(43 days)
Not Found
No
The device description and performance studies focus on immunochromatographic assay technology and manual interpretation of results, with no mention of AI or ML.
No
This device is an immunochromatographic assay for the qualitative determination of substances (MDMA and Phencyclidine) in human urine, making it an in vitro diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." and the "Device Description" section refers to them as "in vitro diagnostic devices".
No
The device is described as an immunochromatographic assay available in physical formats (Strip, Cassette, Dip Card, Cup) and contains physical components like a Test Device, package insert, and desiccant. This indicates it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text explicitly states "For in vitro diagnostic use only" multiple times in the "Intended Use / Indications for Use" and "Device Description" sections.
- Intended Use: The device is intended for the qualitative determination of substances (Methylenedioxymethamphetamine and Phencyclidine) in a human biological sample (urine). This is a core characteristic of an IVD.
- Device Description: The description details the components and format of the device, which is designed to perform a test on a sample outside of the body.
- Regulatory Context: The mention of a "Predicate Device(s) (K number(s) and name(s))" indicates that this device is being compared to a previously cleared device under regulatory frameworks that govern IVDs (like the FDA in the US).
Therefore, based on the provided text, the Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are clearly identified as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 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. It is intended for prescription and for over-the-counter use.
Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 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. It is intended for prescription and for over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
LAF, LCM
Device Description
Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are immunochromatographic assays for Methylenedioxymethamphetamine and Phencyclidine. Each assay test is a lateral flow system for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package Each test device is sealed with a desiccant in an aluminum pouch. insert.
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
It is intended for prescription and for over-the-counter 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
Precision Test Set:
Samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% 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 GC/MS. All sample aliquots were blind labeled and randomized by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format of devices. Different set of operators tested each format.
Method Comparison Test Set:
80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The method comparison studies were performed in-house with three different laboratory assistants for each format of the device.
Lay-user Study Test Set:
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 GC/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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical Performance - Precision
Sample Size: For each concentration level stated in the test set description, tests were performed two runs per day for 25 days, implying 50 tests per concentration level per lot. Several lots were used. For each lot, at some concentrations (e.g., -100%, -75%, -50% -25% cut-off, +25%, +50%, +75%, +100% cut-off), results showed 50-/0+ or 50+/0-, meaning 50 negative results and 0 positive, or 50 positive and 0 negative. At the cut-off concentration, the results were mixed (e.g., 22-/28+, 24-/26+, 30-/20+ for MDMA and 20-/30+, 18-/32+, 22-/28+, 16-/34+ for Phencyclidine), indicating both positive and negative results close to the cutoff. This demonstrates the precision of the device around the cutoff.
Study Type: Analytical Performance - Cut-off
Sample Size: 150 samples for each target drug (MDMA and Phencyclidine), equally distributed at concentrations of -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off.
Key Results: Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for both Methylenedioxymethamphetamine and Phencyclidine tests.
Study Type: Analytical Performance - Interference
Sample Size: Not explicitly stated as a number, but various interfering substances (listed in tables) were added to drug-free urine and target drugs urine at 25% above cut-off levels. Tested using three batches of each device for all formats.
Key Results: Compounds listed showed no interference at a concentration of 100µg/mL. There were no differences observed for different formats.
Study Type: Analytical Performance - Specificity
Sample Size: Not explicitly stated as a number, but drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats.
Key Results: Cross-reactivity percentages were determined for related compounds. For MDMA, Methylenedioxymethamphetamine showed 100% cross-reactivity at 500 ng/mL, 3,4-Methylenedioxyamphetamine HCl (MDA) at 17% (3000 ng/mL), and 3,4-Methylenedioxyethylamphetamine (MDEA) at 167% (300 ng/mL). d-methamphetamine showed 20% cross-reactivity (2500 ng/mL) while other amphetamines were not detected at >100,000. For Phencyclidine, Phencyclidine itself showed 100% at 25 ng/mL, and 4-Hydroxy Phencyclidine at 28% (90 ng/mL).
Study Type: Effect of Urine Specific Gravity and Urine pH
Sample Size: Not explicitly stated as a number, but urine samples with specific gravity from 1.000 to 1.035 or pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. Tested using three batches of each device for all formats.
