The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Test	Calibrator	Cut-off (ng/mL)
6-MAM	6-Monoacetylmorphine	10
AMP	d-Amphetamine	500 or 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 or 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
FEN or FYL	Norfentanyl	5
MDMA	Methylenedioxymethamphetamine	500
MET	d-Methamphetamine	500 or 1000
MTD	Methadone	300
OPI	Morphine	300 or 2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	d-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TRA or TMI	Tramadol	100

The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs

CODE	SUBSTANCE	Cut-off (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	EDDP	300
FYL	Norfentanyl	5
MET/mAMP	Methamphetamine	1000 or 500
MDMA	Ecstasy	500
OPI	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50
TML	Tramadol	100
6-MAM	6-Monoacetylmorphine	10

This drug test cup may contain any combination of the drug tests listed in the table above.

This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Device Description

Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

AI/ML Overview

Acceptance Criteria and Device Performance for Healgen® Accurate Multi-Drug Urine Drug Screen Cup

This document outlines the acceptance criteria and the evidence provided to demonstrate that the Healgen® Accurate Multi-Drug Urine Drug Screen Cup meets these criteria. The information is extracted from the provided FDA 510(k) summary (K243365).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this qualitative immunoassay are primarily demonstrated through a combination of precision, analytical specificity/interference, and a method comparison study. The precision study evaluates the device's ability to consistently produce correct results at various concentrations relative to the cutoff, while the method comparison study assesses its agreement with a gold standard (LC-MS/MS) using clinical samples. The layperson study demonstrates ease of use for over-the-counter applications.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Precision/Reproducibility	Consistent qualitative results (+/- at least 95% at the cutoff concentration, and 100% agreement for samples far from the cutoff) across multiple lots and runs, at various concentrations relative to the cutoff (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%).	For all drugs tested (AMP 1000/500, BAR 300, BUP 10, BZO 300, COC 300/150, EDDP 300, FYL 5, MDMA 500, MET 1000/500, OPI 300/2000, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50, TML 100, 6-MAM 10) across 3 lots: - 100% agreement for concentrations at -100%, -75%, -50%, +50%, +75%, and +100% cutoff (e.g., 0-/50+ or 50-/0+ indicating no false negatives or positives respectively). - At the cutoff concentration, results consistently showed a mix of positive and negative interpretations, typically near 50%/50% (e.g., 23-/27+, 25-/25+), demonstrating sensitivity around the cutoff. - At -25% cutoff, the device predominantly showed negative results (e.g., 50-/0+ or 49-/1+), with a few false positives. - At +25% cutoff, the device predominantly showed positive results (e.g., 0-/50+ or 1-/49+), with a few false negatives. This indicates good precision around the cutoff with expected variability at borderline concentrations.
Analytical Specificity	No significant cross-reactivity with commonly encountered substances (drug metabolites, prescription medications, endogenous compounds) at relevant concentrations, and no interference from variations in pH and specific gravity within a physiological range.	Diverse lists of compounds were tested for cross-reactivity. The results show that: - Many cross-reacting compounds are identified with their minimum concentration needed to yield a positive result and their % Cross-Reactivity (e.g., Hydroxyamphetamine with AMP 1000, Amobarbital with BAR 300). - Numerous compounds showed no detection or were negative at high concentrations (e.g., 100,000 ng/mL), indicating no cross-reactivity for those substances. - pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 were demonstrated to not affect the assay results.
Method Comparison	A high degree of concordance between the device's qualitative results and confirmatory Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) results for clinical urine samples, particularly for samples at or near the cutoff.	For each drug and its cutoff configuration: - 100% agreement was observed for drug-free samples and "low negative" samples (less than -50% of cutoff). - 100% agreement was primarily observed for "high positive" samples (greater than +50% of cutoff). - For "near cutoff negative" (between -50% and cutoff) and "near cutoff positive" (between cutoff and +50%) samples, there was expected variability, with some samples interpreted differently by the device compared to LC-MS/MS, indicating the device's expected performance around the cutoff. The discordant results table details specific samples where device results differed from LC-MS/MS. Generally, the majority of samples near the cutoff were correctly identified by the device.
Lay Person Usability	The device should be easy to understand and use by laypersons as indicated by a high agreement in understanding instructions and performance on prepared samples across different drug classes. A reading level analysis of the instructions for use should demonstrate appropriate readability.	A study with 280 laypersons (mix of male/female, aged 21 to >50, diverse backgrounds) demonstrated: - 100% agreement for interpretation of drug-free and concentrations at -100%, -75%, -50% below cutoff. - 100% agreement for concentrations at +50% and +75% above cutoff. - Expected variability in agreement around the -25% and +25% cutoff concentrations, mostly ranging from 90% to 95%. - All participants indicated the instructions were easy to understand and follow. - The Flesch-Kincaid reading analysis yielded a Grade Level of 7, which is suitable for layperson use.
Stability	The device should maintain its performance characteristics for a specified duration under defined storage conditions.	The device is stable at 2-30°C for 36 months based on real-time stability studies.

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

Precision/Reproducibility Study:

Sample Size: For each drug and each concentration level (total 9 levels per drug), 50 individual tests were performed (2 runs per day for 25 days). Given there are 17 distinct drug analytes, this amounts to 17 drugs * 9 concentrations * 50 tests/concentration = 7,650 tests.
Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. These samples were likely prepared in a laboratory setting, making the data provenance prospective and controlled. The document does not specify a country of origin for the samples/urine, but the study was conducted "in-house."

Method Comparison Study:

Sample Size: For each drug, 80 unaltered urine clinical samples were used. This consisted of 40 negative and 40 positive samples. Given there are 17 distinct drug analytes, this amounts to 17 drugs * 80 samples/drug = 1,360 total clinical samples tested across all drugs.
Data Provenance: Unaltered clinical urine samples. The document does not specify the country of origin but states the study was performed "in-house." The nature of "unaltered clinical samples" suggests these were collected from patients, and their retrospective or prospective nature is not explicitly stated, though being "blind labeled" for comparison suggests they were handled specifically for this study.

Lay Person Study:

Sample Size: 280 lay persons participated. Urine samples were prepared at 7 concentration levels (-100%, +/-75%, +/-50%, +/-25% of cutoff). Each participant tested 1 blind labeled sample. While it states urine samples were prepared at 7 concentrations, the agreement tables show 7 concentrations and 20 tests per concentration for each drug. If we assume each of the 280 participants tested one sample for one drug, the sample sizes per concentration shown in the table (20 tests) indicate that multiple participants contributed data for each drug and concentration, but a single participant did not test all drugs or all concentrations.
Data Provenance: Urine samples were prepared by spiking drugs into drug-free pooled urine specimens. The samples were prepared in a laboratory environment, indicating prospective and controlled data provenance. The lay persons were recruited for the study, making their involvement prospective. The study was performed at "three intended user sites."

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

Precision/Reproducibility Study:

Ground Truth: The "ground truth" for the spiked samples was established by the known concentrations of the spiked drugs, which were confirmed by LC-MS/MS.
Experts/Qualifications: The document states that "Each drug concentration was confirmed by LC-MS/MS." LC-MS/MS is a highly accurate analytical method, and while specific "experts" (e.g., toxicologists, clinical chemists) are not explicitly named, the use of this method implies analysis by qualified laboratory personnel specializing in mass spectrometry. "One operator per lot" (for 3 lots) performed the tests on the device, but the LC-MS/MS confirmation implies separate, expert analysis for ground truth.

