(49 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay, with no mention of AI or ML for analysis or interpretation.
No
The device is described as a rapid lateral flow immunoassay for the qualitative detection of various substances in human urine, providing preliminary results for drug screening. It is a diagnostic tool, not a therapeutic device designed to treat or alleviate a disease or condition.
Yes
Explanation: The device is described as a "rapid lateral flow immunoassay for the qualitative detection of ... in human urine," providing "preliminary results" for the identification of various substances. The intended use is to screen for the presence of certain drugs, which is a diagnostic purpose. The text also mentions that further "confirmatory methods" are needed for a definitive positive result, indicating that this device serves as an initial diagnostic tool.
No
The device description explicitly states it is an "immunochromatographic assay that uses a lateral flow system" and is in a "cup format," indicating it is a physical hardware device for performing a chemical test on urine.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the qualitative detection of various drugs and their metabolites in human urine. This is a biological specimen taken from the human body.
- Diagnostic Purpose: While it provides a "preliminary result," the purpose is to screen for the presence of these substances, which is a diagnostic step in identifying potential drug use.
- Device Description: It's described as an "immunochromatographic assay" and a "lateral flow immunoassay," which are common technologies used in IVD devices for detecting specific substances in biological samples.
- Performance Studies: The document details performance studies using clinical urine samples and comparing results to confirmatory methods like LC-MS/MS. This type of validation is typical for IVD devices.
- Regulatory Information: The mention of "Prescription Use (Part 21 CFR 801 Subpart D)" and "Over-The-Counter Use (21 CFR 801 Subpart C)" indicates that the device is subject to FDA regulations for medical devices, including IVDs.
- Predicate Device: The listed predicate device (K240686; Healgen Accurate Urine Drug Screen Dip Card) is also a drug screening device intended for use with human urine, further supporting the classification as an IVD.
In summary, the device meets the criteria of an IVD because it is used to examine a specimen derived from the human body (urine) to provide information for diagnostic purposes (screening for the presence of drugs).
N/A
Intended Use / Indications for Use
The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine.
The single or multi-test cups can consist of up to eighteen (18) 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.
The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs: Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Norfentanyl, Methamphetamine, Ecstasy, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, 6-Monoacetylmorphine.
This drug test cup may contain any combination of the drug tests listed in the table above.
This test provides only 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.
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 Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup 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 cup 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
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Lay person study: A lay user study was performed at three intended user sites with 280 lay persons. 76 male and 64 female tested Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 1; 73 male and 67 female tested Healgen® Accurate Muti-Drug Urine Drug Screen Cup 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%, +/-50%, +/-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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
a. Precision/Reproducibility: Precision studies were carried out for samples with concentrations of +100% cutoff, +75% 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 cups with one operator per lot.
b. Linearity/assay reportable range: Not applicable. This device is intended for qualitative use only.
c. Stability: The device is stable at 2-30°C for 36 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 was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. 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.
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. Key results are provided in detailed tables for each drug and each operator, showing the number of positive and negative results compared to LC-MS/MS results at various concentration ranges (Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive). Discordant results are also summarized in a table showing the sample number, LC/MS/MS result (ng/mL), and the Accurate Result.
Lay person study: A lay user study was performed at three intended user sites with 280 lay persons (140 for Configuration 1 and 140 for Configuration 2). 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. The detailed results for each drug and concentration level (from -100% cutoff to +75% cutoff) for both configurations are provided showing the number of negative and positive results and the total agreement percentage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
December 17, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Healgen Scientific LLC % Jenny Xia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K243365
Trade/Device Name: Healgen® Accurate Muti-Drug Urine Drug Screen Cup; Healgen® Accurate Home Muti-Drug Urine Test Cup 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: October 26, 2024 Received: October 29, 2024
Dear Jenny 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 (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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows the name Joseph A. Kotarek -S. It also shows that the document was digitally signed by Joseph A. Kotarek -S on December 17, 2024. The time stamp on the document is 10:21:47 -05'00'.
Joseph Kotarek 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
3
Indications for Use
510(k) Number (if known) K243365
Device Name
Healgen® Accurate Muti-Drug Urine Drug Screen Cup; Healgen® Accurate Home Muti-Drug Urine Test Cup
Indications for Use (Describe)
The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol 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 or 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 or 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3- | |
| diphenylpyrolidine | 300 | |
| FEN or FYL | Norfentanyl | 5 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 or 1000 |
| MTD | Methadone | 300 |
| OPI | Morphine | 300 or 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
| TRA or TMI | Tramadol | 100 |
The single or multi-test cups can consist of up to eighteen (18) 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.
The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs
| 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 |
4
| FYL | Norfentanyl | 5 |
|---|---|---|
| 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 |
| TML | Tramadol | 100 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test cup may contain any combination of the drug tests listed in the table above.
This test provides only 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.
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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5
510(k) SUMMARY K243365
| 1. Date: | October 29, 2024 |
|---|---|
| 2. Submitter: | Healgen Scientific LLC. |
| 3818 Fuqua Street | |
| Houston, TX 77047 | |
| 3. Contact person: | Jenny Xia |
| LSI International Inc. | |
| 504 East Diamond Ave., Suite H | |
| Gaithersburg, MD 20877 | |
| Telephone: 301-525-6856 | |
| Email: jxia@lsi-consulting.org | |
| 4. Device Name: | Healgen® Accurate Muti-Drug Urine Drug Screen Cup |
| Healgen® Accurate Home Muti-Drug Urine Test Cup |
5. Classification: Class II
| Product Code
| Target Drug | Regulation Section | Panel |
|---|---|---|
| NFT | ||
| Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTH | ||
| Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGL | ||
| Buprenorphine (BUP) | ||
| Morphine (OPI) | ||
| Oxycodone (OXY) | ||
| 6-Monoacetylmorphine(6-MAM) | ||
| Norfentanyl (FEN) | ||
| Tramadol (TML) | 862.3650, Opiate Test System | Toxicology |
| NFV | ||
| Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | ||
| Cocaine (COC) | 862.3250, Cocaine and cocaine | |
| metabolite test system | Toxicology | |
| PTG | ||
| 2-ethylidene-1,5-dimethyl-3,3- | ||
| diphenylpyrrolidine (EDDP) | ||
| Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGG |
| 862.3610,
Methamphetamine Test System | Toxicology |
6
| Methylenedioxymethamphetamine
(MDMA)
| Methamphetamine (MET) | ||
|---|---|---|
| NGM | ||
| Phencyclidine (PCP) | Unclassified | Toxicology |
| QBF | ||
| Propoxyphene(PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| QAW | ||
| Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs | |
| test system | Toxicology | |
| NFW | ||
| Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology |
Predicate Devices: 6.
Healgen Accurate Urine Drug Screen Dip Card (K240686)
7. Intended Use
The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, Tramadol in human urine. The test cut-off concentrations and the compounds the THC-COOH and 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 |
| FEN or FYL | Norfentanyl | 5 |
| 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 |
7
| TRA or TML | Tramadol | 100 |
|---|---|---|
| ------------ | ---------- | ----- |
The single or multi-test cups can consist of up to eighteen (18) 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 (CC-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 Multi-Drug Urine Test Cup is a rapid qualitative immunoassay.
| 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 |
| FYL | Norfentanyl | 5 |
| 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 |
| TML | Tramadol | 100 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
The device provides preliminary results for the detection of one or more of the following drugs.
This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only 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 massspectrometer 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.
8. Device Description
Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine
8
Drug Screen Cup 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 cup 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 |
| (K240686) | ||
| Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | Same. |
| 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) | ||
| 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 | |
| Norfentanyl | 5 | |
| Methylenedioxymethamphetamine | ||
| (MDMA) | 500 | |
| Methamphetamine (MET) | 1000 or 500 | |
| Morphine (MOP300/OPI2000) | 2000 or 300 | |
| Methadone (MTD) | 300 | |
| Oxycodone (OXY) | 100 | |
| Phencyclidine (PCP) | 25 | |
| Propoxyphene(PPX) | 300 | |
| Nortriptyline (TCA) | 1000 | |
| Same except no | ||
| Norfentanyl and | ||
| Tramadol |
Substantial Equivalence Information 9.
9
| Cannabinoids (THC) | 50 |
|---|---|
| 6-Monoacetylmorphine(6-MAM) | 10 |
| Tramadol | 100 |
| Differences | |
| Configurations | |
| Test cup | Test Dip Card |
10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
Healgen® Accurate Home Muti-Drug Urine Test Cup or Healgen® Accurate Muti-Drug Urine Drug Screen Cup 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.
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, +75% 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 cups with one operator per lot. The results obtained are summarized in the following tables:
10
| 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+ | 23-/27+ | 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+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 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+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP
10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 27-/23+ | 48-/2+ | 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+ |
| BZO
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 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+ |
| COC
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 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+ | 24-/26+ | 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+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| FYL
5 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 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+ | 2-/48+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDMA
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 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+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET
1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 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+ |
| OPI
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 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+ |
| MTD
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+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OXY
100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 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+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP
25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 48-/2+ | 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 | | | | | | | | | |
| PPX | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | 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+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 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+ |
| THC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 50 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TML | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 100 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 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+ |
| 10 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 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+ |
| AMP | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 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+ |
| COC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 150 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 48-/2+ | 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 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | 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+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 2000 | 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+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
11
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30°C for 36 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.
12
| Drug/Cutoff | Compound | Minimum
concentration
required to obtain
a positive result
(ng/mL) | % Cross-
Reactivity |
|--------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|
| AMP 1000 | Hydroxyamphetamine | 8000 | 12.5% |
| | (+/-)- | 400 | 250% |
| | Methylenedioxyamphetamine(MDA) | | |
| | 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
(MDMA) | 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 |
| | (+/-)3,4- | | |
| | Methylenedioxyethylamphetamine
(MDEA) | 100,000(Negative) | Not detected |
| | Alphenal | 150 | 200% |
| BAR 300 | Amobarbital | 300 | 100% |
| | Aprobarbital | 250 | 120% |
| | Butabarbital | 2,500 | 12% |
| | Butethal | 100 | 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% |
| BUP 10 | Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| | Morphine | 100000 (Negative) | Not Detected |
| | Oxymorphone | 100000 (Negative) | Not Detected |
| | Hydromorphone | 100000 (Negative) | Not Detected |
| | a-Hydroxyalprazolam | 1,260 | 23.8% |
| | 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% |
| BZO 300 | 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% |
| | Oxazepam glucuronide | 500 | 60% |
| | 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% |
| COC 300 | 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 |
| | EMDP | 100,000(negative) | Not detected |
| EDDP 300 | 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 |
| | Norfentanyl | 5 | 100% |
| | Fentanyl | 10 | 50% |
| | Acetyl fentanyl | 150 | 3.3% |
| | Acetyl Norfentanyl | 200 | 2.5% |
| | (+)-β-Hydroxythiofentanyl HCl | 2,500 | 0.2% |
| | Acryl Fentanyl | 2,500 | 0.2% |
| | Butyryl Fentanyl | 5,000 | 0.1% |
| FYL 5 | Cis-d, I 3-Methylfentanyl | 50,000 | 0.01% |
| | Furanyl Fentanyl | 10,000 | 0.05% |
| | Para-fluoro butyrl Fentanyl (P-FBF) | 80,000 | 0.01% |
| | Para-fluoro Fentanyl | 40,000 | 0.005% |
| | 9-HydroxyRisperidone | 10,000 | 0.05% |
| | Alfentanil | 20,000 | 0.03% |
| | Isobutyryl Fentanyl | 5,000 | 0.1% |
| | Trans-d. 1-3-Methylfentanyl | 50 | 10% |
| | | | |
| Norcarfentail Oxalate | 50,000 | 0.01% | |
| Remifentanil | 15,000 | 0.03% | |
| Valeryl Fentanyl | 20,000 | 0.03% | |
| Thienyl Fentanyl | 50 | 10% | |
| 4-Fluoro-isobutyryl Fentanyl | 20,000(Negative) | Not detected | |
| Despropionyl fentanyl (4-ANPP) | 20,000(Negative) | Not detected | |
| MT-45 | 100,000(Negative) | Not detected | |
| Ocfentanil | 100,000(Negative) | Not detected | |
| Risperidone | 100,000(Negative) | Not detected | |
| Sufentanil | 100,000(Negative) | Not detected | |
| Carfentanil Oxalate | 100,000(Negative) | Not detected | |
| Labetalol Hydrochloride | 100,000(Negative) | Not detected | |
| Trazodone | 100,000(Negative) | Not detected | |
| U-47700 | 100,000(Negative) | Not detected | |
| ω-1-Hydroxyfentanyl | 20,000(Negative) | Not detected | |
| 6-Acetyl morphine | 100,000(Negative) | Not detected | |
| Amphetamine | 100,000(Negative) | Not detected | |
| Buprenorphine | 100,000(Negative) | Not detected | |
| Buprenorphine -3-D-Glucuronide | 100,000(Negative) | Not detected | |
| Codeine | 100,000(Negative) | Not detected | |
| Dextromethorphan | 100,000(Negative) | Not detected | |
| Dihydrocodeine | 100,000(Negative) | Not detected | |
| EDDP | 100,000(Negative) | Not detected | |
| EMDP | 100,000(Negative) | Not detected | |
| Fluoxetine | 100,000(Negative) | Not detected | |
| Heroin | 100,000(Negative) | Not detected | |
| Hydrocodone | 100,000(Negative) | Not detected | |
| Hydromorphone | 100,000(Negative) | Not detected | |
| Ketamine | 100,000(Negative) | Not detected | |
| Levorphanol tartrate | 100,000(Negative) | Not detected | |
| Meperidine | 100,000(Negative) | Not detected | |
| Methadone | 100,000(Negative) | Not detected | |
| Morphine | 100,000(Negative) | Not detected | |
| Morphine-3-β-D-Glucuronide | 100,000(Negative) | Not detected | |
| | Naloxone hydrochloride | 100,000(Negative) | Not detected |
| | Naltrexone hydrochloride | 100,000(Negative) | Not detected |
| | Norbuprenorphine | 100,000(Negative) | Not detected |
| | Norcodeine | 100,000(Negative) | Not detected |
| | Norketamine | 100,000(Negative) | Not detected |
| | Normeperidine | 100,000(Negative) | Not detected |
| | Normorphine | 100,000(Negative) | Not detected |
| | Noroxycodone | 100,000(Negative) | Not detected |
| | Oxycodone | 100,000(Negative) | Not detected |
| | Oxymorphone | 100,000(Negative) | Not detected |
| | Pentazocine (Talwin) | 100,000(Negative) | Not detected |
| | Pipamperone | 100,000(Negative) | Not detected |
| | Tapentadol hydrochloride | 100,000(Negative) | Not detected |
| | Thioridazine | 100,000(Negative) | Not detected |
| | Tilidine | 100,000(Negative) | Not detected |
| | Tramadol | 100,000(Negative) | Not detected |
| | o-Desmethyl Tramadol | 100,000(Negative) | Not detected |
| | n-Desmethyl Tramadol | 100,000(Negative) | Not detected |
| MDMA 500 | (+/-)3,4-
Methylenedioxymethamphetamine
HCI(MDMA) | 500 | 100% |
| | (+/-)3,4-Methylenedioxyamphetamine
HCI (MDA) | 3,000 | 16.7% |
| | (+/-)3,4-
Methylenedioxyethylamphetamine
(MDEA) | 300 | 167% |
| | L-Methamphetamine | 50,000 | 1% |
| | 7-Aminoclonazepam | 100,000 | 0.5% |
| | d-methamphetamine | 100,000(Negative) | Not detected |
| | d-amphetamine | 100,000(Negative) | Not detected |
| | l-amphetamine | 100,000(Negative) | Not detected |
| MET 1000 | (+/-)3,4-Methylenedioxy-n-
ethylamphetamine (MDEA) | 20,000 | 5% |
| | (+/-)3,4- | 2,500 | 40% |
| | Methylenedioxymethamphetamine
(MDMA) | | |
| | 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% |
| | 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 |
| | l-phenylephrine | 100,000(Negative) | Not detected |
| | (1R,2S)-(-)-Ephedrine | 100,000(Negative) | Not detected |
| | Procaine hydrochloride | 100,000(Negative) | Not detected |
| | 6-acetylmorphine | 2,500 | 80% |
| | Codeine | 1,000 | 200% |
| | Dihydrocodeine | 1,500 | 133.3% |
| OPI 2000 | 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 | 166.7% |
| | (-)-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 |
| TML 100 | Tramadol | 100 | 100% |
| | n-Desmethyl Tramadol | 400 | 25% |
| | o-Desmethyl Tramadol | 1,000 | 10% |
| | o-Desmethyl Venlafaxine | 10,000(Negative) | Not detected |
| | Venlafaxine HCl | 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-B-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 |
| | Tapentadol HCl | 100,000(Negative) | Not detected |
| | Tramadol | 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 |
| COC 150 | Benzoylecogonine | 150 | 100% |
| Cocaethylene | 150 | 100% | |
| Cocaine hydrochloride | 150 | 100% | |
| 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-ß-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 | |
13
14
15
16
17
18
19
20
21
22
23
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 | Diclofenac sodium | Nitroglycerin |
|---|---|---|
| 3-Hydroxytyramine | Diflunisal | Norethindrone |
| 7-Aminoclonazepam (except MDMA test) | Digoxin | Norpropoxyphene |
| 7-Aminoflunitrazepam | Dimethyl-aminoantipyrine | Norpseudoephedrine |
| 7-Aminonitrazepam | Diphenhydramine HCl | Nortriptyline (except TCA test) |
| Acetaminophen | Diphenylhydantoin | Noscapine |
| Acetone (1000 mg/dL) | Disopyramide | Octopamine |
| Acetophenetidin | Dopamine HCl | O-Hydroxyhippuric acid |
| Acetylsalicylic acid | Doxepine (except TCA test) | Olanzapine |
| Acyclovir | Doxylamine | Omeprazole |
| Albumin(100mg/dL) | D-Pseudoephedrine | Oxalic acid (100mg/dL) |
| Albuterol | Duloxetine (except TCA test) | Oxazepam (except BZO test) |
24
| Albuterol sulfate(Proair HFA) | Ecgonine methyl ester | Oxazepam Glucuronide (except
BZO test) |
|-----------------------------------|-------------------------------------------------|-------------------------------------------|
| Alpha Methadol | EMDP | Oxalinic acid |
| Aminophylline | Ephedrine hydrochloride
(except MET test) | Oxymetazoline |
| Aminopyrine | Erythromycin | Paliperidone |
| Amitriptyline(except TCA test) | Esomeprazole Magnesium | Papaverine |
| Amlodipine besylate | Estradiol | Penicillin-G |
| Amobarbital(except BAR test) | Estrone | PenicillinV Potassium |
| Amoxicillin | Ethanol(1%) | Perphenazine |
| Ampicillin | Fenfluramine(except MET test) | Phenacetin |
| Apomorphine | Fenofibrate | Phencyclidine (except PCP test) |
| Aripiprazole | Fenoprofen | Phenelzine |
| Ascorbic acid | Fluoxetine Hydrochloride | Phenylethylamine |
| Aspartame | Fluphenazine | Phenobarbital (except BAR test) |
| Aspirin | Fotemustine | Phentermine (except AMP test) |
| Atomoxetine | Furosemide | Phenylpropanolamine |
| Atorvastatin Calcium | Gabapentin | Prednisone |
| Atropine | Galactose | Pregablin |
| Azithromycin | Gatifloxacin | Procaine |
| Baclofen | Gemfibrozil | Promazine (except TCA test) |
| Benzilic acid | Gentisic acid | Promethazine |
| Benzocaine | Glucose (3000mg/dL) | Propoxyphene (except PPX test) |
| Benzoic acid | Guaiacolglyceryl ether | Propranolol |
| Benzoylecgonine (except COC test) | Hemoglobin | Pseudoephedrine |
| Benzphetamine | Hexobarbital | Pyridoxine |
| Benzylpiperiazine | Hydralazine | Pyrilamine |
| Bilirubin | Hydrochlorothiazide | Pyrogallol |
| Boric Acid (1%) | Hydrocortisone | Quetiapine |
| Bromo-2,5,Dimethoxyphenethylamine | Hydroxybutyric Acid | Quinidine |
| Bupropion | Ibuprofen | Quinine |
| Caffeine | Imipramine(except TCA test) | Quinolinic Acid |
| Cannabidiol | Isoproterenol | Ranitidine |
| Captopril | Isoxsuprine | Riboflavin |
| Carbamazepine | Ketamine | Rifampicin |
| Carfentanil | Ketoprofen | Salicylic acid |
| Carisoprodol | LAAM HC1 | Secobarbital (except BAR test) |
| Cefradine | Labetalol | Serotonin |
| Cephalexin | Lamotrigine | Serotonin (5-Hydroxytyramine) |
| Cetirizine | L-Ephedrine | Sertraline |
| Chloral hydrate | L-Epinephrine | Sildenafil Citrate |
| Chloramphenicol | Levofloxacin Hydrochloride | Simvastatin |
| Chlordiazepoxide(except BZO test) | Levonorgestrel | Sodium Azide |
| Chloroquine | Levothyroxine Sodium | Sulfamethazine |
| Chlorothiazide | Lidocaine Hydrochloride | Sulindac |
| Chlorpheniramine(except TCA test) | Lisinopril | Telmisartan |
| Chlorpromazine | Loperamide | Tetracycline |
| Cholesterol | Loratadine | Tetrahydrocortisone 3-(β-D-glucuronide) |
| Ciprofloxacin Hydrochloride | Lorazepam Glucuronide
(except BZO test) | Tetrahydrocortisone, 3-acetate |
| Citalopram | L-phenylephrine | Tetrahydrozoline |
| Clarithromycin | LSD | THC (except THC test) |
| Clofibrate | L-thyroxine | Theophylline |
| Clomipramine(except TCA test) | Magnesium | Thiamine |
| Clonidine | Maprotiline | Thioridazine |
| Clozapine | Meperidine | Trazodone Hydrochloride |
| Conjugated Estrogens | Meprobamate | Triamterene |
| Cortisone | Metformin | Trifluoperazine |
| Creatine Hydrate | Methapyrilene | Trifluoromethylphenyl-
piperazine |
| Creatinine | Methaqualone | Trimethobenzamide |
| Cyclobenzaprine(except TCA test) | Methoxyphenamine (except
MET test) | Trimethoprim |
| Cyproheptadine | Methylphenidate | Tryptamine |
| D,L-Epinephrine | Metoprolol Tartrate | Tyramine (except AMP test) |
| D,L-Isoproterenol | Metronidazole | Urea (2000 mg/dL) |
| D,L-Lorazepam (except BZO test) | Mifepristone | Uric acid |
| D,L-Octopamine | N-Acetylprocainamide | Valproic acid (250 µg/mL) |
| D,L-Propranolol | NaCl (4000 mg/dL) | Venlafaxine HCl |
| D,L-Tryptophan | Nalidixic acid | Verapamil |
| D,L-Tyrosine | Naloxone hydrochloride
(except OXY test) | Vitamin B2 |
| Delorazepam | Naltrexone
hydrochloride(except OXY
test) | Vitamin C |
| Demoxepam(except BZO test) | Naproxen | Zaleplon |
| Deoxycorticosterone | N-desmethyl Tapentadol | Zolpidem |
| Desloratadine | Niacinamide | Zomepirac |
| Desipramine(except TCA test) | Nicotine | β-Estradiol |
| Dextromethorphan | Nicotinic Acid | γ-Cyclodextrin |
| Diclofenac | Nifedipine | γ-Globulin (500mg/dL) |
25
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
26
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:
| Drug test | Test 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 | 0 | 17 | 22 |
| | A | - | 10 | 14 | 16 | 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 | 1 | 18 | 21 |
| | C | - | 10 | 14 | 15 | 1 | 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 | 1 | 11 | 28 |
| | C | - | 10 | 15 | 14 | 1 | 0 |
| BUP | Operator | + | 0 | 0 | 2 | 18 | 20 |
| | A | - | 10 | 16 | 12 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 18 | 20 |
| | B | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 2 | 18 | 20 |
| | C | - | 10 | 16 | 12 | 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 | 1 | 22 | 16 |
| | C | - | 10 | 17 | 12 | 2 | 0 |
| COC | Operator | + | 0 | 0 | 1 | 16 | 23 |
| (300) | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 2 | 16 | 23 |
| | B | - | 10 | 16 | 12 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 16 | 23 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| COC | Operator | + | 0 | 0 | 1 | 21 | 18 |
| (150) | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 20 | 18 |
| | B | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 21 | 18 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| EDDP | 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 | 0 | 17 | 23 |
| | C | - | 10 | 16 | 14 | 0 | 0 |
| FYL | Operator | + | 0 | 0 | 2 | 15 | 24 |
| | A | - | 10 | 16 | 12 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 24 |
| | B | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| MDMA | Operator | + | 0 | 0 | 2 | 16 | 23 |
| | A | - | 10 | 15 | 13 | 1 | 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 | 0 | 19 | 20 |
| (1000) | A | - | 10 | 17 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 19 | 20 |
| | B | - | 10 | 17 | 12 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 19 | 20 |
| | C | - | 10 | 17 | 13 | 1 | 0 |
| MET | Operator | + | 0 | 0 | 1 | 23 | 17 |
| (500) | A | - | 10 | 15 | 14 | 0 | 0 |
| | Operator | + | 0 | 0 | 1 | 22 | 17 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 22 | 17 |
| | C | - | 10 | 15 | 14 | 1 | 0 |
| OPI (300) | Operator | + | 0 | 0 | 1 | 20 | 19 |
| | A | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 20 | 19 |
| | B | - | 10 | 15 | 15 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 20 | 19 |
| | C | - | 10 | 15 | 14 | 1 | 0 |
| OPI
(2000) | Operator | + | 0 | 0 | 0 | 18 | 22 |
| | A | - | 10 | 16 | 14 | 0 | 0 |
| | Operator | + | 0 | 0 | 1 | 17 | 22 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 17 | 22 |
| | C | - | 10 | 16 | 14 | 1 | 0 |
| MTD | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | A | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 14 | 24 |
| | B | - | 10 | 16 | 14 | 2 | 0 |
| | Operator | + | 0 | 0 | 0 | 15 | 24 |
| | C | - | 10 | 16 | 14 | 1 | 0 |
| OXY | Operator | + | 0 | 0 | 1 | 13 | 25 |
| | A | - | 10 | 15 | 14 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 13 | 25 |
| | C | - | 10 | 15 | 14 | 2 | 0 |
| PCP | Operator | + | 0 | 0 | 1 | 13 | 25 |
| | A | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 13 | 25 |
| | B | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| PPX | 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 | 15 | 24 |
| | C | - | 10 | 16 | 14 | 1 | 0 |
| TCA | Operator | + | 0 | 0 | 1 | 19 | 20 |
| | A | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 19 | 20 |
| | B | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 19 | 20 |
| | C | - | 10 | 15 | 15 | 1 | 0 |
| THC | Operator | + | 0 | 0 | 1 | 16 | 22 |
| | A | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 2 | 16 | 22 |
| | B | - | 10 | 16 | 12 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 16 | 22 |
| | C | - | 10 | 16 | 13 | 2 | 0 |
| TML | Operator | + | 0 | 0 | 1 | 14 | 24 |
| | A | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | B | - | 10 | 16 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 15 | 24 |
| | C | - | 10 | 16 | 13 | 1 | 0 |
| 6-MAM | Operator | + | 0 | 0 | 1 | 18 | 20 |
| | A | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 18 | 20 |
| | B | - | 10 | 16 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 2 | 19 | 20 |
| | C | - | 10 | 16 | 12 | 1 | 0 |
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29
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MS Result
(ng/mL) | Accurate Result |
|----------|------------------|---------------|----------------------------|-----------------|
| 6-MAM 10 | Operator A, C | TF-6-MAM06071 | 8.13 | + |
| | Operator C | TF-6-MAM06001 | 8.54 | + |
| | Operator B | TF-6-MAM06030 | 9.85 | + |
| | Operator B | TF-6-MAM06018 | 10.84 | - |
| | Operator A, B, C | TF-6-MAM06037 | 11.04 | - |
| | Operator A | TF-6-MAM06060 | 11.31 | - |
| AMP 1000 | Operator B | TF-AMP06041 | 968.58 | + |
| | Operator A, B | TF-AMP06035 | 1008.47 | - |
| | Operator C | TF-AMP06027 | 1038.84 | - |
| BAR 300 | Operator A, C | TF-BAR06026 | 274.49 | + |
| | Operator B | TF-BAR06024 | 291.27 | + |
| | Operator A, C | TF-BAR06037 | 316.44 | - |
| BUP 10 | Operator A, C | TF-BUP06058 | 9.22 | + |
| | Operator B, C | TF-BUP06065 | 9.58 | + |
| | Operator A | TF-BUP06032 | 9.79 | + |
| | Operator A | TF-BUP06071 | 10.18 | - |
| | Operator B, C | TF-BUP06002 | 10.33 | - |
| | Operator B | TF-BUP06059 | 10.77 | - |
| | Operator C | TF-BUP06039 | 11.02 | - |
| | Operator A | TF-BUP06057 | 11.22 | - |
| BZO 300 | Operator A, C | TF-BZO06049 | 276.48 | + |
| | Operator B | TF-BZO06004 | 289.45 | + |
| | Operator A, B | TF-BZO06014 | 302.46 | - |
| | Operator A, C | TF-BZO06018 | 318.53 | - |
| | Operator B | TF-BZO06006 | 322.77 | - |
| | Operator C | TF-BZO06071 | 336.40 | - |
| COC 300 | Operator A | TF-COC06076 | 294.37 | + |
| | Operator B | TF-COC06061 | 296.67 | + |
| | Operator B | TF-COC06010 | 288.91 | + |
| | Operator C | TF-COC06066 | 291.80 | + |
| | Operator A | TF-COC06036 | 331.25 | - |
| | Operator B | TF-COC06002 | 302.88 | - |
| | Operator C | TF-COC06029 | 311.54 | - |
| EDDP 300 | Operator B | TF-EDDP06008 | 278.15 | + |
| | Operator A | TF-EDDP06065 | 294.41 | + |
| | Operator B | TF-EDDP06042 | 308.29 | - |
| | Operator B | TF-EDDP06040 | 314.11 | - |
| | Operator A | TF-EDDP06025 | 326.51 | - |
| FYL | Operator A | TF-FYL06017 | 4.28 | + |
| | Operator C | TF-FYL06062 | 4.54 | + |
| | Operator B | TF-FYL06038 | 4.61 | + |
| | Operator A | TF-FYL06078 | 4.83 | + |
| | Operator B | TF-FYL06049 | 5.11 | - |
| | Operator A | TF-FYL06063 | 5.48 | - |
| | Operator C | TF-FYL06073 | 5.63 | - |
| | Operator B | TF-FYL06022 | 5.77 | - |
| MDMA 500 | Operator A | TF-MDMA06047 | 434.68 | + |
| | Operator C | TF-MDMA06080 | 443.57 | + |
| | Operator B | TF-MDMA06072 | 483.40 | + |
| | Operator A | TF-MDMA06046 | 491.32 | + |
| | Operator C | TF-MDMA06006 | 505.64 | - |
| | Operator A, B | TF-MDMA06002 | 519.63 | - |
| MET 1000 | Operator B | TF-MET06052 | 946.52 | + |
| | Operator B | TF-MET06031 | 1064.20 | - |
| | Operator A | TF-MET06007 | 1139.47 | - |
| | Operator C | TF-MET06006 | 1162.76 | - |
| OPI 300 | Operator A, C | TF-MOP06065 | 291.05 | + |
| | Operator B | TF-MOP06062 | 302.36 | - |
| | Operator A | TF-MOP06031 | 317.77 | - |
| MTD 300 | Operator C | TF-MOP06032 | 351.52 | - |
| MTD 300 | Operator A | TF-MTD06025 | 280.13 | + |
| | Operator B | TF-MTD06078 | 306.14 | - |
| | Operator C | TF-MTD06056 | 321.60 | - |
| | Operator A | TF-MTD06006 | 336.27 | - |
| | Operator B | TF-MTD06060 | 351.49 | - |
| OXY 100 | Operator A, C | TF-OXY06058 | 95.88 | + |
| | Operator B | TF-OXY06003 | 97.96 | + |
| | Operator A | TF-OXY06078 | 100.28 | - |
| | Operator A, C | TF-OXY06073 | 100.77 | - |
| | Operator B | TF-OXY06024 | 102.28 | - |
| | Operator C | TF-OXY06060 | 115.34 | - |
| PCP 25 | Operator A, C | TF-PCP06039 | 20.19 | + |
| | Operator B | TF-PCP06002 | 23.68 | + |
| | Operator A, C | TF-PCP06018 | 25.19 | - |
| | Operator A, B | TF-PCP06075 | 25.88 | - |
| | Operator B | TF-PCP06043 | 28.42 | - |
| PPX 300 | Operator B | TF-PPX06066 | 277.71 | + |
| | Operator B | TF-PPX06037 | 304.35 | - |
| | Operator A | TF-PPX06012 | 321.47 | - |
| | Operator C | TF-PPX06045 | 335.28 | - |
| TCA 1000 | Operator B | TF-TCA06015 | 892.55 | + |
| | Operator A | TF-TCA06008 | 951.60 | + |
| | Operator B | TF-TCA06020 | 1013.28 | - |
| | Operator C | TF-TCA06068 | 1120.01 | - |
| | Operator A | TF-TCA06080 | 1120.63 | - |
| THC 50 | Operator B | TF-THC06021 | 42.33 | + |
| | Operator A | TF-THC06073 | 44.93 | + |
| | Operator C | TF-THC06060 | 47.61 | + |
| | Operator B | TF-THC06050 | 49.77 | + |
| | Operator A, C | TF-THC06062 | 53.28 | - |
| | Operator B | TF-THC06014 | 57.74 | - |
| | Operator B | TF-THC06040 | 58.69 | - |
| | Operator A, C | TF-THC06064 | 59.33 | - |
| TML | Operator A | TF-TML06052 | 84.31 | + |
| | Operator C | TF-TML06043 | 90.15 | + |
| | Operator B | TF-TML06024 | 94.68 | + |
| | Operator A | TF-TML06054 | 101.37 | - |
| | Operator B, C | TF-TML06056 | 108.45 | - |
| | Operator A | TF-TML06046 | 114.31 | - |
| AMP 500 | Operator B | TF-SAMP06031 | 447.35 | + |
| | Operator C | TF-SAMP06034 | 465.44 | + |
| | Operator A | TF-SAMP06006 | 479.87 | + |
| | | | | |
| | Operator B | TF-SAMP06055 | 502.90 | - |
| | Operator A | TF-SAMP06075 | 541.26 | - |
| | Operator C | TF-SAMP06054 | 577.15 | - |
| COC 150 | Operator A, B, C | TF-SCOC06030 | 133.67 | + |
| | Operator B | TF-SCOC06062 | 155.27 | - |
| | Operator A, C | TF-SCOC06053 | 160.33 | - |
| | Operator B | TF-SCOC06019 | 165.57 | - |
| MET 500 | Operator B | TF-SMET06029 | 428.49 | + |
| | Operator A, C | TF-SMET06042 | 481.16 | + |
| | Operator B, C | TF-SMET06035 | 512.71 | - |
| OPI 2000 | Operator B | TF-SMOP06029 | 1972.07 | + |
| | Operator B | TF-SMOP06014 | 2108.15 | - |
| | Operator C | TF-SMOP06065 | 2194.62 | - |
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C. Lay person study
A lay user study was performed at three intended user sites with 280 lay persons. 76 male and 64 female tested Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 1; 73 male and 67 female tested Healgen® Accurate Muti-Drug Urine Drug Screen Cup 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%, +/-50%, +/-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 blindlabeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| Drug | Concentration | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Cutoff | |||||||||
| (ng/mL) | Results | -100% | |||||||
| cutoff | -75% | ||||||||
| cutoff | -50% | ||||||||
| cutoff | -25% | ||||||||
| cutoff | +25% | ||||||||
| cutoff | +50% | ||||||||
| cutoff | +75% | ||||||||
| cutoff | |||||||||
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 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 | 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% | ||
| 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 | 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 | 19 | 2 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | ||
| COC | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | ||
| EDDP | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | ||
| FYL | 5 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| 500 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| MDMA | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | ||
| 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |
| MET | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | ||
| 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |
| MOP | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | ||
| 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | |
| MTD | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 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% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| PCP | 25 | 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 | 18 | 1 | 0 | 0 | ||
| PPX | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | ||
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | ||
| THC | 50 | 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% | ||
| TML | 100 | 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% | ||
| 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% |
Result of Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 1:
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34
Result of Healgen® Accurate Muti-Drug Urine Drug Screen Cup Configuration 2:
| Drug | Cutoff
(ng/mL) | Results | -100%
cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff | |
|-------|-------------------|---------------|-----------------|----------------|----------------|----------------|----------------|----------------|----------------|------|
| AMP | 500 | 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% | |
| BAR | 300 | 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% | |
| 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 | 150 | 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% | |
| | | | | | | | | | | |
| EDDP | 300 | Negative | 20 | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| FYL | 5 | Negative | 20 | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| MET | 500 | Negative | 20 | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| MOP | 2000 | Negative | 20 | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | |
| TML | 100 | 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% | 90% | 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% | |
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36
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 Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup are substantially equivalent to the predicate devices.