(36 days)
No
The device description and performance studies indicate a standard immunochromatographic lateral flow assay, which does not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of certain substances in human urine, not for treating or preventing a disease or condition.
Yes
The device is described as "For in vitro diagnostic use only" and is intended for the qualitative detection of Morphine and Methamphetamine in human urine, which are diagnostic purposes.
No
The device description clearly indicates a physical test (lateral flow system) for detecting substances in urine, which is a hardware-based diagnostic method. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section clearly states: "For in vitro diagnostic use only."
- Purpose: The device is designed to detect specific substances (Morphine and Methamphetamine) in a biological sample (human urine) outside of the body. This is the core definition of an in vitro diagnostic device.
- Intended Use: The intended use describes the device's purpose in diagnosing or aiding in the diagnosis of a condition (drug use) by analyzing a sample in a laboratory or similar setting.
- Performance Studies: The document details performance studies conducted to evaluate the device's accuracy and reliability in detecting the target substances in urine samples. This is a standard requirement for IVD devices.
- Comparison to Confirmatory Methods: The document mentions that the test provides preliminary results and that a more specific alternative chemical method (like GC/MS) is needed for confirmation. This is typical for screening IVD tests.
- Predicate Device: The mention of a predicate device (K142580; Chemtrue Multi-Panel DOA DipCard Tests) which is also a drug of abuse test, further supports its classification as an IVD.
Therefore, based on the provided information, the EGENS Urine Test Cup Morphine - Methamphetamine and EGENS Urine Test DipCard Morphine - Methamphetamine are both IVD devices.
N/A
Intended Use / Indications for Use
The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.
EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.
EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Product codes
DNK, LAF
Device Description
EGENS Urine Test Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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
Over-the-Counter & Prescription Use
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
Analytical Performance - Precision Study:
- Sample size: For each concentration (-100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, at the cutoff, +25% cutoff, +75% cutoff, and +100% cutoff), tests were performed in 2 runs per day for 25 days, totaling 50 tests per concentration for each of three lots, by three operators.
- Data source: Samples prepared with known concentrations of Morphine and Methamphetamine from three different lots.
- Annotation protocol: All sample aliquots were masked and randomized. Results were recorded as positive (+) or negative (-).
Analytical Performance - Cut-off study:
- Sample size: A total of 125 morphine samples and 125 methamphetamine samples.
- Data source: Samples equally distributed at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs.
- Annotation protocol: Samples were tested using three different lots by three different operators.
Analytical Performance - Interference study:
- Sample size: Not explicitly stated as a single number, but involves adding potential interfering substances to urine samples containing target drugs (morphine or methamphetamine) at 25% below and 25% above the cut-off.
- Data source: Urine containing target drugs and potential interfering substances found in human urine of physiological or pathological conditions.
- Annotation protocol: These urine samples were tested using three batches of the EGENS Urine Test DipCard (or Cup) Morphine-Methamphetamine by three different operators. No differences observed for different formats.
Analytical Performance - Specificity study:
- Sample size: Not explicitly stated as a single number. Drug metabolites and other components likely to be present in urine samples were tested.
- Data source: Urine samples containing target drug (Morphine or Methamphetamine), its drug metabolites and related compounds.
- Annotation protocol: These samples were tested using three batches of the EGENS Urine Test DipCard (or Cup) Morphine-Methamphetamine by three different operators. The drug metabolites and other components were tested at different concentrations.
Analytical Performance - Effect of Specific Gravity and Urine pH study:
- Sample size: Twelve urine samples. Urine negative pool adjusted to various pH ranges.
- Data source: Urine samples of normal, high, and low specific gravity ranges (1.000 to 1.035) spiked with Morphine or Methamphetamine at 25% below and 25% above the corresponding cut-off level. Urine negative pool adjusted to pH ranges of 4.00 to 9.00 in 1 pH unit increments and spiked with Morphine or Methamphetamine at 25% below and 25% above the corresponding cut-off levels.
- Annotation protocol: These samples were tested using three batches of the EGENS Urine Test DipCard (or Cup) Morphine-Methamphetamine by three different operators.
Comparison Studies (Method Comparison):
- Sample size: 80 (40 negative and 40 positive) unaltered clinical samples for each format (DipCard and Cup).
- Data source: Unaltered clinical samples.
- Annotation protocol: The method comparison was performed in-house with three laboratory assistants for each format. Operators ran the samples, which were masked and randomized. The obtained test results were compared to GC/MS results.
Lay-User Study:
- Sample size: 560 lay persons; 80 tested for drug-free samples, 240 for morphine samples, 240 for methamphetamine samples.
- Data source: Urine samples prepared at -100%, +/-75%, +/-50%, +/-25% of the cut-off by spiking drugs into drug-free pooled urine specimens. Concentrations confirmed by GC/MS. Each sample aliquoted into individual containers, blind-labeled and randomized.
- Annotation protocol: Each participant was provided with the package insert, 1 blind labeled sample and a device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
a. Precision Study:
- Study Type: Precision study.
- Sample Size: 50 tests per concentration (8 concentrations) for each of 3 lots, performed by 3 operators (total 1200 tests per substance for each format - DipCard/Cup).
- Key Results:
- MOP DipCard & Cup: At the cutoff, Lot 1 showed 33+/17-, Lot 2 showed 31+/19-, Lot 3 showed 32+/18- for DipCard. For MOP Cup, Lot 1 showed 31+/19-, Lot 2 showed 32+/18-, Lot 3 showed 33+/17-. All other concentrations (-100% to -25% cutoff, +25% to +100% cutoff) showed 50-/0+ or 50+/0- respectively.
- MET DipCard & Cup: At the cutoff, Lot 1 showed 32+/18-, Lot 2 showed 30+/20-, Lot 3 showed 31+/19- for DipCard. For MET Cup, Lot 1 showed 30+/20-, Lot 2 showed 31+/19-, Lot 3 showed 30+/20-. All other concentrations (-100% to -25% cutoff, +25% to +100% cutoff) showed 50-/0+ or 50+/0- respectively.
b. Linearity: Not applicable.
c. Stability:
- Study Type: Stability testing (accelerated and real-time).
- Key Results: The device is stable at 4-30°C for 24 months.
d. Cut-off Study:
- Study Type: Cut-off verification study.
- Sample Size: 125 morphine samples and 125 methamphetamine samples.
- Key Results: All samples were positive at +25% and +50% cut-off and all negative at -25% and -50% cut-off for both morphine and methamphetamine. Verified cut-off for Morphine (MOP) is 300 ng/mL and for Methamphetamine (MET) is 1000 ng/mL.
e. Interference Study:
- Study Type: Interference study.
- Key Results: No interference observed from various substances at a concentration of 100 ug/mL. Tested 91 substances for Morphine and 96 substances for Methamphetamine.
f. Specificity Study (Cross-Reactivity):
- Study Type: Specificity testing for cross-reactivity.
- Key Results:
- Morphine (MOP): Morphine, Normorphine, 6-Monoacetylmorphine, Codeine, Ethyl Morphine, Heroine showed 100% cross-reactivity at 300 ng/mL. Hydrocodone showed 10% cross-reactivity at 3,000 ng/mL. Hydromorphone showed 8% cross-reactivity at 4,000 ng/mL. Morphine-3-beta-d-glucuronide showed 30% cross-reactivity at 1,000 ng/mL. Thebaine showed 2% cross-reactivity at 15,000 ng/mL. Oxycodone and Oxymorphone showed
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2015
NANTONG EGENS BIOTECHNOLOGY CO., LTD. C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20878
Re: K151557
Trade/Device Name: EGENS Urine Test Cup Morphine - Methamphetamine. EGENS Urine Test DipCard Morphine - Methamphetamine Regulation Number: 21 CFR 862.3640 Regulation Name: Morphine test system Regulatory Class: II Product Code: DNK, LAF Dated: June 3, 2015 Received: June 10, 2015
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151557
Device Name
EGENS Urine Test Cup Morphine - Methamphetamine
Indications for Use (Describe)
The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.
EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use ..
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K151557
Device Name
EGENS Urine Test DipCard Morphine - Methamphetamine
Indications for Use (Describe)
The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.
EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.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
| 1. Date: | July 9, 2015 |
|---|---|
| Submitter: | NANTONG EGENS BIOTECHNOLOGY, LTD. |
| Building 15, 1692 Xinghu Avenue, | |
| Nantong 226010, China | |
| 2. Contact person: | Yan Cao |
| NANTONG EGENS BIOTECHNOLOGY, LTD. | |
| Building 15, 1692 Xinghu Avenue, | |
| Nantong 226010, China | |
| Phone: 86-0513-85920700 | |
| Email: cyhfhjn@163.com |
-
- Device Name: EGENS Urine Test Cup Morphine - Methamphetamine EGENS Urine Test DipCard Morphine - Methamphetamine Classification: Class II
| Product Code | CFR # | Panel |
|---|---|---|
| DNK | 21 CFR, 862.3640 Morphine Test System | Toxicology |
| LAF | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |
- Predicate Devices: K142580
Chemtrue Multi-Panel DOA DipCard Tests
-
- Intended Use:
The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.
- Intended Use:
EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.
EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result.
5
GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
-
- Device Description:
EGENS Urine Test Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
- Device Description:
| Item | Device | Predicate - K142580 |
|---|---|---|
| Indication(s) | ||
| for use | For the qualitative determination of | |
| drugs of abuse in human urine | Same | |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays | ||
| based on the principle of antigen | ||
| antibody immunochemistry. | Same | |
| Results | Qualitative | Same |
| Specimen | ||
| Type | Human urine | Same |
| Cut Off Values | Morphine: 300ng/ml | |
| Methamphetamine: 1000ng/ml | Same for Morphine and | |
| Methamphetamine | ||
| Configurations | Cup and Dipcard | Dipcard |
| Conditions for | ||
| Use | Over-the-Counter & Prescription | |
| Use | Same |
-
- Substantial Equivalence Information
8. Test Principle
The EGENS Urine Test Morphine-Methamphetamine test is a rapid test for the qualitative detection of Morphine and Methamphetamine 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 below its cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
6
9. 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, at the cut-off, +25% cut-off, +75% cut-off and +100% cut-off. For each concentration, tests were performed two runs per day by three operators for 25 days. All sample aliquots were masked and randomized. The results obtained are summarized in the following tables:
| Result
MOP | -100%
cut-off | -75%
cut-off | -50%
cut-off | -25%
cut-off | cut-off | +25%
cut-off | +50%
cut-off | +75%
cut-off | +100%
cut-off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 33+/17- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31+/19- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32+/18- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
A. For Morphine (MOP) DipCard
B. For Methamphetamine (MET) DipCard
| Result
MET | -100%
cut-off | -75%
cut-off | -50%
cut-off | -25%
cut-off | cut-off | +25%
cut-off | +50%
cut-off | +75%
cut-off | +100%
cut-off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32+/18- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30+/20- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31+/19- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
C. For Morphine (MOP) Cup
| Result
MOP | -100%
cut-off | -75%
cut-off | -50%
cut-off | -25%
cut-off | cut-off | +25%
cut-off | +50%
cut-off | +75%
cut-off | +100%
cut-off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31+/19- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32+/18- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 33+/17- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
D. For Methamphetamine (MET) Cup
7
| Result
MET | -100%
cut-off | -75%
cut-off | -50%
cut-off | -25%
cut-off | cut-off | +25%
cut-off | +50%
cut-off | +75%
cut-off | +100%
cut-off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30+/20- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31+/19- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30+/20- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity
Not applicable.
c. Stability
The EGENS Urine Test Morphine-Methamphetamine is stable at 4-30°C for 24 months as determined by conducting accelerated and real-time stability testing.