Method Comparison Study:

Ground Truth: The ground truth for the clinical samples was established by LC-MS/MS results.
Experts/Qualifications: Similar to the precision study, the ground truth was determined by LC-MS/MS, implying analysis by qualified laboratory professionals. No specific number or qualification of "experts" is provided beyond the analytical method itself.

Lay Person Study:

Ground Truth: The "ground truth" for the spiked samples was established by the known concentrations of the spiked drugs, which were confirmed by LC-MS/MS.
Experts/Qualifications: As above, the ground truth was derived from LC-MS/MS analysis, indicating reliance on qualified laboratory personnel.

4. Adjudication Method for the Test Set

Precision/Reproducibility Study:

Adjudication Method: Not applicable in the traditional sense of expert consensus. The ground truth was based on the quantitative LC-MS/MS results of the spiked samples. The device's qualitative results were compared against these known concentrations relative to the cutoff. Discrepancies were noted directly.

Method Comparison Study:

Adjudication Method: Not applicable/Not explicitly stated as an adjudication process involving multiple human readers. The device results were directly compared to the LC-MS/MS results, which served as the definitive "true" value (ground truth). The tables show the device's output (positive/negative) versus the LC-MS/MS quantification, which then categorizes samples as drug-free, low negative, near cutoff negative, near cutoff positive, or high positive.

Lay Person Study:

Adjudication Method: Not applicable in terms of expert consensus. The laypersons' interpretations of the device results were compared against the established ground truth (LC-MS/MS confirmed concentrations of spiked samples). The study aimed to assess if laypersons could correctly interpret the device results against this objective ground truth, not for them to establish ground truth or adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance, as this is an in-vitro diagnostic device (a test cup) not an AI-powered diagnostic imaging or interpretation system. The "operators" in the method comparison study refer to individuals performing the device test, not medical interpreters assisted by AI. The "lay person study" evaluated if laypersons could correctly interpret the device, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is an in-vitro diagnostic (IVD) device (a lateral flow immunoassay test cup), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable in the typical sense for AI/software devices. The device itself provides a visual qualitative result (lines appearing or not appearing), which then requires human observation and interpretation. The performance characteristics described (precision, specificity, method comparison) are inherently "standalone" in that they assess the device's ability to produce correct visual results, which a human then reads. The layperson study specifically evaluates the human (layperson) interpretation of these visual results.

7. The Type of Ground Truth Used

The primary type of ground truth used across all analytical performance studies (Precision, Analytical Specificity, Method Comparison, and Lay Person Study where applicable) is Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) and their tandem mass-spectrometer versions (LC-MS/MS).

These are considered confirmatory analytical methods and are widely accepted as the gold standard for quantitative drug detection in toxicology.

8. The Sample Size for the Training Set

As this device is a lateral flow immunoassay (a chemical/biological test kit), and not an AI/machine learning algorithm, there is no "training set" in the computational sense. The device's performance is based on its inherent physical and chemical properties and reagent formulations, which are developed and optimized through laboratory research and development, rather than machine learning training.

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

Since there is no "training set" for this type of device, this question is not applicable. The development and optimization of the immunoassay undoubtedly involved extensive experimentation with samples of known drug concentrations, likely confirmed by GC-MS/LC-MS, but this is part of the product's research and development process, not analogous to establishing ground truth for a machine learning training set.

Summary

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December 17, 2024

Image /page/0/Picture/1 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.

Healgen Scientific LLC % Jenny Xia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K243365

Trade/Device Name: Healgen® Accurate Muti-Drug Urine Drug Screen Cup; Healgen® Accurate Home Muti-Drug Urine Test Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL,NFT,PTH,NFY,NFV,PTG,NGG,NGM,QBF,QAW,NFW Dated: October 26, 2024 Received: October 29, 2024

Dear Jenny Xia:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image shows the name Joseph A. Kotarek -S. It also shows that the document was digitally signed by Joseph A. Kotarek -S on December 17, 2024. The time stamp on the document is 10:21:47 -05'00'.

Joseph Kotarek Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K243365

Device Name

Healgen® Accurate Muti-Drug Urine Drug Screen Cup; Healgen® Accurate Home Muti-Drug Urine Test Cup

Indications for Use (Describe)

Test	Calibrator	Cut-off (ng/mL)
6-MAM	6-Monoacetylmorphine	10
AMP	d-Amphetamine	500 or 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 or 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
FEN or FYL	Norfentanyl	5
MDMA	Methylenedioxymethamphetamine	500
MET	d-Methamphetamine	500 or 1000
MTD	Methadone	300
OPI	Morphine	300 or 2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	d-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TRA or TMI	Tramadol	100

The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs

CODE	SUBSTANCE	Cut-off (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	EDDP	300

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FYL	Norfentanyl	5
MET/mAMP	Methamphetamine	1000 or 500
MDMA	Ecstasy	500
OPI	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50
TML	Tramadol	100
6-MAM	6-Monoacetylmorphine	10

This drug test cup may contain any combination of the drug tests listed in the table above.

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)

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510(k) SUMMARY K243365

1. Date:	October 29, 2024
2. Submitter:	Healgen Scientific LLC.3818 Fuqua StreetHouston, TX 77047
3. Contact person:	Jenny XiaLSI International Inc.504 East Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 301-525-6856Email: jxia@lsi-consulting.org
4. Device Name:	Healgen® Accurate Muti-Drug Urine Drug Screen CupHealgen® Accurate Home Muti-Drug Urine Test Cup

5. Classification: Class II

Product CodeTarget Drug	Regulation Section	Panel
NFTAmphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
PTHSecobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NGLBuprenorphine (BUP)Morphine (OPI)Oxycodone (OXY)6-Monoacetylmorphine(6-MAM)Norfentanyl (FEN)Tramadol (TML)	862.3650, Opiate Test System	Toxicology
NFVOxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
NFYCocaine (COC)	862.3250, Cocaine and cocainemetabolite test system	Toxicology
PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)Methadone (MTD)	862.3620, Methadone Test System	Toxicology
NGG	862.3610,Methamphetamine Test System	Toxicology

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Methylenedioxymethamphetamine(MDMA)Methamphetamine (MET)
NGMPhencyclidine (PCP)	Unclassified	Toxicology
QBFPropoxyphene(PPX)	862.3700 Propoxyphene test system.	Toxicology
QAWNortriptyline (TCA)	862.3910 Tricyclic antidepressant drugstest system	Toxicology
NFWCannabinoids (THC 50)	862.3870, Cannabinoids Test System	Toxicology

Predicate Devices: 6.

Healgen Accurate Urine Drug Screen Dip Card (K240686)

7. Intended Use

The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, Tramadol in human urine. The test cut-off concentrations and the compounds the THC-COOH and tests are calibrated to are as follows:

Test	Calibrator	Cut-off (ng/mL)
6-MAM	6-Monoacetylmorphine	10
AMP	d-Amphetamine	500 / 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 / 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
FEN or FYL	Norfentanyl	5
MDMA	Methylenedioxymethamphetamine	500
MET	d-Methamphetamine	500 / 1000
MTD	d/l-Methadone	300
OPI	Morphine	300 / 2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	d-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50

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TRA or TML	Tramadol	100
------------	----------	-----

The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (CC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay.