Key Results: 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 formats.
Study Type: Comparison Studies (Clinical samples vs. GC/MS)
Sample Size: 80 unaltered clinical samples (40 negative and 40 positive) for each drug (MDMA and Phencyclidine) and each device format (Strip, Cassette, Cup, Dip Card).
Key Results:
For MDMA (Ecstasy) in Strip, Cassette, Cup, and Dip Card formats, across three viewers (A, B, C):
- Negative, Low Negative, and Near Cutoff Negative samples by GC/MS (e.g., 10 negative, 15 low negative, 15 near cutoff negative) consistently yielded 0 positive results and the full sample count as negative.
- Near Cutoff Positive by GC/MS (e.g., 13 or 14 samples) yielded mostly positive results (e.g., 13 or 14 positive) and few negative results (e.g., 2 to 3 negative).
- High Positive by GC/MS (24 samples) consistently yielded 24 positive results and 0 negative.
- Discordant results indicate some false negatives for samples around the cutoff concentrated around the cutoff concentration as determined by GC/MS.
For Phencyclidine in Strip, Cassette, Cup, and Dip Card formats, across three viewers (A, B, C):
- Negative, Low Negative, and Near Cutoff Negative samples by GC/MS (e.g., 10 negative, 15 low negative, 15 near cutoff negative) consistently yielded 0 positive results and the full sample count as negative.
- Near Cutoff Positive by GC/MS (e.g., 12, 13, or 14 samples) yielded mostly positive results (e.g., 12 to 14 positive) and few negative results (e.g., 2 to 4 negative).
- High Positive by GC/MS (24 samples) consistently yielded 24 positive results and 0 negative.
- Discordant results indicate some false negatives for samples around the cutoff concentrated around the cutoff concentration as determined by GC/MS.
Study Type: Lay-user study
Sample Size: 557 lay persons for MDMA (Ecstasy) devices and 555 lay persons for Phencyclidine devices. Total of 1112 individuals. Age range 21 to >50 years.
Key Results:
For MDMA (Ecstasy) across all formats (Strip, Cassette, Dip Card, Cup):
- For samples at -100%, -75%, -50% Cutoff, 100% correct results (all negative).
- For samples at -25% Cutoff, 95% correct results (1 positive, 19 negative out of 20 samples), except for cassette and cup formats where the value is missing in the table, but indicated by a garbled text implying the same or similar result to dip card.
- For samples at +25% Cutoff, 95% correct results (19 positive, 1 negative out of 20 samples), except for cassette and cup formats where the value is missing in the table, but indicated by a garbled text implying the same or similar result to dip card.
- For samples at +50% and +75% Cutoff, 100% correct results (all positive).
For Phencyclidine across all formats (Strip, Cassette, Dip Card, Cup):
- For samples at -100%, -75%, -50% Cutoff, 100% correct results (all negative).
- For samples at -25% Cutoff, 95% correct results (1 positive, 19 negative out of 20 samples) for Strip and Cassette formats. For DipCard and Cup, it was 90% correct (2 positive, 18 negative out of 20 samples).
- For samples at +25% Cutoff, 95% correct results (19 positive, 1 negative out of 20 samples) for Strip, Cassette and Cup formats. For DipCard, it was 90% correct (18 positive, 2 negative out of 20 samples).
- For samples at +50% and +75% Cutoff, 100% correct results (all positive), except +75% cutoff for Phencyclidine DipCard and Cup where it was 19 samples, 100% correct (all positive).
Surveys indicated that instructions were easily followed (Flesch-Kincaid Grade Level of 7).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Values for sensitivity, specificity, PPV, NPV are not explicitly calculated or presented as such, but the raw data from precision and comparison studies (positive/negative counts at different concentrations relative to cutoff and GC/MS confirmed values) could be used to infer them.
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.
K052115 First Check Multi Drug Cup 12
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
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
March 4, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
HEALGEN SCIENTIFIC LLC C/O JOE XIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877
Re: K150096
Trade/Device Name: Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, LCM Dated: January 12, 2015 Received: January 20, 2015
Dear Mr. Xia:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
Katherine Serrano -A
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150096
Device Name Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card) Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
Indications for Use (Describe)
Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 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. It is intended for prescription and for over-the-counter use.
Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 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. It is intended for prescription and for over-the-counter 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:
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- Date: February 26, 2015
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- Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401
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- Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
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- Device Name: Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card) Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
Classification:
| Product Code | CFR # | Panel |
|---|---|---|
| LCM | This device has not been classified. | |
| LAF | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |
-
- Predicate Devices: K052115 First Check Multi Drug Cup 12
-
- Intended Use / Indications for Use
Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 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. It is intended for prescription and for over-the-counter use.
4
Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 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. It is intended for prescription and for over-the-counter use.
-
- Device Description
Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are immunochromatographic assays for Methylenedioxymethamphetamine and Phencyclidine. Each assay test is a lateral flow system for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package Each test device is sealed with a desiccant in an aluminum pouch. insert.
- Device Description
8. Substantial Equivalence Information
A summary comparison of features of the Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test and the predicate device is provided in Table 1 & Table 2.
| Item | Device | Predicate -
K052115 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended Use | For the qualitative determination of drugs
of abuse in human urine. | Same |
| Drug Analyte | Methylenedioxymethamphetamine | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 500 ng/mL | Same |
| Intended
Population | For over-the-counter and prescription
uses. | For
over-the-counter
use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
Table 1: Features Comparison of Healgen MDMA (Ecstasy) Test and the Predicate Device
Table 2: Features Comparison of Healgen Phencyclidine Test and the Predicate Device
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| Item | Device | Predicate - K052115 |
|---|---|---|
| Intended Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same | |
| Drug Analyte | Phencyclidine | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based | ||
| on the principle of antigen antibody | ||
| immunochemistry. | Same | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 25 ng/mL | Same |
| Intended | ||
| Population | For over-the-counter and prescription | |
| uses. | For over-the-counter | |
| use. | ||
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
9. Test Principle
Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are rapid tests for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (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 will not form in the test line region if the target drug level exceeds its cut-offconcentration 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 test has been performed properly.
10. Performance Characteristics
-
- Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% 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 GC/MS. All sample aliquots were blind labeled and randomized by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for
6
each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:
MDMA (Ecstasy)
| Result | Cut-off | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug | -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:MDMA1201001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cassette Format
| Drug | Result | -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:MDMA1201004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| | Result | -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 |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot:MDMA1201007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CUP Format
| Drug | Result | -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:MDMA1201010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MDMA1201012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Phencyclidine
Strip Format
| | Result | -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 |
|----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot:PCP1111001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:PCP1111002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:PCP1111003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
7
Cassette Format
| | Result | -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 |
|------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot:PCP1111004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:PCP1111005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:PCP1111006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| Result -100% -75% | -50% । | -25% | +25% ' | +50% +75% +100% | |||
|---|---|---|---|---|---|---|---|
| Drug | Cut-off Cut-off Cut-off Cut-off | Cut-off | Cut-off Cut-off Cut-off Cut-off | ||||
| Lot:PCP1111007 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- 50+/0- | ||||||
| Lot:PCP1111008 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- | ||||||
| Lot:PCP1111009 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- |
CUP Format
| | Result | -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 |
|------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot:PCP1111010 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:PCP1111011 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:PCP1111012 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
-
b. Linearity
Not applicable. -
c. Stability
The devices are stable at 4-30℃ for 24 months based on the accelerated stability study at 45℃ and real time stability determination at both 4 ℃ and 30℃.
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
- d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for both Methylenedioxymethamphetamine and Phencyclidine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off
(ng/mL) |
|------|------------|--------------------|
| | | |
8
| MDMA (Ecstasy) Test | Methylenedioxymethamphetamine | 500 |
|---|---|---|
| Phencyclidine Test | Phencyclidine | 25 |
- e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.
Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.
| Acetophenetidin | Ethyl Morphine | Phenelzine |
|---|---|---|
| N-Acetylprocainamide | Ethyl-p-aminobenzoate | Phenobarbital |
| Acetylsalicylic Acid | ||
| (Aspirin) | Fenoprofen | Phentermine |
| Aminopyrine | Furosemide | Phenylephrine-L |
| Amitriptyline | Gentisic acid | Phenylethylamine |
| Amoxicillin | Hemoglobin | Phenylpropanolamine |
| Amobarbital | Hydralazine | Prednisolone Acetate |
| D-Amphetamine | (+/-)-4-Hydroxyamphetamine | |
| HCL | Prednisone | |
| L-Amphetamine | Hydrochlorothiazide | Procaine(Novocaine) |
| Amphetamine Sulfate | Hydrocodone | Promazine |
| Ampicinine(Ampicillin) | Hydrocortisone | Promethazine |
| Apomorphine | a -Hydroxyhippuric acid | Propoxyphene,d- |
| L-Ascorbic Acid | p-Hydroxymethamphetamine | Propranolol |
| Aspartame | Ibuprofen | Pseudoephedrine HCL |
| Atropine | Imipramine | Quinidine |
| Benzilic acid | Isoxsuprine | Quinine |
| Benzphetamine | Isoproterenol-(+/-) | Ranitidine(Zantac) |
| Bezoic Acid | Ketamine | Salicylic Acid |
| Bilirubin | Levorphanol | Secobarbital |
| Caffeine | Loperamide | Serotonin |
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide | ||
| HCL | Meprobamate | Sulindac |
| Chloroquine | Methadone | Temazepam |
| Chlorothiazide | Methoxyphenamine | 11-Nor-Δ9-Tetrahydrocannabi |
| nol |
MDMA (Ecstasy)
9
| Chlorpheniramine | Methylphenidate | Tetracycline |
|---|---|---|
| Chlorpromazine | Nalbuphine | Tetrahydrozoline |
| Cholesterol | Nalidixic acid | Thebaine |
| Clomipramine | Naloxone hydrochloride | Thiamine |
| Clonidine hydrochloride | Naltrexone hydrochloride | L-Thyroxine |
| Codeine | Naproxen | ThioridazineHydrochloride |
| Cortisone | Niacinamide | Triamterene |
| Cotinine(-) | Nifedipine | Triflupromazine |
| Hydrochloride | ||
| Creatinine | Norethindrone | Trimethoprim |
| Deoxyepinephrine | Norpropoxyphene | Trimipramine |
| Dextromethorphan | Noscapine | Tryptamine |
| Diazepam | Oxazepam | DL-Tryptophan |
| Diflunisal | Oxycodone | Tyramine |
| Digoxin | Oxymetazoline | D/L-Tyrosine |
| Doxylamine | Papaverine | Uric Acid |
| Ecgonine methylester | Penicillin | Verapamil |
| R(-)-Epinephrine | Pentobarbital | Zomepirac |
| Erythromycin | Perphenazine | |
| Estrone-3-sulfate | Phencyclidine |
Phencyclidine
| Acetophenetidin | Ethyl-p-aminobenzoate | Phenelzine |
|---|---|---|
| N-Acetylprocainamide | Fenoprofen | Phenobarbital |
| Acetylsalicylic Acid | ||
| (Aspirin) | Furosemide | Phentermine |
| Aminopyrine | Gentisic acid | Phenylephrine-L |
| Amitriptyline | Hemoglobin | Phenylethylamine |
| Amoxicillin | Hydralazine | Phenylpropanolamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine | |
| HCL | Prednisolone Acetate | |
| D-Amphetamine | Hydrochlorothiazide | Prednisone |
| L-Amphetamine | Hydrocodone | Procaine(Novocaine) |
| Amphetamine Sulfate | Hydrocortisone | Promazine |
| Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Promethazine |
| Apomorphine | p-Hydroxymethamphetamine | Propoxyphene,d- |
| L-Ascorbic Acid | Ibuprofen | Propranolol |
| Aspartame | Imipramine | Pseudoephedrine HCL |
| Atropine | Isoxsuprine | Quinidine |
| Benzilic acid | Isoproterenol-(+/-) | Quinine |
10
| Benzphetamine | Ketamine | Ranitidine(Zantac) |
|---|---|---|
| Bezoic Acid | Labetalol | Salicylic Acid |
| Bilirubin | Levorphanol | Secobarbital |
| Caffeine | Loperamide | Serotonin |
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide | ||
| HCL | Meprobamate | Sulindac |
| Chloroquine | Methadone | Temazepam |
| Chlorothiazide | Methoxyphenamine | 11-Nor-Δ9-Tetrahydrocannabi |
| nol | ||
| Chlorpheniramine | (+/-)-Methylenedioxyampheta | |
| mine(MDA) | Tetracycline | |
| Chlorpromazine | Methylphenidate | Tetrahydrozoline |
| Cholesterol | Nalbuphine | Thebaine |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Codeine | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cortisone | Naproxen | Triamterene |
| Cotinine(-) | Niacinamide | Triflupromazine |
| Hydrochloride | ||
| Creatinine | Nifedipine | Trimethoprim |
| Deoxyepinephrine | Norethindrone | Trimipramine |
| Dextromethorphan | Norpropoxyphene | Tryptamine |
| Diazepam | Noscapine | DL-Tryptophan |
| Diflunisal | Oxazepam | Tyramine |
| Digoxin | Oxycodone | D/L-Tyrosine |
| Doxylamine | Oxymetazoline | Uric Acid |
| Ecgonine methylester | Papaverine | Verapamil |
| R(-)-Epinephrine | Penicillin | Zomepirac |
| Erythromycin | Pentobarbital | |
| Estrone-3-sulfate | Perphenazine |
f. Specificity
To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.
