AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Device Facts
| Record ID | K201630 |
|---|---|
| Device Name | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Aug 12, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Intended Use
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of. [Table omitted] Configuration of the AssureTech DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of. [Table omitted] Configuration of the AssureTech Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Story
Single-use in vitro diagnostic devices (dipstick panels or integrated cups) for qualitative detection of drugs of abuse in human urine; utilizes competitive binding, lateral flow immunochromatographic assay principle. Urine sample migrates via capillary action; target drugs below cutoff allow antibody-coated particles to bind immobilized drug-conjugate, forming visible colored test line. If drug exceeds cutoff, binding sites saturate, preventing test line formation. Control line indicates proper test performance. Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits include rapid, simultaneous screening for multiple analytes.
Clinical Evidence
Bench testing only. Performance validated via precision studies across three POC sites using spiked samples confirmed by LC/MS. Method comparison studies performed on 80 clinical samples per drug (40 positive/40 negative) compared against LC/MS. Interference and specificity testing confirmed no cross-reactivity or matrix effects.
Technological Characteristics
Lateral flow immunochromatographic assay; qualitative. Components: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG. Formats: dipstick panel or integrated cup. Sample: human urine. Principle: competitive binding. Shelf-life: 24 months.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (6-MAM, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene) in human urine. Intended for prescription use as a preliminary screening tool; requires confirmatory testing via GC/MS or LC/MS.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate 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).
Predicate Devices
- AssureTech Panel Dip Tests and AssureTech Quick Cup Tests (K181768)
- Advin Biotech ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card (K182123)
Related Devices
- K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · May 27, 2020
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
- K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card · Healgen Scientific,, LLC · Aug 2, 2017
- K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · Nov 19, 2018
- K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup · Assure Tech., LLC · Feb 7, 2025
Submission Summary (Full Text)
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August 12, 2021
Assure Tech (Hangzhou) Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877
Re: K201630
Trade/Device Name: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DKZ, LDJ, DIO, LAF, JXM, DIS, LCM, DJR, LFG, JXN Dated: September 29, 2020 Received: September 30, 2020
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres. Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) k201630
#### Device Name
AssureTech DOA Dipstick Screen Panel Tests AssureTech DOA Integrated Cup Tests
#### Indications for Use (Describe)
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of.
| Drug(Identifier) | Cut-off level |
|--------------------------------|---------------|
| 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 20 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/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 |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of.
| Drug(Identifier) | Cut-off level |
|----------------------|---------------|
| 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine | 500 ng/mL |
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| Oxazepam | 300 ng/mL |
|--------------------------------|------------|
| Cocaine | 150 ng/mL |
| Marijuana | 20 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/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 |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech Cup Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) SUMMARY K201630
- 1. Date: September 29, 2020
- 2. Submitter:
Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030
- Joe Shia 3. Contact person: LSI International Inc. 504E Diamond Ave., Suite J Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
- 4. Device Name: AssureTech DOA Dipstick Screen Panel Tests AssureTech DOA Integrated Cup Tests
| Classification:<br>Product Code | Class 2<br>Classification | Regulation Section | Panel |
|-------------------------------------------|---------------------------|----------------------------------------------------------------|-----------------|
| DJG<br>Monoacetylmorphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) |
| DKZ<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| LDJ<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| DIO<br>Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| LAF<br>Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| DJG<br>Morphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) |
| JXM<br>Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| DJG<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| DIS<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| DJG<br>Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| LAF<br>Methylenedioxy-<br>methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| LCM<br>Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) |
| DJR<br>Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
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| DJR<br>2-ethylidene-1, 5-<br>dimethyl-3, 3-<br>diphenylpyrrolidine<br>(EDDP) | II | 21 CFR § 862.3620, Methadone<br>Test System | Toxicology (91) |
|------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------|----------------------------------------------|
| LFG<br>Nortriptyline | II | 21 CFR, 862.3910 Tricyclic<br>Antidepressant Drugs Test System | Toxicology (91) |
| | JXN<br>Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene<br>Test System |
- 5. Predicate Devices: K181768 & K182123
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests (K181768) Advin Biotech ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card (K182123)
- 6. Indications for Use
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|--------------------------------|---------------|
| 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 20 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/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 |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes.
The test may vield 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
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analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|--------------------------------|---------------|
| 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 20 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/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 |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech DOA Integrated Cup Tests 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. For in vitro diagnostic use only.
- 7. Device Description
The AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DOA Dipstick Screen Panel 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.
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- 8. Substantial Equivalence Information
A summary comparison of features of the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests and the predicate devices is provided in following tables.
| Item | Device | Predicates - K181768<br>& K182123 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and<br>Cut-Off Values | 6-Monoacetylmorphine (6-MAM): 10 ng/mL<br>Amphetamine (AMP): 500 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine (COC): 150 ng/ml<br>Marijuana (THC):20 ng/ml<br>Methamphetamine (MET): 500 ng/ml<br>Morphine (MOR): 300ng/mL<br>Oxycodone (OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-methamphetamine (MDMA):<br>500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml | Same as candidate device<br>with exclusion of 6-<br>Monoacetylmorphine (6-<br>MAM) 10 ng/mL<br>And Marijuana (THC)<br>50 ng/ml |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription | For over-the-counter<br>For prescription |
| Configurations | Dip Card | Same |
Table 1: Features Comparison of AssureTech DOA Dipstick Screen Panel Tests and the Predicate Devices
Table 2: Features Comparison of AssureTech DOA Integrated Cup Tests and the Predicate Devices
| Item | Device | Predicates - K181768 &<br>K182123 |
|------|--------|-----------------------------------|
|------|--------|-----------------------------------|
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| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Calibrator and<br>Cut-Off Values | 6-Monoacetylmorphine (6-MAM): 10 ng/mL<br>Amphetamine (AMP): 500 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine (COC): 150 ng/ml<br>Marijuana (THC):20 ng/ml Methamphetamine<br>(MET): 500 ng/ml<br>Morphine (MOR): 300ng/mL or 2000 ng/ml<br>Oxycodone (OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-methamphetamine (MDMA):<br>500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml | Same as candidate device with<br>exclusion of 6-<br>Monoacetylmorphine (6-<br>MAM) 10 ng/mL<br>And Marijuana (THC)<br>50 ng/ml |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription | For over-the-counter<br>For prescription |
| Configurations | Cup | Same |
### 9. Test Principle
The AssureTech DOA Dipstick Screen Panel Tests, and AssureTech DOA Integrated Cup Tests are rapid tests for the qualitative detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene 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
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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 one run per lot per day for 10 days per device in a randomized order at each testing site. There were total three POC testing sites. The results obtained are summarized in the following tables.
