SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

• K Number: K153646
• Device Name: SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
• Manufacturer: SAFECARE BIOTECH (HANGZHOU)CO.,LTD.
• Date Cleared: 2016-03-18 ( 88 days)
• Product Code: DIO , DKZ , LDJ
• Regulation Number: 862.3250
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: K052115
• Predicate For: K191924

Intended Use

SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Device Description

SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The provided document describes the acceptance criteria and study results for the SAFECARE Urine Test Amphetamine, Cocaine, and Marijuana devices.

Here's an organized summary of the information requested:

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Acceptance Criteria and Device Performance Study

The SAFECARE Urine Test devices are qualitative tests for the detection of Amphetamine, Cocaine (Benzoylecgonine), and Marijuana (Cannabinoids) in human urine at specific cutoff concentrations. The study aims to demonstrate the device's accuracy and reliability through analytical performance and comparison studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%). However, the study design implicitly establishes acceptance criteria through its reported performance, which demonstrates consistent and accurate results around the cutoff concentrations. Given that this is a 510(k) submission and the conclusion states "acceptable performance characteristics" and "substantially equivalent to the predicate," the presented performance implicitly meets the FDA's requirements for substantial equivalence.

Interpreted Acceptance Criteria (Implicitly met by study results):

• Precision: Consistent results across different lots and repeated testing at various concentrations relative to the cutoff. For concentrations well below the cutoff (-100%, -75%, -50% cutoff), results should be consistently negative. For concentrations well above the cutoff (+50%, +75%, +100% cutoff), results should be consistently positive. At concentrations near the cutoff (-25%, cutoff, +25% cutoff), there should be an expected distribution of positive and negative results, demonstrating appropriate cutoff sensitivity.
• Cut-off Verification: All samples at and above +50% cut-off are positive, and all samples at and below -50% cut-off are negative.
• Interference/Specificity: No interference from common physiological substances or cross-reactivity from specified compounds at tested concentrations should lead to false positives/negatives at 25% above cutoff.
• Method Comparison: High agreement with GC/MS results for both negative and positive clinical samples. Low rates of discordant results, particularly for samples well below or well above the cutoff.
• Lay-user Performance: High percentages of correct results when performed by lay users, indicating ease of understanding and use. This is especially critical for over-the-counter devices.

Reported Device Performance (Excerpt for Amphetamine Dip Card - Precision Study):

Drug	Result	-100% Cut-off	-75% Cut-off	-50% Cut-off	-25% Cut-off	Cut-off	+25% Cut-off	+50% Cut-off	+75% Cut-off	+100% Cut-off
Lot 1	Negative	50	50	50	47	24	1	0	0	0
	Positive	0	0	0	3	26	49	50	50	50
Lot 2	Negative	50	50	50	48	26	2	0	0	0
	Positive	0	0	0	2	24	48	50	50	50
Lot 3	Negative	50	50	50	49	26	3	0	0	0
	Positive	0	0	0	1	24	47	50	50	50

Self-correction made: The table in the document uses "50-/0+" format where 50- means 50 negative results and 0+ means 0 positive results. This was separated into two rows for clarity as "Negative" and "Positive".

Lay-User Performance (Excerpt for Amphetamine Cup):

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/MS (ng/mL)	No. of Positive	No. of Negative	The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	250	0	20	100
-50% Cutoff	20	500	0	20	100
-25% Cutoff	20	750	3	17	85
+25% Cutoff	20	1250	18	2	90
+50% Cutoff	20	1500	20	0	100
+75% Cutoff	20	1750	20	0	100

2. Sample Size for the Test Set and Data Provenance

All test sets (precision, cut-off, interference, specificity, method comparison, and lay-user studies) appear to use data that is retrospective in nature, as samples were "prepared by spiking drug in negative samples" or "unaltered clinical samples" were "blind labeled and compared to GC/MS results". The provenance of the data is not explicitly stated as a country of origin but implies laboratory-prepared or collected clinical samples, likely within China where the manufacturer is located, or a contract lab.

Sample Sizes for Test Sets:

• Precision Study:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 9 concentration levels (-100% to +100% of cut-off).
    • Each concentration tested 50 times (2 runs per day for 25 days) for each of 3 lots.
    • Total observations per drug/format: 9 concentrations * 50 tests/concentration * 3 lots = 1350 observations.
• Cut-off Verification Study:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 5 concentration levels (-50%, -25%, cut-off, +25%, +50% of cut-off).
    • Total samples: 150 samples (equally distributed across 5 concentrations, so 30 samples per concentration) tested using 3 different lots by 3 different operators.
• Interference/Specificity Studies:
  • Urine samples (drug-free and spiked at +25% cut-off) tested for each interfering substance/cross-reactant compound. Number of tests per substance (e.g., 3 batches of each device for all formats) is not explicitly listed per substance but implied to be sufficient.
• Method Comparison Studies:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 80 unaltered clinical samples (40 negative, 40 positive).
    • Total samples per drug/format tested by 3 viewers: 80 samples * 3 viewers = 240 observations.
• Lay-user Study:
  • For Amphetamine devices: 420 lay persons.
  • For Cocaine devices: 420 lay persons.
  • For Marijuana devices: 420 lay persons.
  • Each person tested one blind labeled sample and a device.
  • Sample concentrations used: 7 levels (-100% to +75% of cut-off), 20 samples per level. Total samples per drug: 7 concentrations * 20 samples/concentration = 140 samples.

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

• For Analytical Performance (Precision, Cut-off, Interference, Specificity): The ground truth for spiked samples (negative samples spiked with known concentrations of drug) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the "preferred confirmatory method" and considered the gold standard for drug detection and quantification in toxicology. No "experts" in the sense of clinicians or radiologists were used. The document doesn't specify the qualifications of the personnel performing GC/MS.
• For Method Comparison Studies: The ground truth for the 80 unaltered clinical samples was established by GC/MS. These GC/MS results are the reference against which the device's performance was compared.
• For Lay-user Study: The ground truth for the prepared urine samples was confirmed by GC/MS.

4. Adjudication Method for the Test Set

• For Precision Studies: The testing was "performed two runs per day for 25 days" (total 50 tests per concentration per lot). The results are presented as counts of positive/negative. There is no mention of an adjudication method among multiple readers for these analytical studies.
• For Cut-off Verification Study: Testing was performed by "three different operators." There is no explicit adjudication method stated for these observations. The results are presented as all positive or all negative for certain concentration ranges, which implies agreement or a predefined interpretation across operators.
• For Method Comparison Studies: "Three different laboratory assistants" were the "operators" or "viewers" (referred to as Viewer A, B, C) who read the device results. The document lists discordant results individually for each viewer, indicating that results were compared viewer-by-viewer against GC/MS. There is no explicit multi-reader adjudication method (e.g., majority vote like 2+1 or 3+1) mentioned for reaching a consensus device result; rather, individual reader agreement with GC/MS is analyzed.
• For Lay-user Study: Lay persons independently read the results. The comparison is between the lay person's reading and the GC/MS ground truth. No adjudication among lay persons is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study performed a method comparison where individual "viewers" (laboratory assistants) read the devices and their results were compared to GC/MS. There is no comparison of human readers' performance with AI assistance versus without AI assistance, as these are rapid qualitative test devices, not AI-powered diagnostic algorithms.

6. Standalone (Algorithm Only) Performance

The SAFECARE Urine Test devices are immunochromatographic assays, not software algorithms or AI-driven systems. Their performance is inherently standalone (device-only, interpreted by a human user). The reported precision, cut-off, interference, specificity, and method comparison data represent the standalone performance of these physical tests.

7. Type of Ground Truth Used

• GC/MS (Gas Chromatography/Mass Spectrometry): This is consistently stated as the ground truth method for confirming drug concentrations in all performance studies (precision, cut-off, interference, specificity, method comparison, and lay-user studies). GC/MS is a highly accurate analytical method considered the gold standard for drug testing.

8. Sample Size for the Training Set

These devices are immunochromatographic assays, not machine learning or AI models, therefore they do not have a "training set" in the computational sense. Their development typically involves chemical and biological optimization, with analytical and clinical validation serving as the equivalent of performance evaluation.

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

As noted above, these devices do not involve a training set as they are not AI/ML-based. The development of such diagnostic tests relies on established immunochemistry principles and rigorous analytical validation to ensure sensitivity, specificity, and accuracy against a gold standard like GC/MS.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2016

SAFECARE BIOTECH C/O JOE SHIA LSI INTERNATIONAL 504 E DIAMOND AVE, SUITE I GAITHERSBURG, MD, 20877

Re: K153646

Trade/Device Name: SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard), SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard), SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and Cocaine Metabolite Test System Regulatory Class: Class II Product Code: DIO, LAF, LDJ Dated: December 15th, 2015 Received: December 21st, 2015

Dear Mr. 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. 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 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Indications for Use

510(k) Number (if known) K153646

Device Name

SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard) SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard) SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard)

Indications for Use (Describe)

SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at

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a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional iudgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

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

|X 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

1. Date:	March 17, 2016
2. Submitter:	Safecare Biotech Co. Ltd.18 Haishu Road, Yuhang DistrictHangzhou, China
3. Contact person:	Alex QiuSafecare Biotech18 Haishu Road, Yuhang DistrictHangzhou, ChinaTelephone: 86 571-89712897Fax: [phone]Email: [e-mail]

• 4. Device Name: SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard) SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard) SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard)

Classification: Class II

ProductCode	CFR #	Panel
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology
DKZ	21 CFR, 862.3100 Amphetamine Test System	Toxicology
LDJ	21 CFR, 862.3870 Cannabinoid Test System	Toxicology

5. Predicate Devices:

K052115 First Check Multi Drug Cup 12

• 6. Intended Use
     SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

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SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

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SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

• 7. Device Description
     SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

8. Substantial Equivalence Information

A summary comparison of features of the SAFECARE Urine Test and the predicate device is provided in Table 1, Table 2 & Table 3.

Table 1: Features Comparison of SAFECARE Cocaine Test and the Predicate Device
--------------------------------------------------------------------------------	--	--	--	--	--	--	--

Item	Device	Predicate -K052115
------	--------	------------------------

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Item	Device	Predicate - K052115
Indication(s)for Use	For the qualitative determination ofBenzoylecgonine in human urine.	Same
Calibrator	Benzoylecgonine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	Forover-the-counteruse.
Configurations	Cup, Dip Card, Cassette	Cup

Table 2: Features Comparison of SAFECARE Amphetamine Test and the Predicate Device

Item	Device	Predicate - K052115
Indication(s)for Use	For the qualitative determination ofD-amphetamine in human urine.	Same
Calibrator	D-amphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	For over-the-counteruse.
Configurations	Cup, Dip Card, Cassette	Cup

Table 3: Features Comparison of SAFECARE Marijuana Test and the Predicate Device

Item	Device	Predicate - K052115
Indication(s)	For the qualitative determination of	Same

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

Item	Device	Predicate - K052115
for Use	11-nor-Δ9-THC-9 COOH in human urine.
Calibrator	11-nor-Δ9-THC-9 COOH	Same
Methodology	Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	50 ng/mL	Same
IntendedPopulation	For over-the-counter and prescription uses.	For over-the-counter use.
Configurations	Cup, Dip Card, Cassette	Cup

9. Test Principle

SAFECARE Urine Tests are rapid tests for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (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.

10. Performance Characteristics

• 1. Analytical Performance
  • a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% 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 GC/MS. All sample aliquots were blinded labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

Amphetamine (AMP) Dip Card Format

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

Drug	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Lot 1		50-/0+	50-/0+	50-/0+	47-/3+	24-/26+	49+/1-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	49-/1+	26-/24+	47+/3-	50+/0-	50+/0-	50+/0-

Amphetamine (AMP) Cup Format

Drug	Result	-100% Cut-off	-75% Cut-off	-50% Cut-off	-25% Cut-off	Cut-off	+25% Cut-off	+50% Cut-off	+75% Cut-off	+100% Cut-off
Lot 1		50-/0+	50-/0+	50-/0+	48-/2+	24-/26+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	47-/3+	24-/26+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	47-/3+	27-/23+	48+/2-	50+/0-	50+/0-	50+/0-

Amphetamine (AMP) Cassette Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 1		50-/0+	50-/0+	50-/0+	47-/3+	25-/25+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	48/2+	25-/25+	47+/3-	50+/0-	50+/0-	50+/0-

Cocaine (COC) Dip Card Format

ResultDrug	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Lot 1	50-/0+	50-/0+	50-/0+	48-/2+	24-/26+	47+/3-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	47+/3-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	47-/3+	26-/24+	48+/2-	50+/0-	50+/0-	50+/0-

COC Cup Format

Drug	Result-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
------	----------------------------	-----------------	-----------------	-----------------	---------	-----------------	-----------------	-----------------	------------------

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

Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 1	50-/0+	50-/0+	50-/0+	48-/2+	24-/26+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	48-/2+	25-/25+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	47+/3-	50+/0-	50+/0-	50+/0-

COC Cassette Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
	Lot 1	50-/0+	50-/0+	50-/0+	47-/3+	31-/29+	48+/2-	50+/0-	50+/0-	50+/0-
	Lot 2	50-/0+	50-/0+	50-/0+	48-/2+	28-/22+	47+/3-	50+/0-	50+/0-	50+/0-
	Lot 3	50-/0+	50-/0+	50-/0+	47-/3+	28-/22+	49+/1-	50+/0-	50+/0-	50+/0-

