(48 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation.
No
The device is an in vitro diagnostic assay used for qualitative and simultaneous detection of various drugs in human urine. It is not intended for treatment or prevention of any disease or condition.
Yes
The device is explicitly stated to be "For in vitro diagnostic use only" and described as "single-use in vitro diagnostic devices" in the "Device Description" section.
No
The device description clearly states that the devices are "immunochromatographic assays that use a lateral flow system" and come in "Panel Dip Cards or Cups." These are physical, hardware-based test kits, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Device Description: The "Device Description" section describes the products as "single-use in vitro diagnostic devices".
- Nature of the Test: The device performs a qualitative and simultaneous detection of various drugs in human urine. This is a laboratory test performed on a sample taken from the human body, which is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is to detect the presence of specific substances (drugs) in a biological sample (urine) to provide information about a person's health status (presence of drugs).
Therefore, based on the provided text, the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are indeed In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 50 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 Panel Dip Tests and the AssureTech Quick 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)
NFT, NFY, NGG, NFW, NGL, NFV, PTH, NGM, PTG, OAW, OBF
Device Description
The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 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 Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
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 over-the-counter
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
a. Precision: Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. Results for Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500) were summarized in tables, showing the number of negative and positive results at different cut-off percentages across three lots for both Panel Dip and Quick Cup formats.
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) were summarized. There were no differences observed for different devices.
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 were listed for Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500) along with their cross-reactivity percentages. There were no differences observed for different devices.
f. 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 Panel Dip Tests and the AssureTech Quick Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. Results were presented in tables for Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500), showing concordance with LC/MS results across different concentration ranges for each drug and device type, as well as discordant results for specific samples.
-
Lay-user study: A lay user study was performed at three intended user sites with 310 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. The results summary tables for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOR, MTD, OXY, PCP, PPX, TCA, and THC show the number of samples, drug concentration by LC/MS, lay person results (number of positive and negative), and the percentage of correct results. Lay-users also completed surveys, with all indicating ease of understanding instructions. A Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented in the tables are primarily the number of positive/negative results at various concentrations relative to the cutoff, and the percentage of correct results for the lay-user study. Specific sensitivity, specificity, PPV, or NPV values are not explicitly calculated or presented for the comparison studies, though the data for their calculation is present.
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.
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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 20, 2018
Assure Tech (Hangzhou) Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K181768
Trade/Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFY, NGG, NFW, NGL, NFV, PTH, NGM, PTG, OAW, OBF Dated: June 29, 2018 Received: July 19, 2018
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181768
Device Name AssureTech Panel Dip Tests AssureTech Quick Cup Tests
Indications for Use (Describe)
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 50 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 Panel Dip Tests and the AssureTech Quick 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)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
- June 29, 2018 1. Date:
- Submitter:
Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030
-
- Contact person: Eric Lin Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030 Telephone: 510-860-4680 Email: customerservice@assurelabs.com.
