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

K202453 · Safecare Biotech (Hangzhou) Co., Ltd. · NFT · Mar 24, 2021 · Clinical Toxicology

Device Facts

Record IDK202453
Device NameSAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Product CodeNFT · Clinical Toxicology
Decision DateMar 24, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.3100
Device ClassClass 2

Intended Use

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

Device Story

Single-use lateral flow immunochromatographic assays for qualitative drug detection in human urine. Input: urine sample. Principle: competitive binding; target drugs below cutoff allow antibody-coated particles to bind immobilized drug-conjugate, forming visible test line; drug presence above cutoff saturates binding sites, preventing line formation. Output: visual qualitative result (line/no line). Used in home/OTC settings by lay users. Results are preliminary; require GC/MS or LC/MS confirmation. Benefits: rapid, simultaneous screening for multiple substances.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, 2 runs/day), interference testing, specificity/cross-reactivity analysis, and method comparison against LC/MS (80 samples per drug). Lay-user study conducted with 310 participants across diverse demographics, demonstrating high accuracy (90-100%) across various drug concentrations relative to cut-offs. Flesch-Kincaid analysis confirmed 7th-grade reading level for instructions.

Technological Characteristics

Lateral flow immunochromatographic assay. Single-use dip card or cup format. Reagent pads contain monoclonal mouse antibodies. Qualitative visual readout. Stable at 4-30°C for 24 months. No electronic components or software.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, Nortriptyline, Propoxyphene, EDDP) in human urine. Intended for over-the-counter use by lay users. Not intended to distinguish between prescription use and abuse.

Regulatory Classification

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.

Special Controls

*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).

