(159 days)
No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation. There is no mention of AI, ML, or image processing.
No.
The device is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of various drugs in human urine, providing only preliminary test results. It is explicitly stated that a more specific chemical method is needed for confirmed analytical results, indicating it is a diagnostic tool, not a therapeutic one.
Yes.
The device is intended for the "qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine". This act of detection and identification of substances in a biological sample is a form of diagnostic testing. The text explicitly states that it "provides only preliminary test results," which are then subject to "more specific alternative chemical method[s]" for confirmation, further indicating its role in a diagnostic process.
No
The device is described as a "competitive binding, lateral flow immunochromatographic assay" in both the Intended Use and Device Description sections, which are physical test kits (dip cards and cups) for detecting drugs in urine. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine". This involves testing a sample taken from the human body (in vitro) to provide diagnostic information (detection of drugs).
- Device Description: The description details a "lateral flow immunochromatographic assay" that analyzes "human urine samples". This is a common method used in IVD devices.
- Performance Studies: The document describes performance studies using "urine samples" and comparing results to a confirmatory method (GC/MS), which is typical for validating IVD performance.
- Predicate Devices: The listed predicate devices are also described as tests for detecting substances in urine, further indicating that this device falls under the IVD category.
The core function of the device is to perform a test on a biological sample (urine) outside of the body (in vitro) to detect the presence of specific substances, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:
| Drug (identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
Configurations of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine. Nortriptyline or Oxycodone in urine. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
JXM, LFG, DJG, DIO, LDJ, LAF, DKZ, DIS, DJR, LCM
Device Description
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.
A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
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
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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
A lay user study was performed at three intended user sites with 320 lay persons for each format of the device. The lay users had diverse educational and professional backgrounds and ranged in age from 20 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 Each sample was aliquoted into individual containers and the samples were confirmed by GC/MS. Each participant was provided with the package insert, 1 blind labeled sample and a blind-labeled. Each device was tested. device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of precision, cut-off, interference, specificity and method comparison of the devices were reported in K142280, K143187, K141647, K140546, K150791, K150096 and K151348.
Lay User Verification:
A lay user study was performed at three intended user sites with 320 lay persons for each format of the device. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at various concentrations relative to the cutoff (negative, +/-75%, +/-50%, +/-25%). Samples were confirmed by GC/MS. Each participant received a package insert, a blind-labeled sample, and a device.
Key results from the lay user study comparing GC/MS and Lay Person Results for both Dip Card and Cup formats with MOP 300 and MOP 2000 cutoff values, for all tested drugs (Methamphetamine, Cocaine, Cannabinoids, Morphine, Oxazepam, Amphetamine, Oxycodone, Methadone, Secobarbital, Buprenorphine, Phencyclidine, MDMA, EDDP, Nortriptyline), showed generally high percentage agreement (100% at -100%, -75%, -50%, +50%, +75% cutoff levels, and typically 90-95% agreement at +/-25% cutoff levels).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented are "The percentage agreement (%)" of lay person results against GC/MS confirmation.
For Methamphetamine, Cocaine, Cannabinoids, Morphine, Oxazepam, Amphetamine, Oxycodone, Methadone, Secobarbital, Buprenorphine, Phencyclidine, MDMA, EDDP, Nortriptyline across both Dip Card and Cup formats (with MOP 300 and MOP 2000):
- At -100% Cutoff: 100% agreement (0 Positive, 20 Negative)
- At -75% Cutoff: 100% agreement (0 Positive, 20 Negative)
- At -50% Cutoff: 100% agreement (0 Positive, 170 Negative)
- At -25% Cutoff: Ranged from 90% (e.g., Methamphetamine, Oxazepam, Buprenorphine, Phencyclidine, Nortriptyline: 2 Positive, 18 Negative) to 95% (e.g., Cocaine, Cannabinoids, Morphine, Amphetamine, Oxycodone, Methadone, Secobarbital, MDMA, EDDP: 1 Positive, 19 Negative). Oxazepam for Cup with MOP 300 had 85% (3 Positive, 17 Negative).
- At +25% Cutoff: Ranged from 85% (Morphine Dip Card with MOP 300: 17 Positive, 3 Negative; Oxycodone Cup with MOP 300 and MOP 2000: 17 Positive, 3 Negative) to 95% (e.g., Cocaine, Cannabinoids, Amphetamine, Methadone, Secobarbital, MDMA, EDDP: 19 Positive, 1 Negative). Oxazepam, Buprenorphine, Phencyclidine, Nortriptyline for Dip Card and Cup had 90% (18 Positive, 2 Negative).
