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

K240686 · Healgen Scientific,, LLC · NGL · Apr 12, 2024 · Clinical Toxicology

Device Facts

• Record ID: K240686
• Device Name: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
• Applicant: Healgen Scientific,, LLC
• Product Code: NGL · Clinical Toxicology
• Decision Date: Apr 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

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, 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: [Table omitted for brevity]. 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.

Device Story

Lateral flow immunochromatographic dip card for qualitative detection of drugs of abuse in human urine; competitive binding principle using monoclonal antibody-drug conjugates. User dips card into urine sample; capillary action draws sample across pre-coated membrane. Negative result: colored line appears in Test Region (T) when drug concentration is below cutoff. Positive result: no line in Test Region (T) when drug concentration is at or above cutoff. Control line (C) confirms proper test performance. Used in clinical or home settings; operated by clinicians or lay users. Provides preliminary results; requires confirmation by GC-MS or LC-MS. Benefits patient by providing rapid, preliminary screening for potential drug abuse.

Clinical Evidence

Bench testing only. Performance evaluated via precision/reproducibility studies (25 days, 3 lots), analytical specificity/interference testing, and method comparison against LC-MS/MS (80 samples per drug). Lay-user study conducted with 280 participants across diverse demographics, confirming ease of use and performance agreement with LC-MS/MS.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; mouse monoclonal antibody conjugates. Dip card format; ready-to-use; includes desiccant. Stable at 2-30°C for 24 months. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of drugs of abuse in human urine. Intended for both prescription and over-the-counter (OTC) use. Provides preliminary results for 16 analytes (6-MAM, AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MTD, OPI, OXY, PCP, PPX, TCA, THC). Not for monitoring prescription medication.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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 |

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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.

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.

#### 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: [phone] |
| | Email: [e-mail] |

- 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 cocaine<br>metabolite test system | Toxicology |
| Cocaine (COC) | | |
| PTG | 862.3620, Methadone Test System | Toxicology |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | | |
| Methadone (MTD) | | |
| NGG | 862.3610,<br>Methamphetamine Test System | Toxicology |
| Methylenedioxymethamphetamine<br>(MDMA) | | |
| Methamphetamine (MET) | | |
| NGM | Unclassified | Toxicology |
| Phencyclidine (PCP) | | |
| OBE | 862.3700 Propoxyphene test system | Toxicology |

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| Propoxyphene(PPX) | | |
|------------------------------|--------------------------------------------------------|------------|
| QAW<br>Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs<br>test system | Toxicology |
| NFW<br>Cannabinoids (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<br>(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

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.

| Similarities | | |
|--------------|---------------------------------------------------|------------------------|
| Item | Device | Predicate<br>(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 immunochromatographic<br>assay based on antigen-antibody reaction | | Same |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|----------------|----------|
| Type of Test | Qualitative | | Same |
| Specimen Type | Human urine | | Same |
| Target Drug<br>and Cut Off<br>Values | 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-<br>diphenylpyrrolidine (EDDP) | 300 | |
| | Methylenedioxymethamphetamine<br>(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 | Lot<br>Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| AMP<br>1000 | 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+ |
| BAR<br>300 | 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+ |
| BUP<br>10 | 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+ |
| BZO<br>300 | 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+ |
| COC<br>300 | 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+ |
| EDDP<br>300 | 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+ |
| MDM<br>A 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+ |
| MET<br>1000 | 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+ |
| OPI<br>300 | 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+ |
| MTD<br>300 | 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+ |
| OXY<br>100 | 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+ |
| PCP<br>25 | 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+ |
| PPX<br>300 | 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+ |
| TCA<br>1000 | 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+ |
| THC<br>50 | 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-<br>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+ |
| AMP<br>500 | 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+ |
| COC<br>150 | 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+ |
| MET<br>500 | 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+ |
| OPI<br>2000 | 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 | Minimum<br>concentration<br>required to obtain<br>a positive result<br>(ng/mL) | % Cross-<br>Reactivity |
|-------------|-------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|
| AMP 1000 | Hydroxyamphetamine | 8000 | 12.5% |
| | (+/-)-<br>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-<br>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<br>(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-Methylenedioxymethamphetamine<br>HCl(MDMA) | 500 | 100% |
| | (+/-)3,4-Methylenedioxyamphetamine<br>HCL(MDA) | 3,000 | 16.7% |
| | | | |
| (+/-)3,4- | Methylenedioxyethylamphetamine<br>(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-<br>ethylamphetamine (MDEA) | 20,000 | 5% |
| | (+/-)3,4-<br>Methylenedioxymethamphetamine<br>(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<br>(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 h…