Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

K151642 · Healgen Scientific,, LLC · JXM · Aug 13, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151642
• Device Name: Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
• Applicant: Healgen Scientific,, LLC
• Product Code: JXM · Clinical Toxicology
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

The combination of the previously cleared drugs of abuse test devices (cleared in k142280, k143187, k141647, k140546, k150791, and k150096) into the candidate multi-test devices that can detect a combination of up to 12 drugs of abuse at the same time

Device Story

Multi-drug test device; combines multiple previously cleared lateral flow immunoassay strips into single format (strip, cassette, dip card, or cup). Input: human urine specimen. Principle: competitive binding immunoassay; drug in sample competes with drug conjugate for limited antibody binding sites. Output: visual color change on test line indicating presence or absence of specific drug analytes. Used in clinical/point-of-care settings; operated by healthcare professionals. Results interpreted visually by user; provides rapid screening for drug presence to assist clinical decision-making regarding substance use.

Clinical Evidence

Bench testing only. Verification studies conducted to support multi-drug configuration, including interference studies and a lay-user study. No clinical trial data provided.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: multi-drug test cup and dip card. Analyte detection via specific antibody-antigen interactions. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of up to 12 drugs of abuse in human urine specimens. Intended for use by healthcare professionals and in point-of-care settings for screening purposes.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Healgen Oxazepam and Morphine Tests (K142280)
• Healgen Amphetamine and Oxycodone Tests (K143187)
• Healgen Cocaine and Morphine Tests (K141647)
• Healgen Marijuana and Methamphetamine Tests (K140546)
• Healgen Secobarbital, Buprenorphine and Methadone Tests (K150791)
• Healgen Methylenedioxy-methamphetamine and Phencyclidine Tests (K150096)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 13, 2015

HEALGEN SCIENTIFIC LLC C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K151642

Trade/Device Name: Healgen Multi-drug Urine Test Cup, Healgen Multi-drug Urine Test Dip Card Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: DKZ, JXM, DIO, LDJ, DJG, LAF, DIS, LCM, DJR Dated: July 10, 2015 Received: July 14, 2015

Dear Mr. Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) k151642

#### Device Name

Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card

#### Indications for Use (Describe)

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.

| Drug(Identifier) | Cut-off level |
|--------------------------------|-------------------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |

Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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- 1. Date: June 9, 2015
- 2. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401
- 3. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: [phone] Fax: [phone] Email: [e-mail]
- 4. Device Name: Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card

Classification: Class II

| Product Code | Regulation Section | Panel |
|-------------------------------------------|-------------------------------------------------------------------|------------|
| DKZ<br>Amphetamine | 21 CFR § 862.3100, Amphetamine Test System | Toxicology |
| LDJ<br>Cannabinoids | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology |
| DIO<br>Cocaine | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites<br>Test System | Toxicology |
| LAF<br>Methamphetamine | 21 CFR § 862.3610, Methamphetamine Test<br>System | Toxicology |
| DJG<br>Morphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| JXM<br>Oxazepam | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology |
| DJG<br>Oxycodone | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| DIS<br>Secobarbital | 21 CFR § 862.3150, Barbiturate Test System | Toxicology |
| DJG<br>Buprenorphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| LAF<br>Methylenedioxy-<br>methamphetamine | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology |

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| LCM<br>Phencyclidine | Enzyme Immunoassay Phencyclidine | Toxicology |
|----------------------|------------------------------------------|------------|
| DJR<br>Methadone | 21 CFR § 862.3620, Methadone Test System | Toxicology |

- 5. Description of the device:
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

# 6. Predicate Devices:

K142280; Healgen Oxazepam and Morphine Tests (Strip, Cassette, Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Strip, Cassette, Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Strip, Cassette, Dip Card, Cup) K140546; Healgen Marijuana and Methamphetamine Tests (Strip, Cassette, Dip Card, Cup) K150791; Healgen Secobarbital, Buprenorphine and Methadone Tests (Strip, Cassette, Cup, Dip Card) K150096; Healgen Methylenedioxy-methamphetamine and Phencyclidine Tests (Strip, Cassette, Dip Card, Cup)

## 7. Intended Use / Indications for Use

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine at the cutoff concentrations of:

| Drug(Identifier) | Cut-off level |
|-----------------------|---------------|
| Amphetamine(AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |

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| Morphine (MOR) | 300ng/mL or 2000 ng/mL |
|---------------------------------------|------------------------|
| Oxycodone (OXY) | 100 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Methadone (MTD) | 300 ng/mL |

Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

## 8. Substantial Equivalence Information

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are a modified product format derived from the previously FDA-cleared Healgen single DOA Tests. A summary comparison of features of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card and the predicate devices is provided in the following Table

| Item | New Devices | Predicate devices (K142280, K143187, K141647, K140546, K150791, K150096) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication(s) for use | For the qualitative determination of<br>Amphetamine, Oxazepam, Cocaine,<br>Cannabinoids, Methamphetamine, Morphine,<br>Oxycodone, Secobarbital, Buprenorphine,<br>Methylenedioxy-methamphetamine,<br>Phencyclidine and Methadone in human urine.<br>The configurations of the New Devices are<br>available in any combination of the above<br>tests. | For the qualitative determination o<br>Amphetamine, Oxazepam, Cocaine<br>Cannabinoids, Methamphetamine,<br>Morphine, Oxycodone,<br>Secobarbital, Buprenorphine,<br>Methylenedioxy-methamphetamine<br>Phencyclidine and Methadone in<br>human urine. |

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| | | The configurations of the Predicate |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | | devices are only available in single |
| | | drug test. |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on<br>antigen- antibody interactions to indicate<br>positive or negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (OXA):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>Cannabinoids (THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL or 2000 ng/ml<br>Oxycodone (OXY): 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-methamphetamine(MDMA):<br>500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml | Same |
| Configurations | Cup, Dip Card | Same |
| Intended Use | OTC Use & Prescription Use | Same |

Healgen Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 12 drugs of abuse tests while the predicate devices are single-drug test. And the Healgen Multi-Drug Urine Test Dip Card is the same as the test dip card format of the predicate devices except that the Healgen Multi-Drug Urine Test Dip Card is a multi-drug test that offers any combination from 2 to 12 drugs of abuse tests while the predicate devices are single-drug test.

## 9. Conclusion

Verification studies were conducted in support of the modification to have a multi-drug test cup and test card test, including interference studies and a lay-user study. Based on the test principle and acceptable

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performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates.