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

• K Number: K181968
• Device Name: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
• Manufacturer: Safecare Biotech(Hangzhou)Co.,Ltd.
• Date Cleared: 2018-08-20 ( 27 days)
• Product Code: NFT , NFV , NFW , NFY , NGG , NGL , PTG , PTH
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: k153646 , K142396
• Predicate For: N/A

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 and Methadone 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

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 Oxazepam and Secobarbital 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, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone 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

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

The test may yield positive results for the prescription drugs Oxazepam and Secobarbital 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 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, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone (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 SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup devices, which are qualitative lateral flow immunochromatographic assays for detecting various drugs in human urine.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of a minimum performance threshold (e.g., "sensitivity must be >90%"). Instead, it presents the results of precision, specificity, linearity, stability, interference, and comparison studies, implying that the observed performance across these studies is considered acceptable for substantial equivalence. For the qualitative tests, the key performance indicator is the ability to correctly identify samples both above and below the cut-off concentrations.

Below is a summary of the reported device performance for selected drugs based on "Precision" and "Lay-user study" data. The "Precision" study shows how consistently the device performs near the cut-off, while the "Lay-user study" assesses the device's accuracy when used by the intended over-the-counter users.

Acceptance Criteria (Implied for consistency and accuracy related to cut-off)

• Precision: High agreement (ideally 100% negative/positive) for samples far from the cutoff (e.g., -100%, -75%, +75%, +100% cutoff). Some variability (mixed positive/negative results) is expected and acceptable near the cutoff (e.g., -25%, cutoff, +25%).
• Lay-user Performance (Percentage of correct results): High percentage of correct results, especially for samples significantly above or below the cutoff. Some deviation might be acceptable near the cutoff.

Reported Device Performance (Excerpt for Secobarbital Dip Card and for all drugs in Lay-user study)

Precision Study - Secobarbital Dip Card (Illustrative Example from document, similar patterns for other drugs)

Concentration % of Cut-off	Lot 1 (Negative/Positive)	Lot 2 (Negative/Positive)	Lot 3 (Negative/Positive)
-100% Cut-off	50-/0+	50-/0+	50-/0+
-75% Cut-off	50-/0+	50-/0+	50-/0+
-50% Cut-off	50-/0+	50-/0+	50-/0+
-25% Cut-off	50-/0+	50-/0+	50-/0+
Cut-off	25-/25+	26-/24+	26-/24+
+25% Cut-off	50+/0-	50+/0-	50+/0-
+50% Cut-off	50+/0-	50+/0-	50+/0-
+75% Cut-off	50+/0-	50+/0-	50+/0-
+100% Cut-off	50+/0-	50+/0-	50+/0-

Interpretation for Precision (e.g., Secobarbital Dip Card):

• For samples far below the cutoff (-100%, -75%, -50%, -25%), all 50 tests consistently showed negative results (50-/0+), indicating perfect agreement for negative samples sufficiently below the cutoff.
• For samples far above the cutoff (+25%, +50%, +75%, +100%), all 50 tests consistently showed positive results (50+/0-), indicating perfect agreement for positive samples sufficiently above the cutoff.
• At the exact cutoff, there was an expected mix of positive and negative results (e.g., 25-/25+, 26-/24+), demonstrating the device's performance around the critical concentration.

Lay-user Study - Percentage of Correct Results (Summary across drugs for Dip Card)

