Hydrocodone	>10000	<0.1%
Hydromorphone	5000	0.2%
Morphine	10000	0.1%
Morphine-3-glucuronide	>10000	<0.1%
Nalorphine	5000	0.2%
Thebaine	>20000	<0.05%
Dextromethorphan	>100,000	<0.01%
Heroin	100,000	0.01%
Imipramine	>100,000	<0.01%
LAAM (Levacetylmethadol)	>100,000	<0.01%
Levorphanol	>100,000	<0.01%
Meperidine	>100,000	<0.01%
Methadone	>100,000	<0.01%
Mitragynine (kratom)	>20,000	<0.05%
Morphine 6-D-glucuronide	>100,000	<0.01%
Naloxone	>100,000	<0.01%
Naltrexone	>100,000	<0.01%
Naproxen	>100,000	<0.01%
Norbuprenorphine	>10,000	<0.1%
Norbuprenorphine glucuronide	>100,000	<0.01%
Norcodeine	>100,000	<0.01%
Norhydrocodone	>100,000	<0.01%
Normorphine	>100,000	<0.01%
Noroxycodone	>100,000	<0.01%
Noroxymorphone	>100,000	<0.01%
Norpropoxyphene	>100,000	<0.01%
Oxycodone	>100,000	<0.01%

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

Oxymorphone	>100,000	<0.01%
Oxymorphone-3β-D-glucuronide	>100,000	<0.01%
Tapentadol HCl	>100,000	<0.01%
Tramadol	>100,000	<0.01%

Marijuana(Cut-off=20 ng/mL)	ResultPositive at (ng/mL)	% Cross-Reactivity
11-nor-D*-THC-9 COOH	20	100%
11-nor-D8-THC-9 COOH	20	100%
△§-Tetrahydrocannabinol	>10000	<0.25%
△°-Tetrahydrocannabinol	>10000	<0.25%
Cannabinol	>10000	<0.25%

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 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 DOA Dipstick Screen Panel Tests and the AssureTech DOA Integrated Cup Tests were performed at three POC sites 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 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20). The rest data were reported in the K181768.

6-MAM

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	15	25
	Negative	10	20	10	0	0
ViewerB	Positive	0	0	0	15	25
	Negative	10	20	10	0	0
ViewerC	Positive	0	0	0	15	25
	Negative	10	20	10	0	0

DOAIntegratedCup	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%)
--------------------------	----------	----------------------------------------------------	------------------------------------------------------------------------	----------------------------------------------------------------------------	-----------------------------------------------------

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

Viewer		0	0	0	15	25
A	Positive	0	0	0	15	25
	Negative	10	20	10	0	0
Viewer	Positive	0	0	0	15	25
B	Negative	10	20	10	0	0
Viewer	Positive	0	0	0	15	25
C	Negative	10	20	10	0	0

THC20

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	25
	Negative	10	20	10	1	0
ViewerB	Positive	0	0	1	15	25
	Negative	10	20	9	0	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 B	TH79	19.09	Positive
Viewer C	TH79	19.09	Positive
Viewer A	TH10	20.55	Negative

DOAIntegratedCup		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
ViewerA	Negative	10	20	10	1	0
ViewerB	Positive	0	0	0	15	25
ViewerB	Negative	10	20	10	0	0
ViewerC	Positive	0	0	1	15	25
ViewerC	Negative	10	20	9	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer C	TH79	19.09	Positive
Viewer A	TH10	20.55	Negative

3. Clinical Studies

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Not applicable.

11. Conclusion

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

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).