Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow) for qualitative detection, which does not involve AI or ML. There are no mentions of AI, ML, or image processing in the provided text.

Therapeutic

No
Explanation: This device is an in-vitro diagnostic test designed to detect the presence of various drugs in human urine. It is not used for treatment or therapy.

Diagnostic

Yes
The device is described as an "in vitro diagnostic device" designed for the qualitative and simultaneous detection of various drugs in human urine. Its purpose is to provide preliminary test results, which is a key function of diagnostic devices.

SaMD (Software as a Medical Device)

No

The device is described as immunochromatographic assays in the format of Dip Cards or Cups, which are physical, single-use in vitro diagnostic devices. The description explicitly mentions hardware components like the test device, package insert, and urine cup.

IVD (In Vitro Diagnostic)

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

Here's why:

Device Description: The description explicitly states, "The products are single-use in vitro diagnostic devices".
Intended Use: The intended use is for the "qualitative and simultaneous detection of [various drugs] in human urine". Testing human samples (like urine) outside of the body to gain information about a person's health or condition is the core definition of an in vitro diagnostic.
Methodology: The device uses "competitive binding, lateral flow immunochromatographic assays", which is a common methodology for IVD tests.
Performance Studies: The document describes performance studies involving testing human urine samples and comparing results to a reference method (LC/MS), which is standard practice for validating IVD performance.

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, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	500ng/mL
Oxazepam	300 ng/mL
Cocaine	150ng/mL
Marijuana	50 ng/mL
Methamphetamine	500ng/mL
Morphine	300ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	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 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. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	500ng/mL
Oxazepam	300 ng/mL
Cocaine	150ng/mL
Marijuana	50 ng/mL
Methamphetamine	500ng/mL
Morphine	300ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	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 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.

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

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

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, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (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

For 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

Precision Studies:
Samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% 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.

Method Comparison Studies:
In-house study 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.

Lay-user study:
A lay user study was performed at three intended user sites with 310 lay persons for each device format. 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, 1 blind labeled sample and a device. Each device was tested.

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

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, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine 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.

Analytical Performance - Precision:
Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Results were provided in tables for Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. The candidate device uses the same assays (same reagent pads) for other drugs as was cleared in K182654/K181968/K153646/K201120. The cut-off values of 500 ng/mL, 500 ng/mL, and 300 ng/mL for Amphetamine, Cocaine, Methamphetamine and Morphine are verified.

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

Analytical Performance - 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, with the exception of albumin with no interference at a concentration of 100mg/dL and ethanol at 1% volume, were summarized in a table. There were no differences observed between the SAFECARE® Cup and Dip Card formats.

Analytical Performance - 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 in tables for Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. The candidate device uses the same assays (same reagent pads) for other drugs as was cleared in K182654/K181968/K153646/K201120. No differences were observed between the SAFECARE® Cup and Dip Card formats.

Analytical Performance - 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.

Comparison Studies:
Method comparison studies 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. Results were presented in tables for Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. The candidate device uses the same assays (same reagent pads) for other drugs as was cleared in K182654/ K181968/ K153646 and K201120.

Lay-user study:
A lay user study was performed at three intended user sites with 310 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at 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, 1 blind labeled sample and a device. Typical results were shown in tables for AMP500, COC150, THC, BAR, BZO, MET500, MTD, MOP300, MDMA, OXY, BUP, PCP, TCA, PPX, EDDP. 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.

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

Key metrics for precision studies are reported as number of negative (total 50) and number of positive (total 50) results across different cut-off percentages for three lots. For example, for Amphetamine 500 Dip Card, at -100% cut off, the result is 50-/0+ (50 negative, 0 positive). At the cut-off, results vary, e.g., 24-/26+ for Lot 1. At +100% cut off, the result is 50+/0- (50 positive, 0 negative).

Key metrics for lay-user study are reported as:
Number of samples, Drug Concentration by LC/MS (ng/mL), Number of Positive results from lay persons, Number of Negative results from lay persons, and The percentage of correct results (%). For example, for AMP500 at -100% Cutoff (0 ng/mL), 20 samples yielded 0 positive and 20 negative results, with 100% correct results. At -25% Cutoff (375 ng/mL), 20 samples yielded 2 positive and 18 negative results, with 90% correct results. At +25% Cutoff (625 ng/mL), 20 samples yielded 19 positive and 1 negative result, with 95% correct results.

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.

K201120

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.

K182654, 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

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 24, 2021

Safecare Biotech(Hangzhou)Co., Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K202453

Trade/Device Name: SAFECARE Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test Dip-Card Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGI, NFV, NGL, PTH, PTG, QAW, QBF, NGM Dated: August 25, 2020 Received: August 27, 2020

Dear Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K202453

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, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	500ng/mL
Oxazepam	300 ng/mL
Cocaine	150ng/mL
Marijuana	50 ng/mL
Methamphetamine	500ng/mL
Morphine	300ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	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 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. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	500ng/mL
Oxazepam	300 ng/mL
FORM FDA 3881 (7/17)	Page 1 of 2

3

Cocaine	150ng/mL
Marijuana	50 ng/mL
Methamphetamine	500ng/mL
Morphine	300ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	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 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.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

510(k) Number: K202453

1. Date: March 18, 2021
1. Submitter: Safecare Biotech (Hangzhou) Co. Ltd. 18 Haishu Road, Yuhang District Hangzhou, China
1. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
SAFECARE® Multi-Drug Urine Test Dip Card 4. Device Name: SAFECARE® Multi-Drug Urine Test Cup

Classification:

Class 2

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	Toxicology (91)
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

Product Code	Classification	Regulation Section
PTG
2-ethylidene-1, 5-dimethyl-
3, 3-diphenylpyrrolidine	II	21 CFR § 862.3620, Methadone Test
System	Toxicology
(91)

1. Predicate Device
  The SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup (K201120)
1. 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, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine	500ng/mL
Oxazepam	300 ng/mL
Cocaine	150ng/mL
Marijuana	50 ng/mL
Methamphetamine	500ng/mL
Morphine	300ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	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, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d

6

Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine	500ng/mL
Oxazepam	300 ng/mL
Cocaine	150ng/mL
Marijuana	50 ng/mL
Methamphetamine	500ng/mL
Morphine	300ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	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, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (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 table.

7

Features Comparison of SAFECARE® Dip Card Tests and the Predicate Device

Item	Device	Predicate - K201120
Indication(s)
for Use	For the qualitative determination of
Amphetamine, Buprenorphine, Secobarbital,
Oxazepam, Cocaine, 2-ethylidene-1,5-
dimethyl-3,3-diphenylpyrrolidine,
Methamphetamine,
Methylenedioxymethamphetamine,
Morphine, Methadone, Oxycodone,
Phencyclidine, Propoxyphene, Nortriptyline
and Cannabinoids in human urine.	Same
	Similarities
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	Same
	Differences
Calibrator and Cut-Off
Values	Amphetamine (AMP): 500 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 150 ng/ml
11-Nor-△9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 500 ng/ml
Morphine (MOP): 300ng/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
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/mL	Same as candidate device
with exception of
Amphetamine: 1000ng/mL
Cocaine: 300ng/mL
Methamphetamine:
1000ng/mL
Morphine: 2000ng/mL

8

Features Comparison of SAFECARE® Cup Tests and the Predicate Devices

Item	Device	Predicate - K201120
Indication(s)
for Use	For the qualitative determination of
Amphetamine, Buprenorphine,
Secobarbital, Oxazepam, Cocaine, 2-
ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine, Methamphetamine,
Methylenedioxymethamphetamine,
Morphine, Methadone, Oxycodone,
Phencyclidine, Propoxyphene,
Nortriptyline and Cannabinoids in
human urine.	Same
Similarities
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	Cup	Cup
Differences
Calibrator and Cut-Off
Values	Amphetamine (AMP): 500 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 150 ng/ml
11-Nor-△9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 500 ng/ml
Morphine (MOP): 300ng/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
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/mL	Same as candidate device
with exception of
Amphetamine: 1000ng/mL
Cocaine: 300ng/mL
Methamphetamine:
1000ng/mL
Morphine: 2000ng/mL

9

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, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3diphenylpyrrolidine 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, +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 Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. Please refer to K182654 for precision data for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and to K181968 for precision data for Oxazepam, Secobarbital and Methadone, and to K153646 for precision data for Cannabinoids and to K201120 for precision data for EDDP. The candidate device uses the same assays (same reagent pads) for these drugs as was cleared in K182654/K181968/K153646/K201120.

| 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Amphetamine 500 Dip Card

10

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+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

Cocaine 150

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+ | 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+ | 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+	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+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

Methamphetamine 500

50-/0+

Lot 3

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

50-/0+

25-/25+

50+/0-

Cut-off

+100%

50+/0-

Cut-off

+75%

50+/0-

11

Morphine 300
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+	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+	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+	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-

The cut-off values of 500 ng/mL, 500 ng/mL, and 300 ng/mL for Amphetamine, Cocaine, Methamphetamine and Morphine are verified.

b. Linearity
Not applicable.
c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50 ℃ and real time stability studies at 4℃ and 30 ℃.
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, with the exception of albumin with no interference at a concentration of 100mg/dL and ethanol at 1% volume, 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	Erythromycin	Oxalic acid
N-Acetylprocainamide	β-Estradiol	Oxolinic acid
Acetylsalicylic acid	Ethanol (1% vol)	Oxymetazoline
Albumin (100mg/dL)	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
Benzilic acid	3-Hydroxytyramine	Ranitidine
Benzoic acid	Ibuprofen	Salicylic acid

12

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	Meperidine	Thiamine
Cortisone	Meprobamate	Thioridazine
(-) Cotinine	Methoxyphenamine	Triamterene
Creatinine	Nalidixic acid	DL-Tyrosine
Deoxycorticosterone	Naloxone	Trifluoperazine
Dextromethorphan	Naltrexone	Trimethoprim
Diclofenac	Naproxen	D L-Tryptophan
Diflunisal	Niacinamide	Tyramine
Digoxin	Nifedipine	Uric acid
Diphenhydramine	Norethindrone	Verapamil
Disopyramide	Noscapine	Zomepirac

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 Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. Please refer to K182654 for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and to K181968 for Oxazepam, Secobarbital and Methadone, and to K153646 for Cannabinoids and to K201120 for EDDP. There were no differences observed between the SAFECARE® Cup and Dip Card formats. The candidate device uses the same assays (same reagent pads) for these drugs as was cleared in K182654/K181968/K153646/K201120.

| Compounds | Result
Positive at(ng/ml) | % Cross-Reactivity |
|--------------------------------------|------------------------------|--------------------|
| l-Amphetamine | 25000 | 2% |
| dl- Amphetamine | 1500 | 33% |
| 3,4-Methylenedioxyamphetamine (MDA) | 2500 | 20% |
| Phentermine | 1500 | 33% |
| Hydroxyamphetamine | 8000 | 6% |
| β-Phenylethylamine | 100000 | 0.5% |
| Tyramine | 100000 | 0.5% |
| p-Hydroxynorephedrine | 100000 | 0.5% |
| p-Hydroxyamphetamine | 100000 | 0.5% |
| d/l-Norephedrine | 100000 | 0.5% |
| d-Methamphetamine | >100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 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, 1 blind labeled sample and a device. Each device was tested. Typical results are shown below.

AMP500:

| % 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 | 125 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 250 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 375 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 625 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 750 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 878 | 20 | 0 | 100 |

19

COC150:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct
results (%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | 100 |
| -75% Cutoff | 20 | 38 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 75 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 113 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 188 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 225 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 263 | 20 | 0 | 100 |

THC:

| % 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 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 25 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 37 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 62 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 76 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 87 | 20 | 0 | 100 |

BAR:

| % 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 | 170 | 151 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 226 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 373 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 450 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 526 | 20 | 0 | 100 |

20

| % 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 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 151 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 224 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 524 | 20 | 0 | 100 |

BZO:

MET500:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|-----------------------|------------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive 0 | No. of
Negative 20 | 100 |
| -75% Cutoff | 20 | 124 | No. of
Positive 0 | No. of
Negative 20 | 100 |
| -50% Cutoff | 170 | 251 | No. of
Positive 0 | No. of
Negative 170 | 100 |
| -25% Cutoff | 20 | 375 | No. of
Positive 2 | No. of
Negative 18 | 90 |
| +25% Cutoff | 20 | 625 | No. of
Positive 19 | No. of
Negative 1 | 95 |
| +50% Cutoff | 40 | 750 | No. of
Positive 40 | No. of
Negative 0 | 100 |
| +75% Cutoff | 20 | 877 | No. of
Positive 20 | No. of
Negative 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 | 170 | 152 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 451 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 524 | 20 | 0 | 100 |

21

MOP300:

| % 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 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 151 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

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 | 124 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 250 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 377 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 622 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 749 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 874 | 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 | 170 | 50 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 75 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 124 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 151 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100 |

22

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	170	5	0	170	100
-25% Cutoff	20	8	2	18	90
+25% Cutoff	20	13	18	2	90
+50% Cutoff	40	15	40	0	100
+75% Cutoff	20	18	20	0	100

PCP:

| % 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 | 170 | 13 | 0 | 170 | 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 |

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 | 170 | 501 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 752 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1255 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1503 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1751 | 20 | 0 | 100 |

23

| % 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 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 150 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 374 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 523 | 20 | 0 | 100 |

PPX:

EDDP:

| % 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 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 150 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 374 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 450 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 524 | 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.

1. Clinical Studies
  Not applicable.

11. Conclusion

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