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

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

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

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

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

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

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

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

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

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

Device Description

The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The document describes the performance characteristics and studies for the SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section. However, the performance data presented implies a very high standard for accuracy, particularly around the established cutoff concentrations. The "precision" studies demonstrate the device's ability to consistently produce correct results for samples at varying concentrations relative to the cutoff. The "comparison studies" compare the device's qualitative results to a quantitative gold standard (LC/MS) to establish concordance. The "lay-user study" assesses the ability of untrained individuals to correctly use and interpret the device.

Based on the provided data, the implied acceptance criteria for qualitative immunoassay devices for drug testing would typically be:

100% agreement for samples significantly below the cutoff (Negative).
100% agreement for samples significantly above the cutoff (Positive).
High percentage agreement for samples near the cutoff (typically >90%).

For the Precision Study (Analytical Performance - "Test Set" Data):

The table below summarizes the reported performance for Methylenedioxymethamphetamine (MDMA), Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, and Propoxyphene (results from 3 lots, 50 tests per concentration per lot, per device type). The format is (Number of Negative Results)/(Number of Positive Results).

Drug (Identifier)	Cut-off Level	Concentration	Reported Performance (Typical across 3 lots)	Implied Acceptance Criteria Met?
Methylenedioxymethamphetamine (MDMA) (Dip Card & Cup)	500 ng/mL	-100% Cut-off	50-/0+	Yes (100% negative)
		-75% Cut-off	50-/0+	Yes (100% negative)
		-50% Cut-off	50-/0+	Yes (100% negative)
		-25% Cut-off	50-/0+	Yes (100% negative)
		Cut-off	25-/25+ or 26-/24+	Yes (near 50/50 split at cutoff)
		+25% Cut-off	50+/0-	Yes (100% positive)
		+50% Cut-off	50+/0-	Yes (100% positive)
		+75% Cut-off	50+/0-	Yes (100% positive)
		+100% Cut-off	50+/0-	Yes (100% positive)
Oxycodone (Dip Card & Cup)	100 ng/mL	-100% Cut-off	50-/0+	Yes (100% negative)
		-75% Cut-off	50-/0+	Yes (100% negative)
		-50% Cut-off	50-/0+	Yes (100% negative)
		-25% Cut-off	50-/0+	Yes (100% negative)
		Cut-off	24-/26+ or 26-/24+ or 25-/25+	Yes (near 50/50 split at cutoff)
		+25% Cut-off	50+/0-	Yes (100% positive)
		+50% Cut-off	50+/0-	Yes (100% positive)
		+75% Cut-off	50+/0-	Yes (100% positive)
		+100% Cut-off	50+/0-	Yes (100% positive)
Buprenorphine (Dip Card & Cup)	10 ng/mL	-100% Cut-off	50-/0+	Yes (100% negative)
		-75% Cut-off	50-/0+	Yes (100% negative)
		-50% Cut-off	50-/0+	Yes (100% negative)
		-25% Cut-off	50-/0+	Yes (100% negative)
		Cut-off	27-/23+, 25-/25+, 24-/26+, 26-/24+	Yes (near 50/50 split at cutoff)
		+25% Cut-off	50+/0-	Yes (100% positive)
		+50% Cut-off	50+/0-	Yes (100% positive)
		+75% Cut-off	50+/0-	Yes (100% positive)
		+100% Cut-off	50+/0-	Yes (100% positive)
Phencyclidine (Dip Card & Cup)	25 ng/mL	-100% Cut-off	50-/0+	Yes (100% negative)
		-75% Cut-off	50-/0+	Yes (100% negative)
		-50% Cut-off	50-/0+	Yes (100% negative)
		-25% Cut-off	50-/0+	Yes (100% negative)
		Cut-off	26-/24+, 25-/25+, 24-/26+	Yes (near 50/50 split at cutoff)
		+25% Cut-off	50+/0-	Yes (100% positive)
		+50% Cut-off	50+/0-	Yes (100% positive)
		+75% Cut-off	50+/0-	Yes (100% positive)
		+100% Cut-off	50+/0-	Yes (100% positive)
Nortriptyline (Dip Card & Cup)	1000 ng/mL	-100% Cut-off	50-/0+	Yes (100% negative)
		-75% Cut-off	50-/0+	Yes (100% negative)
		-50% Cut-off	50-/0+	Yes (100% negative)
		-25% Cut-off	50-/0+	Yes (100% negative)
		Cut-off	25-/25+, 26-/24+, 24-/26+	Yes (near 50/50 split at cutoff)
		+25% Cut-off	50+/0-	Yes (100% positive)
		+50% Cut-off	50+/0-	Yes (100% positive)
		+75% Cut-off	50+/0-	Yes (100% positive)
		+100% Cut-off	50+/0-	Yes (100% positive)
Propoxyphene (Dip Card & Cup)	300 ng/mL	-100% Cut-off	50-/0+	Yes (100% negative)
		-75% Cut-off	50-/0+	Yes (100% negative)
		-50% Cut-off	50-/0+	Yes (100% negative)
		-25% Cut-off	50-/0+	Yes (100% negative)
		Cut-off	23-/27+, 26-/24+, 24-/26+, 25-/25+	Yes (near 50/50 split at cutoff)
		+25% Cut-off	50+/0-	Yes (100% positive)
		+50% Cut-off	50+/0-	Yes (100% positive)
		+75% Cut-off	50+/0-	Yes (100% positive)
		+100% Cut-off	50+/0-	Yes (100% positive)