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
d. Cut-off
Cut-off studies were conducted using a total of 125 morphine samples and 125 methamphetamine samples equally distributed at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs. These samples were tested using three different lots by three different operators. Results were all positive at +25% and +50% cut-off and all negative at -25% and -50% cut-off for both morphine and methamphetamine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off
(ng/ml) |
|-----------------------|-------------------|--------------------|
| Morphine (MOP ) | Morphine | 300 |
| Methamphetamine (MET) | D-Methamphetamine | 1000 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to urine containing target drugs (morphine or methamphetamine) at 25% below and 25% above the cut-off. These urine samples were tested using three batches of the EGENS Urine Test DipCard (or Cup) Morphine-Methamphetamine by three different operators. There were no differences observed for different formats. Compounds that showed no interference at a concentration of 100ug/mL are summarized below:
8
Morphine
| 4-Acetamidophenol | Ecgonine methylester | Oxolinic acid |
|---|---|---|
| Acetaminophen | (-)-Y-Ephedrine | Oxycodone |
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N-Acetvprocainamide | Fenoprofen | Penicillin-G |
| Acetylsalicylate | Furosemide | Pentobarbital |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amityptyline | Hemoglobin | Phencyclidine |
| Amorbarbital | Hydralazine | Phenelzine |
| Amoxicillin | Hydrochlorothiazide | Phenobarbital |
| Ampicillin | Hydrocortisone | L-Phenylephrine |
| l-Ascorbic Acid | O-Hydroxyhippuric acid | b-Phenylethylamine |
| Apormorphine | p-Hydroxy-methamphetamine | Phenylpropanotamine |
| Aspartame | 3-Hydroxytyramine | Prednisone |
| Atropine | Ibuprofen | Prednisolone |
| Benzilic acid | Imipramine | Procaine |
| Benzoic acid | (±)Isoproterenol | D.L-Propanolol |
| Benzoylecgonine | Isoxsuprine | D-Propoxyphene |
| Bilirubin | Ketamine | D-Pseudoephedrine |
| Caffeine | Ketoprofen | Quinine |
| Cannabidiol | Labetalol | Ranitidine |
| Chloralhydrate | Loperamide | Salicylic acid |
| Chloramphenicol | Loxapine succinate | Secobarbital |
| Chlordiazepoxide | Maprotiline | Serotonin |
| (5-Hydroxytyramine) | ||
| Chlorothiazide | Meperidine | Sulfamethazine |
| Chlorpromazine | Meprobamate | Sulindac |
| Chlorquine | Methadone | Temazepam |
| Cholesterol | Methoxyphenamine | Tetracycline |
| Clomipramine | (+)3,4-Methylenedioxy-amphetamine | Tetrahydrocortisone,3 |
| Acetate | ||
| Clonidine | (+)3,4-Methylenedioxy-methamphetamine | Tetrahydrocortisone 3 |
| (ß-D glucuronide) | ||
| Cocaine hydrochloride | Nalidixic acid | Tetrahydrozoline |
| (-)cotinine | Nalorphine | Thiamine |
| Creatinine | Naloxone | Thioridazine |
| Dextromethlorphan | Naltrexone | D.L-Tyrosine |
| Deoxycorticosterone | Naproxen | Tolbutamide |
| Diazepam | Niacinamide | Triamterene |
| Diclolrfenac | Nifedipine | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Diaoxin | D-Norpropoxyphene | Tryptamine |
| Diphenhydramine | Noscapine | D.L-Tryptophan |
| Doxylamine | D.L-Octopamine | Tyramine |
| Ecgonine hydrochloride | Oxalic acid | Uric acid |
| β-Estradiol | Oxazepam | Verapamil |
| Estrone-3-sulfate | Papaverine | Zomepirac |
9
Methamphetamine
| 4-Acetamidophenol | Estrone-3-sulfate | Oxycodone |
|---|---|---|
| Acetaminophen | Erythromycin | Papaverine |
| Acetophenetidin | Fenoprofen | Penicillin-G |
| N-Acetylprocainamide | Furosemide | Pentobarbital |
| Acetylsalicylate | Gentisic acid | Perphenazine |
| Aminopyrine | Hemoglobin | Phencyclidine |
| Amitriptyline | Hydralazine | Phenelzine |
| Amorbarbital | Hydrochlorothiazide | Phenobarbital |
| Amoxicillin | Hydrocodone | L-Phenylephrine |
| Ampicillin | Hydrocortisone | Phenylpropanotamine |
| 1-Ascorbic Acid | O-Hydroxyhippuric acid | Prednisone |
| Apormorphine | 3-Hydroxytyramine | Prednisolone |
| Aspartame | Ibuprofen | Procaine |
| Atropine | Imipramine | D.L-Propanolol |
| Benzilic acid | (±)Isoproterenol | D-Propoxyphene |
