The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/l-Methadone, d-Methamphetamine, d1-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH 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 / 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 / 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
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

The single or multi-test panels can consist of up to sixteen (16) 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 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 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 Urine Drug Test Dip Card is a rapid qualitative immunoassay.

The device provides preliminary results for the detection of potential abuse of one or more at the cutoff concentrations of table below.

This is not a screening device to monitor prescription medication.

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
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
6-MAM	6-Monoacetylmorphine	10

This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.

This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

Device Description

Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card 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 dip card 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

Here's a breakdown of the acceptance criteria and study information for the Healgen Accurate Urine Drug Screen Dip Card and Healgen Accurate Home Urine Drug Test Dip Card, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the reported performance, specifically the agreement rates with LC-MS/MS and within the lay user study, particularly around the established cut-off concentrations. A device is considered to meet the acceptance criteria if its performance demonstrates accurate qualitative detection of the target drugs at and around the specified cut-off concentrations.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Assessment Category	Implied Acceptance Criteria	Reported Device Performance
Precision	Consistent positive/negative results at concentrations significantly above/below cutoff. Mixed results at and near cutoff.	Generally 100% agreement for concentrations ±50% to ±100% of the cutoff. Mixed results at cutoff and ±25% of cutoff, indicating appropriate sensitivity at the threshold.
Analytical Specificity/Interference	No interference or cross-reactivity from specified non-structural compounds at 100 µg/mL. Acceptable cross-reactivity for structurally related analogs.	Extensive list of compounds showing "Not detected" or specific cross-reactivity percentages. pH (4-9) and specific gravity (1.000-1.035) showed no interference.
Method Comparison (Clinical Samples)	High agreement (concordance) with LC-MS/MS results, especially for clearly negative and clearly positive samples.	High concordance with LC-MS/MS, with discordant results primarily located near the cutoff concentrations. For example, for AMP (1000ng/mL), 0 false positives were seen among "Drug-Free" and "Low Negative" samples, and 0 false negatives among "High Positive" samples across all operators.
Lay Person Study	High agreement with expected results by lay users, demonstrating ease of use and accurate interpretation. Instructions should be easy to understand.	High agreement (mostly 90-100%) near and away from cutoff concentrations for various drugs for both configurations. All participants found instructions easy to understand, and the Flesch-Kincaid reading level was 7.
Stability	Device remains stable and performs within specifications for the claimed shelf life.	24 months at 2-30℃ based on real-time stability study.

Detailed Study Information:

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

Precision/Reproducibility Study:
- For each drug and each concentration (-100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff, +100% cutoff), 50 tests were performed per lot.
- With 3 lots, this amounts to 150 tests per concentration per drug.
- There are 16 different drugs/cut-offs for which precision was tested. So, 16 drugs * 9 concentrations * 50 tests/concentration * 3 lots = 21,600 individual test results.
- Data Provenance: Not explicitly stated, but implies laboratory-prepared spiked samples using drug-free urine.
Analytical Specificity/Interference Study:
- "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."
- "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."
- Sample Size: Not explicitly given as a total number of tests for all compounds but a significant number of tests were performed for each compound listed.
- Data Provenance: Laboratory-prepared spiked samples using drug-free urine.
Method Comparison Study:
- Sample Size: 80 "unaltered urine clinical samples" (40 negative and 40 positive) for each drug.
- With 16 different drugs/cut-offs, this amounts to 16 drugs * 80 samples = 1280 clinical samples.
- These samples were tested by 3 operators, meaning 1280 samples * 3 operators = 3840 individual test results.
- Data Provenance: "Unaltered urine clinical samples." The country of origin is not specified but is likely the US given the FDA submission.
Lay Person Study:
- Sample Size: 280 lay persons.
- 78 male and 62 female tested Configuration 1 (140 participants).
- 76 male and 64 female tested Configuration 2 (140 participants).
- Urine samples were prepared at 7 concentrations: -100%, +/-75%, +/-50%, +/-25% of the cutoff. Each participant received one blind-labeled sample.
- For each drug, 20 samples were prepared for each of the 7 concentrations, meaning 140 samples per drug.
- With 16 drugs, 16 drugs * 140 samples = 2240 samples. Since there were different configurations, the actual number of unique samples tested is likely higher.
- Data Provenance: Laboratory-prepared spiked samples using drug-free urine, presented to lay users.

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

Precision/Reproducibility, Analytical Specificity/Interference, and Lay Person Studies: The ground truth for these studies was established by LC-MS/MS confirming the spiked concentrations. No human experts were involved in establishing the ground truth for these specific tests.
Method Comparison Study: The ground truth for this study was established using LC-MS/MS results. The document states that "The samples were blind labeled and compared to LC-MS/MS results." No human experts were used for establishing the ground truth beyond the analytical method itself.

4. Adjudication Method for the Test Set:

Method Comparison Study: "The samples were blind labeled and compared to LC-MS/MS results." This suggests direct comparison to the LC-MS/MS ground truth, with no explicit human adjudication mentioned for discrepancies. The discordant results table shows instances where the dip card result differed from the LC-MS/MS result for individual operators, but there's no mention of a formal adjudication process involving multiple experts to re-evaluate the LC-MS/MS results or the dip card interpretations. The "Accurate Result" column in the discordant table appears to consistently follow the LC-MS/MS result.
Lay Person Study: The results were generated by lay persons. The "Agreement (%)" indicates concordance with the known spiked concentration as confirmed by LC-MS/MS, not a consensus among lay users or experts evaluating their interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No MRMC comparative effectiveness study was done. This device is a rapid lateral flow immunoassay (a dip card), not an AI-powered diagnostic device. The studies evaluate the device's performance directly and its usability by laypersons, not the improvement of human readers with AI assistance.

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

This question is not applicable as the device is a manual, qualitative immunoassay. Its "standalone" performance is what is evaluated in the precision, specificity, and method comparison studies (excluding the lay person aspect). There is no algorithm or AI component. The interpretation is visual.

7. The Type of Ground Truth Used:

LC-MS/MS (Liquid Chromatography-Mass Spectrometry), and its tandem mass-spectrometer versions (LC-MS/MS), were used as the preferred confirmatory method to establish ground truth for all analytical and method comparison studies. For the lay person study, the known spiked concentrations, confirmed by LC-MS/MS, served as the ground truth.

8. The Sample Size for the Training Set:

This information is not provided in the document. As this is an immunoassay and not a machine learning model, the concept of a "training set" in the context of AI is not relevant. The device is developed and manufactured, and its performance is then validated.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text. The logo is clean and professional, conveying the authority and trustworthiness of the FDA.

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

Re: K240686

Trade/Device Name: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card 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: March 9, 2024 Received: March 12, 2024

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 (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.

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).

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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.

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-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,

Joseph A. Digitally signed by Kotarek -S Date: 2024.04.12
12:04:54 -S 12:04:54 -04'00' Joseph Kotarek, Ph.D. 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) K240686

Device Name

Healgen Accurate Urine Drug Screen Dip Card Healgen Accurate Home Urine Drug Test Dip Card

Indications for Use (Describe)

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
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

The single or multi-test panels can consist of up to sixteen (16) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay.

The device provides preliminary results for the detection of potential abuse of one or more at the cutoff concentrations of table below.

This is not a screening device to monitor prescription medication.

CODE	SUBSTANCE	CUT-OFF (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300

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COC	Cocaine	300 or 150
EDDP	EDDP	300
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
6-MAM	6-Monoacetylmorphine	10

This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.