For the Lay-user Study:

The acceptance criteria for the lay-user study would typically be a high percentage of correct results, especially for samples clearly negative or positive, and a reasonable proportion around the cutoff. The document shows the "percentage of correct results (%)" for each concentration level. The implied acceptance criteria for OTC urine drug screens are usually very high concordance (e.g., >90%) with the ground truth for samples away from the cutoff, and some level of agreement for near-cutoff samples (where variability is expected). The device performance meets these generally implied high standards, especially for samples clearly below or above the cutoff (100% for most categories). For samples near +/-25% of cutoff, the accuracy ranges from 85-95%, which is typical for qualitative tests and acceptable for over-the-counter use where confirmation is recommended for positive results.

2. Sample Size Used for the Test Set and Data Provenance

Precision Studies (Test Set):
- For each drug, device type (Dip Card/Cup), and each of the 9 concentration levels: 50 tests were performed per concentration.
- This was repeated for 3 different lots for each device type.
- Therefore, for a single drug and device type, the test set size for precision was: 9 concentrations * 50 tests/concentration * 3 lots = 1350 tests.
- Data Provenance: The samples were prepared by "spiking drug in negative samples" and confirmed by LC/MS. This suggests controlled, prospective laboratory-prepared samples rather than retrospective clinical samples from specific countries. The testing was "in-house."
Comparison Studies (Test Set):
- For each drug and device type (Dip Card/Cup): 80 unaltered clinical samples (40 negative and 40 positive) were used.
- Data Provenance: "unaltered clinical samples." The document does not specify the country of origin, but given the manufacturer (China) and submission to US FDA, the samples could be from various global sources or acquired for the study. It's a retrospective analysis against independently confirmed samples.
Lay-user Study (Test Set):
- For each device format (presumably Dip Card and Cup, though only combined results are shown in the given table): 300 lay persons participated.
- The total number of samples processed for each drug across the different concentration levels in the lay-user study tables is: 20 + 20 + 160 + 20 + 20 + 40 + 20 = 300 samples. (It seems 300 samples were tested for each drug type, probably with each of the 300 lay users testing one sample)
- Data Provenance: Urine samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." These were laboratory-prepared samples. The study involved "three intended user sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Precision Studies: Ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a definitive quantitative analytical method. It's an instrumental method, so human "experts" in interpretation are typically not specified in the same way as for imaging or clinical diagnosis. The samples were "blindly labeled by the person who prepared the samples," which indicates blinding to the LC/MS results during the device testing.
Comparison Studies: Ground truth was established by LC/MS results. The document states, "The samples were blind labeled and compared to LC/MS results." These are definitive chemical analysis results.
Lay-user Study: Ground truth for the samples was established by LC/MS confirmation of the spiked drug concentrations.