| MDMA | Result | % |
|---|---|---|
| ------ | -------- | --- |
11
| Methylenedioxymethamphetamine
| (Cut-off=500 ng/mL) | Cross-Reactivity | |
|---|---|---|
| Methylenedioxymethamphetamine | Positive at 500 ng/mL | 100% |
| 3,4-Methylenedioxyamphetamine HCl | ||
| (MDA) | Positive at 3000 ng/mL | 17% |
| 3,4-Methylenedioxyethylamphetamine | ||
| (MDEA) | Positive at 300 ng/mL | 167% |
| d-methamphetamine | Positive at 2500 ng/mL | 20% |
| d-amphetamine | >100,000 | Not detected |
| l-amphetamine | >100,000 | Not detected |
| l-methamphetamine | >100,000 | Not detected |
| Phencyclidine
| (Cut-off=25 ng/mL) | Result | % Cross-Reactivity |
|---|---|---|
| Phencyclidine | Positive at 25 ng/mL | 100% |
| 4-Hydroxy Phencyclidine | Positive at 90 ng/mL | 28% |
g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine samples with of 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 batches of each device for all formats. 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 formats.
-
- Comparison Studies
The method comparison studies for the MDMA (Ecstasy) Test, and the Phencyclidine Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
- Comparison Studies
| IVALLA VIZA LEZULO V | ||||||
|---|---|---|---|---|---|---|
| Strip | ||||||
| format | Negative | Low | ||||
| Negative | ||||||
| by GC/MS | ||||||
| (less than | ||||||
| -50%) | Near Cutoff | |||||
| Negative by | ||||||
| GC/MS | ||||||
| (Between | ||||||
| -50% and | ||||||
| cut-off) | Near | |||||
| Cutoff | ||||||
| Positive by | ||||||
| GC/MS | ||||||
| (Between | ||||||
| the cut-off | ||||||
| and +50%) | High | |||||
| Positive by | ||||||
| GC/MS | ||||||
| (greater | ||||||
| than +50%) | ||||||
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| MDMA (Ecstasy) | |
|---|---|
| -- | ---------------- |
12
| Viewer B | Negative | 10 | 15 | 15 | 3 | 0 |
|---|---|---|---|---|---|---|
| Positive | 0 | 0 | 0 | 12 | 24 | |
| Viewer C | Negative | 10 | 15 | 15 | 4 | 0 |
| Positive | 0 | 0 | 0 | 13 | 24 | |
| Negative | 10 | 15 | 15 | 3 | 0 |
Discordant Results of MDMA (Ecstasy) Strip
| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 1008 | ર૦તે | Negative |
| Viewer A | 1033 | ર૦ર | Negative |
| Viewer A | 1076 | 507 | Negative |
| Viewer B | 1008 | ર૦તે | Negative |
| Viewer B | 1033 | ર૦ર | Negative |
| Viewer B | 1076 | 507 | Negative |
| Viewer B | 1037 | 211 | Negative |
| Viewer C | 1008 | ર૦તે | Negative |
| Viewer C | 1033 | ર૦ર | Negative |
| Viewer C | 1076 | 507 | Negative |
| Cassette format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of MDMA (Ecstasy) Cassette
| Cassette Format | |||
|---|---|---|---|
| Viewer | Sample Number | GC/MS Result | Viewer Results |
| Viewer A | 1008 | 509 | Negative |
| Viewer A | 1033 | 505 | Negative |
| Viewer A | 1076 | 507 | Negative |
| Viewer B | 1033 | 505 | Negative |
| Viewer B | 1037 | 511 | Negative |
13
| Viewer | Sample Number | GC/MS Result | Cassette Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer B | 1076 | 507 | Negative |
| Viewer C | 1033 | 505 | Negative |
| Viewer C | 1076 | 507 | Negative |
| Cup format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 24 |
| Negative | 10 | 15 | 15 | 4 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 |
Discordant Results of MDMA (Ecstasy) Cup
| Viewer | Sample Number | GC/MS Result | Cup Format | |
|---|---|---|---|---|
| Viewer Results | ||||
| Viewer A | 1008 | ર09 | Negative | |
| Viewer A | 1033 | ર૦ર | Negative | |
| Viewer A | 1076 | 507 | Negative | |
| Viewer B | 1008 | ર૦તે | Negative | |
| Viewer B | 1033 | ૨૦૨ | Negative | |
| Viewer B | 1076 | 507 | Negative | |
| Viewer B | 1037 | 211 | Negative | |
| Viewer C | 1008 | ર૦તે | Negative | |
| Viewer C | 1033 | ર૦ર | Negative | |
| Viewer C | 1076 | 507 | Negative |
| Dip Card
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
14
| Negative | 10 | 15 | 15 | 2 | 0 | |
|---|---|---|---|---|---|---|
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 15 | 15 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 |
Discordant Results of MDMA (Ecstasy) Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 1033 | 505 | Negative |
| Viewer A | 1076 | 507 | Negative |
| Viewer B | 1033 | 505 | Negative |
| Viewer C | 1008 | 509 | Negative |
| Viewer C | 1033 | 505 | Negative |
| Viewer C | 1076 | 507 | Negative |
| Phencyclidine | ||||||
|---|---|---|---|---|---|---|
| Strip format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 |
Discordant Results of Phencyclidine Strip
| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 774 | 26 | Negative |
| Viewer A | 721 | 25 | Negative |
| Viewer A | 779 | 27 | Negative |
| Viewer B | 774 | 26 | Negative |
| Viewer B | 721 | 25 | Negative |
| Viewer B | 702 | 27 | Negative |
| Viewer C | 721 | 25 | Negative |
| Viewer C | 704 | 27 | Negative |
15
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|---|---|---|---|
| Viewer C | 779 | 27 | Negative |
| Cassette format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 24 |
| Negative | 10 | 15 | 15 | 4 | 0 |
Discordant Results of Phencyclidine Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results |
|---|---|---|---|
| Viewer A | 774 | 26 | Negative |
| Viewer A | 721 | 25 | Negative |
| Viewer B | 774 | 26 | Negative |
| Viewer B | 721 | 25 | Negative |
| Viewer B | 702 | 27 | Negative |
| Viewer C | 774 | 26 | Negative |
| Viewer C | 721 | 25 | Negative |
| Viewer C | 704 | 27 | Negative |
| Viewer C | 779 | 27 | Negative |
| Dip Card
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
16
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
|---|---|---|---|---|---|---|
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 24 |
| Negative | 10 | 15 | 15 | 4 | 0 |
| Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results |
|---|---|---|---|
| Viewer A | 774 | 26 | Negative |
| Viewer A | 721 | 25 | Negative |
| Viewer A | 779 | 27 | Negative |
| Viewer B | 774 | 26 | Negative |
| Viewer B | 721 | 25 | Negative |
| Viewer B | 702 | 27 | Negative |
| Viewer C | 774 | 26 | Negative |
| Viewer C | 721 | 25 | Negative |
| Viewer C | 779 | 27 | Negative |
| Viewer C | 704 | 27 | Negative |
Discordant Results of Phencyclidine Dip Card
| Cup
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|---------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
Discordant Results of Phencyclidine Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
|---|---|---|---|
| Viewer A | 774 | 26 | Negative |
| Viewer A | 721 | 25 | Negative |
| Viewer A | 779 | 27 | Negative |
| Viewer B | 774 | 26 | Negative |
| Viewer B | 721 | 25 | Negative |
17
| Viewer | Sample Number | GC/MS Result | Cup Format
Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer B | 702 | 27 | Negative |
| Viewer C | 721 | 25 | Negative |
| Viewer C | 779 | 27 | Negative |
| Viewer C | 704 | 27 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 557 lay persons testing the MDMA(Ecstasy) devices and another set of 555 persons testing the Phencyclidine devices. Total of 1112 individuals performed the study. A total of 230 females and 327 males tested the MDMA(Ecstasy) samples, and 226 females and 329 males tested the Phencyclidine samples. They had diverse educational and professional backgrounds and ranged in age from 21 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 GC/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. The results are summarized below.