CODE	SUBSTANCE	CUT-OFF(ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	EDDP	300
FYL	Norfentanyl	5
MET/mAMP	Methamphetamine	1000 or 500
MDMA	Ecstasy	500
OPI	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50
TML	Tramadol	100
6-MAM	6-Monoacetylmorphine	10

The device provides preliminary results for the detection of one or more of the following drugs.

This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

8. Device Description

Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine

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Drug Screen Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Similarities
Item	Device	Predicate(K240686)
Intended use	Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use	Same.
Methodology	Competitive binding, lateral flowimmunochromatographic assay based on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drugand Cut OffValues	Target Drugs	Cutoff(ng/mL)
	Amphetamine(AMP)	1000 or 500
	Secobarbital (BAR)	300
	Buprenorphine (BUP)	10
	Oxazepam (BZO)	300
	Cocaine (COC)	300 or 150
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300
	Norfentanyl	5
	Methylenedioxymethamphetamine(MDMA)	500
	Methamphetamine (MET)	1000 or 500
	Morphine (MOP300/OPI2000)	2000 or 300
	Methadone (MTD)	300
	Oxycodone (OXY)	100
	Phencyclidine (PCP)	25
	Propoxyphene(PPX)	300
	Nortriptyline (TCA)	1000
		Same except noNorfentanyl andTramadol

Substantial Equivalence Information 9.

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

Cannabinoids (THC)	50
6-Monoacetylmorphine(6-MAM)	10
Tramadol	100
Differences
Configurations
Test cup	Test Dip Card

10. Standard/Guidance Document Reference (if applicable)

None referenced.

11. Test Principle

Healgen® Accurate Home Muti-Drug Urine Test Cup or Healgen® Accurate Muti-Drug Urine Drug Screen Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.

When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.

12. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups with one operator per lot. The results obtained are summarized in the following tables:

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Drug	LotNumber	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
AMP1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
BAR300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
BUP10	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	27-/23+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
BZO300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
COC300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
EDDP300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
FYL5	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
MDMA500	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
MET1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
OPI300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
MTD300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
OXY100	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
PCP25	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3
PPX	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
300	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
TCA	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
1000	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
THC	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
50	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
TML	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
100	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
6-MAM	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
10	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
AMP	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
500	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
COC	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
150	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+
MET	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
500	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
OPI	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
2000	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+

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b. Linearity/assay reportable range:

Not applicable. This device is intended for qualitative use only.

c. Stability:

The device is stable at 2-30°C for 36 months based on real time stability study.

d. Analytical specificity/Interference:

To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device.

Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.

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Drug/Cutoff	Compound	Minimumconcentrationrequired to obtaina positive result(ng/mL)	% Cross-Reactivity
AMP 1000	Hydroxyamphetamine	8000	12.5%
	(+/-)-	400	250%
	Methylenedioxyamphetamine(MDA)
	D,L-Amphetamine	1,000	100%
	D-Amphetamine	1,000	100%
	Diethylstilbestrol	5,000	20%
	L-Amphetamine	50,000	2%
	Phentermine	8,000	12.5%
	β-Phenylethylamine	100,000	1%
	Tyramine	100,000	1%
	p-Hydroxynorephedrine	100,000	1%
	D,L-Norephedrine	100,000	1%
	p-Hydroxyamphetamine	100,000	1%
	D-Methamphetamine	100,000(Negative)	Not detected
	L-Methamphetamine	100,000(Negative)	Not detected
	Ephedrine hydrochloride	100,000(Negative)	Not detected
	(+/-)3,4-
	Methylenedioxymethamphetamine(MDMA)	100,000(Negative)	Not detected
	Phenylpropanolamine	100,000(Negative)	Not detected
	Benzphetamine	100,000(Negative)	Not detected
	L-Ephedrine	100,000(Negative)	Not detected
	L-Epinephrine	100,000(Negative)	Not detected
	D,L-Epinephrine	100,000(Negative)	Not detected
	(+/-)3,4-
	Methylenedioxyethylamphetamine(MDEA)	100,000(Negative)	Not detected
	Alphenal	150	200%
BAR 300	Amobarbital	300	100%
	Aprobarbital	250	120%
	Butabarbital	2,500	12%
	Butethal	100	300%
	Cyclopentobarbital	600	50%
	Pentobarbital	250	120%
	Phenobarbital	250	120%
	Secobarbital	300	100%
	Butalbital	2,500	12%
	Buprenorphine	10	100%
	Buprenorphine -3-D-Glucuronide	160	6.25%
	Norbuprenorphine	10	100%
BUP 10	Norbuprenorphine-3-D-Glucuronide	200	5%
	Morphine	100000 (Negative)	Not Detected
	Oxymorphone	100000 (Negative)	Not Detected
	Hydromorphone	100000 (Negative)	Not Detected
	a-Hydroxyalprazolam	1,260	23.8%
	Alprazolam	200	150%
	Bromazepam	1,560	19.2%
	Chlordiazepoxide	1,560	19.2%
	Clobazam	100	300%
	Clonazepam	2,500	12%
	Clorazepate Dipotassium	200	150%
	Desalkylflurazepam	400	75%
	Diazepam	200	150%
BZO 300	Estazolam	2,500	12%
	Flunitrazepam	400	75%
	D,L-Lorazepam	1,560	19.2%
	Midazolam	12,500	2.4%
	Nitrazepam	100	300%
	Norchlordiazepoxide	200	150%
	Nordiazepam	400	75%
	Oxazepam	300	100%
	Oxazepam glucuronide	500	60%
	R,S-Lorazepam glucuronide	160	187.5%
	Temazepam	100	300%
	Triazolam	2,500	12%
	Demoxepam	2,000	15%
	Flurazepam	500	60%
	Delorazepam	100,000(negative)	Not detected
COC 300	Benzoylecogonine	300	100%
	Cocaethylene	300	100%
	Cocaine hydrochloride	300	100%
COC 300	Ecgonine	50,000	0.6%
	Norcocaine	100,000	0.3%
	Ecgonine methyl ester	100,000(negative)	Not detected
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300	100%
	Methadone	100,000(negative)	Not detected
	EMDP	100,000(negative)	Not detected
EDDP 300	Doxylamine	100,000(negative)	Not detected
	Levacetylmethadol (LAAM)	100,000(negative)	Not detected
	Disopyramide	100,000(negative)	Not detected
	Alpha Methadol	100,000(negative)	Not detected
	Norfentanyl	5	100%
	Fentanyl	10	50%
	Acetyl fentanyl	150	3.3%
	Acetyl Norfentanyl	200	2.5%
	(+)-β-Hydroxythiofentanyl HCl	2,500	0.2%
	Acryl Fentanyl	2,500	0.2%
	Butyryl Fentanyl	5,000	0.1%
FYL 5	Cis-d, I 3-Methylfentanyl	50,000	0.01%
	Furanyl Fentanyl	10,000	0.05%
	Para-fluoro butyrl Fentanyl (P-FBF)	80,000	0.01%
	Para-fluoro Fentanyl	40,000	0.005%
	9-HydroxyRisperidone	10,000	0.05%
	Alfentanil	20,000	0.03%
	Isobutyryl Fentanyl	5,000	0.1%
	Trans-d. 1-3-Methylfentanyl	50	10%

