(36 days)
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-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl 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 |
| 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-∆9-THC-COOH | 50 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
The single or multi-test panels 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 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 drugs in human urine 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 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
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 or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
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.
N/A
FDA 510(k) Clearance Letter - Healgen Accurate Urine Drug Screen Dip Card
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.06.09
December 23, 2025
Healgen Scientific LLC
℅ Jenny Shia
LSI International Inc
504 East Diamond Ave., Suite H
Gaithersburg, Maryland 20877
Re: K253567
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: November 16, 2025
Received: November 17, 2025
Dear Jenny 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).
Page 2
K253567 - Jenny Shia Page 2
December 23, 2025
Healgen Scientific LLC
℅ Jenny Shia
LSI International Inc
504 East Diamond Ave., Suite H
Gaithersburg, Maryland 20877
Re: K253567
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: November 16, 2025
Received: November 17, 2025
Dear Jenny 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.
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 (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-safety-reporting-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-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,
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
Digitally signed by JOSEPH A. KOTAREK -S
Date: 2025.12.23 09:15:09 -05'00'
Page 3
FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K253567
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, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl 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 |
| 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-∆9-THC-COOH | 50 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
The single or multi-test panels 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 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 drugs in human urine 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 |
Page 4
FORM FDA 3881 (8/23) Page 2 of 2
| 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 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
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 or LC/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)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) SUMMARY
1. Date: November 16, 2025
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 Urine Drug Screen Dip Card
Healgen Accurate Home Urine Drug Test Dip Card
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 (MOP/OPI)Oxycodone (OXY)6-Monoacetylmorphine(6-MAM)Norfentanyl (NFYL)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 | Methylenedioxymethamphetamine (MDMA)Methamphetamine (MET) | 862.3610, Methamphetamine Test System | Toxicology |
| NGM | Unclassified | Toxicology |
Page 6
| Phencyclidine (PCP) | | |
| 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 |
6. Predicate Devices:
Healgen Accurate Urine Drug Screen Dip Card (K240686)
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-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl 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 / 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-∆9-THC-COOH | 50 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
The single or multi-test panels 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 method must be
Page 7
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 drugs in human urine 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 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
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 or LC/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.
Page 8
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.
9. Substantial Equivalence Information
Similarities
| Item | Device | Predicate (K240686) |
|---|---|---|
| Intended use | Qualitative detection of drugs of abuse in urine. For 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) | Same except no NFYL and TML |
| 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 (MOP300/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 | ||
| Norfentanyl (NFYL) - 5 | ||
| Tramadol (TML) - 100 | ||
| Configurations | Test Dip Card | Same |
10. Standard/Guidance Document Reference (if applicable)
None referenced.
Page 9
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.
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 dipcards. The results obtained are summarized only for Tramadol (TML) and Norfentanyl (NFYL) in the following tables. The rest data were reported in the K240686.
| Drug | Lot Number | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|---|
| TML 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+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| NFYL 5 | 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+ | 26-/24+ | 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+ |
Page 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 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. These urine samples were tested using three lots of the device. The results obtained are summarized only for Tramadol (TML) and Norfentanyl (NFYL) in the following tables. The rest data were reported in the K240686.
Norfentanyl with Cutoff 5ng/mL
| Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|
| 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% |
| 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% |
| Norcarfentail Oxalate | 50,000 | 0.01% |
| Remifentanil | 15,000 | 0.03% |
| Valeryl Fentanyl | 20,000 | 0.03% |
| Thienyl Fentnayl | 50 | 10% |
| Trans-d, I 3-Methylfentanyl | 50 | 10% |
| 4-Fluoro-isobutyryl Fentanyl | >20,000 | -- |
| Despropionyl fentanyl (4-ANPP) | >20,000 | -- |
| MT-45 | >100,000 | -- |
| Ocfentanil | >100,000 | -- |
| Risperidone | >100,000 | -- |
Page 11
| Sufentanil | >100,000 | -- |
| Carfentanil Oxalate | >10,000 | -- |
| Labetalol Hydrochloride | >100,000 | -- |
| Trazodone | >100,000 | -- |
| U-47700 | >100,000 | -- |
| ω-1-Hydroxyfentanyl | >20,000 | -- |
| 6-Acetyl morphine | >100,000 | -- |
| Amphetamine | >100,000 | -- |
| Buprenorphine | >100,000 | -- |
| Buprenorphine -3-D-Glucuronide | >100,000 | -- |
| Codeine | >100,000 | -- |
| Dextromethorphan | >100,000 | -- |
| Dihydrocodeine | >100,000 | -- |
| EDDP | >100,000 | -- |
| EMDP | >100,000 | -- |
| Fluoxetine | >100,000 | -- |
| Heroin | >100,000 | -- |
| Hydrocodone | >100,000 | -- |
| Hydromorphone | >100,000 | -- |