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. March 24, 2021 Safecare Biotech(Hangzhou)Co., Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 Re: K202453 Trade/Device Name: SAFECARE Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test Dip-Card Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGI, NFV, NGL, PTH, PTG, QAW, QBF, NGM Dated: August 25, 2020 Received: August 27, 2020 Dear Joe Shia: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Kellie Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) k202453 #### Device Name SAFECARE® Multi-Drug Urine Test Dip Card SAFECARE® Multi-Drug Urine Test Cup #### Indications for Use (Describe) SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |-----------------------------------------------------|---------------| | Amphetamine | 500ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 150ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 500ng/mL | | Morphine | 300ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |----------------------|---------------| | Amphetamine | 500ng/mL | | Oxazepam | 300 ng/mL | | FORM FDA 3881 (7/17) | Page 1 of 2 | {3}------------------------------------------------ | Cocaine | 150ng/mL | |-----------------------------------------------------|------------| | Marijuana | 50 ng/mL | | Methamphetamine | 500ng/mL | | Morphine | 300ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### 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.gov "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 #### 510(k) Number: k202453 - 1. Date: March 18, 2021 - 2. Submitter: Safecare Biotech (Hangzhou) Co. Ltd. 18 Haishu Road, Yuhang District Hangzhou, China - 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com - SAFECARE® Multi-Drug Urine Test Dip Card 4. Device Name: SAFECARE® Multi-Drug Urine Test Cup Classification: Class 2 | Product Code | Classification | Regulation Section | Panel | |---------------------------------------|----------------|----------------------------------------------------------------|-----------------| | NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) | | NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) | | NFY<br>Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) | | NGG<br>Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | NGI<br>Morphine | II | 21 CFR § 862.3640, Morphine Test System | Toxicology (91) | | NFV<br>Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) | | NGL<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) | | NGL<br>Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | NGG<br>Methylenedioxy-methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | NGM<br>Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) | | PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) | | QAW<br>Nortriptyline | II | 21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System | Toxicology (91) | | QBF<br>Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology (91) | {5}------------------------------------------------ | Product Code | Classification | Regulation Section | Panel | |----------------------------------------------------------------|----------------|---------------------------------------------|--------------------| | PTG<br>2-ethylidene-1, 5-dimethyl-<br>3, 3-diphenylpyrrolidine | II | 21 CFR § 862.3620, Methadone Test<br>System | Toxicology<br>(91) | - 5. Predicate Device The SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup (K201120) - 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, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |-----------------------------------------------------|---------------| | Amphetamine | 500ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 150ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 500ng/mL | | Morphine | 300ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d {6}------------------------------------------------ Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |-----------------------------------------------------|---------------| | Amphetamine | 500ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 150ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 500ng/mL | | Morphine | 300ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. #### 7. Device Description The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch. #### 8. Substantial Equivalence Information A summary comparison of features of the SAFECARE® Dip Card Tests and SAFECARE® Cup Tests and the predicate devices is provided in following table. {7}------------------------------------------------ ## Features Comparison of SAFECARE® Dip Card Tests and the Predicate Device | Item | Device | Predicate - K201120 | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication(s)<br>for Use | For the qualitative determination of<br>Amphetamine, Buprenorphine, Secobarbital,<br>Oxazepam, Cocaine, 2-ethylidene-1,5-<br>dimethyl-3,3-diphenylpyrrolidine,<br>Methamphetamine,<br>Methylenedioxymethamphetamine,<br>Morphine, Methadone, Oxycodone,<br>Phencyclidine, Propoxyphene, Nortriptyline<br>and Cannabinoids in human urine. | Same | | | Similarities | | | Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human Urine | Same | | Intended Use | For over-the-counter | Same | | Configurations | Dip Card | Same | | | Differences | | | Calibrator and Cut-Off<br>Values | Amphetamine (AMP): 500 