Norcarfentail Oxalate	50,000	0.01%
Remifentanil	15,000	0.03%
Valeryl Fentanyl	20,000	0.03%
Thienyl Fentanyl	50	10%
4-Fluoro-isobutyryl Fentanyl	20,000(Negative)	Not detected
Despropionyl fentanyl (4-ANPP)	20,000(Negative)	Not detected
MT-45	100,000(Negative)	Not detected
Ocfentanil	100,000(Negative)	Not detected
Risperidone	100,000(Negative)	Not detected
Sufentanil	100,000(Negative)	Not detected
Carfentanil Oxalate	100,000(Negative)	Not detected
Labetalol Hydrochloride	100,000(Negative)	Not detected
Trazodone	100,000(Negative)	Not detected
U-47700	100,000(Negative)	Not detected
ω-1-Hydroxyfentanyl	20,000(Negative)	Not detected
6-Acetyl morphine	100,000(Negative)	Not detected
Amphetamine	100,000(Negative)	Not detected
Buprenorphine	100,000(Negative)	Not detected
Buprenorphine -3-D-Glucuronide	100,000(Negative)	Not detected
Codeine	100,000(Negative)	Not detected
Dextromethorphan	100,000(Negative)	Not detected
Dihydrocodeine	100,000(Negative)	Not detected
EDDP	100,000(Negative)	Not detected
EMDP	100,000(Negative)	Not detected
Fluoxetine	100,000(Negative)	Not detected
Heroin	100,000(Negative)	Not detected
Hydrocodone	100,000(Negative)	Not detected
Hydromorphone	100,000(Negative)	Not detected
Ketamine	100,000(Negative)	Not detected
Levorphanol tartrate	100,000(Negative)	Not detected
Meperidine	100,000(Negative)	Not detected
Methadone	100,000(Negative)	Not detected
Morphine	100,000(Negative)	Not detected
Morphine-3-β-D-Glucuronide	100,000(Negative)	Not detected
	Naloxone hydrochloride	100,000(Negative)	Not detected
	Naltrexone hydrochloride	100,000(Negative)	Not detected
	Norbuprenorphine	100,000(Negative)	Not detected
	Norcodeine	100,000(Negative)	Not detected
	Norketamine	100,000(Negative)	Not detected
	Normeperidine	100,000(Negative)	Not detected
	Normorphine	100,000(Negative)	Not detected
	Noroxycodone	100,000(Negative)	Not detected
	Oxycodone	100,000(Negative)	Not detected
	Oxymorphone	100,000(Negative)	Not detected
	Pentazocine (Talwin)	100,000(Negative)	Not detected
	Pipamperone	100,000(Negative)	Not detected
	Tapentadol hydrochloride	100,000(Negative)	Not detected
	Thioridazine	100,000(Negative)	Not detected
	Tilidine	100,000(Negative)	Not detected
	Tramadol	100,000(Negative)	Not detected
	o-Desmethyl Tramadol	100,000(Negative)	Not detected
	n-Desmethyl Tramadol	100,000(Negative)	Not detected
MDMA 500	(+/-)3,4-MethylenedioxymethamphetamineHCI(MDMA)	500	100%
	(+/-)3,4-MethylenedioxyamphetamineHCI (MDA)	3,000	16.7%
	(+/-)3,4-Methylenedioxyethylamphetamine(MDEA)	300	167%
	L-Methamphetamine	50,000	1%
	7-Aminoclonazepam	100,000	0.5%
	d-methamphetamine	100,000(Negative)	Not detected
	d-amphetamine	100,000(Negative)	Not detected
	l-amphetamine	100,000(Negative)	Not detected
MET 1000	(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	20,000	5%
	(+/-)3,4-	2,500	40%
	Methylenedioxymethamphetamine(MDMA)
	D-Methamphetamine	1,000	100%
	L-Methamphetamine	25,000	4%
	Fenfluramine	50,000	2%
	p-Hydroxymethamphetamine	10,000	10%
	D,L-Methamphetamine	1,000	100%
	β-Phenylethylamine	50,000	2%
	Mephetermine	50,000	2%
	Methoxyphenamine hydrochloride	50,000	2%
	L-Amphetamine	75,000	1.33%
	D-Amphetamine	100,000(Negative)	Not detected
	D,L-Amphetamine	100,000(Negative)	Not detected
	Chloroquine	100,000(Negative)	Not detected
	Ephedrine hydrochloride	100,000(Negative)	Not detected
	(+/-)3,4-Methylenedioxyamphetamine(MDA)	100,000(Negative)	Not detected
	Trimethobenzamide	100,000(Negative)	Not detected
	l-phenylephrine	100,000(Negative)	Not detected
	(1R,2S)-(-)-Ephedrine	100,000(Negative)	Not detected
	Procaine hydrochloride	100,000(Negative)	Not detected
	6-acetylmorphine	2,500	80%
	Codeine	1,000	200%
	Dihydrocodeine	1,500	133.3%
OPI 2000	EthylMorphine	2,500	80%
	Codeine-6-β-D-glucuronide	2,500	80%
	Heroin	5,000	40%
	Hydrocodone	5,000	40%
	Hydromorphone	2,500	80%
	Levorphanol tartrate	10,000	20%
	Morphine	2,000	100%
	Nalorphine hydrochloride	5,000	40%
	Norcodeine	4,000	50%
	Normorphine	5.000	40%
	Oxymorphone	75,000	2.7%
	s-Monoacetylmorphine	2,000	100%
	Morphine-6-β-D-glucuronide	2,000	100%
	Thebaine	13,000	15.4%
	Morphine 3-β-D-glucuronide	2,000	100%
	6-Monoacetylmorphine (6-MAM)	1,500	133%
	6-Acetylcodeine	10,000	20%
	Oxycodone	100,000(Negative)	Not detected
	Procaine	100,000(Negative)	Not detected
	Norpropoxyphene	100,000(Negative)	Not detected
MTD 300	EDDP	100,000(Negative)	Not detected
	Doxylamine	100,000(Negative)	Not detected
	Levacetylmethadol (LAAM)	100,000(Negative)	Not detected
	EMDP	100,000(Negative)	Not detected
	Alpha Methadol	100,000(Negative)	Not detected
OXY 100	Ethyl Oxycodone	75,000	0.13%
	Hydrocodone	5,000	2%
	Hydromorphone	25,000	0.4%
	Levorphanol tartrate	25,000	0.4%
	Naloxone hydrochloride	10,000	1%
	Naltrexone hydrochloride	50,000	0.2%
	Oxycodone	100	100%
	Oxymorphone	200	50%
	Oxymorphone-3β-D-glucuronide	500	20%
	Noroxycodone	1,500	6.7%
	Noroxymorphone	3,000	3.3%
	Dihydrocodeine	100,000(Negative)	Not detected
	Codeine	100,000(Negative)	Not detected
	Morphine	100,000(Negative)	Not detected
	Buprenorphine	100,000(Negative)	Not detected
	Ethylmorphine	100,000(Negative)	Not detected
	Thebaine	100,000(Negative)	Not detected
	6-acetylmorphine	100,000(Negative)	Not detected
PCP 25	Phencyclidine	25	100%
	4-Hydroxy Phencyclidine	12,500	0.2%
PPX 300	d-Propoxyphene	300	100%
	d-Norpropoxyphene	300	100%
TCA 1000	Amitriptyline	1,500	66.7%
	Chlorpheniramine	50,000	2%
	Clomipramine	10,000	10%
	Cyclobenzaprine Hydrochloride	5,000	20%
	Desipramine	1,000	100%