Marijuana (THC) Dip Card Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 1		50-/0+	50-/0+	50-/0+	49-/1+	24-/26+	47+/3-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	48+/2-	50+/0-	50+/0-	50+/0-

THC Cup Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 1		50-/0+	50-/0+	50-/0+	48-/2+	24-/26+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	48-/2+	26-/24+	49+/1-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	48-/2+	27-/23+	47+/3-	50+/0-	50+/0-	50+/0-

THC Cassette Format

Drug	Result	-100% Cut-off	-75% Cut-off	-50% Cut-off	-25% Cut-off	Cut-off	+25% Cut-off	+50% Cut-off	+75% Cut-off	+100% Cut-off

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

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 1		50-/0+	50-/0+	50-/0+	48-/2+	25-/25+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	47-/3+	26-/24+	49+/1-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	49-/1+	25-/25+	47+/3-	50+/0-	50+/0-	50+/0-

b. Linearity

Not applicable, these are visually read devices.

c. Stability

The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C. Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

d. Cut-off

A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +50% cut-off and all negative at and below -50% cut-off for Amphetamine, Cocaine and Marijuana. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off (ng/mL)
One Step Amphetamine Test	D-amphetamine	1000
One Step Cocaine Test	Benzoylecogonine	300
One Step Marijuana Test	11-nor-Δ9-THC-9 COOH	50

e. Interference

Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.

Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.

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

4-Acetamidophenol	L-Ephedrine	Oxycodone
Acetophenetidin	(-) Y Ephedrine	Oxymetazoline
N-Acetylprocainamide	Erythromycin	Papaverine
Acetylsalicylic acid	ẞ-Estradiol	Penicillin-G
Aminopyrine	Estrone-3-sulfate	Pentazocaine
Amitryptyline	Ethyl-p-aminobenzoate	Pentobarbital
Amobarbital	Fenfluramine	Perphenazine
Amoxicillin	Fenoprofen	Phencyclidine
Ampicillin	Furosemide	Phenelzine
Ascorbic acid	Gentisic acid	Phenobarbital
Aspartame	Hemoglobin	Phetoin
Atropine	Hydralazine	L-Phenylephrine
Benzilic acid	Hydrochlorothiazide	Phenylpropanolamine
Benzoic acid	Hydrocodone	Prednisolone
Benzoylecgonine	Hydrocortisone	Prednisone
Bilirubin	O-Hydroxyhippuric acid	Procaine
Brompheniramine	3-Hydroxytyramine	Promazine
Caffeine	Ibuprofen	Promethazine
Cannabidiol	Imipramine	D,L-Propanolol
Cannabinol	(-) Isoproterenol	D-Propoxyphene
Chloralhydrate	Isoxsuprine	Quinidine
Chloramphenicol	Ketamine	Quinine
Chlordiazepoxide	Ketoprofen	Ranitidine
Chlorothiazide	Labetalol	Salicylic acid
(±) Chlorpheniramine	Levorphanol	Secobarbital
Chlorpromazine	Loperamide	Sulfamethazine
Chlorquine	Maprotiline	Sulindac
Cholesterol	Meperidine	Temazepam
Clomipramine	Meprobamate	Tetracycline
Clonidine	Methadone	Tetrahydrocortisone
Cocaine hydrochloride	Methylphenidate	Tetrahydrozoline
Codeine	Morphine-3-Dglucuronide	49-THC-COOH
Cortisone	Nalidixic acid	Thebaine
(-) Cotinine	Naloxone	Thiamine
Creatinine	Naltrexone	Thioridazine
Deoxycorticosterone	Naproxen	D,L-Thyroxine
Dextromethorphan	Niacinamide	Tolbutamine
Diazepam	Nifedipine	Triamterene
Diclofenac	Norcodein	Trifluoperazine

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

Diflunisal	Norethindrone	Trimethoprim
Digoxin	D-Norpropoxyphene	Trimipramine
Diphenhydramine	Noscapine	Tryptamine
Doxylamine	D,L-Octopamine	D, L-Tyrosine
Ecgonine hydrochloride	Oxalic acid	Uric acid
Ecgonine methylester	Oxazepam	Verapamil
(IR,2S)-(-)-Ephedrine	Oxolinic acid	Zomepirac

COC

Acetominophen	Estrone-3-sulfate	Oxymetazoline
Acetophenetidin	Ethyl-p-aminobenzoate	Papaverine
N-Acetylprocainamide	Fenoprofen	Penicillin-G
Acetylsalicylic acid	Furosemide	Pentobarbital
Aminopyrine	Gentisic acid	Perphenazine
Amitryptyline	Hemoglobin	Phencyclidine
Amobarbital	Hydralazine	Phenelzine
Amoxicillin	Hydrochlorothiazide	Phenobarbital
Ampicillin	Hydrocodone	Phentermine
L-Ascorbic acid	Hydrocortisone	L-Phenylephrine
DL-Amphetamine Sulfate	O-Hydroxyhippuric acid	β-Phenylethylamine
Apomorphine	p-Hydroxymethamphetamine	Phenylpropanolamine
Aspartame	3-Hydroxytyramine	Prednisolone
Atropine	Ibuprofen	Prednisone
Benzilic acid	Imipramine	Procaine
Benzoic acid	Iproniazid	Promazine
Benzphetamine	(±) - Isoproterenol	Promethazine
(±) -Brompheniramine	Isoxsuprine	DL-Propranolol
Caffeine	Ketamine	D-Propoxyphene
Cannabidiol	Ketoprofen	D-Pseudoephedrine
Cannabinol	Labetalol	Quinidine
Chloralhydrate	Levorphanol	Quinine
Chloramphenicol	Loperamide	Ranitidine
Chlordiazepoxide	Maprotiline	Salicylic acid
Chlorothiazide	Meperidine	Secobarbital
(±) -Chlorpheniramine	Meprobamate	Serotonin
Chlorpromazine	Methadone	Sulfamethazine
Chlorquine	Methoxyphenamine	Sulindac
Cholesterol	(±) -3,4-Methylenedioxyamphetamine	Temazepam

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

Clomipramine	hydrochloride(±)-3,4-Methylene- dioxymethamphetaminehydrochloride	Tetracycline
Clonidine	Morphine-3-B-D glucuronide	Tetrahydrocortisone3-(β-D glucuronide)
Codeine	Morphine Sulfate	Tetrahydrozoline
Cortisone	Nalidixic acid	Thebaine
(-) Cotinine	Naloxone	Thiamine
Creatinine	Naltrexone	Thioridazine
Deoxycorticosterone	Naproxen	DL-Tyrosine
Dextromethorphan	Niacinamide	Tolbutamide
Diazepam	Nifedipine	Triamterene
Diclofenac	Norcodein	Trifluoperazine
Diflunisal	Norethindrone	Trimethoprim
Digoxin	D-Norpropoxyphene	Trimipramine
Diphenhydramine	Noscapine	Tryptamine
Doxylamine	DL-Octopamine	DL-Tryptophan
Ecgonine methylester	Oxalic acid	Tyramine
(-) - Ψ-Ephedrine	Oxazepam	Uric acid
Erythromycin	Oxolinic acid	Verapamil
β-Estradiol	Oxycodone	Zomepirac

THC

4-Acetamidophenol	β-Estradiol	Papaverine
Acetophenetidin	Estrone-3-sulfate	Penicillin-G
N-Acetylprocainamide	Ethyl-p-aminobenzoate	Pentazocine
Acetylsalicylic acid	Fenoprofen	Pentobarbital
Aminopyrine	Furosemide	Perphenazine
Amitryptyline	Gentisic acid	Phencyclidine
Amobarbital	Hemoglobin	Phenelzine
Amoxicillin	Hydralazine	Phenobarbital
Ampicillin	Hydrochlorothiazide	Phentermine
Ascorbic acid	Hydrocodone	L-Phenylephrine
D,L-Amphetamine	Hydrocortisone	β-Phenylethlamine
L-Amphetamine	O-Hydroxyhippuric acid	β-Phenyllethylamine
Apomorphine	3-Hydroxytyramine	Phenylpropanolamine
Aspartame	Ibuprofen	Prednisolone
Atropine	Imipramine	Prednisone
Benzilic acid	Iproniazid	Procaine
Benzoic acid	(-) Isoproterenol	Promazine
Benzoylecgonine	Isoxsuprine	Promethazine
Benzphetamine	Ketamine	D,L-Propanolol
Bilirubin	Labetalol	D-Propoxyphene
Brompheniramine	Levorphanol	D-Pseudoephedrine
Caffeine	Loperamide	Quinidine
Chloralhydrate	Maprotiline	Quinine
Chloramphenicol	Meprobamate	Ranitidine
Chlordiazepoxide	Methadone	Salicylic acid
Chlorothiazide	Methoxyphenamine	Secobarbital
(±) Chlorpheniramine	(+)3,4-Methylenedioxyamphetamine	Serotonin(5-Hydroxytyramine)
Chlorpromazine	(+)3,4-Methylenedioxymethamphetamine	Sulfamethazine
Chlorquine	Methylphenidate	Sulindac
Cholesterol	Methyprylon	Temazepam
Clomipramine	Morphine-3-β-Dglucuronide	Tetracycline
Clonidine	Nalorphine	Tetrahydrocortisone3(5-Dglucuronide)
Cocaine hydrochloride	Naloxone	Tetrahydrozoline
Codeine	Nalidixic acid	Thebaine
Cortisone	Naltrexone	Thiamine
(-) Cotinine	Naproxen	Thioridazine
Creatinine	Niacinamide	D, L-Thyroxine
Deoxycorticosterone	Nifedipine	Tolbutamine
Dextromethorphan	Norcodein	Triamterene
Diazepam	Norethindrone	Trifluoperazine
Diclofenac	D-Norpropoxyphene	Trimethoprim
Diflunisal	Noscapine	Trimipramine
Digoxin	D,L-Octopamine	Tryptamine
Diphenhydramine	Oxalic acid	D, L-Tryptophan
Doxylamine	Oxazepam	Tyramine
Ecgonine hydrochloride	Oxolinic acid	D, L-Tyrosine
Ecgonine methylester	Oxycodone	Uric acid
(-) Y Ephedrine	Oxymetazoline	Verapamil
Erythromycin	p-Hydroxymethamphetamine	Zomepirac

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

f. Specificity

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

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.

AMP(d-Amphetamine, Cut-off=1000 ng/mL)	Result	%Cross-Reactivity
d1-Amphetamine	Positive at 3000 ng/mL	33%
l-Amphetamine	Positive at 20000 ng/mL	5%
(+/-) 3,4-methylene-dioxyamphetamine (MDA)	Positive at 20000 ng/mL	5%
Phentermine	Positive at 30000 ng/mL	3%
Hydroxyamphetamine	Positive at 8000 ng/mL	12.5%
d-Methamphetamine	>100000	<1%
l-Methamphetamine	>100000	<1%
ephedrine	>100000	<1%
3,4-Methylenedioxyethylamphetamine (MDE)	>100000	<1%
3,4-methylenedioxy-methamphetamine (MDMA)	>100000	<1%

COC(Benzoylecogonine, Cut-off=300 ng/mL)	Result	% Cross-Reactivity
Cocaine HCl	Positive at 750 ng/mL	40%
Cocaethylene	Positive at 12500 ng/mL	2.4%
Ecgonine	Positive at 32000 ng/mL	0.9%

THC	Result	%
(11-Nor- $\Delta^9$ -Tetrahydrocannabinol-9-COOH,Cut-off=50 ng/mL)	Positive at 50 ng/mL	Cross-Reactivity100%
11-Hydroxy- $\Delta^9$ -Tetrahydrocannabinol	Positive at 5000 ng/mL	1%
11-Nor- $\Delta^8$ -Tetrahydrocannabinol-9-COOH	Positive at 50	100%

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

	ng/mL
Cannabinol	Positive at20000 ng/mL	0.3%
Δ8-Tetrahydrocannabinol	Positive at10000 ng/mL	0.5%
Δ9-Tetrahydrocannabinol	Positive at10000 ng/mL	0.5%
Cannabidiol	Positive at20000 ng/mL	0.3%
11-Nor-Δ9-THC-carboxy glucuronide	Positive at2500 ng/mL	2%
(-)-11-nor-9-carboxy-Δ 9-THC	Positive at2500 ng/mL	2%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples with of 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 batches of each device for all formats. 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 for different formats.

• 2. Comparison Studies
     The method comparison studies for the SAFECARE Urine Test (Amphetamine, Cocaine and Marijuana) were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results are presented in the tables below:

Cassetteformat	AMI
	Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	1	19	20
	Negative	10	10	19	1	0
Viewer B	Positive	0	0	2	19	20
	Negative	10	10	18	1	0

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

Viewer C	Positive	0	0	2	18	20
	Negative	10	10	18	2	0

Discordant Results of AMP Cassette
Viewer	Sample Number	GC/MS Result	Cassette FormatViewer Results
Viewer A	114130	920	Positive
Viewer B	112663	903	Positive
Viewer B	116513	872	Positive
Viewer C	114130	920	Positive
Viewer C	112663	903	Positive
Viewer A	116032	1086	Negative
Viewer B	113001	1025	Negative
Viewer C	113001	1025	Negative
Viewer C	116032	1086	Negative