| Result | 6-MAM | | | AMP | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6 | 23+/7- | 25+/5- | 23+/7- | 23+/7- | 27+/3- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
DOA Dipstick Screen Panel
| Result | BAR | | BUP | |
|---------------------------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 1 | Lot 2 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 27+/3- | 27+/3- | 27+/3- | 27+/3- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | BZO | | | COC | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 28+/2- | 28+/2- | 27+/3- | 22+/8- | 25+/5- | 23+/7- |
{10}------------------------------------------------
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
|-------|--------|--------|--------|--------|--------|--------|
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | EDDP | | | MDMA | | | Result | MET | | | MOR | | |
|---------------------------|--------|--------|--------|--------|--------|--------|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 24+/6- | 24+/6- | 24+/6- | 24+/6- | 22+/8- | cutoff | 25+/5 | 25+/5- | 24+/6- | 23+/7- | 24+/6- | 25+/5- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | MTD | | | OXY | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 27+/3- | 26+/4- | 26+/4- | 28+/2- | 27+/3- | 28+/2- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | PCP | | | PPX | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 25+/5- | 25+/5- | 24+/6- | 25+/5- | 25+/5- | 26+/4- |
{11}------------------------------------------------
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
|-------|--------|--------|--------|--------|--------|--------|
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | TCA | | | THC | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 23+/7- | 23+/7- | 24+/6- | 24+/6- | 22+/8- | 22+/8- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
# DOA Integrated Cup
| Result | 6-MAM | | | AMP | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 23+/7- | 23+/7- | 23+/7- | 24+/6- | 26+/4- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | BAR | | BUP | |
|---------------------------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 1 | Lot 2 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 28+/2- | 26+/4- | 28+/2- | 28+/2- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | BZO | | | COC | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
{12}------------------------------------------------
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
|--------|--------|--------|--------|--------|--------|--------|
| cutoff | 28+/2- | 28+/2- | 29+/1- | 23+/7- | 26+/4- | 24+/6- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | EDDP | | | MDMA | | | Result | MET | | | MOR | | |
|---------------------------|--------|--------|--------|--------|--------|--------|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 24+/6- | 25+/5- | 23+/7- | 22+/8- | 22+/8- | cutoff | 23+/7- | 27+/3- | 23+/7- | 22+/8- | 24+/6- | 23+/7- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | MTD | | | OXY | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 26+/4- | 27+/3- | 27+/3- | 27+/3- | 28+/2- | 28+/2- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | PCP | | | PPX | | |
|---------------------------|--------|--------|--------|--------|--------|--------|
| Drug Conc.<br>% of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
{13}------------------------------------------------
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
|--------|--------|--------|--------|--------|--------|--------|
| cutoff | 25+/5- | 25+/5- | 24+/6- | 25+/5- | 27+/3- | 25+/5- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| Result | Drug Conc.<br>% of cutoff | TCA | | | THC | | |
|--------|---------------------------|--------|--------|--------|--------|--------|--------|
| | | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| | -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| | -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| | -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| | -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| | cutoff | 24+/6- | 25+/5- | 23+/7- | 23+/7- | 24+/6- | 24+/6- |
| | +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
### c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 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 lots of each device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL and ethanol at 1%) are summarized in the following table. There were no differences observed for different devices.
| Acetaminophen | ß-Estradiol | Oxalic acid |
|----------------------|------------------------|--------------------------------------------|
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | Ethanol (1%) | Oxymetazoline |
| Acetylsalicylic acid | Fenoprofen | Papaverine |
| Albumin (100 mg/dL) | Furosemide | Penicillin G |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Apomorphine | Hydrochlorothiazide | (±)-Propranolol |
| Ascorbic acid | Hydrocortisone | Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloral hydrate | Ketamine | Sulindac |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(ß-<br>Dglucuronide) |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
{14}------------------------------------------------
| Cholesterol | Meperidine | Thiamine |
|-----------------------|------------------|-----------------|
| Clonidine | Meprobamate | Thioridazine |
| Cortisone | Methoxyphenamine | Triamterene |
| (-)-Cotinine | Nalidixic acid | Trifluoperazine |
| Creatinine | Naloxone | Trimethoprim |
| Deoxycorticosterone | Naltrexone | DL-Tryptophan |
| Dextromethorphan | Naproxen | Tyramine |
| Diclofenac | Niacinamide | DL-Tyrosine |
| Diflunisal | Nifedipine | Uric acid |
| Digoxin | Norethindrone | Verapamil |
| Diphenhydramine | Noscapine | Zomepirac |
| Ecgonine methyl ester | (±)-Octopamine | |
e. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20). The rest data were reported in the k181768. There were no differences observed for different devices.
| 6-acetylmorphine<br>(Cut-off=10 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|----------------------------------------|-------------------------------|--------------------|
| 6-acetylmorphine | 10 | 100% |
| Acetylcodeine | >10000 | <0.1% |
| Buprenorphine | >10000 | <0.1% |
| Codeine | >10000 | <0.1% |
| Diacetylmorphine | 1000 | 1% |
| Dihydrocodeine | >10000 | <0.1% |
| Ethylmorphine | >10000 | <0.1% |
| Hydrocodone | >10000 | <0.1% |
| Hydromorphone | 5000 | 0.2% |
| Morphine | 10000 | 0.1% |
| Morphine-3-glucuronide | >10000 | <0.1% |
| Nalorphine | 5000 | 0.2% |
| Thebaine | >20000 | <0.05% |
| Dextromethorphan | >100,000 | <0.01% |
| Heroin | 100,000 | 0.01% |
| Imipramine | >100,000 | <0.01% |
| LAAM (Levacetylmethadol) | >100,000 | <0.01% |
| Levorphanol | >100,000 | <0.01% |
| Meperidine | >100,000 | <0.01% |
| Methadone | >100,000 | <0.01% |
| Mitragynine (kratom) | >20,000 | <0.05% |
| Morphine 6-D-glucuronide | >100,000 | <0.01% |
| Naloxone | >100,000 | <0.01% |
| Naltrexone | >100,000 | <0.01% |
| Naproxen | >100,000 | <0.01% |
| Norbuprenorphine | >10,000 | <0.1% |
| Norbuprenorphine glucuronide | >100,000 | <0.01% |
| Norcodeine | >100,000 | <0.01% |
| Norhydrocodone | >100,000 | <0.01% |
| Normorphine | >100,000 | <0.01% |
| Noroxycodone | >100,000 | <0.01% |
| Noroxymorphone | >100,000 | <0.01% |
| Norpropoxyphene | >100,000 | <0.01% |
| Oxycodone | >100,000 | <0.01% |
{15}------------------------------------------------
| Oxymorphone | >100,000 | <0.01% |
|------------------------------|----------|--------|
| Oxymorphone-3β-D-glucuronide | >100,000 | <0.01% |
| Tapentadol HCl | >100,000 | <0.01% |
| Tramadol | >100,000 | <0.01% |
| Marijuana<br>(Cut-off=20 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|---------------------------------|-------------------------------|--------------------|
| 11-nor-D*-THC-9 COOH | 20 | 100% |
| 11-nor-D8-THC-9 COOH | 20 | 100% |
| △§-Tetrahydrocannabinol | >10000 | <0.25% |
| △°-Tetrahydrocannabinol | >10000 | <0.25% |
| Cannabinol | >10000 | <0.25% |
### 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 for different devices.
### 2. Comparison Studies
Method comparison studies for the AssureTech DOA Dipstick Screen Panel Tests and the AssureTech DOA Integrated Cup Tests were performed at three POC sites 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 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20). The rest data were reported in the k181768.
### 6-MAM
| Panel<br>Dip | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff 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 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| DOA<br>Integrated<br>Cup | 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%) |
|--------------------------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
|--------------------------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
{16}------------------------------------------------
| Viewer | | 0 | 0 | 0 | 15 | 25 |
|--------|----------|----|----|----|----|----|
| A | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 15 | 25 |
| B | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 15 | 25 |
| C | Negative | 10 | 20 | 10 | 0 | 0 |
# THC20
| Panel<br>Dip | | 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 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
## Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer B | TH79 | 19.09 | Positive |
| Viewer C | TH79 | 19.09 | Positive |
| Viewer A | TH10 | 20.55 | Negative |
| DOA<br>Integrated<br>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 | 0 | 14 | 25 |
| Viewer<br>A | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 15 | 25 |
| Viewer<br>B | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 15 | 25 |
| Viewer<br>C | Negative | 10 | 20 | 9 | 0 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer C | TH79 | 19.09 | Positive |
| Viewer A | TH10 | 20.55 | Negative |
# 3. Clinical Studies
{17}------------------------------------------------
Not applicable.
## 11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, and method comparison studies of the devices, it's concluded that the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are substantially equivalent to the predicate.
