SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

K182654 · Safecare Biotech (Hangzhou) Co., Ltd. · NGG · Nov 19, 2018 · Clinical Toxicology

Device Facts

• Record ID: K182654
• Device Name: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
• Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
• Product Code: NGG · Clinical Toxicology
• Decision Date: Nov 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamine, Phencyclidine, Methadone, Nortriotyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunichromatographic assays for qualitative and simultaneous detection of Amphetanine, Oxazepam, Methamphetamine, Morghine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of SAFECARE® Multi-Drug Urine Test Cup contination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine. Oxazenam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

Device Story

Single-use in vitro diagnostic devices (Dip Card or Cup formats) for qualitative detection of drugs of abuse in human urine. Operates via competitive binding, lateral flow immunochromatographic assay; urine sample migrates via capillary action. If target drug concentration is below cutoff, specific monoclonal mouse antibody-coated particles bind to immobilized drug-conjugate, forming a visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line forms regardless of drug presence. Used by lay users in home/OTC settings. Results are preliminary; positive results require confirmation via GC/MS or LC/MS. Provides rapid screening to assist in identifying potential drug use.

Clinical Evidence

No clinical diagnostic studies performed. Evidence consists of analytical performance (precision, interference, cross-reactivity) and a lay user study (n=300 per format). Lay user study demonstrated high concordance with LC/MS confirmed samples across various concentrations relative to cutoff levels.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use, visually read. No instrumentation required. Components include test device, package insert, and urine collection cup. Sealed in aluminum pouch with desiccant.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, MDMA, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphene) in human urine. Intended for over-the-counter use. Not for distinguishing between prescription use and abuse.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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).

Predicate Devices

• K142396

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "ADMINISTRATION".

November 19, 2018

Safecare Biotech (Hangzhou) Co., Ltd. % Joe Shia Regulatory Consultant LSI International Inc. 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877

Re: k182654

Trade/Device Name: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: NGG, NGL, NGM, QAW, QBF, NFT, NFW, NFY, NGI, NFV, PTH, PTG Dated: September 21, 2018 Received: September 25, 2018

Dear Joe Shia:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Courtney H. Lias -S

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

Enclosure

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

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### Device Name

SAFECARE® Multi-Drug Urine Test Dip Card SAFECARE® Multi-Drug Urine Test Cup

#### Indications for Use (Describe)

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamine, Phencyclidine, Methadone, Nortriotyline and d-Propoxyphene in human urine at the cutoff concentrations of:

| Drug(Identifier) | Cut-off level |
|-------------------------------|---------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

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

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

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunichromatographic assays for qualitative and simultaneous detection of Amphetanine, Oxazepam, Methamphetamine, Morghine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

| Drug(Identifier) | Cut-off level |
|------------------|---------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

{3}------------------------------------------------

| Morphine | 2000 ng/mL |
|-------------------------------|------------|
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |

Configuration of SAFECARE® Multi-Drug Urine Test Cup contination of the above listed drug analytes.

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

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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

### 510(k) SUMMARY

- November 1, 2018 1. Date:
- Safecare Biotech (Hangzhou) Co. Ltd. 2. Submitter: 18 Haishu Road, Yuhang District Hangzhou, China
- Alex Qiu 3. Contact person: Safecare Biotech 18 Haishu Road, Yuhang District Hangzhou, China Telephone: [phone] Fax: [phone] Email: [e-mail]
- SAFECARE Multi-Drug Urine Test Dip Card 4. Device Name: SAFECARE Multi-Drug Urine Test Cup

| Product Code | Classification | Regulation Section | Panel | |
|----------------------|-------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------|---------------------------------------------|
| NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine<br>Test System | Toxicology (91) | |
| | NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids<br>Test System | Toxicology (91) |
| NFY<br>Cocaine | | II | 21 CFR § 862.3250, Cocaine and<br>Cocaine Metabolites Test System | Toxicology (91) |
| | NGG<br>Methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology (91) |
| NGI<br>Morphine | | II | 21 CFR § 862.3640, Morphine<br>Test System | Toxicology (91) |
| | NFV<br>Oxazepam | II | 21 CFR § 862.3170,<br>Benzodiazepine Test System | Toxicology (91) |
| NGL<br>Oxycodone | | II | 21 CFR § 862.3650, Opiate Test<br>System | Toxicology (91) |
| | PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate<br>Test System | Toxicology (91) |
| NGL<br>Buprenorphine | | II | 21 CFR § 862.3650,<br>Opiate Test System | Toxicology (91) |
| | NGG<br>Methylenedioxy-<br>methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology (91) |
| NGM<br>Phencyclidine | | unclassified | Enzyme Immunoassay<br>Phencyclidine | Toxicology (91) |
| | | PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone<br>Test System |
| QAW<br>Nortriptyline | II | | 21 CFR, 862.3910 Tricyclic<br>Antidepressant Drugs Test System | Toxicology (91) |
| | QBF<br>Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene<br>Test System | Toxicology (91) |

5. Predicate Devices: K142396

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

- 6. Intended Use
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene in human urine at the cutoff concentrations of:

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

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

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

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-------------------|---------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |

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

| Methadone | 300 ng/mL |
|-------------------------------|------------|
| Methylenedioxymethamphetamine | 500 ng/mL |
| Oxycodone | 100 ng/mL |
| Buprenorphine | 10 ng/mL |
| Phencyclidine | 25 ng/mL |
| Nortriptyline | 1000 ng/mL |
| Propoxyphene | 300 ng/mL |

Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

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

- 7. Device Description
The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone,

Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

- 8. Substantial Equivalence Information
A summary comparison of features of the SAFECARE Dip Card Tests and SAFECARE Cup Tests and the predicate devices is provided in following tables.

| Item | Device | Predicate - K142396 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is<br>different) |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine (COC): 300 ng/ml<br>11-Nor-Δ9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (OPI): 2000ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml | Same |

Table 1: Features Comparison of SAFECARE Dip Card Tests and the Predicate Devices

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

| | Methylenedioxymethamphetamine<br>(MDMA): 500 ng/ml | |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|----------|
| | Oxycodone (OXY): 100 ng/ml | |
| | Buprenorphine (BUP): 10 ng/ml | |
| | Phencyclidine (PCP): 25 ng/ml | |
| | Nortriptyline (TCA): 1000 ng/ml | |
| | Propoxyphene (PPX): 300 ng/ml | |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Dip Card | Dip Card |

| Table 2: Features Comparison of SAFECARE Cup Tests and the Predicate Devices | | |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | | |
| Item | Device | Predicate - K142396 |
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine (COC): 300 ng/ml<br>11-Nor-Δ9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (OPI): 2000ng/mL<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Methylenedioxymethamphetamine<br>(MDMA): 500 ng/ml<br>Oxycodone (OXY): 100 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |

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

| Specimen Type | Human Urine | Same |
|----------------|----------------------|----------|
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Dip Card |

### 9. Test Principle

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

#### 10. Performance Characteristics

- 1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine. Nortriptyline and Propoxyphene. Please refer to k181968 for precision data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to k153646 for precision data for Amphetamine, Cocaine, and Cannabinoids.

| Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Methylenedioxymethamphetamine (MDMA)

Dip Card

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

| Cup | | | | | | | | | |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# Oxycodone
Dip Card

| Dip Card Results | | | | | | | | | |
|------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

| Cup | | | | | | | | | |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# Buprenorphine
Dip Card

| Dip Card | | | | | | | | | | |
|---------------|---------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | Results | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| | Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

| Cup | | | | | | | | | |
|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Results<br>Lot | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Number | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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

# Phencyclidine
Dip Card

| Dip Card | | | | | | | | | |
|---------------|-----------------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | Results<br>-100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

## Cup

| Results | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# Nortriptyline
Dip Card

| Dip Card | | | | | | | | | |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

| r<br>) |
|--------|
|--------|

| Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# Propoxyphene
Dip Card

Dip Card

| Results | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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

| Cup | | | | | | | | | |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### The following cut-off values are verified.

| Drug (Identifier) | Cut-off level |
|---------------------------------------|---------------|
| Methylenedioxy-Methamphetamine (MDMA) | 500 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |

#### b. Linearity

Not applicable.

- c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50 °C and real time stability studies at 4°C and 30 °C.

#### d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed between the SAFECARE Cup and Dip Card formats.

| Acetominophen (4-<br>Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine |
|---------------------------------------|------------------------|-------------------|
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | β-Estradiol | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
| Aspartame | Hydrocortisone | D-Pseudoephedrine |
| Atropine | O-Hydroxyhippuric acid | Quinine |

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

| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
|---------------------|-------------------|----------------------------------------|
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Cholesterol | Loperamide | Tetrahydrozoline |
| Clonidine | Maprotiline | Thiamine |
| Cortisone | Meperidine | Thioridazine |
| (-) Cotinine | Meprobamate | Triamterene |
| Creatinine | Methoxyphenamine | DL-Tyrosine |
| Deoxycorticosterone | Nalidixic acid | Trifluoperazine |
| Dextromethorphan | Naloxone | Trimethoprim |
| Diclofenac | Naltrexone | D L-Tryptophan |
| Diflunisal | Naproxen | Tyramine |
| Digoxin | Niacinamide | Uric acid |
| Diphenhydramine | Nifedipine | Verapamil |
| Disopyramide | Norethindrone | Zomepirac |
| EDDP | Noscapine | |