- At +50% Cutoff: 100% agreement (50 Positive, 0 Negative)
- At +75% Cutoff: 100% agreement (20 Positive, 0 Negative)
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.
K142280, K143187, K141647, K140546, K150791, K150096, K151348
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
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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 U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
HEALGEN SCIENTIFIC LLC C/O JOE XIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE., SUITE I GAITHERSBURG MD 20877
Re: K153597
Trade/Device Name: Healgen Multi-drug Urine Test Cup, Healgen Multi-drug Urine Test Dip Card Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, LFG, DJG, DIO, LDJ, LAF, DKZ, DIS, DJR, LCM Dated: April 18, 2016 Received: April 25, 2016
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 (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
Indications for Use
510(k) Number (if known) K153597
Device Name
Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card
Indications for Use (Describe)
The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine,
Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:
| Drug (identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
Configurations of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine. Nortriptyline or Oxycodone in urine. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
-
- Date: May 23, 2016
-
- Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401
-
- Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: 713-733-8088 Fax: 713-733-8848 Email: bryan@healgen.com
-
- Device Name: Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card
Classification: Class II
| Product Code | Regulation Section | Panel |
|---|---|---|
| DKZ | ||
| Amphetamine | 21 CFR § 862.3100, Amphetamine Test System | Toxicology |
| LDJ | ||
| Cannabinoids | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology |
| DIO | ||
| Cocaine | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites | |
| Test System | Toxicology | |
| LAF | ||
| Methamphetamine | 21 CFR § 862.3610, Methamphetamine Test | |
| System | Toxicology | |
| DJG | ||
| Morphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| JXM | ||
| Oxazepam | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology |
| DJG | ||
| Oxycodone | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| DIS | ||
| Secobarbital | 21 CFR § 862.3150, Barbiturate Test System | Toxicology |
| DJG | ||
| Buprenorphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| LAF | ||
| Methylenedioxy- | ||
| methamphetamine | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology |
5
| LCM
| Phencyclidine | Enzyme Immunoassay Phencyclidine | Toxicology |
|---|---|---|
| DJR | ||
| Methadone | 21 CFR § 862.3620, Methadone Test System | Toxicology |
| DJR | ||
| EDDP | 21 CFR § 862.3620, Methadone Test System | Toxicology |
| LFG | ||
| Nortriptyline | 21 CFR, 862.3910 Tricyclic antidepressant drugs | |
| test system Test System | Toxicology | |
5. Description of the device:
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.
A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
6. Predicate Devices:
K142280; Healgen Oxazepam and Morphine Tests (Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Dip Card, Cup) K140546; Healgen Marijuana and Methamphetamine Tests (Dip Card, Cup) K150791; Healgen Secobarbital, Buprenorphine and Methadone Tests (Cup, Dip Card) K150096; Healgen Methylenedioxy-methamphetamine and Phencyclidine Tests (Dip Card, Cup) K151348; Healgen Nortriptyline and EDDP Tests (DipCard. Cup)
-
- Intended Use / Indications for Use
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone in human urine at the cutoff concentrations of:
- Intended Use / Indications for Use
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
6
| Oxazepam (OXA) | 300 ng/mL |
|---|---|
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 300ng/mL or 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine, Oxazepam, Secobarbital, Nortriptyline or Oxycodone in urine. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
-
- Substantial Equivalence Information
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are a modified product format derived from the previously FDA-cleared Healgen single DOA Tests. A summary comparison of features of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card and the predicate devices is provided in the following Table
- Substantial Equivalence Information
7
| Item | New Devices | Predicate devices (K142280,
K143187, K141647, K140546,
K150791, K150096, K151348) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication(s) for use | For the qualitative determination of
Amphetamine, Oxazepam, Cocaine,
Cannabinoids, Methamphetamine, Morphine,
Oxycodone, Secobarbital, Buprenorphine,
Methylenedioxy-methamphetamine,
Phencyclidine, EDDP, Nortriptyline and
Methadone in human urine.
The configurations of the New Devices are
available in any combination of the above
tests. | For the qualitative determination of
Amphetamine, Oxazepam, Cocaine,
Cannabinoids, Methamphetamine,
Morphine, Oxycodone,
Secobarbital, Buprenorphine,
Methylenedioxy-methamphetamine,
Phencyclidine, EDDP, Nortriptyline
and Methadone in human urine.