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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FORM FDA 3881 (8/23)

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510(k) SUMMARY K240686

1. Date:	April 11, 2024
2. Submitter:	Healgen Scientific LLC.
	3818 Fuqua Street
	Houston, TX 77047
3. Contact person:	Joe Shia
	LSI International Inc.
	504 East Diamond Ave., Suite H
	Gaithersburg, MD 20877
	Telephone: 240-505-7880
	Email: shiajl@yahoo.com

Device Name: Healgen Accurate Urine Drug Screen Dip Card 4. Healgen Accurate Home Urine Drug Test Dip Card Classification: 5. Class II

Product Code	Regulation Section	Panel
Target Drug
NFT	862.3100, Amphetamine Test System	Toxicology
Amphetamine (AMP)
PTH	862.3150, Barbiturate Test System	Toxicology
Secobarbital (BAR)
NGL	862.3650, Opiate Test System	Toxicology
Buprenorphine (BUP)
Morphine (OPI)
Oxycodone (OXY)
6-Monoacetylmorphine(6-MAM)
NFV	862.3170, Benzodiazepine Test System	Toxicology
Oxazepam (BZO)
NFY	862.3250, Cocaine and cocainemetabolite test system	Toxicology
Cocaine (COC)
PTG	862.3620, Methadone Test System	Toxicology
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
Methadone (MTD)
NGG	862.3610,Methamphetamine Test System	Toxicology
Methylenedioxymethamphetamine(MDMA)
Methamphetamine (MET)
NGM	Unclassified	Toxicology
Phencyclidine (PCP)
OBE	862.3700 Propoxyphene test system	Toxicology

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Propoxyphene(PPX)
QAWNortriptyline (TCA)	862.3910 Tricyclic antidepressant drugstest system	Toxicology
NFWCannabinoids (THC 50)	862.3870, Cannabinoids Test System	Toxicology

Predicate Devices: 6.

Dochek® Multi-Drug Urine Test Cup (K232659)

7. Intended Use

The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH 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 / 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 / 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
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

The single or multi-test panels can consist of up to sixteen (16) 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.

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The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.

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
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
6-MAM	6-Monoacetylmorphine	10

This is not a screening device to monitor prescription medication.

This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device. This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

8. Device Description

The device is a dip card 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(K232659)
Intended use	Qualitative detection of drugs of abuse in urine.	Same.

9. Substantial Equivalence Information

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Methodology	Competitive binding, lateral flow immunochromatographicassay 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)	Same
	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
	Methylenedioxymethamphetamine(MDMA)	500
	Methamphetamine (MET)	1000 or 500
	Morphine (OPI300/OPI2000)	2000 or 300
	Methadone (MTD)	300
	Oxycodone (OXY)	100
	Phencyclidine (PCP)	25
	Propoxyphene(PPX)	300
	Nortriptyline (TCA)	1000
	Cannabinoids (THC)	50
	6-Monoacetylmorphine(6-MAM)	10
Configurations	Test Dip Card		Test cup

10. Standard/Guidance Document Reference (if applicable)

None referenced.

11. Test Principle

Healgen Accurate Home Urine Drug Test Dip Card or Healgen Accurate Urine Drug Screen Dip Card 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.

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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, +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 dipcards. The results obtained are summarized in the following tables:

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+	21-/29+	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+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
BAR300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	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+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
BUP10	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	27-/23+	49-/1+	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+
BZO300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	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+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
COC300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	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+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	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+
	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
MDMA 500	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	50-/0+	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+
MET1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
OPI300	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+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
MTD300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	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+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
OXY100	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	22-/28+	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+	48-/2+	50-/0+	50-/0+	50-/0+
PCP25	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	25-/25+	49-/1+	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+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
PPX300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	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	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
TCA1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	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+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
THC50	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	22-/28+	49-/1+	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+
6-MAM	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	27-/23+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	28-/22+	48-/2+	50-/0+	50-/0+	50-/0+
AMP500	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	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+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
COC150	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	25-/25+	49-/1+	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+
MET500	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
OPI2000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	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+

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

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

b. Linearity/assay reportable range:

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

c. Stability:

The device is stable at 2-30℃ for 24 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.

Drug/Cutoff	Compound	Minimumconcentrationrequired to obtaina positive result(ng/mL)	% Cross-Reactivity
AMP 1000	Hydroxyamphetamine	8000	12.5%
	(+/-)-Methylenedioxyamphetamine(MDA)	400	250%
	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	100,000(Negative)	Not detected
	(MDMA)
	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%
	Amobarbital	300	100%
	Aprobarbital	250	120%
	Butabarbital	2,500	12%
	Butethal	100	300%
BAR 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%
	Norbuprenorphine-3-D-Glucuronide	200	5%
BUP 10	Morphine	100000 (Negative)	Not Detected
	Oxymorphone	100000 (Negative)	Not Detected
	Hydromorphone	100000 (Negative)	Not Detected
	a-Hydroxyalprazolam	1,260	23.8%
BZO 300	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%
	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%
	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%
	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
EDDP 300	EMDP	100,000(negative)	Not detected
	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
MDMA 500	(+/-)3,4-MethylenedioxymethamphetamineHCl(MDMA)	500	100%
	(+/-)3,4-MethylenedioxyamphetamineHCL(MDA)	3,000	16.7%

(+/-)3,4-	Methylenedioxyethylamphetamine(MDEA)	300	167%
	L-Methamphetamine	50,000	1%
	d-methamphetamine	100,000(Negative)	Not detected
	d-amphetamine	100,000(Negative)	Not detected
	l-amphetamine	100,000(Negative)	Not detected
	(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	20,000	5%
	(+/-)3,4-Methylenedioxymethamphetamine(MDMA)	2,500	40%
	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%
MET 1000	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
	1-phenylephrine	100,000(Negative)	Not detected
	(1R,2S)-(-)-Ephedrine	100,000(Negative)	Not detected
	Procaine hydrochloride	100,000(Negative)	Not detected
OPI 2000	6-acetylmorphine	2,500	80%
	Codeine	1,000	200%
	Dihydrocodeine	1,500	133.3%

	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
	(-)-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
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-β-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
	TapentadolHCl	100,000(Negative)	Not detected
	Tramadol hydrochloride	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
	Benzoylecogonine	150	100%
	Cocaethylene	150	100%
	Cocaine hydrochloride	150	100%
COC 150	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-β-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

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

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

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

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

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

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

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

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

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

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	Dextromethorphan	Nitroglycerin
3-Hydroxytyramine	Diclofenac	Nordoxepin
Acetaminophen	Diclofenac sodium	Norethindrone
Acetophenetidin	Diflunisal	Norfentanyl
Acetylsalicylic acid	Digoxin	Noscapine

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

Acyclovir	Diphenhydramine HCl	O-Hydroxyhippuric acid
Albumin (100mg/dL)	Disopyramide	Olanzapine
Albuterol sulfate (Proair HFA)	Dopamine HCl	Omeprazole
Alpha Methadol	Doxylamine	Oxalic acid
Aminophylline	D-Pseudoephedrine	Oxolinic acid
Aminopyrine	Duloxetine (except TCA test)	Oxymetazoline
Amoxicillin	Ecgonine methyl ester	Paliperidone
Ampicillin	EMDP	Papaverine
Apomorphine	Erythromycin	Penicillin-G
Aripiprazole	Esomeprazole Magnesium	Penicillin V Potassium
Ascorbic acid	Ethanol (1%)	Perphenazine
Aspartame	Fenoprofen	Phenacetin
Aspirin	Fluoxetine Hydrochloride	Phenelzine
Atomoxetine	Furosemide	Phenethylamine
Atorvastatin Calcium	Gabapentin	Phenylpropanolamine
Atropine	Gatifloxacin	Prednisone
Azithromycin	Gentisic acid	Pregablin
Benzilic acid	Glucose	Procaine
Benzocaine	Hemoglobin	Promethazine
Benzoic acid	Hydralazine	Quetiapine
Benzphetamine	Hydrochlorothiazide	Quinine
Bilirubin	Hydrocortisone	Ranitidine
Bupropion	Ibuprofen	Rifampicin
Cannabidiol	Isoxsuprine	Risperidone
Captopril	Ketamine	Salicylic acid
Carbamazepine	Ketoprofen	Serotonin (5-Hydroxytyramine)
Carfentanil	LAAM HCl	Sertraline
Cefradine	Labetalol	Sildenafil Citrate
Cephalexin	L-Ephedrine	Simvastatin
Chloralhydrate	L-Epinephrine	Sulfamethazine
Chloramphenicol	Levofloxacin Hydrochloride	Sulindac
Chloroquine	Levonorgestrel	Telmisartan
Chlorothiazide	Levothyroxine Sodium	Tetrahydrocortisone 3-(β-D-glucuronide)
Chlorpheniramine (except TCA test)	Lidocaine Hydrochloride	Tetrahydrocortisone, 3-acetate
Chlorpromazine	Lisinopril	Tetrahydrozoline
Cholesterol	Loperamide	Theophylline
Ciprofloxacin Hydrochloride	Loratadine	Thiamine
Citalopram	L-phenylephrine	Thioridazine
Clarithromycin	Magnesium	Tramadol Hydrochloride
Clonidine	Maprotiline	Trazodone Hydrochloride
Clozapine	Meperidine	Triamterene
Conjugated Estrogens	Meprobamate	Trifluoperazine
Cortisone	Methoxyphenamine (exceptMET test)	Trimethobenzamide
Creatinine	Metoprolol Tartrate	Trimethoprim
D,L-Epinephrine	Mifepristone	Tyramine (except AMP test)
D,L-Isoproterenol	N-Acetylprocainamide	Uric acid
D,L-Octopamine	Nalidixic acid	Venlafaxine HCl
D,L-Propranolol	Naloxone hydrochloride(except OXY test)	Verapamil
D,L-Tryptophan	Naltrexone hydrochloride(except OXY test)	Vitamin B2
D,L-Tyrosine	Naproxen	Vitamin C
Delorazepam	Niacinamide	Zaleplon
Deoxycorticosterone	Nicotine	Zomepirac
Desloratadine	Nifedipine	β-Estradiol