| Ketamine | >100,000 | -- |
| Levorphanol tartrate | >100,000 | -- |
| Meperidine | >100,000 | -- |
| Methadone | >100,000 | -- |
| Morphine | >100,000 | -- |
| Morphine-3-β-D-glucuronide | >100,000 | -- |
| Naloxone hydrochloride | >100,000 | -- |
| Naltrexone hydrochloride | >100,000 | -- |
| Norbuprenorphine | >100,000 | -- |
| Norcodeine | >100,000 | -- |
| Norketamine | >100,000 | -- |
| Normeperidine | >100,000 | -- |
| Normorphine | >100,000 | -- |
| Noroxycodone | >100,000 | -- |
| Oxycodone | >100,000 | -- |
| Oxymorphone | >100,000 | -- |
| Pentazocine (Talwin) | >100,000 | -- |
| Pipamperone | >100,000 | -- |
| Tapentadol hydrochloride | >100,000 | -- |
| Thioridazine | >100,000 | -- |
| Tilidine | >100,000 | -- |
| Tramadol | >100,000 | -- |
| o-Desmethyl Tramadol | >100,000 | -- |
| n-Desmethyl Tramadol | >100,000 | -- |
Page 12
Tramadol with Cutoff 100ng/mL
| Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|
| Tramadol | 100 | 100% |
| n-Desmethyl Tramadol | 400 | 25% |
| o-Desmethyl Tramadol | 1,000 | 10% |
| o-Desmethyl Venlafaxine | >10,000 | -- |
| Venlafaxine HCl | >100,000 | -- |
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) |
| Albuterol sulfate(Proair HFA) | Ecgonine methyl ester | Oxazepam Glucuronide (except BZO test) |
| Alpha Methadol | EMDP | Oxolinic acid |
| Aminophylline | Ephedrine hydrochloride (except MET test) | Oxymetazoline |
| Aminopyrine | Erythromycin | Paliperidone |
| Amitriptyline(except TCA test) | Esomeprazole Magnesium | Papaverine |
| Amlodipine besylate | Estradiol | Penicillin-G |
Page 13
| 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(3000 mg/dL) | Propoxyphene(except PPX test) |
| Benzoic acid | Guaiacolglyceryl ether | Propranolol |
| Benzoylecogonine (except COC test) | Hemoglobin | Pseudoephedrine |
| Benzphetamine | Hexobarbital | Pyridoxine |
| Benzylpiperiazine | Hydralazine | Pyrilamine |
| Bilirubin | Hydrochlorothiazide | Pyrogallol |
| Boric Acid (1%) | Hydrocortisone | Quetiapine |
| Bromo2,5,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 HCl | 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 |
Page 14
| 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 | Loratidine | Tetrahydrocortisone 3-(βDglucuronide) |
| 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 (except OXY test) | Vitamin B2 |
| Delorazepam | Naltrexone (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) |
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 obtained are summarized only for Tramadol (TML) and Norfentanyl (NFYL) in the following tables. The rest data were reported in the K240686.
| 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%) |
|---|---|---|---|---|---|---|
| TML (100) | Operator A | + | 0 | 0 | 1 | 12 |
| - | 10 | 15 | 14 | 1 | ||
| Operator B | + | 0 | 0 | 1 | 11 | |
| - | 10 | 15 | 14 | 2 | ||
| Operator C | + | 0 | 0 | 1 | 12 | |
| - | 10 | 15 | 14 | 1 | ||
| NFYL (5) | Operator A | + | 0 | 0 | 2 | 13 |
| - | 10 | 15 | 13 | 2 | ||
| Operator B | + | 0 | 0 | 2 | 13 | |
| - | 10 | 15 | 13 | 2 | ||
| Operator C | + | 0 | 0 | 2 | 14 | |
| - | 10 | 15 | 13 | 1 |
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Accurate Result |
|---|---|---|---|---|
| TML 100 | Operator A | TC-TML06058 | 87.96 | + |
| Operator B | TC-TML06002 | 96.78 | + | |
| Operator C | TC-TML06067 | 83.87 | + | |
| Operator B | TC-TML06005 | 100.73 | - |
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| Operator C | TC-TML06023 | 109.70 | - |
| Operator B | TC-TML06061 | 116.75 | - |
| Operator A | TC-TML06035 | 120.71 | - |
| NFYL 5 | Operator A | TC-FYL06048 | 4.37 | + |
| Operator C | TC-FYL06040 | 4.41 | + |
| Operator B | TC-FYL06017 | 4.46 | + |
| Operator B | TC-FYL06019 | 4.57 | + |
| Operator C | TC-FYL06052 | 4.64 | + |
| Operator A | TC-FYL06045 | 4.95 | + |
| Operator B | TC-FYL06047 | 5.57 | - |
| Operator B, C | TC-FYL06054 | 5.63 | - |
| Operator A | TC-FYL06033 | 5.68 | - |
| Operator A | TC-FYL06043 | 5.73 | - |
C. Lay person study
141 male and 139 female tested Healgen Accurate Urine Drug Screen Dip Card. 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. The results are summarized below.
Result of Healgen Accurate Urine Drug Screen Dip Card Configuration 1:
| 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 | 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% |
| 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 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
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| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| COC | 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% |
| EDDP | 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% |
| FYL | 5 | 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% |
| 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% | 95% | 95% | 100% | 100% |
| MET | 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% |
| MOP | 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% |
| MTD | 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% |
| OXY | 100 | 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% |
| 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 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| PPX | 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% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
Page 17
| | | 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 | 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% |
| 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 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 |
| 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 | 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 | 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 | 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 |
Page 18
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| FYL | 5 | 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% |
| 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% | 95% | 95% | 100% | 100% |
| MET | 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% | 95% | 95% | 100% | 100% |
| MOP | 2000 | 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% |
| MTD | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| OXY | 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% |
| 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 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| PPX | 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% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| THC | 50 | 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% |
| TML | 100 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
Page 19
| | | 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% |
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.
Page 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% |
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.
§ 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).