4. Adjudication Method for the Test Set

Precision Studies: No explicit human adjudication method mentioned, as the device results are quantitative categories (positive/negative) and compared to definitive LC/MS values. The results are reported as counts (e.g., 25-/25+).
Comparison Studies: The device results were read by "three laboratory assistants." For discordant results, the individual viewer's result is listed against the LC/MS truth, but no specific human adjudication process (e.g., 2+1 majority voting) is described for resolving discrepancies among the assistants or between the assistants and LC/MS. The LC/MS is the definitive ground truth here.
Lay-user Study: The results are presented as aggregated counts of positive/negative readings by the lay users compared to the known ground truth (LC/MS confirmed concentrations). No human adjudication process is mentioned among the lay users.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret images or complex data, and the AI serves as an aid.
This device is a qualitative, over-the-counter urine drug test. Its performance is evaluated against chemical analytical ground truth, and its usability is assessed with lay users, not by evaluating how it assists expert readers.

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

This device is a physical, qualitative immunoassay test kit, not a standalone algorithm/AI for analysis. The "performance" of the device itself (the reaction on the dip card/cup) is evaluated.
However, the Comparison Studies and Precision Studies could be considered the "standalone" performance of the device when read by trained laboratory personnel (3 laboratory assistants), as it's the device's output itself being compared to LC/MS.
The Lay-user study evaluates the device performance when interpreted by the intended "human-in-the-loop" (a lay user).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used for all performance studies (Precision, Comparison, Lay-user) is quantitative chemical analysis by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted method for confirming drug concentrations in urine.
For the precision and lay-user studies, urine samples were spiked with known concentrations of drugs, and these concentrations were confirmed by LC/MS.
For the comparison studies, "unaltered clinical samples" were used, with LC/MS providing the definitive truth for the presence and concentration of drugs.

8. The Sample Size for the Training Set

This document describes premarket notification (510(k)) for a drug test kit, which is a physical diagnostic device based on immunochromatography, not an AI/Machine Learning algorithm.
Therefore, there is no "training set" in the context of machine learning model development. The device's performance relies on its physical and chemical design, not on a trained algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no AI/ML algorithm or training set, this question is not applicable.

Summary

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

November 19, 2018

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

Re: K182654

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

Dear Joe Shia:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Courtney H. Lias -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

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

Indications for Use (Describe)

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

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

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

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

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

See PRA Statement below.

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

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

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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510(k) SUMMARY

November 1, 2018 1. Date:
Safecare Biotech (Hangzhou) Co. Ltd. 2. Submitter: 18 Haishu Road, Yuhang District Hangzhou, China
Alex Qiu 3. Contact person: Safecare Biotech 18 Haishu Road, Yuhang District Hangzhou, China Telephone: 86 571-89712897 Fax: 86 571-80389223 Email: alexqiu@safecare.com.cn
SAFECARE Multi-Drug Urine Test Dip Card 4. Device Name: SAFECARE Multi-Drug Urine Test Cup

Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, AmphetamineTest System	Toxicology (91)
	NFWCannabinoids	II	21 CFR § 862.3870, CannabinoidsTest System	Toxicology (91)
NFYCocaine		II	21 CFR § 862.3250, Cocaine andCocaine Metabolites Test System	Toxicology (91)
	NGGMethamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology (91)
NGIMorphine		II	21 CFR § 862.3640, MorphineTest System	Toxicology (91)
	NFVOxazepam	II	21 CFR § 862.3170,Benzodiazepine Test System	Toxicology (91)
NGLOxycodone		II	21 CFR § 862.3650, Opiate TestSystem	Toxicology (91)
	PTHSecobarbital	II	21 CFR § 862.3150, BarbiturateTest 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 ImmunoassayPhencyclidine	Toxicology (91)
		PTGMethadone	II	21 CFR § 862.3620, MethadoneTest System
QAWNortriptyline	II		21 CFR, 862.3910 TricyclicAntidepressant Drugs Test System	Toxicology (91)
	QBFPropoxyphene	II	21 CFR, 862.3700 PropoxypheneTest System	Toxicology (91)