Drug	% of Cutoff	Percentage of Correct Results (%)
Amphetamine	-100%	100
	-75%	100
	-50%	100
	-25%	95 (19 negative out of 20)
	+25%	85 (17 positive out of 20)
	+50%	100
	+75%	100
Cocaine	-100%	100
	-75%	100
	-50%	100
	-25%	90 (18 negative out of 20)
	+25%	90 (18 positive out of 20)
	+50%	100
	+75%	100
Cannabinoids	-100%	100
	-75%	100
	-50%	100
	-25%	90 (18 negative out of 20)
	+25%	95 (19 positive out of 20)
	+50%	100
	+75%	100
Secobarbital	-100%	100
	-75%	100
	-50%	100
	-25%	95 (19 negative out of 20)
	+25%	90 (18 positive out of 20)
	+50%	100
	+75%	100
Oxazepam	-100%	100
	-75%	100
	-50%	100
	-25%	85 (17 negative out of 20)
	+25%	95 (19 positive out of 20)
	+50%	100
	+75%	100
Methamphetamine	-100%	100
	-75%	100
	-50%	100
	-25%	85 (17 negative out of 20)
	+25%	90 (18 positive out of 20)
	+50%	100
	+75%	100
Methadone	-100%	100
	-75%	100
	-50%	100
	-25%	95 (19 negative out of 20)
	+25%	90 (18 positive out of 20)
	+50%	100
	+75%	100
Morphine	-100%	100
	-75%	100
	-50%	100
	-25%	95 (19 negative out of 20)
	+25%	95 (19 positive out of 20)
	+50%	100
	+75%	100

Interpretation for Lay-user Study:
The lay-user study for both Dip Card and Cup formats consistently shows 100% correct results for samples well above (+50%, +75%) and well below (-50%, -75%, -100%) the cutoff. Near the cutoff point (-25% and +25%), the percentage of correct results typically drops to between 85% and 95%, which is expected given the concentrations are close to the detection threshold. The study indicates the devices perform as intended for over-the-counter use.

2. Sample size used for the test set and the data provenance

• Precision Study: For each drug and each device type (Dip Card/Cup), the samples were prepared at 9 different concentrations relative to the cut-off (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100%). For each concentration, tests were performed "two runs per day for 25 days per device in a randomized order." This implies a total of 50 tests per concentration per drug per device, for each of the three lots.
  • Example for Secobarbital Dip Card: 9 concentrations * 50 tests/concentration * 3 lots = 1350 test results.
  • Data Provenance: "These samples were prepared by spiking drug in negative samples." The document specifies these are "spiked" samples into "negative samples" (presumably drug-free urine), and concentrations were confirmed by LC/MS. This suggests laboratory-controlled samples (retrospective fabrication) rather than patient-derived clinical samples.
• Comparison Studies (Lab Assistant/Clinical Performance): For each drug, "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug."
  • This means 80 clinical samples per drug were used.
  • Data Provenance: "unaltered clinical samples." The document states this was "performed in-house," but does not specify the country of origin. Given the submitter is Safecare Biotech (Hangzhou) Co. Ltd. from China, the in-house clinical samples likely originated from China. The samples were compared to LC/MS results.
• Lay-user Study: "A lay user study was performed at three intended user sites with 240 lay persons for each device format."
  • The test set comprised urine samples prepared at 7 different concentrations relative to the cut-off (negative, +/-75%, +/-50%, +/-25% of the cutoff). The document indicates for each concentration, approximately 20 to 100 samples were tested for each drug (e.g., 20 at -100% cutoff, 100 at -50% cutoff, 40 at +50% cutoff, totaling around 20 * 5 + 100 * 2 = 300 test results per drug).
  • 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." Concentrations confirmed by LC/MS. This implies laboratory-controlled spiked samples, similar to the precision study.

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

• Precision Studies & Lay-user Study: The ground truth (drug concentration) was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly accurate analytical method. The document does not specify human experts for establishing ground truth for these studies, as the LC/MS directly provides quantitative measurements.
• Comparison Studies (Lab Assistant/Clinical Performance): The ground truth for the "unaltered clinical samples" was established by LC/MS results. The study mentions "three laboratory assistants" who "ran" the tests and "compared to LC/MS results," but these assistants are the operators of the device under test, not the ground truth experts.

4. Adjudication method for the test set

• Precision Studies & Lay-user Study: The ground truth was based on objective analytical measurements (LC/MS). There was no human "adjudication" in the sense of reconciling differing expert opinions. The comparison was directly between the device's qualitative result and the known quantitative drug concentration relative to the cut-off.
• Comparison Studies (Lab Assistant/Clinical Performance): The document does not describe an explicit adjudication method. The results from the device, interpreted by "three laboratory assistants," were directly compared to the LC/MS results, which served as the gold standard. Discordant results are individually reported (e.g., Viewer A found Positive, LC/MS was 289 ng/mL), but no adjudication of discrepant viewer readings against each other or a higher authority is mentioned. Each viewer's interpretation was compared against the LC/MS.

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

• Not Applicable. This device is a rapid diagnostic test (lateral flow immunochromatographic assay), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or described. The "readers" in the "Comparison Studies" are "three laboratory assistants" interpreting the visual lines on the test.

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

• Not Applicable. This device is a manual, visually interpreted lateral flow assay. It does not employ an algorithm for interpretation. The performance is inherently "standalone" in the sense that the device produces a visual result, but it requires human interpretation. The "Lay-user study" specifically assesses performance without expert human-in-the-loop, relying on typical users' interpretation.

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

• The primary ground truth used in all analytical and comparative studies (Precision, Comparison, Lay-user) was Liquid Chromatography-Mass Spectrometry (LC/MS) results. This is a gold standard analytical method for precise and accurate quantification of drug concentrations.
• For the comparison studies, "unaltered clinical samples" were used, and their status (positive/negative relative to cutoff) was determined by LC/MS.

8. The sample size for the training set

• The document does not describe any "training set." These are diagnostic devices that do not involve machine learning or AI models requiring a training phase for their interpretation logic. Their "training" is in their manufacturing process and the inherent biochemical reactions.

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

• Not Applicable as there is no training set described for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.

August 20, 2018

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

Re: K181968

Trade/Device Name: SAFECARE Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test DipCard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGL, NFV, PTH, PTG Dated: July 18, 2018 Received: July 24, 2018

Dear Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 Part

{1}------------------------------------------------

801 and Part 809); medical device reporting of 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.

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

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

Sincerely,

Kellie B. Kelm -S

for 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181698

Device Name

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

Indications for Use (Describe)

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone 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

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 Oxazepam and Secobarbital 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, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone 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

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

The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration

{3}------------------------------------------------

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 is the preferred confirmatory method. The tests are intended for over-the-counter use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) SUMMARY K181968

• August 17, 2018 1. Date: 2. Submitter: Safecare Biotech (Hangzhou) Co. Ltd. 18 Haishu Road, Yuhang District Hangzhou, China
• Alex Qiu 3. Contact person: Safecare Biotech 18 Haishu Road, Yuhang District Hangzhou, China Telephone: [phone] Fax: [phone] Email: [e-mail]
• 4. Device Name: SAFECARE Multi-Drug Urine Test Dip Card SAFECARE Multi-Drug Urine Test Cup

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology (91)
NFWCannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology (91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine Test System	Toxicology (91)
NGGMethamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
NGLMorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
NFVOxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology (91)
PTHSecobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology (91)
PTGMethadone	II	21 CFR § 862.3620, Methadone Test System	Toxicology (91)

• 5. Predicate Devices: K142396
     The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
• 6. Intended Use
     SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone 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

{5}------------------------------------------------

Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Secobarbital	300 ng/mL
Methadone	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 Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone 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

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

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

7. Device Description

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

{6}------------------------------------------------

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

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

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 and Cut-OffValues	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (OPI): 2000ng/mLSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/ml	Same
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 and Cut-OffValues	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (OPI): 2000ng/mLSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/ml	Same

{7}------------------------------------------------

Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Cup	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, Methamphetamine, Morphine, Secobarbital and Methadone 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 antibodycoated 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 Secobarbital, Oxazepam, Methamphetamine, Methadone and Morphine. The rest data were reported in K153646 for Amphetamine, Marijuana and Cocaine.

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

Secobarbital Din Card

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

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

Oxazepam

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+	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-
Cup

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+	23-/27+	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-

Methamphetamine

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

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

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

Methadone

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

Cup 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+	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+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

Morphine

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+	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-

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

The following cut-off values are verified.

Drug(Identifier)	Cut-off level
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL
Methadone (MTD)	300 ng/mL
Morphine (OPI)	2000 ng/mL

b. Linearity

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

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
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

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

for Secobarbital, Oxazepam, Methamphetamine, Methadone and Morphine. The rest data were reported in K153646 for Amphetamine, Marijuana and Cocaine. There were no differences observed between the SAFECARE Cup and Dip Card formats.

Secobarbital(Cut-off=300 ng/mL)	ResultPositive at (ng/mL)	% Cross-Reactivity
Secobarbital	300	100%
Amobarbital	625	48%
Alphenol	625	48%
Aprobarbital	200	150%
Butabarbital	100	300%
Butathal	200	150%
Butalbital	2500	12%
Cyclopentobarbital	400	75%
Pentobarbital	1000	30%
Phenobarbital	300	100%

Oxazepam(Cut-off=300 ng/mL)	ResultPositive at (ng/mL)	% Cross-Reactivity
Oxazepam	300	100%
Alprazolam	250	120%
a-Hydroxyalprazolam	1000	30%
Bromazepam	625	48%
Chlordiazepoxide	2500	12%
Clonazepam	2500	12%
Clobazam	125	240%
Clorazepate dipotassium	100	300%
Desalkylflurazepam	250	120%
Diazepam	250	120%
Estazolam	5000	6%
Flunitrazepam	375	80%
D,L-Lorazepam	10000	3%
Midazolam	90000	0.33%
Nitrazepam	25000	1.2%
Norchlordiazepoxide	250	120%
Nordiazepam	500	60%
Temazepam	125	240%
Triazolam	5000	6%

Methamphetamine(Cut-off=1000 ng/mL)	ResultPositive at (ng/mL)	% Cross-Reactivity
D(+)-Methamphetamine	1000	100%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	50000	2%
D/L-Methamphetamine	1000	100%
p-Hydroxymethamphetamine	10000	10%
D-Amphetamine	Negative at 100000	≤1%
L-Amphetamine	Negative at 100000	≤1%
Chloroquine	25000	4%
(+/-)-Ephedrine	4000	25%
L-Methamphetamine	10000	10%
(+/-)3,4-Methylenedioxyamphetamine(MDA)	Negative at 100000	≤1%
β -Phenylethylamine	7500	13%
Trimethobenzamide	20000	5%
(+/-)3,4-methylenedioxymethamphetamine	2000	50%

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

(MDMA)
--------	--	--

Methadone(Cut-off=300 ng/mL)	ResultPositive at(ng/ml)	% Cross-Reactivity
Methadone	300	100%
Doxylamine	5000	6%
LAAM HCl	10000	3%
Alpha Methadol	2000	15%
EDDP	>100000	<0.3%
EMDP	>100000	<0.3%

Morphine(Cut-off=2000 ng/mL)	ResultPositive at(ng/ml)	% Cross-Reactivity
Morphine	2000	100 %
Acetylmorphine	2500	80 %
Codeine	2000	100 %
Ethyl Morphine	600	333 %
Heroin	2000	100%
Hydromorphone	15000	13%
Hydrocodone	15000	13%
Thebaine	20000	10%
Morphine-3-β-d-glucuronide	10000	20%
Procaine	Negative at 400000	≤0.5%
Levorphanol	Negative at 400000	≤0.5%
Oxycodone	20000	10%
Oxymorphine	20000	10%

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 Secobarbital, Oxazepam, Methamphetamine, Methadone and Morphine. The rest data were reported in K153646 for Amphetamine, Marijuana and Cocaine.

Secobarbital

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%)
----------	----------	-------------------------------------------	------------------------------------------------------------	----------------------------------------------------------------	-----------------------------------------------

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

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

Viewer	Sample Number	LC/MS Result	Dip Card Viewer Results
Viewer A	SM8315	289	Positive
Viewer B	SM8315	289	Positive
Viewer B	SM2505	235	Positive
Viewer C	SM5420	249	Positive

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

Discordant Results

Viewer	Sample Number	LC/MS Result	Cup Viewer Results
Viewer A	SM5080	289	Positive
Viewer A	SM9194	249	Positive
Viewer B	SM5080	289	Positive
Viewer C	SM9194	249	Positive

Oxazepam

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

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

ViewerC	Positive	0	0	2	20	20
	Negative	10	10	19	0	0

Discordant Results
Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	SM9014	236	Positive
Viewer A	SM6306	288	Positive
Viewer B	SM7026	245	Positive
Viewer C	SM9014	236	Positive
Viewer C	SM7026	245	Positive
Viewer A	SM6235	367	Negative
Viewer B	SM6235	367	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%)
ViewerA	Positive	0	0	2	19	20
	Negative	10	10	18	1	0
ViewerB	Positive	0	0	2	19	20
	Negative	10	10	18	1	0
ViewerC	Positive	0	0	1	19	20
	Negative	10	10	19	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	SM1575	236	Positive
Viewer A	SM3552	288	Positive
Viewer B	SM3552	288	Positive
Viewer B	SM5707	245	Positive
Viewer C	SM3552	288	Positive
Viewer A	SM3141	367	Negative
Viewer B	SM3141	367	Negative
Viewer C	SM3141	367	Negative

Methamphetamine

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	0	20	20
	Negative	10	10	20	0	0

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

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

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer B	SM5938	1279	Negative

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	0	19	20
ViewerA	Negative	10	10	20	1	0
ViewerB	Positive	0	0	0	20	20
ViewerB	Negative	10	10	20	0	0
ViewerC	Positive	0	0	0	20	20
ViewerC	Negative	10	10	20	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	SM7866	1279	Negative

Methadone

Dip Card		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	19	20
	Negative	10	10	19	1	0
ViewerB	Positive	0	0	1	19	20
	Negative	10	10	19	1	0
ViewerC	Positive	0	0	0	19	20
	Negative	10	10	20	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	SM7688	238	Positive
Viewer B	SM5599	246	Positive
Viewer A	SM4407	361	Negative

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

Viewer B	SM6683	372	Negative
Viewer C	SM4407	361	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	19	20
ViewerA	Negative	10	10	19	1	0
ViewerB	Positive	0	0	1	20	20
ViewerB	Negative	10	10	19	0	0
ViewerC	Positive	0	0	2	18	20
ViewerC	Negative	10	10	18	2	0

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	SM0442	246	Positive
Viewer B	SM3857	238	Positive
Viewer C	SM0442	246	Positive
Viewer C	SM8431	228	Positive
Viewer A	SM3805	372	Negative
Viewer C	SM3805	372	Negative
Viewer C	SM5346	361	Negative

Morphine

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

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	SM1232	1994	Positive
Viewer B	SM8496	1928	Positive
Viewer C	SM8496	1928	Positive

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

Viewer C	SM1232	1994	Positive
Viewer A	SM8757	2049	Negative
Viewer B	SM4835	2184	Negative
Viewer B	SM9254	2100	Negative
Viewer C	SM8757	2049	Negative
Viewer C	SM9254	2100	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	0	18	20
B	Negative	10	10	20	2	0
Viewer	Positive	0	0	1	19	20
C	Negative	10	10	19	1	0

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer A	SM3243	1994	Positive
Viewer C	SM3243	1994	Positive
Viewer A	SM5564	2049	Negative
Viewer A	SM8381	2184	Negative
Viewer B	SM5564	2049	Negative
Viewer B	SM9915	2100	Negative
Viewer C	SM8381	2184	Negative

Lay-user study

A lay user study was performed at three intended user sites with 240 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Results are shown below. Dip Card

AMP

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage ofcorrect results(%)
-100% Cutoff	20	0	No. ofPositive	No. ofNegative	100
-75% Cutoff	20	248	0	20	100

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

-50% Cutoff	100	રે રેણવાડી તેમ જ દિવસ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે ખાતે ખાતે ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પત્તમજૂરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થ		100	100
-25% Cutoff	20	754		19	તેરિ
+25% Cutoff	20	1259	17		૪૨
+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		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	100	152	0	100	100
-25% Cutoff	20	224	2	18	90
+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		Percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.6	0	20	100
-50% Cutoff	100	25	0	100	100
-25% Cutoff	20	37.2	2	18	90
+25% Cutoff	20	62.3	19	1	95
+50% Cutoff	40	75	40	0	100
+75% Cutoff	20	87.4	20	0	100

BAR

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	76	0	20	100
-50% Cutoff	100	151	0	100	100
-25% Cutoff	20	226	1	19	95
+25% Cutoff	20	372	18	2	90
+50% Cutoff	40	448	40	0	100
+75% Cutoff	20	529	20	0	100
BZO

Lay person Results Number of Drug Percentage of % of Cutoff samples Concentration by correct results No. of No. of LC/MS (ng/mL) Positive Negative (%)

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

-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	100	149	0	100	100
-25% Cutoff	20	224	3	17	85
+25% Cutoff	20	376	19	1	95
+50% Cutoff	40	454	40	0	100
+75% Cutoff	20	520	20	0	100

MET

% of Cutoff	Number of samples	Drug Concentration by LC/MS (ng/mL)	Lay person ResultsNo. of Positive	Lay person ResultsNo. of Negative	Percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	251	0	20	100
-50% Cutoff	100	502	0	100	100
-25% Cutoff	20	758	2	18	90
+25% Cutoff	20	1259	18	2	90
+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		Percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	74	0	20	100
-50% Cutoff	100	151	0	100	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	376	18	2	90
+50% Cutoff	40	447	40	0	100
+75% Cutoff	20	522	20	0	100

OPI

OPI
% of Cutoff	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	505	0	20	100
-50% Cutoff	100	1009	0	100	100
-25% Cutoff	20	1510	1	19	95
+25% Cutoff	20	2511	18	2	90
+50% Cutoff	40	3031	40	0	100
+75% Cutoff	20	3521	20	0	100

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

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	248	0	20	100
-50% Cutoff	100	505	0	100	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 ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	74	0	20	100
-50% Cutoff	100	152	0	100	100
-25% Cutoff	20	224	1	19	95
+25% Cutoff	20	373	18	2	90
+50% Cutoff	40	452	40	0	100
+75% Cutoff	20	522	20	0	100

THC

% of Cutoff	Number of samples	Drug Concentration by LC/MS (ng/mL)	Lay person Results		Percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.6	0	20	100
-50% Cutoff	100	25	0	100	100
-25% Cutoff	20	37.2	2	18	90
+25% Cutoff	20	62.3	19	1	95
+50% Cutoff	40	75	40	0	100
+75% Cutoff	20	87.4	20	0	100

BAR

% of Cutoff	Number of samples	Drug Concentration by LC/MS (ng/mL)	Lay person Results		Percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	76	0	20	100
-50% Cutoff	100	151	0	100	100
-25% Cutoff	20	226	3	17	85
+25% Cutoff	20	372	19	1	95
+50% Cutoff	40	448	40	0	100

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

+75% Cutoff	20	529	20	0	100
BZO
% of Cutoff	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage of
			No. ofPositive	No. ofNegative	correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	100	149	0	100	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

MET

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS (ng/mL)	Lay person Results		Percentage ofcorrect results(%)
-100% Cutoff	20	0	No. ofPositive	No. ofNegative	100
-75% Cutoff	20	251	0	20	100
-50% Cutoff	100	502	0	100	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 ofsamples	DrugConcentration byLC/MS (ng/mL)	No. ofPositive	No. ofNegative	Percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	74	0	20	100
-50% Cutoff	100	151	0	100	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
% of Cutoff	Number of samples	Drug Concentration by LC/MS (ng/mL)	Lay person Results		Percentage of correct results (%)
-100% Cutoff	20	0	No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	505	0	20	100
-50% Cutoff	100	1009	0	100	100
-25% Cutoff	20	1510	3	17	85

OPI

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

+25% Cutoff	20	2511	19	1	95
+50% Cutoff	40	3031	40	0	100
+75% Cutoff	20	3521	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, method comparison, and lay-user studies of the devices, it's concluded that the SAFECARE Dip Card Tests and SAFECARE Cup Tests are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

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