| Benzoic acid | Isoxsuprine | D-Pseudoephedrine |
| Benzoylecgonine | Ketamine | Quinine |
| Bilirubin | Ketoprofen | Ranitidine |
| Caffeine | Labetalol | Salicylic acid |
| Cannabidiol | Loperamide | Secobarbital |
| Chloralhydrate | Loxapine succinate | Serotonin |
| (5-Hydroxytyramine) | ||
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide | Meperidine | Sulindac |
| Chlorothiazide | Meprobamate | Temazepam |
| Chlorpromazine | Methadone | Tetracycline |
| Cholesterol | Methoxyphenamine | Tetrahydrocortisone,3 Acetate |
| Clomipramine | Morphine-3-β-Dglucuronide | Tetrahydrocortisone 3 (β-D |
| glucuronide) | ||
| Clonidine | Nalidixic acid | Tetrahydrozoline |
10
| Cocaine hydrochloride | Nalorphine | Thebaine |
|---|---|---|
| Codeine | Naloxone | Thiamine |
| (-)cotinine | Naltrexone | Thioridazine |
| Creatinine | Naproxen | D.L-Tyrosine |
| Dextromethlorphan | Niacinamide | Tolbutamide |
| Deoxycorticosterone | Nifedipine | Triamterene |
| Diazepam | Norethindrone | Trifluoperazine |
| Diclolrfenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Tryptamine |
| Diaoxin | D.L-Octopamine | D.L-Tryptophan |
| Diphenhydramine | Oxalic acid | Tyramine |
| Doxylamine | Oxazepam | Uric acid |
| Ecgonine | ||
| hydrochloride | Oxolinic acid | Verapamil |
| β-Estradiol | Oxymetazoline | Zomepirac |
| Ecgonine methylester |
f. Specificity
To test the specificity, drug metabolites and other components that are likely to be present in urine samples were tested. The target drug (Morphine or Methamphetamine), its drug metabolites and the related compounds were studied. These samples were tested using three batches of the EGENS Urine Test DipCard (or Cup) Morphine-Methamphetamine by three different operators. The drug metabolites and other components were tested at different concentrations. The obtained lowest detectable concentration was used to calculate the cross-reactivity. Results are shown in the following tables. There were no differences observed for different formats.
| MOP
(Morphine,
Cut-off=300 ng/mL) | Result | %
Cross-Reactivity |
|-----------------------------------------|--------------------------|-----------------------|
| Morphine | Positive at 300 ng/mL | 100% |
| Normorphine | Positive at 300 ng/mL | 100% |
| 6-Monoacetylmorphine | Positive at 300 ng/mL | 100% |
| Codeine | Positive at 300 ng/mL | 100% |
| Ethyl Morphine | Positive at 300 ng/mL | 100% |
| Heroine | Positive at 300 ng/mL | 100% |
| Hydrocodone | Positive at 3,000 ng/mL | 10% |
| Hydromorphone | Positive at 4,000 ng/mL | 8% |
| Morphine-3-β-d-glucuronide | Positive at 1,000 ng/mL | 30% |
| Thebaine | Positive at 15,000 ng/mL | 2% |
11
| Oxycodone | Negative at 100,000 ng/mL | 50 years. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cut-off by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:
| DipCard format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Morphine | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 2 | 18 | 90% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% | |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Methamphetamine | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 2 | 18 | 90% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
15
| Cup format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Morphine | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 85% | |
| +25% | 20 | 2 | 18 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% | |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Methamphetamine | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 85% | |
| +25% | 20 | 2 | 18 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 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 the package insert and the score revealed a reading grade level of less than 7.
-
- Clinical Studies
Not applicable.
- Clinical Studies
10. Conclusion
Based on the test principle and performance characteristics of the device, it's concluded that EGENS Urine Test DipCard Morphine -Methamphetamine and EGENS Urine Test Cup Morphine -Methamphetamine are substantially equivalent to the predicate.