#### e. Specificity

To test specificity, drug metabolites and other structure related compounds that are likely to cross-react in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Please refer to k181968 for specificity data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to k153646 for specificity data for Amphetamine, Cocaine, and Cannabinoids. There were no differences observed between the SAFECARE Cup and Dip Card formats.

| Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|-------------------------------------------|------------------------------|--------------------|
| Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-Methylenedioxyamphetamine (MDA) | 5000 | 10% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 166% |
| d-methamphetamine | >100000 | <1% |
| d-amphetamine | >100000 | <1% |
| l-amphetamine | >100000 | <1% |
| l-methamphetamine | >100000 | <1% |

| Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|----------------|------------------------------|--------------------|
| Oxycodone | 100 | 100% |
| Oxymorphone | 250 | 40% |
| Hydrocodone | 3125 | 3.2 % |
| Dihydrocodeine | >100000 | <0.1% |
| Codeine | >100000 | <0.1% |
| Hydromorphone | >100000 | <0.1% |
| Morphine | >100000 | <0.1% |
| Buprenorphine | >100000 | <0.1% |
| Ethylmorphine | >100000 | <0.1% |

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

| Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|----------------------------------|------------------------------|--------------------|
| Buprenorphine | 10 | 100% |
| Buprenorphine -3-D-Glucuronide | 10 | 100% |
| Norbuprenorphine | 50 | 20% |
| Norbuprenorphine-3-D-Glucuronide | 100 | 10% |
| Morphine | >100000 | <0.01% |
| Oxymorphone | >100000 | <0.01% |
| Hydromorphone | >100000 | <0.01% |

| Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|------------------------|------------------------------|--------------------|
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 75 | 33% |

| Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|-------------------------------|------------------------------|--------------------|
| Nortriptyline | 1000 | 100% |
| Amitriptyline | 750 | 133.30% |
| Clomipramine | 10000 | 10% |
| Desipramine | 200 | 500% |
| Doxepin | 1250 | 80% |
| Imipramine | 625 | 160% |
| Maprotiline | 2000 | 50% |
| Nordoxepin | 1000 | 100% |
| Promazine | 1500 | 66.70% |
| Promethazine | 25000 | 4% |
| Trimipramine | 3000 | 33.30% |
| Cyclobenzaprine Hydrochloride | 5000 | 20% |
| Norclomipramine | 3000 | 33.30% |

| Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|-------------------|------------------------------|--------------------|
| d-Propoxyphene | 300 | 100% |
| D-Norpropoxyphene | 330 | 91% |

#### f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed between the SAFECARE Cup and Dip Card formats.

#### 2. Comparison Studies

Method comparison studies for the SAFECARE Dip Card Tests and the SAFECARE Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Please refer to k181968 for method comparison data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to k153646 for method

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

comparison data for Amphetamine, Cocaine, and Cannabinoids.

| Dip<br>Card | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than +50%) |
|-------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2 | 0 |

# Methylenedioxymethamphetamine (MDMA)

## Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | AM1822 | 491 | Positive |
| Viewer B | AM5121 | 497 | Positive |
| Viewer C | AM1822 | 491 | Positive |
| Viewer C | AM5121 | 497 | Positive |
| Viewer A | AM2281 | 517 | Negative |
| Viewer A | AM3339 | 509 | Negative |
| Viewer B | AM2281 | 517 | Negative |
| Viewer B | AM6217 | 525 | Negative |
| Viewer C | AM6217 | 525 | Negative |
| Viewer C | AM3339 | 509 | Negative |

| Cup | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and +50%) | High Positive by<br>LC/MS<br>(greater than +50%) |
|-------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 2 | 18 | 20 |
| Viewer<br>A | Negative | 10 | 10 | 18 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 |
| Viewer<br>B | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 2 | 18 | 20 |
| Viewer<br>C | Negative | 10 | 10 | 18 | 2 | 0 |

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

| Discordant Results | | | |
|--------------------|---------------|--------------|-----------------------|
| Viewer | Sample Number | LC/MS Result | Cup<br>Viewer Results |
| Viewer A | AM5135 | 491 | Positive |
| Viewer A | AM6745 | 497 | Positive |
| Viewer B | AM5135 | 491 | Positive |
| Viewer C | AM5135 | 491 | Positive |
| Viewer C | AM6745 | 497 | Positive |
| Viewer A | AM8048 | 517 | Negative |
| Viewer A | AM4472 | 509 | Negative |
| Viewer B | AM4472 | 509 | Negative |
| Viewer B | AM4835 | 525 | Negative |
| Viewer C | AM8048 | 517 | Negative |
| Viewer C | AM4472 | 509 | Negative |