The configurations of the Predicate
devices are only available in single
drug test. |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on antigen-
antibody interactions to indicate positive or
negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (OXA):300 ng/ml
Cocaine(COC): 300 ng/ml
Cannabinoids (THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOR): 300ng/mL or 2000 ng/ml
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-methamphetamine(MDMA):
500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml
EDDP: 300 ng/ml
Nortriptyline : 1000 ng/ml | Same |
| Configurations | Cup, Dip Card | Same |
| Intended Use | OTC Use & Prescription Use | Same |
8
Healgen Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 14 drugs of abuse tests while the predicate devices are single-drug test. And the Healgen Multi-Drug Urine Test Dip Card is the same as the test dip card format of the predicate devices except that the Healgen Multi-Drug Urine Test Dip Card is a multi-drug test that offers any combination from 2 to 14 drugs of abuse tests while the predicate devices are single-drug test.
9. Performance
Performance data of precision, cut-off, interference, specificity and method comparison of the devices were reported in K142280, K143187, K141647, K140546, K150791, K150096 and K151348.
10.Lay User Verification
A lay user study was performed at three intended user sites with 320 lay persons for each format of the device. The lay users had diverse educational and professional backgrounds and ranged in age from 20 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 Each sample was aliquoted into individual containers and the samples were confirmed by GC/MS. Each participant was provided with the package insert, 1 blind labeled sample and a blind-labeled. Each device was tested. device.
| Drugs | % of Cutoff | Number
of samples | Lay person results | | The percentage
agreement
(%) |
|-----------------|--------------|----------------------|--------------------|-----------------|------------------------------------|
| | | | No. of
Positive | No. of Negative | |
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cannabinoids | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Morphine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 17 | 3 | 85% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Oxazepam | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Amphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Oxycodone | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Methadone | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Secobarbital | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Buprenorphine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Phencyclidine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| MDMA | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| EDDP (Methadone | -25% Cutoff | 20 | 1 | 19 | 95% |
| Metabolites) | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| Nortriptyline | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results for Dip Card with MOP 300
9
10
11
Comparison between GC/MS and Lay Person Results for Dip Card with MOP 2000
| Drugs | % of Cutoff | Number
of samples | Lay person results | | The percentage
agreement
(%) |
|---------------------------------|--------------|----------------------|--------------------|-----------------|------------------------------------|
| | | | No. of
Positive | No. of Negative | |
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cannabinoids | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Morphine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Oxazepam | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | | | | | |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Amphetamine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Oxycodone | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Methadone | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Secobarbital | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| Buprenorphine | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| Phencyclidine | -75% Cutoff | 20 | 0 | 20 | 100% |
| | | | | | |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| MDMA | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| EDDP (Methadone
Metabolites) | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Nortriptyline | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
12
13
Comparison between GC/MS and Lay Person Results for Cup with MOP 300
| Drugs | % of Cutoff | Number
of samples | Lay person results | | The
percentage
agreement
(%) |
|---------------------------------|--------------|----------------------|--------------------|--------------------|---------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | | | | | |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| Cannabinoids | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | | | | | |
| Morphine | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 20 | 0 | 100% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | | | | | |
| Oxazepam | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 3 | 17 | 85% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | | | | | |
| Amphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Oxycodone | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 17 | 3 | 85% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | | | | | |
| Methadone | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| MDMA | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Secobarbital | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Buprenorphine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Phencyclidine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| EDDP (Methadone
Metabolites) | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Nortriptyline | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
14
15
16
Comparison between GC/MS and Lay Person Results for Cup with MOP 2000
| Drugs | % of Cutoff | Number
of samples | Lay person results | | The percentage
agreement
(%) |
|---------------------------------|-------------|----------------------|--------------------|----------|------------------------------------|
| | | | No. of | No. of | |
| | | | Positive | Negative | |
| Methamphetamine | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cocaine | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cannabinoids | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Morphine | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | | | | | |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Oxazepam | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 3 | 17 | 85% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Amphetamine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Oxycodone | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 17 | 3 | 85% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| Methadone | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| MDMA | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| Secobarbital | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | | | | | |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Buprenorphine | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
| Phencyclidine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | | -100%Cutoff | 20 | 0 | 20 |
| | | -75%Cutoff | 20 | 0 | 20 |
| | | -50% Cutoff | 170 | 0 | 170 |
| EDDP (Methadone
Metabolites) | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | | -100%Cutoff | 20 | 0 | 20 |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| Nortriptyline | -50% Cutoff | 170 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 50 | 50 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | | -100%Cutoff | 20 | 0 | 20 |
| | | -75%Cutoff | 20 | 0 | 20 |
| | -50% Cutoff | 170 | 0 | 170 | 100% |
17
18
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.
11.Conclusion
Verification studies were conducted in support of the modification to have a multi-drug test cup and test card test, including interference studies and a lay-user study. Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates.