(31 days)
Not Found
No
The device description and performance studies focus on traditional immunoassay technology and do not mention any AI or ML components.
No
This device is a diagnostic tool used to detect the presence of certain drugs in urine; it does not provide therapy or treatment.
Yes
The device detects specific substances (drugs) in human urine, providing a preliminary result that indicates the presence or absence of these substances. This detection of the presence of certain analytes for medical purposes is characteristic of a diagnostic device.
No
The device description clearly states it is an immunochromatographic assay using a lateral flow system in a dip card format, which is a physical hardware device.
Based on the provided information, the Healgen Accurate Urine Drug Screen Dip Card is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the qualitative detection of various substances in human urine. This clearly indicates it is used to examine specimens derived from the human body.
- Device Description: It is described as an immunochromatographic assay that uses a lateral flow system. These are common technologies used in IVD devices for detecting specific analytes in biological samples.
- Performance Studies: The document details performance studies including method comparison studies using clinical urine samples and a lay user study. These types of studies are standard for evaluating the performance of IVD devices.
- Regulatory Information: The indication of "Over-The-Counter Use (21 CFR 801 Subpart C)" is a regulatory classification for certain IVD devices that can be sold directly to consumers.
- Predicate Device: The mention of a predicate device (K232659; Dochek® Multi-Drug Urine Test Cup) which is also a drug screening device, further supports its classification as an IVD.
In summary, the device meets the definition of an In Vitro Diagnostic because it is intended for use in the examination of specimens derived from the human body (urine) to provide information for medical purposes (detection of drugs of abuse).
N/A
Intended Use / Indications for Use
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/l-Methadone, d-Methamphetamine, d1-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 / 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 / 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 / 1000 |
| MTD | d/l-Methadone | 300 |
| OPI | Morphine | 300 / 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test panels can consist of up to sixteen (16) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of potential abuse of one or more at the cutoff concentrations of table below.
This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|---|---|---|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.
This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
Product codes (comma separated list FDA assigned to the subject device)
NGL, NFT, PTH, NFY, NFV, PTG, NGG, NGM, QBF, QAW, NFW
Device Description
Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a dip card format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Precision/Reproducibility:
Samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test dipcards.
Method comparison study:
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility:
Study Type: Precision/Reproducibility study
Sample Size: 50 tests per concentration per lot for each drug (total 150 tests per concentration per drug across 3 lots). Concentrations tested: +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, Cutoff, -25% cutoff, -50% cutoff, -75% cutoff, -100% cutoff.
Key Results: For most analytes, 100% agreement (50+/0- or 0+/50-) was observed at concentrations of +50% cutoff and above, and -50% cutoff and below. At the cutoff concentration, results varied, generally showing a mix of positive and negative results across the 3 lots, indicating performance at the specified cutoff. For example, for AMP 1000, at cutoff, Lot 1 showed 21-/29+, Lot 2 showed 23-/27+, and Lot 3 showed 24-/26+. Similar distributions were observed for other drugs.
Analytical specificity/Interference:
Study Type: Analytical specificity/Interference study
Description: To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples and tested using three lots of the device. Compounds that show no interference at a concentration of 100µg/mL were also evaluated by adding them to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.
Key Results: Detailed tables of percent cross-reactivity for various compounds with each drug were provided. Numerous compounds showed no interference at 100,000 ng/mL, including common medications and other substances. pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 did not affect the results.
Method comparison study:
Study Type: Method comparison study
Sample Size: 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug for each of three operators.
Key Results: Results were compared to LC-MS/MS. The data shows the performance of the dipcard results (positive/negative) against LC-MS/MS classification (Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive). For most drugs and cutoffs, there were no false positives for drug-free or low negative samples and very few false negatives for high positive samples. Discordant results mainly occurred near the cutoff concentrations, as expected for qualitative assays.
Lay person study:
Study Type: Lay user study
Sample Size: 280 lay persons (78 male, 62 female for Configuration 1; 76 male, 64 female for Configuration 2).
Key Results: Participants tested blind-labeled urine samples prepared at -100%, +/-75%, +/-25% of the cutoff. Agreement percentages for negative and positive results were generally 90% or higher at +/-25% cutoff and 100% at +/-50%, +/-75% and -100% cutoff, indicating good performance across different concentrations near and away from the cutoff for both configurations. All participants found the device instruction easy to understand and follow, and a Flesch-Kincaid reading analysis showed a reading Grade Level of 7 for the package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as separate metrics, but are inferable from the performance study tables (especially method comparison and lay user studies). For example, in the lay user study, Agreement (%) indicates performance against expected results at various concentrations.
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.
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text. The logo is clean and professional, conveying the authority and trustworthiness of the FDA.
Healgen Scientific LLC % Joe Shia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K240686
Trade/Device Name: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL NFT PTH NFY NFV PTG NGG NGM QBF QAW NFW Dated: March 9, 2024 Received: March 12, 2024
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph A. Digitally signed by Kotarek -S Date: 2024.04.12
12:04:54 -S 12:04:54 -04'00' Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K240686
Device Name
Healgen Accurate Urine Drug Screen Dip Card Healgen Accurate Home Urine Drug Test Dip Card
Indications for Use (Describe)
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/l-Methadone, d-Methamphetamine, d1-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 / 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 / 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 / 1000 |
| MTD | d/l-Methadone | 300 |
| OPI | Morphine | 300 / 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test panels can consist of up to sixteen (16) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of potential abuse of one or more at the cutoff concentrations of table below.
This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|---|---|---|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
3
| COC | Cocaine | 300 or 150 |
|---|---|---|
| EDDP | EDDP | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.
This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/23)
4
510(k) SUMMARY K240686
| 1. Date: | April 11, 2024 |
|---|---|
| 2. Submitter: | Healgen Scientific LLC. |
| 3818 Fuqua Street | |
| Houston, TX 77047 | |
| 3. Contact person: | Joe Shia |
| LSI International Inc. | |
| 504 East Diamond Ave., Suite H | |
| Gaithersburg, MD 20877 | |
| Telephone: 240-505-7880 | |
| Email: shiajl@yahoo.com |
- Device Name: Healgen Accurate Urine Drug Screen Dip Card 4. Healgen Accurate Home Urine Drug Test Dip Card Classification: 5. Class II
| Product Code | Regulation Section | Panel |
|---|---|---|
| Target Drug | ||
| NFT | 862.3100, Amphetamine Test System | Toxicology |
| Amphetamine (AMP) | ||
| PTH | 862.3150, Barbiturate Test System | Toxicology |
| Secobarbital (BAR) | ||
| NGL | 862.3650, Opiate Test System | Toxicology |
| Buprenorphine (BUP) | ||
| Morphine (OPI) | ||
| Oxycodone (OXY) | ||
| 6-Monoacetylmorphine(6-MAM) | ||
| NFV | 862.3170, Benzodiazepine Test System | Toxicology |
| Oxazepam (BZO) | ||
| NFY | 862.3250, Cocaine and cocaine | |
| metabolite test system | Toxicology | |
| Cocaine (COC) | ||
| PTG | 862.3620, Methadone Test System | Toxicology |
| 2-ethylidene-1,5-dimethyl-3,3- | ||
| diphenylpyrrolidine (EDDP) | ||
| Methadone (MTD) | ||
| NGG | 862.3610, | |
| Methamphetamine Test System | Toxicology | |
| Methylenedioxymethamphetamine | ||
| (MDMA) | ||
| Methamphetamine (MET) | ||
| NGM | Unclassified | Toxicology |
| Phencyclidine (PCP) | ||
| OBE | 862.3700 Propoxyphene test system | Toxicology |
5
| Propoxyphene(PPX) | ||
|---|---|---|
| QAW | ||
| Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs | |
| test system | Toxicology | |
| NFW | ||
| Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology |
Predicate Devices: 6.
Dochek® Multi-Drug Urine Test Cup (K232659)
7. Intended Use
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 / 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 / 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 / 1000 |
| MTD | d/l-Methadone | 300 |
| OPI | Morphine | 300 / 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test panels can consist of up to sixteen (16) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
6
The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.
| CODE | SUBSTANCE | CUT-OFF
(ng/mL) |
|----------|----------------------|--------------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This is not a screening device to monitor prescription medication.
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device. This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
8. Device Description
Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a dip card format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| (K232659) | ||
| Intended use | Qualitative detection of drugs of abuse in urine. | Same. |
9. Substantial Equivalence Information
7
| Methodology | Competitive binding, lateral flow immunochromatographic
assay based on antigen-antibody reaction | | Same |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|----------------|----------|
| Type of Test | Qualitative | | Same |
| Specimen Type | Human urine | | Same |
| Target Drug
and Cut Off
Values | Target Drugs | Cutoff (ng/mL) | Same |
| | Amphetamine(AMP) | 1000 or 500 | |
| | Secobarbital (BAR) | 300 | |
| | Buprenorphine (BUP) | 10 | |
| | Oxazepam (BZO) | 300 | |
| | Cocaine (COC) | 300 or 150 | |
| | 2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP) | 300 | |
| | Methylenedioxymethamphetamine
(MDMA) | 500 | |
| | Methamphetamine (MET) | 1000 or 500 | |
| | Morphine (OPI300/OPI2000) | 2000 or 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Propoxyphene(PPX) | 300 | |
| | Nortriptyline (TCA) | 1000 | |
| | Cannabinoids (THC) | 50 | |
| | 6-Monoacetylmorphine(6-MAM) | 10 | |
| Configurations | Test Dip Card | | Test cup |
10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
Healgen Accurate Home Urine Drug Test Dip Card or Healgen Accurate Urine Drug Screen Dip Card is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
8
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
12. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test dipcards. The results obtained are summarized in the following tables:
| Drug | Lot
Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| AMP
1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP
10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| EDDP
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDM
A 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET
1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MTD
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OXY
100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP
25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PPX
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA
1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| THC
50 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 6-
MAM | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 28-/22+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| AMP
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC
150 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI
2000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
9
10
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30℃ for 24 months based on real time stability study.
d. Analytical specificity/Interference:
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.
| Drug/Cutoff | Compound | Minimum
concentration
required to obtain
a positive result
(ng/mL) | % Cross-
Reactivity |
|-------------|-------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|
| AMP 1000 | Hydroxyamphetamine | 8000 | 12.5% |
| | (+/-)-
Methylenedioxyamphetamine(MDA) | 400 | 250% |
| | D,L-Amphetamine | 1,000 | 100% |
| | D-Amphetamine | 1,000 | 100% |
| | Diethylstilbestrol | 5,000 | 20% |
| | L-Amphetamine | 50,000 | 2% |
| | Phentermine | 8,000 | 12.5% |
| | β-Phenylethylamine | 100,000 | 1% |
| | Tyramine | 100,000 | 1% |
| | p-Hydroxynorephedrine | 100,000 | 1% |
| | D,L-Norephedrine | 100,000 | 1% |
| | p-Hydroxyamphetamine | 100,000 | 1% |
| | D-Methamphetamine | 100,000(Negative) | Not detected |
| | L-Methamphetamine | 100,000(Negative) | Not detected |
| | Ephedrine hydrochloride | 100,000(Negative) | Not detected |
| | (+/-)3,4-
Methylenedioxymethamphetamine | 100,000(Negative) | Not detected |
| | (MDMA) | | |
| | Phenylpropanolamine | 100,000(Negative) | Not detected |
| | Benzphetamine | 100,000(Negative) | Not detected |
| | L-Ephedrine | 100,000(Negative) | Not detected |
| | L-Epinephrine | 100,000(Negative) | Not detected |
| | D,L-Epinephrine | 100,000(Negative) | Not detected |
| | (+/-)3,4- | | |
| | Methylenedioxyethylamphetamine
(MDEA) | 100,000(Negative) | Not detected |
| | Alphenal | 150 | 200% |
| | Amobarbital | 300 | 100% |
| | Aprobarbital | 250 | 120% |
| | Butabarbital | 2,500 | 12% |
| | Butethal | 100 | 300% |
| BAR 300 | Cyclopentobarbital | 600 | 50% |
| | Pentobarbital | 250 | 120% |
| | Phenobarbital | 250 | 120% |
| | Secobarbital | 300 | 100% |
| | Butalbital | 2,500 | 12% |
| | Buprenorphine | 10 | 100% |
| | Buprenorphine -3-D-Glucuronide | 160 | 6.25% |
| | Norbuprenorphine | 10 | 100% |
| | Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| BUP 10 | Morphine | 100000 (Negative) | Not Detected |
| | Oxymorphone | 100000 (Negative) | Not Detected |
| | Hydromorphone | 100000 (Negative) | Not Detected |
| | a-Hydroxyalprazolam | 1,260 | 23.8% |
| BZO 300 | Alprazolam | 200 | 150% |
| | Bromazepam | 1,560 | 19.2% |
| | Chlordiazepoxide | 1,560 | 19.2% |
| | Clobazam | 100 | 300% |
| | Clonazepam | 2,500 | 12% |
| | Clorazepate Dipotassium | 200 | 150% |
| | Desalkylflurazepam | 400 | 75% |
| | Diazepam | 200 | 150% |
| | Estazolam | 2,500 | 12% |
| | Flunitrazepam | 400 | 75% |
| | D,L-Lorazepam | 1,560 | 19.2% |
| | Midazolam | 12,500 | 2.4% |
| | Nitrazepam | 100 | 300% |
| | Norchlordiazepoxide | 200 | 150% |
| | Nordiazepam | 400 | 75% |
| | Oxazepam | 300 | 100% |
| | R,S-Lorazepam glucuronide | 160 | 187.5% |
| | Temazepam | 100 | 300% |
| | Triazolam | 2,500 | 12% |
| | Demoxepam | 2,000 | 15% |
| | Flurazepam | 500 | 60% |
| | Delorazepam | 100,000(negative) | Not detected |
| COC 300 | Benzoylecogonine | 300 | 100% |
| | Cocaethylene | 300 | 100% |
| | Cocaine hydrochloride | 300 | 100% |
| | Ecgonine | 50,000 | 0.6% |
| | Norcocaine | 100,000 | 0.3% |
| | Ecgonine methyl ester | 100,000(negative) | Not detected |
| | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | 100% |
| | Methadone | 100,000(negative) | Not detected |
| EDDP 300 | EMDP | 100,000(negative) | Not detected |
| | Doxylamine | 100,000(negative) | Not detected |
| | Levacetylmethadol (LAAM) | 100,000(negative) | Not detected |
| | Disopyramide | 100,000(negative) | Not detected |
| | Alpha Methadol | 100,000(negative) | Not detected |
| MDMA 500 | (+/-)3,4-Methylenedioxymethamphetamine
HCl(MDMA) | 500 | 100% |
| | (+/-)3,4-Methylenedioxyamphetamine
HCL(MDA) | 3,000 | 16.7% |
| | | | |
| (+/-)3,4- | Methylenedioxyethylamphetamine
(MDEA) | 300 | 167% |
| | L-Methamphetamine | 50,000 | 1% |
| | d-methamphetamine | 100,000(Negative) | Not detected |
| | d-amphetamine | 100,000(Negative) | Not detected |
| | l-amphetamine | 100,000(Negative) | Not detected |
| | (+/-)3,4-Methylenedioxy-n-
ethylamphetamine (MDEA) | 20,000 | 5% |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | 2,500 | 40% |
| | D-Methamphetamine | 1,000 | 100% |
| | L-Methamphetamine | 25,000 | 4% |
| | Fenfluramine | 50,000 | 2% |
| | p-Hydroxymethamphetamine | 10,000 | 10% |
| | D,L-Methamphetamine | 1,000 | 100% |
| | β-Phenylethylamine | 50,000 | 2% |
| MET 1000 | Mephetermine | 50,000 | 2% |
| | Methoxyphenamine hydrochloride | 50,000 | 2% |
| | L-Amphetamine | 75,000 | 1.33% |
| | D-Amphetamine | 100,000(Negative) | Not detected |
| | D,L-Amphetamine | 100,000(Negative) | Not detected |
| | Chloroquine | 100,000(Negative) | Not detected |
| | Ephedrine hydrochloride | 100,000(Negative) | Not detected |
| | (+/-)3,4-Methylenedioxyamphetamine
(MDA) | 100,000(Negative) | Not detected |
| | Trimethobenzamide | 100,000(Negative) | Not detected |
| | 1-phenylephrine | 100,000(Negative) | Not detected |
| | (1R,2S)-(-)-Ephedrine | 100,000(Negative) | Not detected |
| | Procaine hydrochloride | 100,000(Negative) | Not detected |
| OPI 2000 | 6-acetylmorphine | 2,500 | 80% |
| | Codeine | 1,000 | 200% |
| | Dihydrocodeine | 1,500 | 133.3% |
| | | | |
| | EthylMorphine | 2,500 | 80% |
| | Codeine-6-β-D-glucuronide | 2,500 | 80% |
| | Heroin | 5,000 | 40% |
| | Hydrocodone | 5,000 | 40% |
| | Hydromorphone | 2,500 | 80% |
| | Levorphanol tartrate | 10,000 | 20% |
| | Morphine | 2,000 | 100% |
| | Nalorphine hydrochloride | 5,000 | 40% |
| | Norcodeine | 4,000 | 50% |
| | Normorphine | 5,000 | 40% |
| | Oxymorphone | 75,000 | 2.7% |
| | s-Monoacetylmorphine | 2,000 | 100% |
| | Morphine-6-β-D-glucuronide | 2,000 | 100% |
| | Thebaine | 13,000 | 15.4% |
| | Morphine 3-β-D-glucuronide | 2,000 | 100% |
| | 6-Monoacetylmorphine (6-MAM) | 1,500 | 133% |
| | 6-Acetylcodeine | 10,000 | 20% |
| | Oxycodone | 100,000(Negative) | Not detected |
| | Procaine | 100,000(Negative) | Not detected |
| | Norpropoxyphene | 100,000(Negative) | Not detected |
| MTD 300 | EDDP | 100,000(Negative) | Not detected |
| | Doxylamine | 100,000(Negative) | Not detected |
| | Levacetylmethadol (LAAM) | 100,000(Negative) | Not detected |
| | EMDP | 100,000(Negative) | Not detected |
| | Alpha Methadol | 100,000(Negative) | Not detected |
| OXY 100 | Ethyl Oxycodone | 75,000 | 0.13% |
| | Hydrocodone | 5,000 | 2% |
| | Hydromorphone | 25,000 | 0.4% |
| | Levorphanol tartrate | 25,000 | 0.4% |
| | Naloxone hydrochloride | 10,000 | 1% |
| | Naltrexone hydrochloride | 50,000 | 0.2% |
| | Oxycodone | 100 | 100% |
| | Oxymorphone | 200 | 50% |
| | Oxymorphone-3β-D-glucuronide | 500 | 20% |
| | | | |
| | Noroxycodone | 1,500 | 6.7% |
| | Noroxymorphone | 3,000 | 3.3% |
| | Dihydrocodeine | 100,000(Negative) | Not detected |
| | Codeine | 100,000(Negative) | Not detected |
| | Morphine | 100,000(Negative) | Not detected |
| | Buprenorphine | 100,000(Negative) | Not detected |
| | Ethylmorphine | 100,000(Negative) | Not detected |
| | Thebaine | 100,000(Negative) | Not detected |
| | 6-acetylmorphine | 100,000(Negative) | Not detected |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxy Phencyclidine | 12,500 | 0.2% |
| PPX 300 | d-Propoxyphene | 300 | 100% |
| | d-Norpropoxyphene | 300 | 100% |
| TCA 1000 | Amitriptyline | 1,500 | 66.7% |
| | Chlorpheniramine | 50,000 | 2% |
| | Clomipramine | 10,000 | 10% |
| | Cyclobenzaprine Hydrochloride | 5,000 | 20% |
| | Desipramine | 1,000 | 100% |
| | Doxepine | 2,000 | 50% |
| | Duloxetine | 10,000 | 10% |
| | Imipramine | 1,000 | 100% |
| | Norclomipramine | 12,500 | 8% |
| | Nordoxepine | 1,000 | 100% |
| | Nortriptyline | 1,000 | 100% |
| | Promazine | 50,000 | 2% |
| | Trimipramine | 10,000 | 10% |
| | Maprotiline | 100,000(Negative) | Not detected |
| | Promethazine hydrochloride | 100,000(Negative) | Not detected |
| | THC 50 | 11-nor-Δ8-THC -9-COOH | 30 |
| | (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% |
| | (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% |
| | 11-nor-Δ9-THC -carboxy glucuronide | 100 | 50% |
| | 11-hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1% |
| | Δ8- Tetrahydrocannabinol | 1,300 | 3.8% |
| | Δ9- Tetrahydrocannabinol | 5,000 | 1% |
| | Cannabinol | 20,000 | 0.25% |
| | Cannabidiol | 100,000(Negative) | Not detected |
| | (±)-11-Hydroxy-Δ9-THC | 100,000(Negative) | Not detected |
| 6-MAM 10 | 6-acetylmorphine | 10 | 100% |
| | 6-Monoacetylmorphine (6-MAM) | 10 | 100% |
| | Heroin | 60 | 16.7% |
| | Morphine | 75,000 | 0.01% |
| | s-Monoacetylmorphine | 10 | 100% |
| | Normorphine | 100,000(Negative) | Not detected |
| | Nalorphine HCl | 100,000(Negative) | Not detected |
| | Hydrocodone | 100,000(Negative) | Not detected |
| | Hydromorphone | 100,000(Negative) | Not detected |
| | Chlordiazepoxide | 100,000(Negative) | Not detected |
| | Clobazam | 100,000(Negative) | Not detected |
| | D-Amphetamine | 100,000(Negative) | Not detected |
| | (±)-Amphetamine | 100,000(Negative) | Not detected |
| | Levorphanol tartrate | 100,000(Negative) | Not detected |
| | Codeine | 100,000(Negative) | Not detected |
| | Ethylmorphine | 100,000(Negative) | Not detected |
| | Morphine3-β-D-glucuronide | 100,000(Negative) | Not detected |
| | Norcodeine | 100,000(Negative) | Not detected |
| | Oxycodone | 100,000(Negative) | Not detected |
| | Oxymorphone | 100,000(Negative) | Not detected |
| | Procaine hydrochloride | 100,000(Negative) | Not detected |
| | Thebaine | 100,000(Negative) | Not detected |
| | 6-Acetylcodeine | 100,000(Negative) | Not detected |
| | Buprenorphine | 100,000(Negative) | Not detected |
| | Dihydrocodeine | 100,000(Negative) | Not detected |
| | Dextromethorphan | 100,000(Negative) | Not detected |
| | Imipramine hydrochloride | 100,000(Negative) | Not detected |
| | Meperidine | 100,000(Negative) | Not detected |
| | (±)-Methadone | 100,000(Negative) | Not detected |
| | Mitragynine(kratom) | 100,000(Negative) | Not detected |
| | Morphine-6-β-D-glucuronide | 100,000(Negative) | Not detected |
| | Naloxone hydrochloride | 100,000(Negative) | Not detected |
| | Naltrexone hydrochloride | 100,000(Negative) | Not detected |
| | Naproxen | 100,000(Negative) | Not detected |
| | Norbuprenorphine | 100,000(Negative) | Not detected |
| | Norbuprenorphine-3-D-Glucuronide | 100,000(Negative) | Not detected |
| | Noroxycodone HCL | 100,000(Negative) | Not detected |
| | Noroxymorphone HCL | 100,000(Negative) | Not detected |
| | (+)-Norpropoxyphene maleate | 100,000(Negative) | Not detected |
| | Oxymorphone-3β-D-glucuronide | 100,000(Negative) | Not detected |
| | TapentadolHCl | 100,000(Negative) | Not detected |
| | Tramadol hydrochloride | 100,000(Negative) | Not detected |
| AMP 500 | Hydroxyamphetamine | 4,000 | 12.5% |
| | (+/-)-
Methylenedioxyamphetamine(MDA) | 200 | 250% |
| | D,L-Amphetamine | 500 | 100% |
| | D-Amphetamine | 500 | 100% |
| | Diethylstilbestrol | 2,500 | 20% |
| | L-Amphetamine | 25,000 | 2% |
| | Phentermine | 4,000 | 12.5% |
| | β-Phenylethylamine | 50,000 | 1% |
| | Tyramine | 50,000 | 1% |
| | p-Hydroxynorephedrine | 50,000 | 1% |
| | p-Hydroxyamphetamine | 50,000 | 1% |
| | D,L-Norephedrine | 50,000 | 1% |
| | (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 100,000 | 0.5% |
| | d-Methamphetamine | 100,000(Negative) | Not detected |
| | l-Methamphetamine | 100,000(Negative) | Not detected |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | 100,000(Negative) | Not detected |
| | Ephedrine hydrochloride | 100,000(Negative) | Not detected |
| | Phenylpropanolamine | 100,000(Negative) | Not detected |
| | Benzphetamine | 100,000(Negative) | Not detected |
| | L-Ephedrine | 100,000(Negative) | Not detected |
| | L-Epinephrine | 100,000(Negative) | Not detected |
| | D,L-Epinephrine | 100,000(Negative) | Not detected |
| | Benzoylecogonine | 150 | 100% |
| | Cocaethylene | 150 | 100% |
| | Cocaine hydrochloride | 150 | 100% |
| COC 150 | Ecgonine | 25,000 | 0.6% |
| | Norcocaine | 50,000 | 0.3% |
| | Ecgonine methyl Ester | 100,000(negative) | Not detected |
| MET 500 | (+/-)3,4-Methylenedioxy-n-
ethylamphetamine (MDEA) | 10,000 | 5% |
| | (+/-)3,4-
methylenedioxumethamphetamine
(MDMA) | 1,250 | 40% |
| | D-Methamphetamine | 500 | 100% |
| | L-Methamphetamine | 12,500 | 4% |
| | Fenfluramine | 25,000 | 2% |
| | p-Hydroxymethamphetamine | 5,000 | 10% |
| | D,L-Methamphetamine | 500 | 100% |
| | β-Phenylethylamine | 25,000 | 2% |
| | Mephetermine | 25,000 | 2% |
| | Methoxyphenamine hydrochloride | 25,000 | 2% |
| | L-Amphetamine | 40,000 | 1.25% |
| | Ephedrine hydrochloride | 100,000 | 0.5% |
| | (1R,2S)-(-)-Ephedrine | 100,000 | 0.5% |
| | D-Amphetamine | 100,000(negative) | Not detected |
| | Chloroquine | 100,000(negative) | Not detected |
| | (+/-)3,4-
Methylenedioxyamphetamine(MDA) | 100,000(negative) | Not detected |
| | L-Phenylephrine | 100,000(negative) | Not detected |
| | Trimethobenzamide | 100,000(negative) | Not detected |
| | Procaine hydrochloride | 100,000(negative) | Not detected |
| | d/l-Amphetamine | 100,000(negative) | Not detected |
| OPI 300 | 6-acetylmorphine | 400 | 75% |
| | Codeine | 300 | 100% |
| | Dihydrocodeine | 1,000 | 30% |
| | EthylMorphine | 100 | 300% |
| | Heroin | 600 | 50% |
| | Hydrocodone | 500 | 60% |
| | Hydromorphone | 1,000 | 30% |
| | Levorphanol tartrate | 10,000 | 3% |
| | Morphine | 300 | 100% |
| | Nalorphine hydrochloride | 50,000 | 0.6% |
| | Thebaine | 6,240 | 4.8% |
| | s-Monoacetylmorphine | 300 | 100% |
| | Morphine-3-β-d-glucuronide | 1,000 | 30% |
| | 6-Monoacetylmorphine (6-MAM) | 150 | 200% |
| | Codeine-6-β-D-glucuronide | 150 | 200% |
| | Morphine-6-β-D-glucuronide | 150 | 200% |
| | 6-Acetylcodeine | 900 | 33.3% |
| | Normorphine | 100,000(negative) | Not detected |
| | Oxycodone | 100,000(negative) | Not detected |
| | Oxymorphone | 100,000(negative) | Not detected |
| | Norcodeine | 100,000(negative) | Not detected |
| | Procaine | 100,000(negative) | Not detected |
| | Norpropoxyphene | 100,000(negative) | Not detected |
11
12
13
14
15
16
17
18
19
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.
Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| (-) Cotinine | Dextromethorphan | Nitroglycerin |
|---|---|---|
| 3-Hydroxytyramine | Diclofenac | Nordoxepin |
| Acetaminophen | Diclofenac sodium | Norethindrone |
| Acetophenetidin | Diflunisal | Norfentanyl |
| Acetylsalicylic acid | Digoxin | Noscapine |
20
| Acyclovir | Diphenhydramine HCl | O-Hydroxyhippuric acid |
|---|---|---|
| Albumin (100mg/dL) | Disopyramide | Olanzapine |
| Albuterol sulfate (Proair HFA) | Dopamine HCl | Omeprazole |
| Alpha Methadol | Doxylamine | Oxalic acid |
| Aminophylline | D-Pseudoephedrine | Oxolinic acid |
| Aminopyrine | Duloxetine (except TCA test) | Oxymetazoline |
| Amoxicillin | Ecgonine methyl ester | Paliperidone |
| Ampicillin | EMDP | Papaverine |
| Apomorphine | Erythromycin | Penicillin-G |
| Aripiprazole | Esomeprazole Magnesium | Penicillin V Potassium |
| Ascorbic acid | Ethanol (1%) | Perphenazine |
| Aspartame | Fenoprofen | Phenacetin |
| Aspirin | Fluoxetine Hydrochloride | Phenelzine |
| Atomoxetine | Furosemide | Phenethylamine |
| Atorvastatin Calcium | Gabapentin | Phenylpropanolamine |
| Atropine | Gatifloxacin | Prednisone |
| Azithromycin | Gentisic acid | Pregablin |
| Benzilic acid | Glucose | Procaine |
| Benzocaine | Hemoglobin | Promethazine |
| Benzoic acid | Hydralazine | Quetiapine |
| Benzphetamine | Hydrochlorothiazide | Quinine |
| Bilirubin | Hydrocortisone | Ranitidine |
| Bupropion | Ibuprofen | Rifampicin |
| Cannabidiol | Isoxsuprine | Risperidone |
| Captopril | Ketamine | Salicylic acid |
| Carbamazepine | Ketoprofen | Serotonin (5-Hydroxytyramine) |
| Carfentanil | LAAM HCl | Sertraline |
| Cefradine | Labetalol | Sildenafil Citrate |
| Cephalexin | L-Ephedrine | Simvastatin |
| Chloralhydrate | L-Epinephrine | Sulfamethazine |
| Chloramphenicol | Levofloxacin Hydrochloride | Sulindac |
| Chloroquine | Levonorgestrel | Telmisartan |
| Chlorothiazide | Levothyroxine Sodium | Tetrahydrocortisone 3-(β-D-glucuronide) |
| Chlorpheniramine (except TCA test) | Lidocaine Hydrochloride | Tetrahydrocortisone, 3-acetate |
| Chlorpromazine | Lisinopril | Tetrahydrozoline |
| Cholesterol | Loperamide | Theophylline |
| Ciprofloxacin Hydrochloride | Loratadine | Thiamine |
| Citalopram | L-phenylephrine | Thioridazine |
| Clarithromycin | Magnesium | Tramadol Hydrochloride |
| Clonidine | Maprotiline | Trazodone Hydrochloride |
| Clozapine | Meperidine | Triamterene |
| Conjugated Estrogens | Meprobamate | Trifluoperazine |
| Cortisone | Methoxyphenamine (except | |
| MET test) | Trimethobenzamide | |
| Creatinine | Metoprolol Tartrate | Trimethoprim |
| D,L-Epinephrine | Mifepristone | Tyramine (except AMP test) |
| D,L-Isoproterenol | N-Acetylprocainamide | Uric acid |
| D,L-Octopamine | Nalidixic acid | Venlafaxine HCl |
| D,L-Propranolol | Naloxone hydrochloride | |
| (except OXY test) | Verapamil | |
| D,L-Tryptophan | Naltrexone hydrochloride | |
| (except OXY test) | Vitamin B2 | |
| D,L-Tyrosine | Naproxen | Vitamin C |
| Delorazepam | Niacinamide | Zaleplon |
| Deoxycorticosterone | Nicotine | Zomepirac |
| Desloratadine | Nifedipine | β-Estradiol |
21
Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
B. Method comparison study
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:
22
| Drug test | Test Dipcard
Result | Drug-
Free | Low
Negative by
LC-MS/MS
(less than -
50%) | Near Cutoff
Negative by
LC-MS/MS
(Between -
50% and the
Cutoff) | Near Cutoff
Positive by
LC-MS/MS
(Between
the cutoff
and +50%) | High Positive
by LC-
MS/MS
(greater than
+50%) | |
|---------------|------------------------|---------------|--------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------|----|
| AMP
(1000) | Operator + | 0 | 0 | 1 | 17 | 22 | |
| | A - | 10 | 14 | 15 | 1 | 0 | |
| | Operator + | 0 | 0 | 1 | 17 | 22 | |
| | B - | 10 | 14 | 15 | 1 | 0 | |
| | Operator + | 0 | 0 | 0 | 17 | 22 | |
| | C - | 10 | 14 | 16 | 1 | 0 | |
| AMP
(500) | Operator + | 0 | 0 | 1 | 18 | 21 | |
| | A - | 10 | 14 | 15 | 1 | 0 | |
| | Operator + | 0 | 0 | 1 | 18 | 21 | |
| | B - | 10 | 14 | 15 | 1 | 0 | |
| | Operator + | 0 | 0 | 0 | 19 | 21 | |
| | C - | 10 | 14 | 16 | 0 | 0 | |
| BAR | Operator + | 0 | 0 | 1 | 11 | 28 | |
| | A - | 10 | 15 | 14 | 1 | 0 | |
| | Operator + | 0 | 0 | 1 | 12 | 28 | |
| | B - | 10 | 15 | 14 | 0 | 0 | |
| | Operator + | 0 | 0 | 0 | 12 | 28 | |
| | C - | 10 | 15 | 15 | 0 | 0 | |
| BUP | Operator + | 0 | 0 | 2 | 18 | 20 | |
| | A - | 10 | 16 | 12 | 2 | 0 | |
| | Operator + | 0 | 0 | 1 | 19 | 20 | |
| | B - | 10 | 16 | 13 | 1 | 0 | |
| | Operator + | 0 | 0 | 1 | 18 | 20 | |
| | C - | 10 | 16 | 13 | 2 | 0 | |
| BZO | Operator + | 0 | 0 | 1 | 22 | 16 | |
| | A - | 10 | 17 | 12 | 2 | 0 | |
| | Operator + | 0 | 0 | 1 | 22 | 16 | |
| | B - | 10 | 17 | 12 | 2 | 0 | |
| | Operator + | 0 | 0 | 0 | 23 | 16 | |
| | C - | 10 | 17 | 13 | 1 | 0 | |
| COC
(300) | Operator + | 0 | 0 | 1 | 16 | 23 | |
| | A - | 10 | 16 | 13 | 1 | 0 | |
| | Operator + | 0 | 0 | 1 | 15 | 23 | |
| | B - | 10 | 16 | 13 | 2 | 0 | |
| | Operator + | 0 | 0 | 1 | 16 | 23 | |
| | C - | 10 | 16 | 13 | 1 | 0 | |
| COC | Operator | + | 0 | 0 | 1 | 22 | 18 |
| (150) | A | - | 10 | 16 | 13 | 0 | 0 |
| | Operator | + | 0 | 0 | 1 | 21 | 18 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 21 | 18 |
| | C | - | 10 | 16 | 14 | 1 | 0 |
| EDDP | Operator | + | 0 | 0 | 1 | 16 | 23 |
| | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 16 | 23 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 16 | 23 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| MDMA | Operator | + | 0 | 0 | 1 | 17 | 23 |
| | A | - | 10 | 15 | 14 | 0 | 0 |
| | Operator | + | 0 | 0 | 1 | 16 | 23 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 16 | 23 |
| | C | - | 10 | 15 | 14 | 1 | 0 |
| MET | Operator | + | 0 | 0 | 1 | 19 | 20 |
| (1000) | A | - | 10 | 17 | 12 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 19 | 20 |
| | B | - | 10 | 17 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 20 | 20 |
| | C | - | 10 | 17 | 13 | 0 | 0 |
| MET | Operator | + | 0 | 0 | 1 | 22 | 17 |
| (500) | A | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 22 | 17 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 23 | 17 |
| | C | - | 10 | 15 | 15 | 0 | 0 |
| OPI | Operator | + | 0 | 0 | 1 | 21 | 19 |
| (300) | A | - | 10 | 15 | 14 | 0 | 0 |
| | Operator | + | 0 | 0 | 1 | 20 | 19 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 21 | 19 |
| | C | - | 10 | 15 | 14 | 0 | 0 |
| OPI | Operator | + | 0 | 0 | 1 | 18 | 22 |
| (2000) | A | - | 10 | 16 | 13 | 0 | 0 |
| | Operator | + | 0 | 0 | 0 | 18 | 22 |
| | B | - | 10 | 16 | 14 | 0 | 0 |
| | Operator | + | 0 | 0 | 0 | 18 | 22 |
| | C | - | 10 | 16 | 14 | 0 | 0 |
| MTD | Operator | + | 0 | 0 | 0 | 15 | 24 |
| | A | - | 10 | 16 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 16 | 24 |
| | C | - | 10 | 16 | 14 | 0 | 0 |
| OXY | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | A | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | C | - | 10 | 15 | 14 | 1 | 0 |
| PCP | Operator | + | 0 | 0 | 0 | 14 | 25 |
| | A | - | 10 | 16 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| PPX | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 16 | 24 |
| | C | - | 10 | 16 | 14 | 0 | 0 |
| TCA | Operator | + | 0 | 0 | 0 | 19 | 20 |
| | A | - | 10 | 15 | 15 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 20 | 20 |
| | B | - | 10 | 15 | 14 | 0 | 0 |
| | Operator | + | 0 | 0 | 0 | 20 | 20 |
| | C | - | 10 | 15 | 15 | 0 | 0 |
| THC | Operator | + | 0 | 0 | 1 | 17 | 22 |
| | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 17 | 22 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 17 | 22 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| 6-MAM | Operator | + | 0 | 0 | 1 | 19 | 20 |
| | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 19 | 20 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 19 | 20 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
23
24
25
| Discordant Results are summarized below. | |
|---|---|
| Drug | Operator | Sample Number | LC/MS/MS
Result (ng/mL) | Accurate Result |
|----------|---------------|---------------|----------------------------|-----------------|
| 6-MAM 10 | Operator A | TB-6-MAM06049 | 8.67 | + |
| | Operator B, C | TB-6-MAM06038 | 9.96 | + |
| | Operator A | TB-6-MAM06080 | 11.23 | - |
| | Operator B | TB-6-MAM06039 | 10.04 | - |
| | Operator C | TB-6-MAM06061 | 11.52 | - |
| AMP 1000 | Operator A | TB-AMP06069 | 937.22 | + |
| | Operator B | TB-AMP06054 | 920.78 | + |
| | Operator A, C | TB-AMP06009 | 1048.74 | - |
| | Operator B | TB-AMP06031 | 1060.21 | - |
| BAR 300 | Operator A | TB-BAR06019 | 298.32 | + |
| | Operator B | TB-BAR06018 | 277.18 | + |
| | Operator A | TB-BAR06035 | 319.55 | - |
| BUP 10 | Operator A | TB-BUP06053 | 9.01 | + |
| | Operator A | TB-BUP06076 | 9.40 | + |
| | Operator B | TB-BUP06033 | 9.05 | + |
| | Operator C | TB-BUP06005 | 9.32 | + |
| | Operator A | TB-BUP06054 | 10.05 | - |
| | Operator A | TB-BUP06026 | 10.40 | - |
| | Operator B | TB-BUP06015 | 10.07 | - |
| | Operator C | TB-BUP06042 | 10.40 | - |
| | Operator C | TB-BUP06073 | 10.85 | - |
| BZO 300 | Operator A | TB-BZO06069 | 277.00 | + |
| | Operator B | TB-BZO06042 | 259.17 | + |
| | Operator A | TB-BZO06032 | 300.10 | - |
| | Operator A | TB-BZO06005 | 305.06 | - |
| | Operator B, C | TB-BZO06074 | 304.44 | - |
| | Operator B | TB-BZO06072 | 306.50 | - |
| COC 300 | Operator A, B | TB-COC06006 | 298.37 | + |
| | Operator C | TB-COC06042 | 286.01 | + |
| | Operator A | TB-COC06051 | 308.67 | - |
| | Operator B | TB-COC06061 | 309.92 | - |
| | Operator B | TB-COC06013 | 318.07 | - |
| | Operator C | TB-COC06075 | 316.92 | - |
| EDDP 300 | Operator A | TB-EDDP06040 | 296.14 | + |
| | Operator B, C | TB-EDDP06061 | 287.24 | + |
| | Operator A | TB-EDDP06051 | 343.11 | - |
| | Operator B | TB-EDDP06039 | 301.03 | - |
| | Operator C | TB-EDDP06037 | 325.29 | - |
| MDMA 500 | Operator A, C | TB-MDMA06078 | 496.69 | + |
| | | | | |
| | Operator B | TB-MDMA06023 | 488.51 | + |
| | Operator B | TB-MDMA06040 | 500.24 | - |
| | Operator C | TB-MDMA06020 | 521.36 | - |
| MET 1000 | Operator A | TB-MET06054 | 952.69 | + |
| | Operator A | TB-MET06072 | 1156.77 | - |
| | Operator B | TB-MET06045 | 1053.21 | - |
| OPI 300 | Operator A | TB-MOP06029 | 258.98 | + |
| | Operator B | TB-MOP06046 | 281.89 | + |
| | Operator C | TB-MOP06010 | 273.31 | + |
| | Operator B | TB-MOP06015 | 305.57 | - |
| MTD 300 | Operator B | TB-MTD06013 | 289.56 | + |
| | Operator A | TB-MTD06078 | 346.35 | - |
| | Operator B | TB-MTD06039 | 300.18 | - |