## Oxycodone

| Dip<br>Card | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| | | | | | | |
| Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 10 | 19 | 3 | 0 |

## Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | AM8592 | 95 | Positive |
| Viewer B | AM3867 | 98 | Positive |
| Viewer C | AM7495 | 92 | Positive |
| Viewer A | AM1177 | 104 | Negative |
| Viewer A | AM3128 | 107 | Negative |
| Viewer B | AM9817 | 106 | Negative |
| Viewer B | AM9785 | 109 | Negative |
| Viewer C | AM0928 | 108 | Negative |
| Viewer C | AM1177 | 104 | Negative |
| Viewer C | AM3128 | 107 | Negative |

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

| Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 |
| Viewer<br>A | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 17 | 20 |
| Viewer<br>B | Negative | 10 | 10 | 19 | 3 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 17 | 20 |
| Viewer<br>C | Negative | 10 | 10 | 19 | 3 | 0 |

# Discordant Results

| Viewer | Sample Number | LC/MS Result | Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------|
| Viewer A | AM0623 | 98 | Positive |
| Viewer B | AM5357 | 95 | Positive |
| Viewer C | AM0623 | 98 | Positive |
| Viewer A | AM7016 | 105 | Negative |
| Viewer A | AM3335 | 106 | Negative |
| Viewer B | AM7525 | 104 | Negative |
| Viewer B | AM0654 | 107 | Negative |
| Viewer B | AM3335 | 106 | Negative |
| Viewer C | AM7016 | 105 | Negative |
| Viewer C | AM7525 | 104 | Negative |
| Viewer C | AM3335 | 106 | Negative |

# Buprenorphine

| Dip<br>Card | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1 | 0 |

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

| Discordant Results | | | |
|--------------------|---------------|--------------|----------------------------|
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
| Viewer A | AM7493 | 9 | Positive |
| Viewer B | AM1093 | 9 | Positive |
| Viewer C | AM1093 | 9 | Positive |
| Viewer A | AM6936 | 11 | Negative |
| Viewer A | AM0902 | 11 | Negative |
| Viewer B | AM6497 | 11 | Negative |
| Viewer B | AM0902 | 11 | Negative |
| Viewer C | AM6936 | 11 | Negative |

| Cup | | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------|---|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer | A | Positive | 0 | 0 | 1 | 18 | 20 |
| | | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer | B | Positive | 0 | 0 | 1 | 18 | 20 |
| | | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer | C | Positive | 0 | 0 | 1 | 18 | 20 |
| | | Negative | 10 | 10 | 19 | 2 | 0 |

# Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | AM8338 | 9 | Positive |
| Viewer B | AM4130 | 9 | Positive |
| Viewer C | AM4130 | 9 | Positive |
| Viewer A | AM3059 | 11 | Negative |
| Viewer A | AM5605 | 11 | Negative |
| Viewer B | AM5605 | 11 | Negative |
| Viewer B | AM2763 | 11 | Negative |
| Viewer C | AM3059 | 11 | Negative |
| Viewer C | AM2763 | 11 | Negative |

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

# Phencyclidine

| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
|----------|----------|----------|----------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer A | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| Viewer B | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer C | Negative | 10 | 10 | 19 | 1 | 0 |

# Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | AM1553 | 23 | Positive |
| Viewer B | AM1159 | 24 | Positive |
| Viewer C | AM1159 | 24 | Positive |
| Viewer A | AM2982 | 25.3 | Negative |
| Viewer B | AM5901 | 26 | Negative |
| Viewer B | AM2982 | 25.3 | Negative |
| Viewer C | AM2982 | 25.3 | Negative |

| Cup | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and +50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) | |
|-------------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------|----|
| Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 |
| Viewer<br>A | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer<br>B | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 18 | 20 |
| Viewer<br>C | Negative | 10 | 10 | 19 | 2 | 0 |

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

| Discordant Results | | | |
|--------------------|---------------|--------------|--------------------|
| Viewer | Sample Number | LC/MS Result | Cup Viewer Results |
| Viewer A | AM7467 | 24 | Positive |
| Viewer B | AM6637 | 23 | Positive |
| Viewer C | AM7467 | 24 | Positive |
| Viewer A | AM1449 | 26 | Negative |
| Viewer A | AM8727 | 25.3 | Negative |
| Viewer B | AM8727 | 25.3 | Negative |
| Viewer C | AM1449 | 26 | Negative |
| Viewer C | AM8727 | 25.3 | Negative |

# Nortriptyline

| Dip<br>Card | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative…