(216 days)
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, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Propoxyphene | 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.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
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, Propoxyphene, 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, Propoxyphene, 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.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each drug for the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card in the lay user study can be inferred as achieving at least 85% agreement with GC/MS results for urine samples near the cutoff concentrations (+/- 25% of cutoff). For samples further away from the cutoff (±50%, ±75%, -100% of cutoff), the acceptance criterion appears to be 100% agreement.
Healgen Multi-Drug Urine Test Cup and Dip Card Performance (Lay User Study Data)
| Drug | % of Cutoff | Number of Samples | % Agreement (Lay Person vs. GC/MS) |
|---|---|---|---|
| Methamphetamine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Cocaine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Cannabinoids (THC) | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Morphine (MOP 300) | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 85% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Morphine (MOP 2000) | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Oxazepam | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 85% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Amphetamine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Oxycodone | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Methadone | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 85% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Secobarbital | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Buprenorphine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Phencyclidine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| MDMA | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Propoxyphene | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Tricyclic Antidepressants | -100% | 20 | 100% |
| (Nortriptyline) | -75% | 20 | 100% |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% |
The device meets these acceptance criteria, as all reported percentage agreements are at or above the specified thresholds for each drug and concentration level.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For each drug analyte tested in the lay user study, the total number of samples evaluated was 300 per format (Cup and Dip Card) across different concentration levels.
- Specifically, for each drug analyte, the breakdown of samples by concentration was:
- -100% Cutoff: 20 samples
- -75% Cutoff: 20 samples
- -50% Cutoff: 160 samples
- -25% Cutoff: 20 samples
- +25% Cutoff: 20 samples
- +50% Cutoff: 40 samples
- +75% Cutoff: 20 samples
- Data Provenance: The document does not explicitly state the country of origin of the data. However, as it is a submission to the United States FDA, it is implied that the data is intended for use in the US market. The study utilized "drug free-pooled urine specimens" which were then spiked with drugs, indicating a controlled laboratory setting for sample preparation. The study was conducted at "three intended user sites" with "lay persons," suggesting a prospective evaluation of the device by untrained users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the context of this study. The ground truth was not established by human experts interpreting results from the device itself.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an objective chemical analysis method, not a subjective interpretation requiring adjudication among experts. The lay users independently read the results from the test devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement of the device's results (read by lay users) with a gold standard (GC/MS), rather than comparing the performance of human readers with and without AI assistance. The device itself is a lateral flow immunoassay, not an AI system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone study was done in the sense that the device's performance was compared directly against a definitive analytical method (GC/MS). The lay user study involved individuals interpreting the results of the device directly, without the intervention of an algorithm or AI to assist in that interpretation. The comparison is between the human interpretation of the device and the chemical gold standard, effectively evaluating the standalone performance of the rapid immunoassay device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The concentrations of the samples were confirmed by GC/MS." GC/MS is a highly accurate and widely accepted method for confirming the presence and concentration of drugs in urine, thus serving as the gold standard.
8. The Sample Size for the Training Set
- The document does not explicitly mention a training set in the context of the lay user study or the development of this specific final product (Healgen Multi-Drug Urine Test Cup/Dip Card). The performance data cited (precision, cut-off, interference, specificity, and method comparison) refers to earlier, individual FDA-cleared predicate devices (K142280, K143187, etc.). It's possible that earlier development and validation work for those predicate devices constituted a "training" or development phase, but details are not provided here. This document primarily describes the validation of the multi-drug format for lay use against a gold standard.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly described for this submission, the method for establishing its ground truth is not provided. However, for similar in-vitro diagnostic devices, the ground truth for training/development (if applicable) would typically be established using validated laboratory reference methods such as GC/MS or LC/MS, similar to the method used for the test set.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
HEALGEN SCIENTIFIC LLC C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877
August 2, 2017
Re: K163704
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, DJG, DIO, LDJ, LCM, LAF, DKZ, DIS, DJR, JXN, LFG Dated: June 26, 2017 Received: July 03, 2017
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
{1}------------------------------------------------
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/Resourcesfor You/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,
Donald J. St Pierre -S
Donald J. St. Pierre Acting Director Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card
Indications for Use (Describe)
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, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Propoxyphene | 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.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
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.
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-
- Date: December 18, 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: 713-733-8088 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 |
|---|---|---|
| DKZAmphetamine | 21 CFR § 862.3100, Amphetamine Test System | Toxicology |
| LDJCannabinoids | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology |
| DIOCocaine | 21 CFR § 862.3250, Cocaine and Cocaine MetabolitesTest System | Toxicology |
| LAFMethamphetamine | 21 CFR § 862.3610, Methamphetamine TestSystem | Toxicology |
| DJGMorphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| JXMOxazepam | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology |
| DJGOxycodone | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| DISSecobarbital | 21 CFR § 862.3150, Barbiturate Test System | Toxicology |
| DJGBuprenorphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| LAFMethylenedioxy-methamphetamine | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology |
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| LCMPhencyclidine | Enzyme Immunoassay Phencyclidine | Toxicology |
|---|---|---|
| DJRMethadone | 21 CFR § 862.3620, Methadone Test System | Toxicology |
| JXNPropoxyphene | 21 CFR § 862.3700, Propoxyphene Test System | Toxicology |
| LFGNortriptyline | 21 CFR, 862.3910 Tricyclic antidepressant drugstest 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, Propoxyphene, 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, Propoxyphene, 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 Propoxyphene Tests (DipCard, Cup) K152269; Healgen Amphetamine, Cocaine and Methamphetamine Tests (Dip Card, 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, Propoxyphene, Nortriptyline and Methadone in human urine at the cutoff concentrations of:
- Intended Use / Indications for Use
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 500 ng/mL |
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| Oxazepam (OXA) | 300 ng/mL |
|---|---|
| Cocaine (COC) | 150 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300ng/mL or 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Propoxyphene | 300 ng/mL |
| Nortriptyline (TCA) | 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.
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. 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
| Item | New Devices | Predicate devices (K142280,K143187, K141647, K140546,K150791, K150096, K151348,K152269) |
|---|---|---|
| Indication(s) for use | For the qualitative determination ofAmphetamine, Oxazepam, Cocaine,Cannabinoids, Methamphetamine, Morphine,Oxycodone, Secobarbital, Buprenorphine,Methylenedioxy-methamphetamine,Phencyclidine, Propoxyphene, Nortriptylineand Methadone in human urine.The configurations of the New Devices areavailable in any combination of the abovetests. | For the qualitative determination ofAmphetamine, Oxazepam, Cocaine,Cannabinoids, Methamphetamine,Morphine, Oxycodone,Secobarbital, Buprenorphine,Methylenedioxy-methamphetamine,Phencyclidine, Propoxyphene,Nortriptyline and Methadone inhuman urine.The configurations of the Predicatedevices are only available in singledrug test. |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely onantigen- antibody interactions to indicatepositive or negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 500 ng/mlOxazepam (OXA):300 ng/mlCocaine(COC): 150 ng/mlCannabinoids (THC):50 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOR): 300ng/mL or 2000 ng/mlOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlBuprenorphine (BUP): 10 ng/mlMethylenedioxy-methamphetamine(MDMA):500 ng/mlPhencyclidine (PCP): 25 ng/mlMethadone (MTD): 300 ng/mlPropoxyphene: 300 ng/mlNortriptyline (TCA): 1000 ng/ml | Same |
| Configurations | Cup, Dip Card | Same |
| Intended Use | OTC Use & Prescription Use | Same |
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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, K15079, K150096, K151348 and K152269.
10.Lay User Verification
A lay user study was performed at three intended user sites with 300 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 the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and Each participant was provided with the package insert, blind labeled samples and test blind-labeled. devices.
| 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 | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cannabinoids | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Morphine | -25% Cutoff | 20 | 3 | 17 | 85% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Oxazepam | -25% Cutoff | 20 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 17 | 3 | 85% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Amphetamine | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Oxycodone | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Methadone | -25% Cutoff | 20 | 3 | 17 | 85% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Secobarbital | -100%Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Buprenorphine | -25% Cutoff | 20 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Phencyclidine | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| MDMA | -25% Cutoff | 20 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Propoxyphene | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| Tricyclic | -50% Cutoff | 160 | 0 | 160 | 100% |
| Antidepressants | -25% Cutoff | 20 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
Comparison between GC/MS and Lav Person Results for Dip Card with MOP 300
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
| +75% Cutoff | 20 | 20 | 0 | 100% | |
|---|---|---|---|---|---|
| Drugs | % of Cutoff | Number of samples | Lay person results No. of Positive | Lay person results No. of Negative | The percentage agreement (%) |
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cannabinoids | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Morphine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Oxazepam | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Comparison between GC/MS and Lay Person Results for Dip Card with MOP 2000 | |||||
| Amphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 3 | 17 | 85% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Oxycodone | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 3 | 17 | 85% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Methadone | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Secobarbital | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 0 | 20 | 100% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Buprenorphine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Phencyclidine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| MDMA | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Propoxyphene | -25% Cutoff | 20 | 3 | 17 | 85% |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| TricyclicAntidepressants | -25% Cutoff | 20 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% |
{12}------------------------------------------------
{13}------------------------------------------------
Comparison between GC/MS and Lay Person Results for Cup with MOP 300
| Drugs | % of Cutoff | Numberof samples | Lay person results | Thepercentageagreement(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| Cannabinoids | +50% Cutoff | 40 | 40 | 0 | 100% |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 3 | 17 | 85% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| Morphine | +50% Cutoff | 40 | 40 | 0 | 100% |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| Oxazepam | +50% Cutoff | 40 | 40 | 0 | 100% |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| Amphetamine | +50% Cutoff | 40 | 40 | 0 | 100% |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| Oxycodone | +50% Cutoff | 40 | 40 | 0 | 100% |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| Methadone | +50% Cutoff | 40 | 40 | 0 | 100% |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | તેરજ | |
| +25% Cutoff | 20 | 1 d | l | તેરજ | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| MDMA | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 19 | l | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી ત | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Secobarbital | -25% Cutoff | 20 | 1 | 19 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી |
| +25% Cutoff | 20 | 1 d | l | તે તે જેવી 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 | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| Buprenorphine | -25% Cutoff | 20 | 1 | 19 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 1 60 | 100% | |
| Phencyclidine | -25% Cutoff | 20 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 19 | l | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી ત | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| Propoxyphene | -50% Cutoff | 160 | 0 | 160 | 100% |
| -25% Cutoff | 20 | 1 | 19 | તેરજ | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100%Cutoff | 20 | 0 | 20 | 100% | |
| TricyclicAntidepressants | -75%Cutoff | 20 | 0 | 20 | 100% |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 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 Positive | No. of Negative | ||||
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 17 | 3 | 85% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Cannabinoids | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Morphine | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Oxazepam | -100% Cutoff | 20 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| Amphetamine | -50% Cutoff | 160 | 0 | 160 | 100% |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| -75% Cutoff | 20 | 0 | 20 | 100% | |
| Oxycodone | -50% Cutoff | 160 | 0 | 160 | 100% |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| Methadone | -75% Cutoff | 20 | 0 | 20 | 100% |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| MDMA | -75% Cutoff | 20 | 0 | 20 | 100% |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| -100% Cutoff | 20 | 0 | 20 | 100% | |
| Secobarbital | -75% Cutoff | 20 | 0 | 20 | 100% |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Buprenorphine | -100%Cutoff | 20 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Phencyclidine | -100%Cutoff | 20 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| Propoxyphene | -100%Cutoff | 20 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 1 | 19 | 95% | |
| +25% Cutoff | 20 | 18 | 2 | 90% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 100% | |
| TricyclicAntidepressants | -100%Cutoff | 20 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 0 | 20 | 100% | |
| -50% Cutoff | 160 | 0 | 160 | 100% | |
| -25% Cutoff | 20 | 2 | 18 | 90% | |
| +25% Cutoff | 20 | 19 | 1 | 95% | |
| +50% Cutoff | 40 | 40 | 0 | 100% | |
| +75% Cutoff | 20 | 20 | 0 | 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.
§ 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).