| OXY 100 | Operator A | TB-OXY06071 | 98.32 | + |
| | Operator B, C | TB-OXY06052 | 99.64 | + |
| | Operator A | TB-OXY06038 | 107.03 | - |
| | Operator B | TB-OXY06019 | 101.68 | - |
| | Operator C | TB-OXY06053 | 105.12 | - |
| PCP 25 | Operator B | TB-PCP06055 | 24.89 | + |
| | Operator C | TB-PCP06010 | 20.38 | + |
| | Operator A | TB-PCP06069 | 26.36 | - |
| | Operator B | TB-PCP06065 | 25.26 | - |
| | Operator C | TB-PCP06024 | 25.41 | - |
| PPX 300 | Operator A, B | TB-PPX06039 | 281.09 | + |
| | Operator A | TB-PPX06052 | 328.41 | - |
| | Operator B | TB-PPX06048 | 307.57 | - |
| TCA 1000 | Operator B | TB-TCA06055 | 965.66 | + |
| | Operator A | TB-TCA06072 | 1033.73 | - |
| THC 50 | Operator A | TB-THC06058 | 46.39 | + |
| | Operator B, C | TB-THC06041 | 47.36 | + |
| | Operator A, C | TB-THC06070 | 51.82 | - |
| | Operator B | TB-THC06021 | 58.47 | - |
| AMP 500 | Operator A | TB-SAMP06030 | 469.26 | + |
| | Operator B | TB-SAMP06004 | 463.35 | + |
| | Operator A, B | TB-SAMP06029 | 508.87 | - |
| COC 150 | Operator A, B | TB-SCOC06054 | 143.67 | + |
| | Operator B | TB-SCOC06079 | 150.72 | - |
| | Operator C | TB-SCOC06072 | 161.86 | - |
| MET 500 | Operator A, B | TB-SMET06004 | 495.39 | + |
| | Operator B | TB-SMET06050 | 526.74 | - |
| | Operator A | TB-SMET06030 | 534.71 | - |
| OPI 2000 | Operator A | TB-SMOP06059 | 1982.35 | + |
26
27
C. Lay person study
A lay user study was performed at three intended user sites with 280 lay persons. 78 male and 62 female tested Healgen Accurate Urine Drug Screen Dip Card Configuration 1; 76 male and 64 female tested Healgen Accurate Urine Drug Screen Dip Card Configuration 2. They had diverse educational and professional backgrounds and their age range from 21 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| Drug | Cutoff (ng/mL) | Results | Concentration | ||||||
|---|---|---|---|---|---|---|---|---|---|
| -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | |||
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | ||
| BAR | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% | ||
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% | ||
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | ||
| COC | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% | ||
| EDDP | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | ||
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થય | 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 તેમ | 100% | 100% | ||
| MET | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | ||
| 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 100% | તેરજ | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | ||
| OPI | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 90% | તેરજ | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | ||
| MTD | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 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, આંગણવાડી તેમ જ દૂધની ડે | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| OXY | 100 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | તેરજ | 90% | 100% | 100% | ||
| 25 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | ||
| PCP | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | તેરજ | 90% | 100% | 100% | ||
| 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |
| PPX | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | તેરજ | તેરજ | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | ||
| TCA | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| THC | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |
| 50 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | તેરજ | 90% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | ||
| 6-MAM | 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | તેરજ | 90% | 100% | 100% |
Result of Healgen Accurate Urine Drug Screen Dip Card Configuration 1:
28
Result of Healgen Accurate Urine Drug Screen Dip Card Configuration 2:
| Drug | Cutoff
(ng/mL) | Results | Concentration | | | | | | |
|-------|-------------------|---------------|---------------|-------------|-------------|-------------|-------------|-------------|-------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| | | | | | | | | | |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| AMP | 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| BAR | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| BUP | 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| BZO | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| COC | 150 | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| EDDP | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| MDMA | 500 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| MET | 500 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| OPI | 2000 | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| MTD | 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| OXY | 100 | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| PPX | 300 | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| TCA | 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| THC | 50 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
29
30
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
Clinical Studies: Not applicable.
13. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are substantially equivalent to the predicate devices.