	Doxepine	2,000	50%
	Duloxetine	10,000	10%
	Imipramine	1,000	100%
	Norclomipramine	12,500	8%
	Nordoxepine	1,000	100%
	Nortriptyline	1,000	100%
	Promazine	50,000	2%
	Trimipramine	10,000	10%
	Maprotiline	100,000(Negative)	Not detected
	Promethazine hydrochloride	100,000(Negative)	Not detected
THC 50	11-nor-Δ8-THC -9-COOH	30	166.7%
	(-)-11-nor-9-carboxy-Δ9-THC	50	100%
	(±)-11-nor-9-Carboxy-Δ9-THC	50	100%
	11-nor-Δ9-THC -carboxy glucuronide	100	50%
	11-hydroxy-Δ9-Tetrahydrocannabinol	5,000	1%
	Δ8- Tetrahydrocannabinol	1,300	3.8%
	Δ9- Tetrahydrocannabinol	5,000	1%
	Cannabinol	20,000	0.25%
	Cannabidiol	100,000(Negative)	Not detected
	(±)-11-Hydroxy-Δ9-THC	100,000(Negative)	Not detected
TML 100	Tramadol	100	100%
	n-Desmethyl Tramadol	400	25%
	o-Desmethyl Tramadol	1,000	10%
	o-Desmethyl Venlafaxine	10,000(Negative)	Not detected
	Venlafaxine HCl	100,000(Negative)	Not detected
6-MAM 10	6-acetylmorphine	10	100%
6-Monoacetylmorphine (6-MAM)	10	100%
Heroin	60	16.7%
Morphine	75,000	0.01%
s-Monoacetylmorphine	10	100%
Normorphine	100,000(Negative)	Not detected
Nalorphine HCl	100,000(Negative)	Not detected
Hydrocodone	100,000(Negative)	Not detected
Hydromorphone	100,000(Negative)	Not detected
Chlordiazepoxide	100,000(Negative)	Not detected
Clobazam	100,000(Negative)	Not detected
D-Amphetamine	100,000(Negative)	Not detected
(±)-Amphetamine	100,000(Negative)	Not detected
Levorphanol tartrate	100,000(Negative)	Not detected
Codeine	100,000(Negative)	Not detected
Ethylmorphine	100,000(Negative)	Not detected
Morphine3-β-D-glucuronide	100,000(Negative)	Not detected
Norcodeine	100,000(Negative)	Not detected
Oxycodone	100,000(Negative)	Not detected
Oxymorphone	100,000(Negative)	Not detected
Procaine hydrochloride	100,000(Negative)	Not detected
Thebaine	100,000(Negative)	Not detected
6-Acetylcodeine	100,000(Negative)	Not detected
Buprenorphine	100,000(Negative)	Not detected
Dihydrocodeine	100,000(Negative)	Not detected
Dextromethorphan	100,000(Negative)	Not detected
Imipramine hydrochloride	100,000(Negative)	Not detected
Meperidine	100,000(Negative)	Not detected
(±)-Methadone	100,000(Negative)	Not detected
Mitragynine(kratom)	100,000(Negative)	Not detected
Morphine-6-B-D-glucuronide	100,000(Negative)	Not detected
Naloxone hydrochloride	100,000(Negative)	Not detected
Naltrexone hydrochloride	100,000(Negative)	Not detected
Naproxen	100,000(Negative)	Not detected
Norbuprenorphine	100,000(Negative)	Not detected
	Norbuprenorphine-3-D-Glucuronide	100,000(Negative)	Not detected
	Noroxycodone HCL	100,000(Negative)	Not detected
	Noroxymorphone HCL	100,000(Negative)	Not detected
	(+)-Norpropoxyphene maleate	100,000(Negative)	Not detected
	Oxymorphone-3β-D-glucuronide	100,000(Negative)	Not detected
	Tapentadol HCl	100,000(Negative)	Not detected
	Tramadol	100,000(Negative)	Not detected
AMP 500	Hydroxyamphetamine	4,000	12.5%
	(+/-)-Methylenedioxyamphetamine(MDA)	200	250%
	D,L-Amphetamine	500	100%
	D-Amphetamine	500	100%
	Diethylstilbestrol	2,500	20%
	L-Amphetamine	25,000	2%
	Phentermine	4,000	12.5%
	β-Phenylethylamine	50,000	1%
	Tyramine	50,000	1%
	p-Hydroxynorephedrine	50,000	1%
	p-Hydroxyamphetamine	50,000	1%
	D,L-Norephedrine	50,000	1%
	(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	100,000	0.5%
	d-Methamphetamine	100,000(Negative)	Not detected
	l-Methamphetamine	100,000(Negative)	Not detected
	(+/-)3,4-Methylenedioxymethamphetamine(MDMA)	100,000(Negative)	Not detected
	Ephedrine hydrochloride	100,000(Negative)	Not detected
	Phenylpropanolamine	100,000(Negative)	Not detected
	Benzphetamine	100,000(Negative)	Not detected
	L-Ephedrine	100,000(Negative)	Not detected
	L-Epinephrine	100,000(Negative)	Not detected
	D,L-Epinephrine	100,000(Negative)	Not detected
COC 150	Benzoylecogonine	150	100%
Cocaethylene	150	100%
Cocaine hydrochloride	150	100%
Ecgonine	25,000	0.6%
Norcocaine	50,000	0.3%
Ecgonine methyl Ester	100,000(negative)	Not detected
MET 500	(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	10,000	5%
	(+/-)3,4-methylenedioxumethamphetamine(MDMA)	1,250	40%
	D-Methamphetamine	500	100%
	L-Methamphetamine	12,500	4%
	Fenfluramine	25,000	2%
	p-Hydroxymethamphetamine	5,000	10%
	D,L-Methamphetamine	500	100%
	β-Phenylethylamine	25,000	2%
	Mephetermine	25,000	2%
	Methoxyphenamine hydrochloride	25,000	2%
	L-Amphetamine	40,000	1.25%
	Ephedrine hydrochloride	100,000	0.5%
	(1R,2S)-(-)-Ephedrine	100,000	0.5%
	D-Amphetamine	100,000(negative)	Not detected
	Chloroquine	100,000(negative)	Not detected
	(+/-)3,4-Methylenedioxyamphetamine(MDA)	100,000(negative)	Not detected
	L-Phenylephrine	100,000(negative)	Not detected
	Trimethobenzamide	100,000(negative)	Not detected
	Procaine hydrochloride	100,000(negative)	Not detected
	d/l-Amphetamine	100,000(negative)	Not detected
OPI 300	6-acetylmorphine	400	75%
	Codeine	300	100%
	Dihydrocodeine	1,000	30%
	EthylMorphine	100	300%
	Heroin	600	50%
Hydrocodone	500	60%
Hydromorphone	1,000	30%
Levorphanol tartrate	10,000	3%
Morphine	300	100%
Nalorphine hydrochloride	50,000	0.6%
Thebaine	6,240	4.8%
s-Monoacetylmorphine	300	100%
Morphine-3-β-d-glucuronide	1,000	30%
6-Monoacetylmorphine (6-MAM)	150	200%
Codeine-6-ß-D-glucuronide	150	200%
Morphine-6-β-D-glucuronide	150	200%
6-Acetylcodeine	900	33.3%
Normorphine	100,000(negative)	Not detected
Oxycodone	100,000(negative)	Not detected
Oxymorphone	100,000(negative)	Not detected
Norcodeine	100,000(negative)	Not detected
Procaine	100,000(negative)	Not detected
Norpropoxyphene	100,000(negative)	Not detected

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

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

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

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

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

{18}------------------------------------------------

{19}------------------------------------------------

{20}------------------------------------------------

{21}------------------------------------------------

{22}------------------------------------------------

{23}------------------------------------------------

To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.

Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.

(-) Cotinine	Diclofenac sodium	Nitroglycerin
3-Hydroxytyramine	Diflunisal	Norethindrone
7-Aminoclonazepam (except MDMA test)	Digoxin	Norpropoxyphene
7-Aminoflunitrazepam	Dimethyl-aminoantipyrine	Norpseudoephedrine
7-Aminonitrazepam	Diphenhydramine HCl	Nortriptyline (except TCA test)
Acetaminophen	Diphenylhydantoin	Noscapine
Acetone (1000 mg/dL)	Disopyramide	Octopamine
Acetophenetidin	Dopamine HCl	O-Hydroxyhippuric acid
Acetylsalicylic acid	Doxepine (except TCA test)	Olanzapine
Acyclovir	Doxylamine	Omeprazole
Albumin(100mg/dL)	D-Pseudoephedrine	Oxalic acid (100mg/dL)
Albuterol	Duloxetine (except TCA test)	Oxazepam (except BZO test)

{24}------------------------------------------------

Albuterol sulfate(Proair HFA)	Ecgonine methyl ester	Oxazepam Glucuronide (exceptBZO test)
Alpha Methadol	EMDP	Oxalinic acid
Aminophylline	Ephedrine hydrochloride(except MET test)	Oxymetazoline
Aminopyrine	Erythromycin	Paliperidone
Amitriptyline(except TCA test)	Esomeprazole Magnesium	Papaverine
Amlodipine besylate	Estradiol	Penicillin-G
Amobarbital(except BAR test)	Estrone	PenicillinV Potassium
Amoxicillin	Ethanol(1%)	Perphenazine
Ampicillin	Fenfluramine(except MET test)	Phenacetin
Apomorphine	Fenofibrate	Phencyclidine (except PCP test)
Aripiprazole	Fenoprofen	Phenelzine
Ascorbic acid	Fluoxetine Hydrochloride	Phenylethylamine
Aspartame	Fluphenazine	Phenobarbital (except BAR test)
Aspirin	Fotemustine	Phentermine (except AMP test)
Atomoxetine	Furosemide	Phenylpropanolamine
Atorvastatin Calcium	Gabapentin	Prednisone
Atropine	Galactose	Pregablin
Azithromycin	Gatifloxacin	Procaine
Baclofen	Gemfibrozil	Promazine (except TCA test)
Benzilic acid	Gentisic acid	Promethazine
Benzocaine	Glucose (3000mg/dL)	Propoxyphene (except PPX test)
Benzoic acid	Guaiacolglyceryl ether	Propranolol
Benzoylecgonine (except COC test)	Hemoglobin	Pseudoephedrine
Benzphetamine	Hexobarbital	Pyridoxine
Benzylpiperiazine	Hydralazine	Pyrilamine
Bilirubin	Hydrochlorothiazide	Pyrogallol
Boric Acid (1%)	Hydrocortisone	Quetiapine
Bromo-2,5,Dimethoxyphenethylamine	Hydroxybutyric Acid	Quinidine
Bupropion	Ibuprofen	Quinine
Caffeine	Imipramine(except TCA test)	Quinolinic Acid
Cannabidiol	Isoproterenol	Ranitidine
Captopril	Isoxsuprine	Riboflavin
Carbamazepine	Ketamine	Rifampicin
Carfentanil	Ketoprofen	Salicylic acid
Carisoprodol	LAAM HC1	Secobarbital (except BAR test)
Cefradine	Labetalol	Serotonin
Cephalexin	Lamotrigine	Serotonin (5-Hydroxytyramine)
Cetirizine	L-Ephedrine	Sertraline
Chloral hydrate	L-Epinephrine	Sildenafil Citrate
Chloramphenicol	Levofloxacin Hydrochloride	Simvastatin
Chlordiazepoxide(except BZO test)	Levonorgestrel	Sodium Azide
Chloroquine	Levothyroxine Sodium	Sulfamethazine
Chlorothiazide	Lidocaine Hydrochloride	Sulindac
Chlorpheniramine(except TCA test)	Lisinopril	Telmisartan
Chlorpromazine	Loperamide	Tetracycline
Cholesterol	Loratadine	Tetrahydrocortisone 3-(β-D-glucuronide)
Ciprofloxacin Hydrochloride	Lorazepam Glucuronide(except BZO test)	Tetrahydrocortisone, 3-acetate
Citalopram	L-phenylephrine	Tetrahydrozoline
Clarithromycin	LSD	THC (except THC test)
Clofibrate	L-thyroxine	Theophylline
Clomipramine(except TCA test)	Magnesium	Thiamine
Clonidine	Maprotiline	Thioridazine
Clozapine	Meperidine	Trazodone Hydrochloride
Conjugated Estrogens	Meprobamate	Triamterene
Cortisone	Metformin	Trifluoperazine
Creatine Hydrate	Methapyrilene	Trifluoromethylphenyl-piperazine
Creatinine	Methaqualone	Trimethobenzamide
Cyclobenzaprine(except TCA test)	Methoxyphenamine (exceptMET test)	Trimethoprim
Cyproheptadine	Methylphenidate	Tryptamine
D,L-Epinephrine	Metoprolol Tartrate	Tyramine (except AMP test)
D,L-Isoproterenol	Metronidazole	Urea (2000 mg/dL)
D,L-Lorazepam (except BZO test)	Mifepristone	Uric acid
D,L-Octopamine	N-Acetylprocainamide	Valproic acid (250 µg/mL)
D,L-Propranolol	NaCl (4000 mg/dL)	Venlafaxine HCl
D,L-Tryptophan	Nalidixic acid	Verapamil
D,L-Tyrosine	Naloxone hydrochloride(except OXY test)	Vitamin B2
Delorazepam	Naltrexonehydrochloride(except OXYtest)	Vitamin C
Demoxepam(except BZO test)	Naproxen	Zaleplon
Deoxycorticosterone	N-desmethyl Tapentadol	Zolpidem
Desloratadine	Niacinamide	Zomepirac
Desipramine(except TCA test)	Nicotine	β-Estradiol
Dextromethorphan	Nicotinic Acid	γ-Cyclodextrin
Diclofenac	Nifedipine	γ-Globulin (500mg/dL)

{25}------------------------------------------------

Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The

{26}------------------------------------------------

results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.

