(159 days)
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.
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.
The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are devices for qualitative and simultaneous detection of various drugs in human urine. The study conducted was a lay user study to verify the device's performance when used by individuals without professional training.
Here's the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the percentage agreement with GC/MS (Gas Chromatography/Mass Spectrometry) results for different drug concentrations relative to the cutoff level. While no explicit percentage agreement threshold is stated as an "acceptance criteria", standard practice in such studies would expect high agreement for samples at or significantly away from the cutoff. The reported performance shows high agreement, particularly at concentrations of -50% Cutoff, +50% Cutoff, and +75% Cutoff.
Reported Device Performance based on Lay User Study (Agreement with GC/MS):
| Drug Category | Concentration (% of Cutoff) | Number of Samples | % Agreement (Lay Person vs. GC/MS) |
|---|---|---|---|
| For all Drugs Tested | -100% Cutoff | 20 | 100% |
| -75% Cutoff | 20 | 100% | |
| -50% Cutoff | 170 | 100% | |
| -25% Cutoff | 20 | 85-95% (varied by drug/device) | |
| +25% Cutoff | 20 | 85-95% (varied by drug/device) | |
| +50% Cutoff | 50 | 100% | |
| +75% Cutoff | 20 | 100% |
Note: The specific percentage agreement for -25% and +25% cutoff concentrations varied slightly across different drugs and device types (dip card vs. cup). For instance, Morphine at +25% Cutoff for the dip card and Oxycodone at +25% Cutoff for the cup showed 85% agreement, while others were 90-95%. Oxazepam at -25% Cutoff for the cup also showed 85% agreement.
2. Sample Sizes and Data Provenance
- Test Set Sample Size: For each drug and concentration level (e.g., Methamphetamine at -100% Cutoff), there were between 20 and 170 samples tested. Each device format (Cup and Dip Card) was tested with these samples across all drugs.
- For -100%, -75%, -25%, +25%, +75% Cutoff, there were 20 samples each.
- For -50% Cutoff, there were 170 samples.
- For +50% Cutoff, there were 50 samples.
- Total samples per drug per device format were 20+20+170+20+20+50+20 = 320 samples.
- Given there are 14 drugs, the total number of samples processed by lay users for each device format would be approximately 14 drugs * 320 samples/drug = 4480 samples.
- Data Provenance: Not explicitly stated regarding the country of origin of the data. The study was a prospective lay user study where urine samples were prepared and then tested by lay users.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of human readers for generating ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was established by an independent laboratory method (GC/MS, see point 7).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this was not a MRMC comparative effectiveness study involving human readers with and without AI assistance. This study focused on the performance of a point-of-care test when interpreted by lay users.
6. Standalone Performance
- Standalone Performance: Yes, the study evaluates the standalone performance of the device (Healgen Multi-Drug Urine Test Cup and Dip Card) when used directly by lay users. The outcome of the device (positive/negative line on the test strip) as interpreted by the lay user is compared against the GC/MS reference standard.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test set was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug concentration in urine samples.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a separate training set. The device is a lateral flow immunochromatographic assay, not an AI/ML algorithm that typically requires a training set. The "performance data of precision, cut-off, interference, specificity and method comparison" were reported in predicate device submissions (K142280, K143187, K141647, K140546, K150791, K150096 and K151348), implying these established characteristics during the development of earlier versions.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable as there is no specific "training set" for the device in the context of AI/ML or expert interpretation. The performance characteristics of the assay would have been established through a series of analytical studies using known concentrations and confirmed methods (like GC/MS) during its development and prior submissions, which serve as the foundation for the assay's expected behavior.
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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
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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 |
|---|---|---|
| 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 |
{5}------------------------------------------------
| LCMPhencyclidine | Enzyme Immunoassay Phencyclidine | Toxicology |
|---|---|---|
| DJRMethadone | 21 CFR § 862.3620, Methadone Test System | Toxicology |
| DJREDDP | 21 CFR § 862.3620, Methadone 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, 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 |
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| 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 ofAmphetamine, Oxazepam, Cocaine,Cannabinoids, Methamphetamine, Morphine,Oxycodone, Secobarbital, Buprenorphine,Methylenedioxy-methamphetamine,Phencyclidine, EDDP, Nortriptyline andMethadone 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, EDDP, Nortriptylineand Methadone in human 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 on antigen-antibody interactions to indicate positive ornegative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/mlOxazepam (OXA):300 ng/mlCocaine(COC): 300 ng/mlCannabinoids (THC):50 ng/mlMethamphetamine (MET): 1,000 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/mlEDDP: 300 ng/mlNortriptyline : 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 | Numberof samples | Lay person results | The percentageagreement(%) | |
|---|---|---|---|---|---|
| No. ofPositive | 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 | Numberof samples | Lay person results | The percentageagreement(%) | |
|---|---|---|---|---|---|
| No. ofPositive | 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 (MethadoneMetabolites) | -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 | 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 | 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 (MethadoneMetabolites) | -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 | Numberof samples | Lay person results | The percentageagreement(%) | |
|---|---|---|---|---|---|
| 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 (MethadoneMetabolites) | -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.
§ 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).