Predicate Devices: K142396

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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, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene in human urine at the cutoff concentrations of:

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

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

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

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

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

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

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

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

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

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

Item	Device	Predicate - K142396
Indication(s)for Use	For the qualitative determination of drugs ofabuse in human urine.	Same (but the number ofdrugs detected isdifferent)
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 300 ng/ml11-Nor-Δ9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (OPI): 2000ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/ml	Same

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

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	Methylenedioxymethamphetamine(MDMA): 500 ng/ml
	Oxycodone (OXY): 100 ng/ml
	Buprenorphine (BUP): 10 ng/ml
	Phencyclidine (PCP): 25 ng/ml
	Nortriptyline (TCA): 1000 ng/ml
	Propoxyphene (PPX): 300 ng/ml
Methodology	Competitive binding, lateral 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	Dip Card

Table 2: Features Comparison of SAFECARE Cup Tests and the Predicate Devices

Item	Device	Predicate - K142396
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 300 ng/ml11-Nor-Δ9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (OPI): 2000ng/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/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same

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

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

9. Test Principle

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

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine. Nortriptyline and Propoxyphene. Please refer to K181968 for precision data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to K153646 for precision data for Amphetamine, Cocaine, and Cannabinoids.

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+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

Methylenedioxymethamphetamine (MDMA)

Dip Card

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

Cup
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+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

Oxycodone

Dip Card

Dip Card Results
LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

Cup
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+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

Buprenorphine

Dip Card

Dip Card
LotNumber	Results	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
	Lot 1		50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

Cup
ResultsLot	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Number
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

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

Phencyclidine

Dip Card

Dip Card
LotNumber	Results-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-

Cup

Results	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
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+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

Nortriptyline

Dip Card

Dip Card
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+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

r)
--------

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

Propoxyphene

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+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

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

Cup
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+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-

The following cut-off values are verified.

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

b. Linearity

Not applicable.

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

d. Interference

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

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

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

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

e. Specificity

To test specificity, drug metabolites and other structure related compounds that are likely to cross-react in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Please refer to K181968 for specificity data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to K153646 for specificity data for Amphetamine, Cocaine, and Cannabinoids. There were no differences observed between the SAFECARE Cup and Dip Card formats.

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

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

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

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

Compounds	ResultPositive at(ng/ml)	% Cross-Reactivity
Phencyclidine	25	100%
4-Hydroxyphencyclidine	75	33%

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

Compounds	ResultPositive at(ng/ml)	% Cross-Reactivity
d-Propoxyphene	300	100%
D-Norpropoxyphene	330	91%

f. Effect of Urine Specific Gravity and Urine pH

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

2. Comparison Studies

Method comparison studies for the SAFECARE Dip Card Tests and the SAFECARE Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Please refer to K181968 for method comparison data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to K153646 for method

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

comparison data for Amphetamine, Cocaine, and Cannabinoids.

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

Methylenedioxymethamphetamine (MDMA)

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	AM1822	491	Positive
Viewer B	AM5121	497	Positive
Viewer C	AM1822	491	Positive
Viewer C	AM5121	497	Positive
Viewer A	AM2281	517	Negative
Viewer A	AM3339	509	Negative
Viewer B	AM2281	517	Negative
Viewer B	AM6217	525	Negative
Viewer C	AM6217	525	Negative
Viewer C	AM3339	509	Negative

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

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

Discordant Results
Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	AM5135	491	Positive
Viewer A	AM6745	497	Positive
Viewer B	AM5135	491	Positive
Viewer C	AM5135	491	Positive
Viewer C	AM6745	497	Positive
Viewer A	AM8048	517	Negative
Viewer A	AM4472	509	Negative
Viewer B	AM4472	509	Negative
Viewer B	AM4835	525	Negative
Viewer C	AM8048	517	Negative
Viewer C	AM4472	509	Negative

Oxycodone

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
	Negative	10	10	19	2	0
ViewerB	Positive	0	0	1	18	20
	Negative	10	10	19	2	0
ViewerC	Positive	0	0	1	17	20
	Negative	10	10	19	3	0

Discordant Results

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

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

Cup		Negative	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	1	17	20
ViewerB	Negative	10	10	19	3	0
ViewerC	Positive	0	0	1	17	20
ViewerC	Negative	10	10	19	3	0

Discordant Results

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	AM0623	98	Positive
Viewer B	AM5357	95	Positive
Viewer C	AM0623	98	Positive
Viewer A	AM7016	105	Negative
Viewer A	AM3335	106	Negative
Viewer B	AM7525	104	Negative
Viewer B	AM0654	107	Negative
Viewer B	AM3335	106	Negative
Viewer C	AM7016	105	Negative
Viewer C	AM7525	104	Negative
Viewer C	AM3335	106	Negative

Buprenorphine

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
	Negative	10	10	19	2	0
ViewerB	Positive	0	0	1	18	20
	Negative	10	10	19	2	0
ViewerC	Positive	0	0	1	19	20
	Negative	10	10	19	1	0

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

Discordant Results
Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	AM7493	9	Positive
Viewer B	AM1093	9	Positive
Viewer C	AM1093	9	Positive
Viewer A	AM6936	11	Negative
Viewer A	AM0902	11	Negative
Viewer B	AM6497	11	Negative
Viewer B	AM0902	11	Negative
Viewer C	AM6936	11	Negative

Cup			Negative	Low Negative 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	A	Positive	0	0	1	18	20
		Negative	10	10	19	2	0
Viewer	B	Positive	0	0	1	18	20
		Negative	10	10	19	2	0
Viewer	C	Positive	0	0	1	18	20
		Negative	10	10	19	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	AM8338	9	Positive
Viewer B	AM4130	9	Positive
Viewer C	AM4130	9	Positive
Viewer A	AM3059	11	Negative
Viewer A	AM5605	11	Negative
Viewer B	AM5605	11	Negative
Viewer B	AM2763	11	Negative
Viewer C	AM3059	11	Negative
Viewer C	AM2763	11	Negative

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

Phencyclidine

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

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	AM1553	23	Positive
Viewer B	AM1159	24	Positive
Viewer C	AM1159	24	Positive
Viewer A	AM2982	25.3	Negative
Viewer B	AM5901	26	Negative
Viewer B	AM2982	25.3	Negative
Viewer C	AM2982	25.3	Negative

Cup	Negative	Low Negative 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	1	18	20
ViewerA	Negative	10	10	19	2	0
ViewerB	Positive	0	0	1	19	20
ViewerB	Negative	10	10	19	1	0
ViewerC	Positive	0	0	1	18	20
ViewerC	Negative	10	10	19	2	0

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

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

Nortriptyline

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
	Negative	10	10	19	2	0
ViewerB	Positive	0	0	1	18	20
	Negative	10	10	19	2	0
ViewerC	Positive	0	0	1	18	20
	Negative	10	10	19	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	AM9403	982	Positive
Viewer B	AM2316	998	Positive
Viewer C	AM9403	982	Positive
Viewer A	AM7812	1004	Negative
Viewer A	AM0170	1031	Negative
Viewer B	AM4373	1023	Negative
Viewer B	AM0170	1031	Negative
Viewer C	AM7812	1004	Negative
Viewer C	AM4373	1023	Negative

{20}------------------------------------------------

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%)
ViewerA	Positive	0	0	1	18	20
ViewerA	Negative	10	10	19	2	0
ViewerB	Positive	0	0	1	18	20
ViewerB	Negative	10	10	19	2	0
ViewerC	Positive	0	0	1	18	20
ViewerC	Negative	10	10	19	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Cup Viewer Results
Viewer A	AM0528	998	Positive
Viewer B	AM0528	998	Positive
Viewer C	AM0528	998	Positive
Viewer A	AM6084	1004	Negative
Viewer A	AM6157	1031	Negative
Viewer B	AM6084	1004	Negative
Viewer B	AM9869	1023	Negative
Viewer C	AM9869	1023	Negative
Viewer C	AM6157	1031	Negative

Propoxyphene

DipCard		Negative	Low Negative byLC/MS(less than -50%)	Near Cutoff Negative byLC/MS(Between -50% andcutoff)	Near Cutoff Positive byLC/MS(Between the cutoff and+50%)	High Positiveby LC/MS(greater than +50%)
ViewerA	Positive	0	0	1	18	20
	Negative	10	10	19	2	0
ViewerB	Positive	0	0	1	18	20
	Negative	10	10	19	2	0
ViewerC	Positive	0	0	0	17	20
	Negative	10	10	20	3	0

{21}------------------------------------------------

Discordant Results
Viewer	Sample Number	LC/MS Result	Dip Card Viewer Results
Viewer A	AM9748	294	Positive
Viewer B	AM8770	290	Positive
Viewer A	AM6660	315	Negative
Viewer A	AM8794	306	Negative
Viewer B	AM6660	315	Negative
Viewer B	AM2236	309	Negative
Viewer C	AM6660	315	Negative
Viewer C	AM8794	306	Negative
Viewer C	AM2236	309	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	18	20
A	Negative	10	10	19	2	0
Viewer	Positive	0	0	1	17	20
B	Negative	10	10	19	3	0
Viewer	Positive	0	0	1	18	20
C	Negative	10	10	19	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Cup Viewer Results
Viewer A	AM7095	290	Positive
Viewer B	AM1226	294	Positive
Viewer C	AM7095	290	Positive
Viewer A	AM9825	306	Negative
Viewer A	AM6247	309	Negative
Viewer B	AM8797	315	Negative
Viewer B	AM9825	306	Negative
Viewer B	AM6247	309	Negative
Viewer C	AM8797	315	Negative
Viewer C	AM6247	309	Negative

Lay-user study

A lay user study was performed at three intended user sites with 300 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,

{22}------------------------------------------------

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

AMP:

	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		The percentage
% of Cutoff			No. ofPositive	No. ofNegative	of correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	248	0	20	100
-50% Cutoff	160	505	0	160	100
-25% Cutoff	20	754	2	18	90
+25% Cutoff	20	1259	18	2	90
+50% Cutoff	40	1508	40	0	100
+75% Cutoff	20	1759	20	0	100

COC:

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

THC:

% of Cutoff	Number 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	13	0	20	100
-50% Cutoff	160	25	0	160	100
-25% Cutoff	20	37	2	18	90
+25% Cutoff	20	62	19	1	95
+50% Cutoff	40	75	40	0	100
+75% Cutoff	20	87	20	0	100

{23}------------------------------------------------

% of Cutoff	Number 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	76	0	20	100
-50% Cutoff	160	151	0	160	100
-25% Cutoff	20	226	3	17	85
+25% Cutoff	20	372	19	1	95
+50% Cutoff	40	448	40	0	100
+75% Cutoff	20	529	20	0	100

BAR:

BZO:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS(ng/mL)	Lay person Results		The percentageof correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	160	149	0	160	100
-25% Cutoff	20	224	1	19	95
+25% Cutoff	20	376	18	2	90
+50% Cutoff	40	454	40	0	100
+75% Cutoff	20	520	20	0	100

% of Cutoff	Number 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	251	0	20	100
-50% Cutoff	160	502	0	160	100
-25% Cutoff	20	758	3	17	85
+25% Cutoff	20	1259	19	1	95
+50% Cutoff	40	1512	40	0	100
+75% Cutoff	20	1759	20	0	100

MTD:

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

{24}------------------------------------------------

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

OPI:

MDMA:

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

OXY:

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

BUP:

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

{25}------------------------------------------------

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

PCP:

TCA:

% of Cutoff	Number of samples	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	160	499	0	160	100
-25% Cutoff	20	759	2	18	90
+25% Cutoff	20	1258	19	1	95
+50% Cutoff	40	1503	40	0	100
+75% Cutoff	20	1751	20	0	100

PPX:

% of Cutoff	Number 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	77	0	20	100
-50% Cutoff	160	149	0	160	100
-25% Cutoff	20	225	2	18	90
+25% Cutoff	20	374	19	1	95
+50% Cutoff	40	448	40	0	100
+75% Cutoff	20	523	20	0	100

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

1. Clinical Studies
  Not applicable.

11. Conclusion

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

{26}------------------------------------------------

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

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).