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

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 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:

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

Drug test	Test DipcardResult	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	1	17	22
	A -	10	14	15	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	0	19	21
	C -	10	14	16	0	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	0	12	28
	C -	10	15	15	0	0
BUP	Operator +	0	0	2	18	20
	A -	10	16	12	2	0
	Operator +	0	0	1	19	20
	B -	10	16	13	1	0
	Operator +	0	0	1	18	20
	C -	10	16	13	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	0	23	16
	C -	10	17	13	1	0
COC(300)	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	1	16	23
	C -	10	16	13	1	0
COC	Operator	+	0	0	1	22	18
(150)	A	-	10	16	13	0	0
	Operator	+	0	0	1	21	18
	B	-	10	16	13	1	0
	Operator	+	0	0	0	21	18
	C	-	10	16	14	1	0
EDDP	Operator	+	0	0	1	16	23
	A	-	10	16	13	1	0
	Operator	+	0	0	1	16	23
	B	-	10	16	13	1	0
	Operator	+	0	0	1	16	23
	C	-	10	16	13	1	0
MDMA	Operator	+	0	0	1	17	23
	A	-	10	15	14	0	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	1	19	20
(1000)	A	-	10	17	12	1	0
	Operator	+	0	0	0	19	20
	B	-	10	17	13	1	0
	Operator	+	0	0	0	20	20
	C	-	10	17	13	0	0
MET	Operator	+	0	0	1	22	17
(500)	A	-	10	15	14	1	0
	Operator	+	0	0	1	22	17
	B	-	10	15	14	1	0
	Operator	+	0	0	0	23	17
	C	-	10	15	15	0	0
OPI	Operator	+	0	0	1	21	19
(300)	A	-	10	15	14	0	0
	Operator	+	0	0	1	20	19
	B	-	10	15	14	1	0
	Operator	+	0	0	1	21	19
	C	-	10	15	14	0	0
OPI	Operator	+	0	0	1	18	22
(2000)	A	-	10	16	13	0	0
	Operator	+	0	0	0	18	22
	B	-	10	16	14	0	0
	Operator	+	0	0	0	18	22
	C	-	10	16	14	0	0
MTD	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	16	24
	C	-	10	16	14	0	0
OXY	Operator	+	0	0	1	14	25
	A	-	10	15	14	1	0
	Operator	+	0	0	1	14	25
	B	-	10	15	14	1	0
	Operator	+	0	0	1	14	25
	C	-	10	15	14	1	0
PCP	Operator	+	0	0	0	14	25
	A	-	10	16	14	1	0
	Operator	+	0	0	1	14	25
	B	-	10	16	13	1	0
	Operator	+	0	0	1	14	25
	C	-	10	16	13	1	0
PPX	Operator	+	0	0	1	15	24
	A	-	10	16	13	1	0
	Operator	+	0	0	1	15	24
	B	-	10	16	13	1	0
	Operator	+	0	0	0	16	24
	C	-	10	16	14	0	0
TCA	Operator	+	0	0	0	19	20
	A	-	10	15	15	1	0
	Operator	+	0	0	1	20	20
	B	-	10	15	14	0	0
	Operator	+	0	0	0	20	20
	C	-	10	15	15	0	0
THC	Operator	+	0	0	1	17	22
	A	-	10	16	13	1	0
	Operator	+	0	0	1	17	22
	B	-	10	16	13	1	0
	Operator	+	0	0	1	17	22
	C	-	10	16	13	1	0
6-MAM	Operator	+	0	0	1	19	20
	A	-	10	16	13	1	0
	Operator	+	0	0	1	19	20
	B	-	10	16	13	1	0
	Operator	+	0	0	1	19	20
	C	-	10	16	13	1	0

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

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

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

Discordant Results are summarized below.

Drug	Operator	Sample Number	LC/MS/MSResult (ng/mL)	Accurate Result
6-MAM 10	Operator A	TB-6-MAM06049	8.67	+
	Operator B, C	TB-6-MAM06038	9.96	+
	Operator A	TB-6-MAM06080	11.23	-
	Operator B	TB-6-MAM06039	10.04	-
	Operator C	TB-6-MAM06061	11.52	-
AMP 1000	Operator A	TB-AMP06069	937.22	+
	Operator B	TB-AMP06054	920.78	+
	Operator A, C	TB-AMP06009	1048.74	-
	Operator B	TB-AMP06031	1060.21	-
BAR 300	Operator A	TB-BAR06019	298.32	+
	Operator B	TB-BAR06018	277.18	+
	Operator A	TB-BAR06035	319.55	-
BUP 10	Operator A	TB-BUP06053	9.01	+
	Operator A	TB-BUP06076	9.40	+
	Operator B	TB-BUP06033	9.05	+
	Operator C	TB-BUP06005	9.32	+
	Operator A	TB-BUP06054	10.05	-
	Operator A	TB-BUP06026	10.40	-
	Operator B	TB-BUP06015	10.07	-
	Operator C	TB-BUP06042	10.40	-
	Operator C	TB-BUP06073	10.85	-
BZO 300	Operator A	TB-BZO06069	277.00	+
	Operator B	TB-BZO06042	259.17	+
	Operator A	TB-BZO06032	300.10	-
	Operator A	TB-BZO06005	305.06	-
	Operator B, C	TB-BZO06074	304.44	-
	Operator B	TB-BZO06072	306.50	-
COC 300	Operator A, B	TB-COC06006	298.37	+
	Operator C	TB-COC06042	286.01	+
	Operator A	TB-COC06051	308.67	-
	Operator B	TB-COC06061	309.92	-
	Operator B	TB-COC06013	318.07	-
	Operator C	TB-COC06075	316.92	-
EDDP 300	Operator A	TB-EDDP06040	296.14	+
	Operator B, C	TB-EDDP06061	287.24	+
	Operator A	TB-EDDP06051	343.11	-
	Operator B	TB-EDDP06039	301.03	-
	Operator C	TB-EDDP06037	325.29	-
MDMA 500	Operator A, C	TB-MDMA06078	496.69	+

	Operator B	TB-MDMA06023	488.51	+
	Operator B	TB-MDMA06040	500.24	-
	Operator C	TB-MDMA06020	521.36	-
MET 1000	Operator A	TB-MET06054	952.69	+
	Operator A	TB-MET06072	1156.77	-
	Operator B	TB-MET06045	1053.21	-
OPI 300	Operator A	TB-MOP06029	258.98	+
	Operator B	TB-MOP06046	281.89	+
	Operator C	TB-MOP06010	273.31	+
	Operator B	TB-MOP06015	305.57	-
MTD 300	Operator B	TB-MTD06013	289.56	+
	Operator A	TB-MTD06078	346.35	-
	Operator B	TB-MTD06039	300.18	-
OXY 100	Operator A	TB-OXY06071	98.32	+
	Operator B, C	TB-OXY06052	99.64	+
	Operator A	TB-OXY06038	107.03	-
	Operator B	TB-OXY06019	101.68	-
	Operator C	TB-OXY06053	105.12	-
PCP 25	Operator B	TB-PCP06055	24.89	+
	Operator C	TB-PCP06010	20.38	+
	Operator A	TB-PCP06069	26.36	-
	Operator B	TB-PCP06065	25.26	-
	Operator C	TB-PCP06024	25.41	-
PPX 300	Operator A, B	TB-PPX06039	281.09	+
	Operator A	TB-PPX06052	328.41	-
	Operator B	TB-PPX06048	307.57	-
TCA 1000	Operator B	TB-TCA06055	965.66	+
	Operator A	TB-TCA06072	1033.73	-
THC 50	Operator A	TB-THC06058	46.39	+
	Operator B, C	TB-THC06041	47.36	+
	Operator A, C	TB-THC06070	51.82	-
	Operator B	TB-THC06021	58.47	-
AMP 500	Operator A	TB-SAMP06030	469.26	+
	Operator B	TB-SAMP06004	463.35	+
	Operator A, B	TB-SAMP06029	508.87	-
COC 150	Operator A, B	TB-SCOC06054	143.67	+
	Operator B	TB-SCOC06079	150.72	-
	Operator C	TB-SCOC06072	161.86	-
MET 500	Operator A, B	TB-SMET06004	495.39	+
	Operator B	TB-SMET06050	526.74	-
	Operator A	TB-SMET06030	534.71	-
OPI 2000	Operator A	TB-SMOP06059	1982.35	+

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

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

C. Lay person study

A lay user study was performed at three intended user sites with 280 lay persons. 78 male and 62 female tested Healgen Accurate Urine Drug Screen Dip Card Configuration 1; 76 male and 64 female tested Healgen Accurate Urine Drug Screen Dip Card 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%, +/-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 blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

Drug	Cutoff (ng/mL)	Results	Concentration
			-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff
AMP	1000	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%
BAR	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%
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	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%
EDDP	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%
MDMA	500	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%	તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થય	તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ	100%	100%
MET		Negative	20	20	20	20	1	0	0
		Positive	0	0	0	0	19	20	20
	1000	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	તેરજ	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
OPI	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	તેરજ	100%	100%
		Negative	20	20	20	18	1	0	0
MTD	300	Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડે	100%	100%
		Negative	20	20	20	19	2	0	0
OXY	100	Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	તેરજ	90%	100%	100%
	25	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
PCP		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	તેરજ	90%	100%	100%
	300	Negative	20	20	20	19	1	0	0
PPX		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	તેરજ	તેરજ	100%	100%
		Negative	20	20	20	20	1	0	0
TCA		Positive	0	0	0	0	19	20	20
	1000	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	100%	100%
		Negative	20	20	20	19	2	0	0
THC		Positive	0	0	0	1	18	20	20
	50	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	તેરજ	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
6-MAM	10	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	તેરજ	90%	100%	100%

Result of Healgen Accurate Urine Drug Screen Dip Card Configuration 1:

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

Result of Healgen Accurate Urine Drug Screen Dip Card Configuration 2:

Drug	Cutoff(ng/mL)	Results	Concentration
			-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff

		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
AMP	500	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
BAR	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
BUP	10	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
BZO	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
COC	150	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
	300	Negative	20	20	20	18	2	0	0
EDDP		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
MDMA	500	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	19	1	0	0
MET	500	Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
		Negative	20	20	20	18	0	0	0
OPI	2000	Positive	0	0	0	2	20	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	100%	100%	100%
		Negative	20	20	20	19	1	0	0
MTD	300	Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	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%
PCP	25	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
PPX	300	Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
TCA	1000	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	19	1	0	0
THC	50	Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	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%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20

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

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

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 Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card 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).