| | Number
of
samples | MDMA Concentration by
GC/MS
(ng/mL) | Lay person results | | The |
|--------------|-------------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 125 | 0 | 20 | 100% |
| -50% Cutoff | 19 | 250 | 0 | 19 | 100% |
| -25% Cutoff | 20 | 375 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 625 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 750 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 875 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) Strip)
Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) Cassette)
| | Number | MDMA Concentration by
GC/MS
(ng/mL) | Lay person results | | The |
|-------------|---------------|-------------------------------------------|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| % of Cutoff | of
samples | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 19 | 125 | 0 | 19 | 100% |
| -50% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 375 | 1 | 19 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય |
| +25% Cutoff | 20 | ર્ભ (૧૯૮૮) | 19 | 1 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત |
18
| +50% Cutoff | 20 | 750 | 20 | 0 | 100% |
|---|---|---|---|---|---|
| +75% Cutoff | 20 | 875 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) DipCard)
| Number | MDMA Concentration by | Lay person results | The | ||
|---|---|---|---|---|---|
| % of Cutoff | of | ||||
| samples | GC/MS | ||||
| (ng/mL) | No. of | ||||
| Positive | No. of | ||||
| Negative | percentage of | ||||
| correct results | |||||
| (%) | |||||
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 125 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 375 | 1 | 19 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો |
| +25% Cutoff | 20 | ર્ભ (૧૯૮૮) | 19 | 1 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો |
| +50% Cutoff | 20 | 750 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 875 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (MDMA(Ecstasy) Cup)
| % of Cutoff | Number
of
samples | MDMA Concentration by
GC/MS
(ng/mL) | Lay person results | | The |
|-------------|-------------------------|-------------------------------------------|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 125 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 375 | 1 | 19 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય |
| +25% Cutoff | 20 | ર્ભ (૧૯૮૮) | 19 | 1 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય |
| +50% Cutoff | 19 | 750 | 19 | 0 | 100% |
| +75% Cutoff | 20 | 875 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Phencyclidine Strip)
| | Number | Phencyclidine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|-------------|---------------|----------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| % of Cutoff | of
samples | | No. of
Positive | No. of
Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 19 | 6 | 0 | 19 | 100% |
| -50% Cutoff | 20 | 12.5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 19 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 31 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100% |
19
| | Number
of
samples | Phencyclidine
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|-------------|-------------------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 19 | 12.5 | 0 | 19 | 100% |
| -25% Cutoff | 20 | 19 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 31 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Phencyclidine Cassette)
Comparison between GC/MS and Lay Person Results (Phencyclidine DipCard)
| | Number
of
samples | Phencyclidine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|-------------|-------------------------|----------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| % of Cutoff | of
samples | Phencyclidine
Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | The
percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 12.5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 19 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 31 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% |
| +75% Cutoff | 19 | 44 | 19 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Phencyclidine Cup)
| % of Cutoff | Number
of
samples | Phencyclidine
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|-------------|-------------------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 19 | 12.5 | 0 | 19 | 100% |
| -25% Cutoff | 20 | 19 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 31 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 37.5 | 20 | 0 | 100% |
| +75% Cutoff | 19 | 44 | 19 | 0 | 100% |
20
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 and method comparison of the devices, it's concluded that the Healgen MDMA(Ecstasy) Test, and Healgen Phencyclidine Test are substantially equivalent to the predicate.