B. Method comparison study

The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:

Drug test	Test Result		Drug-Free	LowNegative byLC-MS/MS(less than -50%)	Near CutoffNegative byLC-MS/MS(Between -50% and theCutoff)	Near CutoffPositive byLC-MS/MS(Betweenthe cutoffand +50%)	High Positiveby LC-MS/MS(greater than+50%)
AMP(1000)	Operator	+	0	0	0	17	22
	A	-	10	14	16	1	0
	Operator	+	0	0	1	17	22
	B	-	10	14	15	1	0
	Operator	+	0	0	0	17	22
	C	-	10	14	16	1	0
AMP(500)	Operator	+	0	0	1	18	21
	A	-	10	14	15	1	0
	Operator	+	0	0	1	18	21
	B	-	10	14	15	1	0
	Operator	+	0	0	1	18	21
	C	-	10	14	15	1	0
BAR	Operator	+	0	0	1	11	28
	A	-	10	15	14	1	0
	Operator	+	0	0	1	12	28
	B	-	10	15	14	0	0
	Operator	+	0	0	1	11	28
	C	-	10	15	14	1	0
BUP	Operator	+	0	0	2	18	20
	A	-	10	16	12	2	0
	Operator	+	0	0	1	18	20
	B	-	10	16	13	2	0
	Operator	+	0	0	2	18	20
	C	-	10	16	12	2	0
BZO	Operator	+	0	0	1	22	16
	A	-	10	17	12	2	0
	Operator	+	0	0	1	22	16
	B	-	10	17	12	2	0
	Operator	+	0	0	1	22	16
	C	-	10	17	12	2	0
COC	Operator	+	0	0	1	16	23
(300)	A	-	10	16	13	1	0
	Operator	+	0	0	2	16	23
	B	-	10	16	12	1	0
	Operator	+	0	0	1	16	23
	C	-	10	16	13	1	0
COC	Operator	+	0	0	1	21	18
(150)	A	-	10	16	13	1	0
	Operator	+	0	0	1	20	18
	B	-	10	16	13	2	0
	Operator	+	0	0	1	21	18
	C	-	10	16	13	1	0
EDDP	Operator	+	0	0	1	16	23
	A	-	10	16	13	1	0
	Operator	+	0	0	1	15	23
	B	-	10	16	13	2	0
	Operator	+	0	0	0	17	23
	C	-	10	16	14	0	0
FYL	Operator	+	0	0	2	15	24
	A	-	10	16	12	1	0
	Operator	+	0	0	1	14	24
	B	-	10	16	13	2	0
	Operator	+	0	0	1	15	24
	C	-	10	16	13	1	0
MDMA	Operator	+	0	0	2	16	23
	A	-	10	15	13	1	0
	Operator	+	0	0	1	16	23
	B	-	10	15	14	1	0
	Operator	+	0	0	1	16	23
	C	-	10	15	14	1	0
MET	Operator	+	0	0	0	19	20
(1000)	A	-	10	17	13	1	0
	Operator	+	0	0	1	19	20
	B	-	10	17	12	1	0
	Operator	+	0	0	0	19	20
	C	-	10	17	13	1	0
MET	Operator	+	0	0	1	23	17
(500)	A	-	10	15	14	0	0
	Operator	+	0	0	1	22	17
	B	-	10	15	14	1	0
	Operator	+	0	0	1	22	17
	C	-	10	15	14	1	0
OPI (300)	Operator	+	0	0	1	20	19
	A	-	10	15	14	1	0
	Operator	+	0	0	0	20	19
	B	-	10	15	15	1	0
	Operator	+	0	0	1	20	19
	C	-	10	15	14	1	0
OPI(2000)	Operator	+	0	0	0	18	22
	A	-	10	16	14	0	0
	Operator	+	0	0	1	17	22
	B	-	10	16	13	1	0
	Operator	+	0	0	0	17	22
	C	-	10	16	14	1	0
MTD	Operator	+	0	0	1	15	24
	A	-	10	16	13	1	0
	Operator	+	0	0	0	14	24
	B	-	10	16	14	2	0
	Operator	+	0	0	0	15	24
	C	-	10	16	14	1	0
OXY	Operator	+	0	0	1	13	25
	A	-	10	15	14	2	0
	Operator	+	0	0	1	14	25
	B	-	10	15	14	1	0
	Operator	+	0	0	1	13	25
	C	-	10	15	14	2	0
PCP	Operator	+	0	0	1	13	25
	A	-	10	16	13	2	0
	Operator	+	0	0	1	13	25
	B	-	10	16	13	2	0
	Operator	+	0	0	1	14	25
	C	-	10	16	13	1	0
PPX	Operator	+	0	0	0	15	24
	A	-	10	16	14	1	0
	Operator	+	0	0	1	15	24
	B	-	10	16	13	1	0
	Operator	+	0	0	0	15	24
	C	-	10	16	14	1	0
TCA	Operator	+	0	0	1	19	20
	A	-	10	15	14	1	0
	Operator	+	0	0	1	19	20
	B	-	10	15	14	1	0
	Operator	+	0	0	0	19	20
	C	-	10	15	15	1	0
THC	Operator	+	0	0	1	16	22
	A	-	10	16	13	2	0
	Operator	+	0	0	2	16	22
	B	-	10	16	12	2	0
	Operator	+	0	0	1	16	22
	C	-	10	16	13	2	0
TML	Operator	+	0	0	1	14	24
	A	-	10	16	13	2	0
	Operator	+	0	0	1	15	24
	B	-	10	16	13	1	0
	Operator	+	0	0	1	15	24
	C	-	10	16	13	1	0
6-MAM	Operator	+	0	0	1	18	20
	A	-	10	16	13	2	0
	Operator	+	0	0	1	18	20
	B	-	10	16	13	2	0
	Operator	+	0	0	2	19	20
	C	-	10	16	12	1	0

{27}------------------------------------------------

{28}------------------------------------------------

{29}------------------------------------------------

Discordant Results are summarized below.

Drug	Operator	Sample Number	LC/MS/MS Result(ng/mL)	Accurate Result
6-MAM 10	Operator A, C	TF-6-MAM06071	8.13	+
	Operator C	TF-6-MAM06001	8.54	+
	Operator B	TF-6-MAM06030	9.85	+
	Operator B	TF-6-MAM06018	10.84	-
	Operator A, B, C	TF-6-MAM06037	11.04	-
	Operator A	TF-6-MAM06060	11.31	-
AMP 1000	Operator B	TF-AMP06041	968.58	+
	Operator A, B	TF-AMP06035	1008.47	-
	Operator C	TF-AMP06027	1038.84	-
BAR 300	Operator A, C	TF-BAR06026	274.49	+
	Operator B	TF-BAR06024	291.27	+
	Operator A, C	TF-BAR06037	316.44	-
BUP 10	Operator A, C	TF-BUP06058	9.22	+
	Operator B, C	TF-BUP06065	9.58	+
	Operator A	TF-BUP06032	9.79	+
	Operator A	TF-BUP06071	10.18	-
	Operator B, C	TF-BUP06002	10.33	-
	Operator B	TF-BUP06059	10.77	-
	Operator C	TF-BUP06039	11.02	-
	Operator A	TF-BUP06057	11.22	-
BZO 300	Operator A, C	TF-BZO06049	276.48	+
	Operator B	TF-BZO06004	289.45	+
	Operator A, B	TF-BZO06014	302.46	-
	Operator A, C	TF-BZO06018	318.53	-
	Operator B	TF-BZO06006	322.77	-
	Operator C	TF-BZO06071	336.40	-
COC 300	Operator A	TF-COC06076	294.37	+
	Operator B	TF-COC06061	296.67	+
	Operator B	TF-COC06010	288.91	+
	Operator C	TF-COC06066	291.80	+
	Operator A	TF-COC06036	331.25	-
	Operator B	TF-COC06002	302.88	-
	Operator C	TF-COC06029	311.54	-
EDDP 300	Operator B	TF-EDDP06008	278.15	+
	Operator A	TF-EDDP06065	294.41	+
	Operator B	TF-EDDP06042	308.29	-
	Operator B	TF-EDDP06040	314.11	-
	Operator A	TF-EDDP06025	326.51	-
FYL	Operator A	TF-FYL06017	4.28	+
	Operator C	TF-FYL06062	4.54	+
	Operator B	TF-FYL06038	4.61	+
	Operator A	TF-FYL06078	4.83	+
	Operator B	TF-FYL06049	5.11	-
	Operator A	TF-FYL06063	5.48	-
	Operator C	TF-FYL06073	5.63	-
	Operator B	TF-FYL06022	5.77	-
MDMA 500	Operator A	TF-MDMA06047	434.68	+
	Operator C	TF-MDMA06080	443.57	+
	Operator B	TF-MDMA06072	483.40	+
	Operator A	TF-MDMA06046	491.32	+
	Operator C	TF-MDMA06006	505.64	-
	Operator A, B	TF-MDMA06002	519.63	-
MET 1000	Operator B	TF-MET06052	946.52	+
	Operator B	TF-MET06031	1064.20	-
	Operator A	TF-MET06007	1139.47	-
	Operator C	TF-MET06006	1162.76	-
OPI 300	Operator A, C	TF-MOP06065	291.05	+
	Operator B	TF-MOP06062	302.36	-
	Operator A	TF-MOP06031	317.77	-
MTD 300	Operator C	TF-MOP06032	351.52	-
MTD 300	Operator A	TF-MTD06025	280.13	+
	Operator B	TF-MTD06078	306.14	-
	Operator C	TF-MTD06056	321.60	-
	Operator A	TF-MTD06006	336.27	-
	Operator B	TF-MTD06060	351.49	-
OXY 100	Operator A, C	TF-OXY06058	95.88	+
	Operator B	TF-OXY06003	97.96	+
	Operator A	TF-OXY06078	100.28	-
	Operator A, C	TF-OXY06073	100.77	-
	Operator B	TF-OXY06024	102.28	-
	Operator C	TF-OXY06060	115.34	-
PCP 25	Operator A, C	TF-PCP06039	20.19	+
	Operator B	TF-PCP06002	23.68	+
	Operator A, C	TF-PCP06018	25.19	-
	Operator A, B	TF-PCP06075	25.88	-
	Operator B	TF-PCP06043	28.42	-
PPX 300	Operator B	TF-PPX06066	277.71	+
	Operator B	TF-PPX06037	304.35	-
	Operator A	TF-PPX06012	321.47	-
	Operator C	TF-PPX06045	335.28	-
TCA 1000	Operator B	TF-TCA06015	892.55	+
	Operator A	TF-TCA06008	951.60	+
	Operator B	TF-TCA06020	1013.28	-
	Operator C	TF-TCA06068	1120.01	-
	Operator A	TF-TCA06080	1120.63	-
THC 50	Operator B	TF-THC06021	42.33	+
	Operator A	TF-THC06073	44.93	+
	Operator C	TF-THC06060	47.61	+
	Operator B	TF-THC06050	49.77	+
	Operator A, C	TF-THC06062	53.28	-
	Operator B	TF-THC06014	57.74	-
	Operator B	TF-THC06040	58.69	-
	Operator A, C	TF-THC06064	59.33	-
TML	Operator A	TF-TML06052	84.31	+
	Operator C	TF-TML06043	90.15	+
	Operator B	TF-TML06024	94.68	+
	Operator A	TF-TML06054	101.37	-
	Operator B, C	TF-TML06056	108.45	-
	Operator A	TF-TML06046	114.31	-
AMP 500	Operator B	TF-SAMP06031	447.35	+
	Operator C	TF-SAMP06034	465.44	+
	Operator A	TF-SAMP06006	479.87	+

	Operator B	TF-SAMP06055	502.90	-
	Operator A	TF-SAMP06075	541.26	-
	Operator C	TF-SAMP06054	577.15	-
COC 150	Operator A, B, C	TF-SCOC06030	133.67	+
	Operator B	TF-SCOC06062	155.27	-
	Operator A, C	TF-SCOC06053	160.33	-
	Operator B	TF-SCOC06019	165.57	-
MET 500	Operator B	TF-SMET06029	428.49	+
	Operator A, C	TF-SMET06042	481.16	+
	Operator B, C	TF-SMET06035	512.71	-
OPI 2000	Operator B	TF-SMOP06029	1972.07	+
	Operator B	TF-SMOP06014	2108.15	-
	Operator C	TF-SMOP06065	2194.62	-

{30}------------------------------------------------

{31}------------------------------------------------

{32}------------------------------------------------

C. Lay person study

A lay user study was performed at three intended user sites with 280 lay persons. 76 male and 64 female tested Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 1; 73 male and 67 female tested Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 2. They had diverse educational and professional backgrounds and their age range from 21 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blindlabeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

Drug			Concentration
	Cutoff(ng/mL)	Results	-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
	AMP	1000	Negative	20	20	20	19	1	0
Positive			0	0	0	1	19	20	20
Total			20	20	20	20	20	20	20
Agreement (%)			100%	100%	100%	95%	95%	100%	100%
BAR	300	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
BUP	10	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
BZO	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
COC	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
FYL	5	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	1	0	0
	500	Positive	0	0	0	1	19	20	20
MDMA		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
	1000	Negative	20	20	20	19	1	0	0
MET		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
	300	Negative	20	20	20	19	1	0	0
MOP		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
	300	Negative	20	20	20	18	1	0	0
MTD		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
OXY	100	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
PCP	25	Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
PPX	300	Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
TCA	1000	Negative	20	20	20	19	0	0	0
		Positive	0	0	0	1	20	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	100%	100%	100%
THC	50	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
TML	100	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
6-MAM	10	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%

Result of Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 1:

{33}------------------------------------------------

{34}------------------------------------------------

Result of Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 2:

Drug	Cutoff(ng/mL)	Results	-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
AMP	500	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
BAR	300	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
BUP	10	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
BZO	300	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
COC	150	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%

EDDP	300	Negative	20	20	20	20	18	1	0	0
		Positive	0	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	90%	95%	100%	100%
FYL	5	Negative	20	20	20	20	19	2	0	0
		Positive	0	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	90%	100%	100%
MDMA	500	Negative	20	20	20	20	19	1	0	0
		Positive	0	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	95%	100%	100%
MET	500	Negative	20	20	20	20	20	1	0	0
		Positive	0	0	0	0	0	19	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	100%	95%	100%	100%
MOP	2000	Negative	20	20	20	20	19	0	0	0
		Positive	0	0	0	0	1	20	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	100%	100%	100%
MTD	300	Negative	20	20	20	20	19	1	0	0
		Positive	0	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	95%	100%	100%
OXY	100	Negative	20	20	20	20	19	2	0	0
		Positive	0	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	90%	100%	100%
PCP	25	Negative	20	20	20	20	18	2	0	0
		Positive	0	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	90%	90%	100%	100%
PPX	300	Negative	20	20	20	20	19	1	0	0
		Positive	0	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	95%	100%	100%
TCA	1000	Negative	20	20	20	20	19	1	0	0
		Positive	0	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	95%	100%	100%
THC	50	Negative	20	20	20	20	19	2	0	0
		Positive	0	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	90%	100%	100%
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
TML	100	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
6-MAM	10	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%

{35}------------------------------------------------

{36}------------------------------------------------

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. 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.

13. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup are substantially equivalent to the predicate devices.

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).