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine (COC): 150 ng/ml<br>11-Nor-△9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 500 ng/ml<br>Morphine (MOP): 300ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Methylenedioxymethamphetamine<br>(MDMA): 500 ng/ml<br>Oxycodone (OXY): 100 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/mL | Same as candidate device<br>with exception of<br>Amphetamine: 1000ng/mL<br>Cocaine: 300ng/mL<br>Methamphetamine:<br>1000ng/mL<br>Morphine: 2000ng/mL | {8}------------------------------------------------ ## Features Comparison of SAFECARE® Cup Tests and the Predicate Devices | Item | Device | Predicate - K201120 | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication(s)<br>for Use | For the qualitative determination of<br>Amphetamine, Buprenorphine,<br>Secobarbital, Oxazepam, Cocaine, 2-<br>ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine, Methamphetamine,<br>Methylenedioxymethamphetamine,<br>Morphine, Methadone, Oxycodone,<br>Phencyclidine, Propoxyphene,<br>Nortriptyline and Cannabinoids in<br>human urine. | Same | | Similarities | | | | Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human Urine | Same | | Intended Use | For over-the-counter | Same | | Configurations | Cup | Cup | | Differences | | | | Calibrator and Cut-Off<br>Values | Amphetamine (AMP): 500 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine (COC): 150 ng/ml<br>11-Nor-△9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 500 ng/ml<br>Morphine (MOP): 300ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Methylenedioxymethamphetamine<br>(MDMA): 500 ng/ml<br>Oxycodone (OXY): 100 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/mL | Same as candidate device<br>with exception of<br>Amphetamine: 1000ng/mL<br>Cocaine: 300ng/mL<br>Methamphetamine:<br>1000ng/mL<br>Morphine: 2000ng/mL | {9}------------------------------------------------ #### 9. Test Principle The SAFECARE® Dip Card Tests, and SAFECARE® Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3diphenylpyrrolidine in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration. it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly. #### 10. Performance Characteristics - 1. Analytical Performance - a. Precision Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. Please refer to k182654 for precision data for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and to k181968 for precision data for Oxazepam, Secobarbital and Methadone, and to k153646 for precision data for Cannabinoids and to k201120 for precision data for EDDP. The candidate device uses the same assays (same reagent pads) for these drugs as was cleared in k182654/k181968/k153646/k201120. | Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | |--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | #### Amphetamine 500 Dip Card {10}------------------------------------------------ | Cup | | | | | | | | | | |--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Cocaine 150 Dip Card | | Results | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | |---------------|---------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot<br>Number | | | | | | | | | | | | Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Cup | | | | | | | | | | |---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Results | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | | Lot<br>Number | | | | | | | | | | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## Methamphetamine 500 50-/0+ Lot 3 | Dip Card | | | | | | | | |---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------| | Results | | | | | | | | | | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | | Lot<br>Number | | | | | | | | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50-/0+ 50-/0+ | Cup | | | | | | | | | | |--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Results<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | 50-/0+ 25-/25+ 50+/0- 50+/0- Cut-off +100% 50+/0- 50+/0- 50+/0- Cut-off +75% 50+/0- 50+/0- 50+/0- {11}------------------------------------------------ | Morphine 300 | | | | | | | | | | |---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Dip Card | | | | | | | | | | | Results | | | | | | | | | | | | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | | Lot<br>Number | | | | | | | | | | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Cup | | | | | | | | | | | Results | | | | | | | | | | | | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% | | Lot<br>Number | | | | | | | | | | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | The cut-off values of 500 ng/mL, 500 ng/mL, and 300 ng/mL for Amphetamine, Cocaine, Methamphetamine and Morphine are verified. - b. Linearity Not applicable. - c. Stability The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50 ℃ and real time stability studies at 4℃ and 30 ℃. - d. Interference Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100ug/mL, with the exception of albumin with no interference at a concentration of 100mg/dL and ethanol at 1% volume, are summarized in the following tables. There were no differences observed between the SAFECARE® Cup and Dip Card formats. | Acetominophen (4-<br>Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine | |---------------------------------------|------------------------|-------------------| | Acetophenetidin | Erythromycin | Oxalic acid | | N-Acetylprocainamide | β-Estradiol | Oxolinic acid | | Acetylsalicylic acid | Ethanol (1% vol) | Oxymetazoline | | Albumin (100mg/dL) | Fenoprofen | Papaverine | | Aminopyrine | Furosemide | Penicillin-G | | Amoxicillin | Gentisic acid | Perphenazine | | Ampicillin | Hemoglobin | Phenelzine | | Apomorphine | Hydralazine | Prednisone | | Ascorbic acid | Hydrochlorothiazide | DL-Propranolol | | Aspartame | Hydrocortisone | D-Pseudoephedrine | | Atropine | O-Hydroxyhippuric acid | Quinine | | Benzilic acid | 3-Hydroxytyramine | Ranitidine | | Benzoic acid | Ibuprofen | Salicylic acid | {12}------------------------------------------------ | Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) | |---------------------|-------------------|--------------------------------| | Chloralhydrate | Isoxsuprine | Sulfamethazine | | Chloramphenicol | Ketamine | Sulindac | | Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate | | Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β- | | | | Dglucuronide) | | Cholesterol | Loperamide | Tetrahydrozoline | | Clonidine | Meperidine | Thiamine | | Cortisone | Meprobamate | Thioridazine | | (-) Cotinine | Methoxyphenamine | Triamterene | | Creatinine | Nalidixic acid | DL-Tyrosine | | Deoxycorticosterone | Naloxone | Trifluoperazine | | Dextromethorphan | Naltrexone | Trimethoprim | | Diclofenac | Naproxen | D L-Tryptophan | | Diflunisal | Niacinamide | Tyramine | | Digoxin | Nifedipine | Uric acid | | Diphenhydramine | Norethindrone | Verapamil | | Disopyramide | Noscapine | Zomepirac | #### e. Specificity To test specificity, drug metabolites and other structure related compounds that are likely to cross-react in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. Please refer to k182654 for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and to k181968 for Oxazepam, Secobarbital and Methadone, and to k153646 for Cannabinoids and to k201120 for EDDP. There were no differences observed between the SAFECARE® Cup and Dip Card formats. The candidate device uses the same assays (same reagent pads) for these drugs as was cleared in k182654/k181968/k153646/k201120. | Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity | |--------------------------------------|------------------------------|--------------------| | l-Amphetamine | 25000 | 2% | | dl- Amphetamine | 1500 | 33% | | 3,4-Methylenedioxyamphetamine (MDA) | 2500 | 20% | | Phentermine | 1500 | 33% | | Hydroxyamphetamine | 8000 | 6% | | β-Phenylethylamine | 100000 | 0.5% | | Tyramine | 100000 | 0.5% | | p-Hydroxynorephedrine | 100000 | 0.5% | | p-Hydroxyamphetamine | 100000 | 0.5% | | d/l-Norephedrine | 100000 | 0.5% | | d-Methamphetamine | >100,000 | <0.5% | | l-Methamphetamine | >100,000 | <0.5% | | Methylenedioxyethylamphetamine (MDE) | >100,000 | <0.5% | | Methylenedioxymethamphetamine(MDMA) | >100,000 | <0.5% | | Ephedrine | >100,000 | <0.5% | | Phenylpropanolamine | >100,000 | <0.5% | | (±)Phenylpropanolamine | >100,000 | <0.5% | | Benzphetamine | >100,000 | <0.5% | #### Amphetamine {13}------------------------------------------------ | Cocaine | | | |-------------------------------------------------------|------------------------------|--------------------| | Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity | | Cocaine | 375 | 40% | | Cocaethylene | 6250 | 2.4% | | Ecgonine | 16000 | 1% | | Ecgonine methyl ester | >100,000 | <0.2% | | Norcocaine | >100,000 | <0.2% | | Methamphetamine | | | | Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity | | D-Amphetamine | 25000 | 2% | | L- Amphetamine | 37500 | 1% | | Chloroquine | 10000 | 5% | | (+/-)-Ephedrine | 25000 | 2% | | D/L-Methamphetamine | 500 | 100% | | L-Methamphetamine | 10000 | 5% | | (+/-)3,4-Methylenedioxy-n-<br>ethylamphetamine (MDEA) | 500 | 100% | | 3,4-Methylenedioxyamphetamine(MDA) | 500 | 100% | | Methylenedioxymethamphetamine(MDMA) | 2000 | 25% | | β-Phenylethylamine | 25000 | 2% | | Trimethobenzamide | 5000 | 10% | | d/l-Amphetamine | 75000 | 1% | | p-Hydroxymethamphetamine | 15000 | 3% | | Mephentermine | 25000 | 2% | | (1R,2S)-(-)-Ephedrine | 50000 | 1% | | 1-Phenylephrine | 100000 | 0.5% | | (-)-Methamphetamine | 12500 | 2% | | Morphine | | | | Compounds | Result<br>Positive at(ng/ml) | % Cross-Reactivity | | Normorphine | 300 | 100% | | s-Monoacetylmorphine | 300 | 100% | | Codeine | 300 | 100% | | Ethyl Morphine | 100 | 300% | | Heroin | 300 | 100% | | Hydrocodone | 5000 | 6% | | Hydromorphone | 1000 | 30% | | Morphinie-3-β-d-glucuronide | 1000 | 30% | | Oxycodone | >100000 | <0.3% | | Oxymorphone | 100000 | 0.3% | | Thebaine | 3000 | 10% | | Levorphanol | 10000 | 3% | | 6-Monoacetylmorphine (6-MAM) | 150 | 200% | | Norcodeine | 6250 | 5% | | Procaine | 150000 | 0.2% | {14}------------------------------------------------ f. Effect of Urine Specific Gravity and Urine pH To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed between the SAFECARE® Cup and Dip Card formats. ## 2. Comparison Studies Method comparison studies for the SAFECARE® Dip Card Tests and the SAFECARE® Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Amphetamine 500, Cocaine 150, Methamphetamine 500 and Morphine 300. Please refer to k182654 for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and to k181968 for Oxazepam, Secobarbital and Methadone, and to k153646 for Cannabinoids and to k201120 for EDDP. The candidate device uses the same assays (same reagent pads) for these drugs as was cleared in k182654/ k181968/ k153646 and k201120. | Dip<br>Card | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) | |-------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer<br>A | Positive | 0 | 0 | 1 | 20 | 20 | | | Negative | 10 | 10 | 19 | 0 | 0 | | Viewer<br>B | Positive | 0 | 0 | 0 | 19 | 20 | | | Negative | 10 | 10 | 20 | 1 | 0 | | Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 | | | Negative | 10 | 10 | 19 | 0 | 0 | #### Amphetamine 500 | Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results | |----------|---------------|--------------|----------------------------| | Viewer A | LM8554 | 498 | Positive | | Viewer C | LM8554 | 498 | Positive | | Viewer B | LM1169 | 502 | Negative | {15}------------------------------------------------ | Cup | Negative | Low Negative by LC/MS<br>(less than -50%) | Near Cutoff Negative by LC/MS<br>(Between -50% and cutoff) | Near Cutoff Positive by LC/MS<br>(Between the cutoff and +50%) | High Positive by LC/MS<br>(greater than +50%) | |-------------------|----------|-------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------| | Viewer A Positive | 0 | 0 | 0 | 19 | 20 | | Viewer A Negative | 10 | 10 | 20 | 1 | 0 | | Viewer B Positive | 0 | 0 | 1 | 20 | 20 | | Viewer B Negative | 10 | 10 | 19 | 0 | 0 | | Viewer C Positive | 0 | 0 | 0 | 19 | 20 | | Viewer C Negative | 10 | 10 | 20 | 1 | 0 | | Viewer | Sample Number | LC/MS Result | Cup Viewer Results | |----------|---------------|--------------|--------------------| | Viewer B | LM8561 | 498 | Positive | | Viewer A | LM1497 | 502 | Negative | | Viewer C | LM1497 | 502 | Negative | ## Cocaine 150 | Dip Card | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) | | |-------------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|----| | Viewer<br>A | Positive | 0 | 0 | 1 | 20 | 20 | | | Negative | 10 | 10 | 19 | 0 | 0 | | Viewer<br>B | Positive | 0 | 0 | 0 | 19 | 20 | | | Negative | 10 | 10 | 20 | 1 | 0 | | Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 | | | Negative | 10 | 10 | 19 | 0 | 0 | | Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results | |----------|---------------|--------------|----------------------------| | Viewer A | LM8739 | 148 | Positive | | Viewer C | LM8739 | 148 | Positive | | Viewer B | LM7119 | 152 | Negative | {16}------------------------------------------------ | Cup | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and +50%) | High Positive<br>by LC/MS<br>(greater than +50%) | |--------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------| | Viewer | Positive | 0 | 0 | 0 | 19 | 20 | | A | Negative | 10 | 10 | 20 | 1 | 0 | | Viewer | Positive | 0 | 0 | 1 | 20 | 20 | | B | Negative | 10 | 10 | 19 | 0 | 0 | | Viewer | Positive | 0 | 0 | 0 | 20 | 20 | | C | Negative | 10 | 10 | 20 | 0 | 0 | | Viewer | Sample Number | LC/MS Result | Cup<br>Viewer Results | |----------|---------------|--------------|-----------------------| | Viewer B | LM4418 | 148 | Positive | | Viewer A | LM1485 | 152 | Negative | ## Methamphetamine 500 | Dip<br>Card | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) | |-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 | | Viewer<br>A | Negative | 10 | 10 | 19 | 2 | 0 | | Viewer<br>B | Positive | 0 | 0 | 2 | 19 | 20 | | Viewer<br>B | Negative | 10 | 10 | 18 | 1 | 0 | | Viewer<br>C | Positive | 0 | 0 | 0 | 18 | 20 | | Viewer<br>C | Negative | 10 | 10 | 20 | 2 | 0 | | Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results | |----------|---------------|--------------|----------------------------| | Viewer A | LM6106 | 467 | Positive | | Viewer B | LM7710 | 464 | Positive | | Viewer B | LM6106 | 467 | Positive | | Viewer A | LM7165 | 513 | Negative | | Viewer A | LM6198 | 511 | Negative | | Viewer B | LM7165 | 513 | Negative | | Viewer C | LM7165 | 513 | Negative | | Viewer C | LM6198 | 511 | Negative | {17}------------------------------------------------ | Cup | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and +50%) | High Positive<br>by LC/MS<br>(greater than +50%) | |-------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------| | Viewer<br>A | Positive | 0 | 0 | 2 | 19 | 20 | | A | Negative | 10 | 10 | 18 | 1 | 0 | | Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 | | B | Negative | 10 | 10 | 19 | 2 | 0 | | Viewer<br>C | Positive | 0 | 0 | 1 | 19 | 20 | | C | Negative | 10 | 10 | 19 | 1 | 0 | | Viewer | Sample Number | LC/MS Result | Cup Viewer Results | |----------|---------------|--------------|--------------------| | Viewer A | LM3480 | 464 | Positive | | Viewer A | LM8436 | 467 | Positive | | Viewer B | LM3480 | 464 | Positive | | Viewer C | LM8436 | 467 | Positive | | Viewer A | LM5908 | 513 | Negative | | Viewer B | LM8727 | 511 | Negative | | Viewer B | LM5908 | 513 | Negative | | Viewer C | LM5908 | 513 | Negative | ## Morphine 300 | Dip Card | | Negative | Low Negative by LC/MS<br>(less than -50%) | Near Cutoff Negative by LC/MS<br>(Between -50% and cutoff) | Near Cutoff Positive by LC/MS<br>(Between the cutoff and +50%) | High Positive by LC/MS<br>(greater than +50%) | |----------|----------|----------|-------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------| | Viewer A | Positive | 0 | 0 | 1 | 19 | 20 | | Viewer A | Negative | 10 | 10 | 19 | 1 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 20 | 20…
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