-
- Device Name: AssureTech Panel Dip Tests AssureTech Quick Cup Tests
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NFT | |||
| Amphetamine | II | 21 CFR § 862.3100, Amphetamine | |
| Test System | Toxicology (91) | ||
| NFW | |||
| Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids | |
| Test System | Toxicology (91) | ||
| NFY | |||
| Cocaine | II | 21 CFR § 862.3250, Cocaine and | |
| Cocaine Metabolites Test System | Toxicology (91) | ||
| NGG | |||
| Methamphetamine | II | 21 CFR § 862.3610, | |
| Methamphetamine Test System | Toxicology (91) | ||
| NGL | |||
| Morphine | II | 21 CFR § 862.3650, Morphine | |
| Test System | Toxicology (91) | ||
| NFV | |||
| Oxazepam | II | 21 CFR § 862.3170, | |
| Benzodiazepine Test System | Toxicology (91) | ||
| NGL | |||
| Oxycodone | II | 21 CFR § 862.3650, Opiate Test | |
| System | Toxicology (91) | ||
| PTH | |||
| Secobarbital | II | 21 CFR § 862.3150, Barbiturate | |
| Test System | Toxicology (91) | ||
| NGL | |||
| Buprenorphine | II | 21 CFR § 862.3650, | |
| Opiate Test System | Toxicology (91) | ||
| NGG | |||
| Methylenedioxy- | |||
| methamphetamine | II | 21 CFR § 862.3610, | |
| Methamphetamine Test System | Toxicology (91) | ||
| NGM | |||
| Phencyclidine | unclassified | Enzyme Immunoassay | |
| Phencyclidine | Toxicology (91) | ||
| PTG | |||
| Methadone | II | 21 CFR § 862.3620, Methadone | |
| Test System | Toxicology (91) |
5
| PTG
2-ethylidene-1, 5-
dimethyl-3, 3-
diphenylpyrrolidine
(EDDP) | II | 21 CFR § 862.3620, Methadone
Test System | Toxicology (91) |
|------------------------------------------------------------------------------|----|----------------------------------------------------------------|-----------------|
| QAW
Nortriptyline | II | 21 CFR, 862.3910 Tricyclic
Antidepressant Drugs Test System | Toxicology (91) |
| QBF
Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene
Test System | Toxicology (91) |
5. Predicate Devices: K122809
The Advin Multi-Drug Screen Tests
-
- Indications for Use
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
- Indications for Use
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 50 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 Panel Dip Tests and the AssureTech Quick 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.
6
7. Device Description
The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 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 Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
-
- Substantial Equivalence Information
A summary comparison of features of the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests and the predicate devices is provided in following tables.
- Substantial Equivalence Information
| Item | Device | Predicate - K122809 |
|---|---|---|
| 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 | Amphetamine (AMP): 500 ng/ml | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine(COC): 150 ng/ml | ||
| Marijuana (THC):50 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 | |
| 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 over-the-counter | Same |
| Configurations | Dip Card | Same |
Table 1: Features Comparison of AssureTech Panel Dip Tests and the Predicate Devices
7
| Item | Device | Predicate - K122809 |
|---|---|---|
| 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 | Amphetamine (AMP): 500 ng/ml | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine(COC): 150 ng/ml | ||
| Marijuana (THC):50 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 | |
| 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 over-the-counter | Same |
| Configurations | Cup | Same |
Table 2: Features Comparison of AssureTech Ouick Cup Tests and the Predicate Devices
9. Test Principle
The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of 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
8
will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
10. Performance Characteristics
-
- Analytical Performance
- Precision a.
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500). The rest data were reported in the K180349.
AMP500
Panel Dip
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Quick Cup
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 7-/43+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- |
COC150
Panel Dip
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 7-/43+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
MET500
Panel Dip
9
| Lot | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
|---|---|---|---|---|---|---|---|---|---|
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Quick Cup | |||||||||
| Lot | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/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) are summarized in the following table. There were no differences observed for different devices.
| Acetaminophen | β-Estradiol | Oxalic acid |
|---|---|---|
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | Fenoprofen | Oxymetazoline |
| Acetylsalicylic acid | Furosemide | Papaverine |
| Albumin (100 mg/dL) | Gentisic acid | Penicillin G |
| Aminopyrine | Hemoglobin | Perphenazine |
| Amoxicillin | Hydralazine | Phenelzine |
| Ampicillin | Hydrochlorothiazide | Prednisone |
| Apomorphine | Hydrocortisone | (±)-Propranolol |
| Ascorbic acid | O-Hydroxyhippuric acid | Pseudoephedrine |
| Aspartame | 3-Hydroxytyramine | Quinine |
| Atropine | Ibuprofen | Ranitidine |
| Benzilic acid | Isoproterenol | Salicylic acid |
| Benzoic acid | Isoxsuprine | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Ketamine | Sulfamethazine |
| Chloral hydrate | Ketoprofen | Sulindac |
| Chloramphenicol | Labetalol | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorothiazide | Loperamide | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Meperidine | Tetrahydrozoline |
| Cholesterol | Meprobamate | Thiamine |
| Clonidine | Methoxyphenamine | Thioridazine |
| Cortisone | Nalidixic acid | Triamterene |
| (-)-Cotinine | Naloxone | Trifluoperazine |
| Creatinine | Naltrexone | Trimethoprim |
| Deoxycorticosterone | Naproxen | DL-Tryptophan |
| Dextromethorphan | Niacinamide | Tyramine |
10
| Diclofenac | Nifedipine | DL-Tyrosine |
|---|---|---|
| Diflunisal | Norethindrone | Uric acid |
| Digoxin | Noscapine | Verapamil |
| Diphenhydramine | (±)-Octopamine | Zomepirac |
| Ecgonine methyl ester |
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 Amphetamine (AMP500), Cocaine (COC150) and Methamphetamine (MET500). The rest data were reported in the K180349. There were no differences observed for different devices.
| AMP500 | Result | % Cross-Reactivity |
|---|---|---|
| (Cut-off=500 ng/mL) | Positive at (ng/mL) | |
| D - Amphetamine | 500 | 100% |
| L - Amphetamine | 10000 | 5% |
| DL - Amphetamine | 1200 | 42% |
| Phentermine | 15000 | 3.3% |
| Hydroxyamphetamine | 4000 | 12.5% |
| Methylenedioxyamphetamine (MDA) | 500 | 100% |
| d-Methamphetamine | >100000 | 100000 |
The results summary for AMP:
| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 132 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 262 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 381 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 637 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 765 | 40 | 0 | 100 |
14
| +75% Cutoff | 20 | 884 | 20 | 0 | 100 |
|---|---|---|---|---|---|
| The results summary for BAR: |
| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 80 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 160 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 229 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 368 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 528 | 20 | 0 | 100 |
The results summary for BUP:
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 2.4 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 4.6 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 7.7 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 13.2 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 15.2 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 16.9 | 20 | 0 | 100 |
The results summary for BZO:
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 78 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 157 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 220 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 382 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 461 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 531 | 20 | 0 | 100 |
The results summary for COC:
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 39 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 80 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 115 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 192 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 221 | 40 | 0 | 100 |
15
| +75% Cutoff | 20 | 268 | 20 | 0 | 100 |
|---|---|---|---|---|---|
| The results summary for EDDP: |
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 154 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 231 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 376 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 464 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 533 | 20 | 0 | 100 |
The results summary for MDMA:
| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 122 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 265 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 386 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 633 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 768 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 890 | 20 | 0 | 100 |
The results summary for MET:
| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 134 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 259 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 383 | 0 | 20 | 90 |
| +25% Cutoff | 20 | 637 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 771 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 889 | 20 | 0 | 100 |
The results summary for MOR:
| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 78 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 154 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 229 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 369 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 457 | 40 | 0 | 100 |
16
| +75% Cutoff | 20 | 530 | 20 | 0 | 100 |
|---|---|---|---|---|---|
| The results summary for MTD: |
| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 146 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 232 | 0 | 20 | 90 |
| +25% Cutoff | 20 | 379 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 446 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 521 | 20 | 0 | 100 |
The results summary for OXY:
| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 20 | 0 | 100 |
| -75% Cutoff | 20 | 28 | 20 | 0 | 100 |
| -50% Cutoff | 170 | 48 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 79 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 129 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 147 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 179 | 20 | 0 | 100 |
The results summary for PCP:
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | |
| | | | | | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 8 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 14 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 21 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 30 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 39 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 48 | 20 | 0 | 100 |
The results summary for PPX:
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 71 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 152 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 228 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 382 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 455 | 40 | 0 | 100 |
17
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
|---|---|---|---|---|---|
| The results summary for TCA: |
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 265 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 514 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 763 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 1279 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 1531 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1782 | 20 | 0 | 100 |
The results summary for THC:
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 14 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 27 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 39 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 60 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 78 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 84 | 20 | 0 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
- Clinical Studies
Not applicable.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are substantially equivalent to the predicate.