Dip Cardformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
	Positive	0	0	1	19	20
Viewer A	Negative	10	10	19	1	0
Viewer B	Positive	0	0	2	18	20
	Negative	10	10	18	2	0
Viewer C	Positive	0	0	1	18	20
	Negative	10	10	19	2	0

Discordant Results of AMP Dip Card

Viewer	Sample Number	GC/MS Result	Dipcard FormatViewer Results
Viewer A	114130	920	Positive
Viewer B	114130	920	Positive
Viewer B	112663	903	Positive
Viewer C	112663	903	Positive
Viewer A	113001	1025	Negative
Viewer B	113001	1025	Negative
Viewer B	116032	1086	Negative
Viewer C	116032	1086	Negative

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

Viewer	Sample Number	GC/MS Result	Dipcard FormatViewer Results
Viewer C	111305	1129	Negative

Cupformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	18	20
	Negative	10	10	18	2	0
Viewer B	Positive	0	0	2	19	20
	Negative	10	10	18	1	0
Viewer C	Positive	0	0	1	19	20
	Negative	10	10	19	1	0

Discordant Results of AMP Cup

Viewer	Sample Number	GC/MS Result	Cup Format Viewer Results
Viewer A	112663	903	Positive
Viewer A	116513	872	Positive
Viewer B	114130	920	Positive
Viewer B	112663	903	Positive
Viewer C	114130	920	Positive
Viewer A	116032	1086	Negative
Viewer A	111305	1129	Negative
Viewer B	116032	1086	Negative
Viewer C	113001	1025	Negative

COC

Cassetteformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50% )	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	19	20

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

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

Discordant Results of COC Cassette

Discordant Results of COC Cassette
Viewer	Sample Number	GC/MS Result	Cassette Format Viewer Results
Viewer A	126369	294	Positive
Viewer A	125081	293	Positive
Viewer B	126369	294	Positive
Viewer B	125081	293	Positive
Viewer C	126369	294	Positive
Viewer A	123901	325	Negative
Viewer B	124383	319	Negative
Viewer C	123901	325	Negative
Viewer C	124383	319	Negative

Dip Cardformat		Negative	LowNegativeby GC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	18	20
	Negative	10	10	18	2	0
Viewer B	Positive	0	0	1	18	20
	Negative	10	10	19	2	0
Viewer C	Positive	0	0	2	19	20
	Negative	10	10	18	1	0

Discordant Results of COC DipCard

Viewer	Sample Number	GC/MS Result	DipCard Format Viewer Results
Viewer A	125081	293	Positive
Viewer A	126518	288	Positive
Viewer B	126369	294	Positive
Viewer C	126369	294	Positive
Viewer C	125081	293	Positive

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

Viewer	Sample Number	GC/MS Result	DipCard FormatViewer Results
Viewer A	123901	325	Negative
Viewer A	124383	319	Negative
Viewer B	123901	325	Negative
Viewer B	121307	330	Negative
Viewer C	121307	330	Negative

Cupformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +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	2	19	20
	Negative	10	10	18	1	0

Discordant Results of COC Cup

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer A	126369	294	Positive
Viewer B	125081	293	Positive
Viewer C	126369	294	Positive
Viewer C	125081	293	Positive
Viewer A	124383	319	Negative
Viewer A	121307	330	Negative
Viewer B	123901	325	Negative
Viewer B	121307	330	Negative
Viewer C	123901	325	Negative

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

Cassetteformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	2	18	20
	Negative	10	10	18	2	0
Viewer B	Positive	0	0	2	18	20
	Negative	10	10	18	2	0
Viewer C	Positive	0	0	2	17	20
	Negative	10	10	18	3	0

Discordant Results of THC Cassette

Viewer	Sample Number	GC/MS Result	Cassette FormatViewer Results
Viewer A	103932	46	Positive
Viewer A	106313	47	Positive
Viewer B	103587	48	Positive
Viewer B	106313	47	Positive
Viewer C	103587	48	Positive
Viewer C	103932	46	Positive
Viewer A	103201	52	Negative
Viewer A	102396	54	Negative
Viewer B	103201	52	Negative
Viewer B	104659	54	Negative
Viewer C	103201	52	Negative
Viewer C	104659	54	Negative
Viewer C	102396	54	Negative

DipCardformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	2	19	20
	Negative	10	10	18	1	0
Viewer B	Positive	0	0	2	18	20

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

	Negative	10	10	10
Viewer C	Positive			Cl	18	00ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
	Negative	10	10	18

Viewer	Sample Number	GC/MS Result	DipCard Format Viewer Results
Viewer A	103587	48	Positive
Viewer A	103932	46	Positive
Viewer B	103587	48	Positive
Viewer B	104139	45	Positive
Viewer C	103932	46	Positive
Viewer C	106313	47	Positive
Viewer A	104659	54	Negative
Viewer B	103201	52	Negative
Viewer B	104659	54	Negative
Viewer C	103201	52	Negative
Viewer C	102396	54	Negative

Discordant Results of THC DipCard

Cupformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	3	17	20
	Negative	10	10	17	3	0
Viewer B	Positive	0	0	2	18	20
	Negative	10	10	18	2	0
Viewer C	Positive	0	0	2	18	20
	Negative	10	10	18	2	0

Discordant Results of THC Cup

Viewer	Sample Number	GC/MS Result	Cup Format Viewer Results
Viewer A	103587	48	Positive
Viewer A	103932	46	Positive
Viewer A	106313	47	Positive
Viewer B	103587	48	Positive
Viewer B	103932	46	Positive

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

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer C	103587	48	Positive
Viewer C	103401	44	Positive
Viewer A	103201	52	Negative
Viewer A	102368	58	Negative
Viewer A	104659	54	Negative
Viewer B	103201	52	Negative
Viewer B	102396	54	Negative
Viewer C	103201	52	Negative
Viewer C	104659	54	Negative

Lay-user study

A lay user study was performed at three intended user sites with 420 lay persons testing the amphetamine devices, 420 lay persons testing the cocaine devices and 420 lay persons testing the marijuana devices. A total of 208 females and 212 males tested the amphetamine samples, 205 females and 215 males tested cocaine samples, and 212 females and 208 males tested the marijuana samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/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. The results are summarized below.

% of Cutoff	Number of samples	d-AmphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	250	0	20	100
-50% Cutoff	20	500	0	20	100
-25% Cutoff	20	750	2	18	90
+25% Cutoff	20	1250	17	3	85
+50% Cutoff	20	1500	20	0	100
+75% Cutoff	20	1750	20	0	100

Comparison between GC/MS and Lay Person Results AMP Cup

Comparison between GC/MS and Lay Person Results AMP Dip Card

% of Cutoff	Number	d-Amphetamine	Lay person results	The
-------------	--------	---------------	--------------------	-----

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

	ofsamples	Concentration by GC/MS(ng/mL)	No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100
-75%Cutoff	20	250	0	20	100
-50% Cutoff	20	500	0	20	100
-25% Cutoff	20	750	3	17	85
+25% Cutoff	20	1250	18	2	90
+50% Cutoff	20	1500	20	0	100
+75% Cutoff	20	1750	20	0	100

Comparison between GC/MS and Lay Person Results AMP Cassette

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	250	0	20	100
-50% Cutoff	20	500	0	20	100
-25% Cutoff	20	750	2	18	90
+25% Cutoff	20	1250	18	2	90
+50% Cutoff	20	1500	20	0	100
+75% Cutoff	20	1750	20	0	100

Comparison between GC/MS and Lay Person Results COC Cup

% of Cutoff	Numberofsamples	BenzoylecgonineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	2	18	90
+25% Cutoff	20	375	18	2	90
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results COC Dip Card

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

	Numberofsamples	BenzoylecgonineConcentration by GC/MS(ng/mL)	Lay person results		The
% of Cutoff			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100
-75%Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	2	18	90
+25% Cutoff	20	375	17	3	85
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results COC Cassette

% of Cutoff	Number of samples	BenzoylecgonineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	3	17	85
+25% Cutoff	20	375	17	3	85
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results THC Cup

% of Cutoff	Number of samples	11-nor-D9-THC-9-COOHConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	2	18	90
+25% Cutoff	20	62.5	18	2	90
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	100

Comparison between GC/MS and Lay Person Results THC Dip Card

{27}------------------------------------------------

% of Cutoff	Number of samples	11-nor-D9-THC-9-COOHConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	3	17	85
+25% Cutoff	20	62.5	18	2	90
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	100

Comparison between GC/MS and Lay Person Results THC Cassette

	Numberofsamples	11-nor-D9-THC-9-COOHConcentration by GC/MS(ng/mL)	Lay person results		The
% of Cutoff			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	3	17	85
+25% Cutoff	20	62.5	17	3	85
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	100

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

• 3. Clinical Studies
     Not applicable.

• 11.Conclusion
  Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the SAFECARE Urine Test devices are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).