K Number
K201630
Device Name
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Date Cleared
2021-08-12

(422 days)

Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. 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. 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 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.
More Information

Not Found

No
The device description and performance studies focus on immunochromatographic assays and comparisons to LC/MS, with no mention of AI or ML.

No.
The device is used for in-vitro diagnostic testing for qualitative and simultaneous detection of drugs in human urine and is not intended for therapeutic use.

Yes
The intended use statements and device description explicitly state "For in vitro diagnostic use only" and "single-use in vitro diagnostic devices" for qualitative and simultaneous detection of various substances in human urine.

No

The device description clearly states that the devices are "single-use in vitro diagnostic devices, which come in the formats of DOA Dipstick Screen Panel Cards or Cups." These are physical hardware components used for sample collection and testing, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The document explicitly states "For in vitro diagnostic use only" multiple times in the "Intended Use / Indications for Use" and "Device Description" sections.
  • Nature of the Test: The device is a "competitive binding, lateral flow immunochromatographic assay" designed to detect specific substances (drugs and their metabolites) in a biological sample (human urine). This is a classic description of an in vitro diagnostic test.
  • Purpose: The intended use is for the "qualitative and simultaneous detection" of these substances in human urine, which is a diagnostic purpose (providing information about the presence or absence of certain analytes in a sample taken from the body).
  • Device Description: The description further clarifies that the products are "single-use in vitro diagnostic devices".

Therefore, based on the provided text, the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are clearly identified as In Vitro Diagnostic devices.

N/A

Intended Use / Indications for 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.

Drug(Identifier)Cut-off level
6-Monoacetylmorphine10 ng/mL
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Marijuana20 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
EDDP300 ng/mL
Nortriptyline1000 ng/mL
d-Propoxyphene300 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-Monoacetylmorphine10 ng/mL
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Marijuana20 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
EDDP300 ng/mL
Nortriptyline1000 ng/mL
d-Propoxyphene300 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.

Product codes (comma separated list FDA assigned to the subject device)

DJG, DKZ, LDJ, DIO, LAF, JXM, DIS, LCM, DJR, LFG, JXN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For prescription

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance - 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.

Analytical Performance - Stability:
The devices are stable at 4-30 degree C for 24 months based on the accelerated stability study at 45 degree C and real time stability determination at both 4 degree C and 30 degree C.

Analytical Performance - 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.

Analytical Performance - 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. There were no differences observed for different devices.

Analytical Performance - 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.

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.

Clinical Studies:
Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K181768, K182123

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.3650 Opiate test system.

(a)
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.(b)
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).

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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.

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.

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

2

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-Monoacetylmorphine10 ng/mL
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Marijuana20 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
EDDP300 ng/mL
Nortriptyline1000 ng/mL
d-Propoxyphene300 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-Monoacetylmorphine10 ng/mL
Amphetamine500 ng/mL

3

Oxazepam300 ng/mL
Cocaine150 ng/mL
Marijuana20 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
EDDP300 ng/mL
Nortriptyline1000 ng/mL
d-Propoxyphene300 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
    1. 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
    1. Device Name: AssureTech DOA Dipstick Screen Panel Tests AssureTech DOA Integrated Cup Tests

| Classification:
Product Code | Class 2
Classification | Regulation Section | Panel |
|-------------------------------------------|---------------------------|----------------------------------------------------------------|-----------------|
| DJG
Monoacetylmorphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) |
| DKZ
Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| LDJ
Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| DIO
Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| LAF
Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| DJG
Morphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) |
| JXM
Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| DJG
Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| DIS
Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| DJG
Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| LAF
Methylenedioxy-
methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| LCM
Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) |
| DJR
Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |

5

| DJR
2-ethylidene-1, 5-
dimethyl-3, 3-
diphenylpyrrolidine
(EDDP) | II | 21 CFR § 862.3620, Methadone
Test System | Toxicology (91) |
|------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------|----------------------------------------------|
| LFG
Nortriptyline | II | 21 CFR, 862.3910 Tricyclic
Antidepressant Drugs Test System | Toxicology (91) |
| | JXN
Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene
Test System |

    1. 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)
    1. 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-Monoacetylmorphine10 ng/mL
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Marijuana20 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
EDDP300 ng/mL
Nortriptyline1000 ng/mL
d-Propoxyphene300 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

6

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-Monoacetylmorphine10 ng/mL
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Marijuana20 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
EDDP300 ng/mL
Nortriptyline1000 ng/mL
d-Propoxyphene300 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.

    1. 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.

7

    1. 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
& K182123 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Indication(s)
for Use | For the qualitative determination of drugs of
abuse in human urine. | Same (but the number of
drugs detected is different) |
| Calibrator and
Cut-Off Values | 6-Monoacetylmorphine (6-MAM): 10 ng/mL
Amphetamine (AMP): 500 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 150 ng/ml
Marijuana (THC):20 ng/ml
Methamphetamine (MET): 500 ng/ml
Morphine (MOR): 300ng/mL
Oxycodone (OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-methamphetamine (MDMA):
500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 300 ng/ml | Same as candidate device
with exclusion of 6-
Monoacetylmorphine (6-
MAM) 10 ng/mL
And Marijuana (THC)
50 ng/ml |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription | For over-the-counter
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 &
K182123 |

-------------------------------------------------

8

| Indication(s)
for Use | For the qualitative determination of
drugs of abuse in human urine. | Same (but the number of
drugs detected is different) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Calibrator and
Cut-Off Values | 6-Monoacetylmorphine (6-MAM): 10 ng/mL
Amphetamine (AMP): 500 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 150 ng/ml
Marijuana (THC):20 ng/ml Methamphetamine
(MET): 500 ng/ml
Morphine (MOR): 300ng/mL or 2000 ng/ml
Oxycodone (OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-methamphetamine (MDMA):
500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 300 ng/ml | Same as candidate device with
exclusion of 6-
Monoacetylmorphine (6-
MAM) 10 ng/mL
And Marijuana (THC)
50 ng/ml |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription | For over-the-counter
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

9

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.

Result6-MAMAMP
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff24+/623+/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

ResultBARBUP
Drug Conc.
% of cutoffLot 1Lot 2Lot 1Lot 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+
cutoff27+/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-
ResultBZOCOC
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff28+/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-
ResultEDDPMDMAResultMETMOR
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 3Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff24+/6-24+/6-24+/6-24+/6-24+/6-22+/8-cutoff25+/525+/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-
ResultMTDOXY
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff27+/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-
ResultPCPPPX
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff25+/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-
ResultTCATHC
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff23+/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

Result6-MAMAMP
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff24+/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-
ResultBARBUP
Drug Conc.
% of cutoffLot 1Lot 2Lot 1Lot 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+
cutoff28+/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-
ResultBZOCOC
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff28+/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-
ResultEDDPMDMAResultMETMOR
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 3Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff24+/6-24+/6-25+/5-23+/7-22+/8-22+/8-cutoff23+/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-
ResultMTDOXY
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff26+/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-
ResultPCPPPX
Drug Conc.
% of cutoffLot 1Lot 2Lot 3Lot 1Lot 2Lot 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+
cutoff25+/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.
% 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.

Acetaminophenß-EstradiolOxalic acid
AcetophenetidinErythromycinOxolinic acid
N-AcetylprocainamideEthanol (1%)Oxymetazoline
Acetylsalicylic acidFenoprofenPapaverine
Albumin (100 mg/dL)FurosemidePenicillin G
AminopyrineGentisic acidPerphenazine
AmoxicillinHemoglobinPhenelzine
AmpicillinHydralazinePrednisone
ApomorphineHydrochlorothiazide(±)-Propranolol
Ascorbic acidHydrocortisonePseudoephedrine
AspartameO-Hydroxyhippuric acidQuinine
Atropine3-HydroxytyramineRanitidine
Benzilic acidIbuprofenSalicylic acid
Benzoic acidIsoproterenolSerotonin (5- Hydroxytyramine)
BilirubinIsoxsuprineSulfamethazine
Chloral hydrateKetamineSulindac
ChloramphenicolKetoprofenTetrahydrocortisone 3-(ß-
Dglucuronide)
ChlorothiazideLabetalolTetrahydrocortisone 3-acetate
ChlorpromazineLoperamideTetrahydrozoline

14

CholesterolMeperidineThiamine
ClonidineMeprobamateThioridazine
CortisoneMethoxyphenamineTriamterene
(-)-CotinineNalidixic acidTrifluoperazine
CreatinineNaloxoneTrimethoprim
DeoxycorticosteroneNaltrexoneDL-Tryptophan
DextromethorphanNaproxenTyramine
DiclofenacNiacinamideDL-Tyrosine
DiflunisalNifedipineUric acid
DigoxinNorethindroneVerapamil
DiphenhydramineNoscapineZomepirac
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
(Cut-off=10 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|----------------------------------------|-------------------------------|--------------------|
| 6-acetylmorphine | 10 | 100% |
| Acetylcodeine | >10000 | 10000 | 10000 | 10000 | 10000 | 10000 | 10000 | 20000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 20,000 | 100,000 | 100,000 | 100,000 | 100,000 | 10,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 10000 | 10000 | 10000 |