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

• K Number: K182654
• Device Name: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
• Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.
• Date Cleared: 2018-11-19 ( 55 days)
• Product Code: NGG NFT NFV NFW NFY NGI NGL NGM PTG PTH QAW QBF
• Regulation Number: 862.3610

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: | 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 | | 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.

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.

Predicate Devices

K142396

Reference Devices

K181968, K153646

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow) for qualitative detection based on chemical reactions, with no mention of computational analysis, image processing, or AI/ML algorithms.

Therapeutic

No.
The device is an in vitro diagnostic device used to detect specific drug analytes in human urine, not to treat or cure a medical condition.

Diagnostic

Yes
The "Device Description" section explicitly states, "The products are single-use in vitro diagnostic devices." Furthermore, the intended use of detecting various drugs in human urine for qualitative and simultaneous detection aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is described as a physical "Dip Card" or "Cup" that performs immunochromatographic assays on urine samples. This involves physical components and chemical reactions, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine". This is a diagnostic purpose, as it aims to identify the presence of specific substances in a biological sample.
• Device Description: The device description states that the products are "single-use in vitro diagnostic devices". This directly identifies the device as an IVD.
• Anatomical Site: The test is performed on "human urine", which is a biological specimen. IVDs are designed to test biological samples.
• Performance Studies: The document describes performance studies involving testing clinical samples and comparing results to a reference method (LC/MS). This is typical for the validation of an IVD.

Therefore, based on the provided information, the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup are clearly identified and described as In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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:
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:
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 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.

Product codes (comma separated list FDA assigned to the subject device)

NGG, NGL, NGM, QAW, QBF, NFT, NFW, NFY, NGI, NFV, PTH, PTG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

over-the-counter use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Studies:
Sample concentrations: -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.
Samples were prepared by spiking drug in negative samples.
Each drug concentration was confirmed by LC/MS.
Samples were blindly labeled.
Tests were performed in two runs per day for 25 days per device in a randomized order for each concentration.
Results are summarized in tables for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, and Propoxyphene. For other drugs, precision data is referenced from K181968 and K153646.

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

Interference Study:
Potential interfering substances were added to drug-free urine and target drug urine (concentrations at 25% below and 25% above Cut-Off levels). Tested with three batches of each device. No interference observed at 100ug/mL for listed compounds. No differences between SAFECARE Cup and Dip Card formats.

Specificity Study:
Drug metabolites and other structure-related compounds were tested using three batches of each device. The lowest concentration causing a positive result for each compound is listed for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, and Propoxyphene. Other specificity data is referenced from K181968 and K153646. No differences between SAFECARE Cup and Dip Card formats.

Effect of Urine Specific Gravity and Urine pH Study:
Urine samples with 1.000 to 1.035 specific gravity or pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. Tested with 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. No differences between SAFECARE Cup and Dip Card formats.

Comparison Studies (Method Comparison):
Performed in-house with three laboratory assistants for each device format.
Sample Size: 80 unaltered clinical samples (40 negative and 40 positive) for each drug.
Data Source: Unaltered clinical samples.
Annotation Protocol: Samples were blind labeled and compared to LC/MS results.
Results are presented in tables for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, and Propoxyphene, showing counts of positive and negative results across different LC/MS concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive). Discordant results are also listed. References to K181968 and K153646 for other drug data.

Lay-user study:
Sample Size: 300 lay persons for each device format.
Data Source: Urine samples prepared by spiking drugs into drug-free pooled urine specimens at concentrations of negative, +/-75%, +/-50%, +/-25% of the cutoff. Concentrations confirmed by LC/MS.
Annotation Protocol: Each participant was provided with the package insert, one blind labeled sample, and a device. Each device was tested.
Key Results: Representative results for AMP, COC, THC, MTD, OPI, BZO, BAR, MDMA, OXY, BUP, PCP, TCA, PPX show high percentages of correct results across different concentration ranges. For -25% Cutoff and +25% Cutoff samples, percentages were generally in the 85-95% range. For -100%, -75%, -50%, +50%, +75% Cutoff samples, the percentage of correct results was 100%. Lay-users found instructions easy to follow, and the package insert had a Flesch-Kincaid reading Grade Level of 7.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Values are shown in the performance tables under "No. of Positive" and "No. of Negative" for lay-user studies and in the "Comparison Studies" tables for concordance with LC/MS. Specific sensitivity, specificity, PPV, NPV calculations are not directly provided as single metric values but can be inferred from the provided tables.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142396

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K181968, K153646

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
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.(b)
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).

Summary

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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

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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

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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.

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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.

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

5. Predicate Devices: K142396

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• 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

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

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

7

| | Methylenedioxymethamphetamine
(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
immunochromatographic assays based on
the principle of antigen antibody
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)
for Use	For the qualitative determination of
drugs of abuse in human urine.	Same (but the number of
drugs detected is different)
Calibrator and
Cut-Off Values	Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 300 ng/ml
11-Nor-Δ9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (OPI): 2000ng/mL
Secobarbital (BAR): 300 ng/ml
Methadone (MTD): 300 ng/ml
Methylenedioxymethamphetamine
(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	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
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
Lot
Number | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+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
Lot
Number	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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
Number	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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
Lot
Number	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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
Number	Results	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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
Lot	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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
Number	Results
-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot
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
Lot
Number	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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

)
--------

| Results
Lot
Number | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+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%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot
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
Lot
Number	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+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-

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
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 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert,

22

one blind labeled sample and a device. Each device was tested. Representative results are shown below.

AMP:

| | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|---------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 505 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 754 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1259 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1508 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |

COC:

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	74	0	20	100
-50% Cutoff	160	152	0	160	100
-25% Cutoff	20	224	1	19	95
+25% Cutoff	20	373	18	2	90
+50% Cutoff	40	452	40	0	100
+75% Cutoff	20	522	20	0	100

THC:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 25 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 37 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 75 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 87 | 20 | 0 | 100 |

23

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 151 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 226 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 372 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 529 | 20 | 0 | 100 |

BAR:

BZO:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|-----|---------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 149 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 520 | 20 | 0 | 100 |

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 251 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 502 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 758 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 1259 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1512 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |

MTD:

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	74	0	20	100
-50% Cutoff	160	151	0	160	100
-25% Cutoff	20	225	2	18	90
+25% Cutoff	20	376	19	1	95
+50% Cutoff	40	447	40	0	100
+75% Cutoff	20	522	20	0	100

24

| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results (%) |
|--------------|-------------------|------------------------------------|--------------------|-----------------|------------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 505 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 1009 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 1510 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 2511 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 3031 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 3521 | 20 | 0 | 100 |

OPI:

MDMA:

| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|--------------------|-----|---------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 123 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 248 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 376 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 622 | 17 | 3 | 85 |
| +50% Cutoff | 40 | 741 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 871 | 20 | 0 | 100 |

OXY:

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	25	0	20	100
-50% Cutoff	160	49	0	160	100
-25% Cutoff	20	75	1	19	95
+25% Cutoff	20	124	19	1	95
+50% Cutoff	40	149	40	0	100
+75% Cutoff	20	175	20	0	100

BUP:

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	3	0	20	100
-50% Cutoff	160	5	0	160	100
-25% Cutoff	20	8	2	18	90
+25% Cutoff	20	13	19	1	95
+50% Cutoff	40	15	40	0	100
+75% Cutoff	20	18	20	0	100

25

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	6	0	20	100
-50% Cutoff	160	13	0	160	100
-25% Cutoff	20	19	2	18	90
+25% Cutoff	20	31	18	2	90
+50% Cutoff	40	38	40	0	100
+75% Cutoff	20	44	20	0	100

PCP:

TCA:

| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 252 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 499 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 759 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1258 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1503 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1751 | 20 | 0 | 100 |

PPX:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 77 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 149 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 374 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 523 | 20 | 0 | 100 |

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

• 3. Clinical Studies
     Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off,

26

interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the SAFECARE Dip Card Tests and SAFECARE Cup Tests are substantially equivalent to the predicate.