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 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, 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.

AI/ML Overview

The provided document describes the performance characteristics and studies for the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. It does not describe an AI/ML device but rather an in-vitro diagnostic device (IVD) for drug screening. Therefore, several of the requested categories for AI/ML device evaluation are not applicable (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set).

Here's the information extracted from the document, tailored to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically defined by precision around the cutoff concentration. The device is expected to consistently classify samples below the cutoff as negative and above the cutoff as positive. For samples near the cutoff, some variability in classification is expected.

Test Parameter / Drug (Cut-off)	Acceptance Criteria (Implicit from study design)	Reported Device Performance (Precision Study - Example for Dip Card, Lot 1)
Precision	Samples < -25% Cut-off: 100% negative calls. Samples > +25% Cut-off: 100% positive calls. Samples within +/-25% of Cut-off: Expected variability.	Amphetamine 500: -100% Cut-off: 50-/0+ (100% negative) -75% Cut-off: 50-/0+ (100% negative) -50% Cut-off: 50-/0+ (100% negative) -25% Cut-off: 50-/0+ (100% negative) Cut-off: 24-/26+ (48% negative, 52% positive) +25% Cut-off: 50+/0- (100% positive) +50% Cut-off: 50+/0- (100% positive) +75% Cut-off: 50+/0- (100% positive) +100% Cut-off: 50+/0- (100% positive) Cocaine 150: -100% Cut-off: 50-/0+ (100% negative) -75% Cut-off: 50-/0+ (100% negative) -50% Cut-off: 50-/0+ (100% negative) -25% Cut-off: 50-/0+ (100% negative) Cut-off: 24-/26+ (48% negative, 52% positive) +25% Cut-off: 50+/0- (100% positive) +50% Cut-off: 50+/0- (100% positive) +75% Cut-off: 50+/0- (100% positive) +100% Cut-off: 50+/0- (100% positive) Methamphetamine 500: -100% Cut-off: 50-/0+ (100% negative) -75% Cut-off: 50-/0+ (100% negative) -50% Cut-off: 50-/0+ (100% negative) -25% Cut-off: 50-/0+ (100% negative) Cut-off: 24-/26+ (48% negative, 52% positive) +25% Cut-off: 50+/0- (100% positive) +50% Cut-off: 50+/0- (100% positive) +75% Cut-off: 50+/0- (100% positive) +100% Cut-off: 50+/0- (100% positive) Morphine 300: -100% Cut-off: 50-/0+ (100% negative) -75% Cut-off: 50-/0+ (100% negative) -50% Cut-off: 50-/0+ (100% negative) -25% Cut-off: 50-/0+ (100% negative) Cut-off: 24-/26+ (48% negative, 52% positive) +25% Cut-off: 50+/0- (100% positive) +50% Cut-off: 50+/0- (100% positive) +75% Cut-off: 50+/0- (100% positive) +100% Cut-off: 50+/0- (100% positive)
Lay-User Study (Accuracy)	For samples far from cutoff (e.g., -50% and +50%), approximately 100% correct results. For samples near cutoff (e.g., -25% and +25%), high accuracy (e.g., >90%).	AMP500: -50% Cutoff: 100% correct (0 Pos, 170 Neg)+50% Cutoff: 100% correct (40 Pos, 0 Neg)-25% Cutoff: 90% correct (2 Pos, 18 Neg)+25% Cutoff: 95% correct (19 Pos, 1 Neg)(Similar results reported for COC150, THC, BAR, BZO, MET500, MTD, MOP300, MDMA, OXY, BUP, PCP, TCA, PPX, EDDP)

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Precision Study (Test Set):
- For each drug (Amphetamine, Cocaine, Methamphetamine, Morphine), 9 concentrations were tested around the cutoff (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100%).
- For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device. This equates to 50 replicates per concentration per lot, totaling 450 tests per lot per drug.
- Total replicates for 4 drugs (AMP, COC, MET, MOP): 9 concentrations x 50 replicates/concentration x 3 lots = 1350 tests per drug. (Some data for other drugs were referenced from prior 510(k)s: K182654, K181968, K153646, K201120).
- Data Provenance: The document states "in-house" for comparison studies and "urine samples were prepared by spiking drug in negative samples" for precision studies. This suggests a controlled laboratory setting (likely prospective, artificial samples). The document does not specify the country of origin of the data.
Method Comparison Study (Clinical/Test Set):
- 80 "unaltered clinical samples" were used for each drug. These samples were split into categories: 10 negative, 10 low negative, 20 near cutoff negative, 20 near cutoff positive, 20 high positive for each drug.
- Total samples per device type (Dip Card or Cup) for 4 drugs mentioned: 80 samples x 4 drugs = 320 samples per device type.
- Data Provenance: "in-house" and "unaltered clinical samples," implying real-world samples but processed within the manufacturer's lab. The document does not specify the country of origin or whether these clinical samples were retrospective or prospectively collected for the study.
Lay-User Study (Test Set):
- 310 lay persons participated for each device format (Dip Card and Cup).
- Urine samples were prepared at 7 concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff.
- Total samples: For each drug, the number of samples varied across concentrations. For example, for AMP500, 20 samples at -100% cutoff, 20 at -75%, 170 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%. This totals 310 samples per drug per device format.
- Data Provenance: "at three intended user sites." Samples were "prepared by spiking drugs into drug free-pooled urine specimens," making them artificial but intended to mimic a range of concentrations. This suggests a prospective study design, mimicking real-world use conditions but with controlled samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Precision Study: Ground truth was established by preparing urine samples with known drug concentrations confirmed by LC/MS. No human experts were involved in establishing ground truth, as it was an analytical study.
Method Comparison Study: The ground truth for clinical samples was established by LC/MS results. No mention of human experts for ground truth.
Lay-User Study: Ground truth was established by LC/MS results of the prepared spiked urine samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is a qualitative diagnostic test read directly by users, not an AI/ML imaging device requiring expert adjudication. In the method comparison study, three laboratory assistants "ran" the samples, implying they performed the test, but the ground truth was LC/MS, not their consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study comparing human readers with and without AI assistance was mentioned. The lay-user study evaluated the device's performance with lay users, not an "AI assistance" scenario.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical, lateral flow immunochromatographic assay. Its performance inherently involves a human interpreting the result line, even if it's a simple positive/negative visual interpretation. It is not an algorithm-only device. The precision and method comparison studies evaluate the device's analytical performance, which is its inherent "standalone" capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

LC/MS (Liquid Chromatography-Mass Spectrometry) was used as the ground truth method to confirm drug concentrations in both spiked samples (for precision and lay-user studies) and clinical samples (for method comparison studies). This is a highly accurate and quantitative analytical method.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on immunoassay principles.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: 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.

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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

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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)

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 tests are intended for over-the-counter use.

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

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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 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
NFTAmphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology (91)
NFWCannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology (91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System	Toxicology (91)
NGGMethamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
NGIMorphine	II	21 CFR § 862.3640, Morphine Test System	Toxicology (91)
NFVOxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology (91)
NGLOxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
PTHSecobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology (91)
NGLBuprenorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
NGGMethylenedioxy-methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
NGMPhencyclidine	unclassified	Enzyme Immunoassay Phencyclidine	Toxicology (91)
PTGMethadone	II	21 CFR § 862.3620, Methadone Test System	Toxicology (91)
QAWNortriptyline	II	21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System	Toxicology (91)
QBFPropoxyphene	II	21 CFR, 862.3700 Propoxyphene Test System	Toxicology (91)

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Product Code	Classification	Regulation Section	Panel
PTG2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	II	21 CFR § 862.3620, Methadone TestSystem	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

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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

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.

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

Item	Device	Predicate - K201120
Indication(s)for Use	For the qualitative determination ofAmphetamine, Buprenorphine, Secobarbital,Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,Methamphetamine,Methylenedioxymethamphetamine,Morphine, Methadone, Oxycodone,Phencyclidine, Propoxyphene, Nortriptylineand Cannabinoids in human urine.	Same
	Similarities
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	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-OffValues	Amphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 150 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOP): 300ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlMethylenedioxymethamphetamine(MDMA): 500 ng/mlOxycodone (OXY): 100 ng/mlBuprenorphine (BUP): 10 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/mlPropoxyphene (PPX): 300 ng/ml2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP): 300 ng/mL	Same as candidate devicewith exception ofAmphetamine: 1000ng/mLCocaine: 300ng/mLMethamphetamine:1000ng/mLMorphine: 2000ng/mL

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Features Comparison of SAFECARE® Cup Tests and the Predicate Devices

Item	Device	Predicate - K201120
Indication(s)for Use	For the qualitative determination ofAmphetamine, Buprenorphine,Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,Methylenedioxymethamphetamine,Morphine, Methadone, Oxycodone,Phencyclidine, Propoxyphene,Nortriptyline and Cannabinoids inhuman urine.	Same
Similarities
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	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-OffValues	Amphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 150 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOP): 300ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlMethylenedioxymethamphetamine(MDMA): 500 ng/mlOxycodone (OXY): 100 ng/mlBuprenorphine (BUP): 10 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/mlPropoxyphene (PPX): 300 ng/ml2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP): 300 ng/mL	Same as candidate devicewith exception ofAmphetamine: 1000ng/mLCocaine: 300ng/mLMethamphetamine:1000ng/mLMorphine: 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.

ResultsLotNumber	-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
ResultsLotNumber	-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

	-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%
LotNumber
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%
LotNumber
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%
LotNumber
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
ResultsLotNumber	-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%
LotNumber
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%
LotNumber
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	ResultPositive 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	<0.5%
l-Methamphetamine	>100,000	<0.5%
Methylenedioxyethylamphetamine (MDE)	>100,000	<0.5%
Methylenedioxymethamphetamine(MDMA)	>100,000	<0.5%
Ephedrine	>100,000	<0.5%
Phenylpropanolamine	>100,000	<0.5%
(±)Phenylpropanolamine	>100,000	<0.5%
Benzphetamine	>100,000	<0.5%

Amphetamine

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

Cocaine
Compounds	ResultPositive at(ng/ml)	% Cross-Reactivity
Cocaine	375	40%
Cocaethylene	6250	2.4%
Ecgonine	16000	1%
Ecgonine methyl ester	>100,000	<0.2%
Norcocaine	>100,000	<0.2%
Methamphetamine
Compounds	ResultPositive at(ng/ml)	% Cross-Reactivity
D-Amphetamine	25000	2%
L- Amphetamine	37500	1%
Chloroquine	10000	5%
(+/-)-Ephedrine	25000	2%
D/L-Methamphetamine	500	100%
L-Methamphetamine	10000	5%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	500	100%
3,4-Methylenedioxyamphetamine(MDA)	500	100%
Methylenedioxymethamphetamine(MDMA)	2000	25%
β-Phenylethylamine	25000	2%
Trimethobenzamide	5000	10%
d/l-Amphetamine	75000	1%
p-Hydroxymethamphetamine	15000	3%
Mephentermine	25000	2%
(1R,2S)-(-)-Ephedrine	50000	1%
1-Phenylephrine	100000	0.5%
(-)-Methamphetamine	12500	2%
Morphine
Compounds	ResultPositive at(ng/ml)	% Cross-Reactivity
Normorphine	300	100%
s-Monoacetylmorphine	300	100%
Codeine	300	100%
Ethyl Morphine	100	300%
Heroin	300	100%
Hydrocodone	5000	6%
Hydromorphone	1000	30%
Morphinie-3-β-d-glucuronide	1000	30%
Oxycodone	>100000	<0.3%
Oxymorphone	100000	0.3%
Thebaine	3000	10%
Levorphanol	10000	3%
6-Monoacetylmorphine (6-MAM)	150	200%
Norcodeine	6250	5%
Procaine	150000	0.2%

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

f. Effect of Urine Specific Gravity and Urine pH

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

2. Comparison Studies

Method comparison studies for the SAFECARE® Dip Card Tests and the SAFECARE® Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for 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. The candidate device uses the same assays (same reagent pads) for these drugs as was cleared in K182654/ K181968/ K153646 and K201120.

DipCard		Negative	Low Negative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	20	20
	Negative	10	10	19	0	0
ViewerB	Positive	0	0	0	19	20
	Negative	10	10	20	1	0
ViewerC	Positive	0	0	1	20	20
	Negative	10	10	19	0	0

Amphetamine 500

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	LM8554	498	Positive
Viewer C	LM8554	498	Positive
Viewer B	LM1169	502	Negative

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

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

Viewer	Sample Number	LC/MS Result	Cup Viewer Results
Viewer B	LM8561	498	Positive
Viewer A	LM1497	502	Negative
Viewer C	LM1497	502	Negative

Cocaine 150

Dip Card	Negative	Low Negative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	20	20
	Negative	10	10	19	0	0
ViewerB	Positive	0	0	0	19	20
	Negative	10	10	20	1	0
ViewerC	Positive	0	0	1	20	20
	Negative	10	10	19	0	0

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	LM8739	148	Positive
Viewer C	LM8739	148	Positive
Viewer B	LM7119	152	Negative

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

Cup		Negative	Low Negative byLC/MS(less than -50%)	Near Cutoff Negative byLC/MS(Between -50% andcutoff)	Near Cutoff Positive byLC/MS(Between thecutoff and +50%)	High Positiveby LC/MS(greater than +50%)
Viewer	Positive	0	0	0	19	20
A	Negative	10	10	20	1	0
Viewer	Positive	0	0	1	20	20
B	Negative	10	10	19	0	0
Viewer	Positive	0	0	0	20	20
C	Negative	10	10	20	0	0

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer B	LM4418	148	Positive
Viewer A	LM1485	152	Negative

Methamphetamine 500

DipCard		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	18	20
ViewerA	Negative	10	10	19	2	0
ViewerB	Positive	0	0	2	19	20
ViewerB	Negative	10	10	18	1	0
ViewerC	Positive	0	0	0	18	20
ViewerC	Negative	10	10	20	2	0

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	LM6106	467	Positive
Viewer B	LM7710	464	Positive
Viewer B	LM6106	467	Positive
Viewer A	LM7165	513	Negative
Viewer A	LM6198	511	Negative
Viewer B	LM7165	513	Negative
Viewer C	LM7165	513	Negative
Viewer C	LM6198	511	Negative

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

Cup		Negative	Low Negative byLC/MS(less than -50%)	Near Cutoff Negative byLC/MS(Between -50% andcutoff)	Near Cutoff Positive byLC/MS(Between thecutoff and +50%)	High Positiveby LC/MS(greater than +50%)
ViewerA	Positive	0	0	2	19	20
A	Negative	10	10	18	1	0
ViewerB	Positive	0	0	1	18	20
B	Negative	10	10	19	2	0
ViewerC	Positive	0	0	1	19	20
C	Negative	10	10	19	1	0

Viewer	Sample Number	LC/MS Result	Cup Viewer Results
Viewer A	LM3480	464	Positive
Viewer A	LM8436	467	Positive
Viewer B	LM3480	464	Positive
Viewer C	LM8436	467	Positive
Viewer A	LM5908	513	Negative
Viewer B	LM8727	511	Negative
Viewer B	LM5908	513	Negative
Viewer C	LM5908	513	Negative

Morphine 300

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

Viewer	Sample Number	LC/MS Result	Dip Card Viewer Results
Viewer A	LM4260	280	Positive
Viewer B	LM4260	280	Positive
Viewer C	LM4260	280	Positive
Viewer C	LM9616	281	Positive

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

Viewer A	LM2412	305	Negative
Viewer C	LM4067	306	Negative

Cup		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	1	20	20
A	Negative	10	10	19	0	0
Viewer	Positive	0	0	2	19	20
B	Negative	10	10	18	1	0
Viewer	Positive	0	0	0	19	20
C	Negative	10	10	20	1	0

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	LM8592	280	Positive
Viewer B	LM8592	280	Positive
Viewer B	LM1718	281	Positive
Viewer B	LM7813	305	Negative
Viewer C	LM1916	306	Negative

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 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 ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		The percentage
			No. ofPositive	No. ofNegative	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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correctresults (%)
-100% Cutoff	20	0	No. ofPositive	No. ofNegative	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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentage
			No. ofPositive	No. ofNegative	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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
-100% Cutoff	20	0	No. ofPositive 0	No. ofNegative 20	100
-75% Cutoff	20	124	No. ofPositive 0	No. ofNegative 20	100
-50% Cutoff	170	251	No. ofPositive 0	No. ofNegative 170	100
-25% Cutoff	20	375	No. ofPositive 2	No. ofNegative 18	90
+25% Cutoff	20	625	No. ofPositive 19	No. ofNegative 1	95
+50% Cutoff	40	750	No. ofPositive 40	No. ofNegative 0	100
+75% Cutoff	20	877	No. ofPositive 20	No. ofNegative 0	100

MTD:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentage
			No. ofPositive	No. ofNegative	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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof 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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentage
			No. ofPositive	No. ofNegative	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	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
			No. ofPositive	No. ofNegative
-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.

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).