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K Number
K163704
Device Name
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
Manufacturer
HEALGEN SCIENTIFIC LLC
Date Cleared
2017-08-02

(216 days)

Product Code
JXMDIODISDJGDJRDKZJXNLAFLCMLDJLFG
Regulation Number
862.3170
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |--------------------------------|-------------------------| | Amphetamine | 500 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 150 ng/mL | | Cannabinoids | 50 ng/mL | | Methamphetamine | 500 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 | | Propoxyphene | 300 ng/mL | | Nortriptyline | 1000 ng/mL | Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Device Description
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, Propoxyphene, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
More Information

K142280, K143187, K141647, K140546, K150791, K150096, K151348, K152269

K142280, K143187, K141647, K140546, K15079, K150096, K151348, K152269

No
The device description and performance studies describe a standard lateral flow immunochromatographic assay, which relies on chemical reactions and visual interpretation, not AI/ML. There is no mention of AI, ML, or image processing for result interpretation.

No.
This device is an in vitro diagnostic (IVD) device used for detecting various drugs in human urine, providing only preliminary test results. It does not treat or prevent any condition.

Yes

The device is described as an "immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine." This directly indicates its use in identifying the presence of specific substances in a biological sample, which is a core function of a diagnostic device. While it states it provides "only preliminary test results" and requires confirmation, the act of detecting and indicating the presence of these drugs falls under the definition of diagnosis.

No

The device is described as a "competitive binding, lateral flow immunochromatographic assay," which is a physical test strip or cup that reacts with a urine sample to produce a visual result. This involves hardware components and chemical reactions, not just software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs).
  • Device Description: The description details a "lateral flow immunochromatographic assay", which is a common technology used in IVD tests.
  • Performance Studies: The document describes performance studies using human urine samples and comparing results to a reference method (GC/MS), which is typical for validating IVD devices.
  • Anatomical Site: The specified anatomical site is "human urine".
  • Intended User / Care Setting: The indication for both "Prescription Use" and "Over-The-Counter Use" aligns with the regulatory framework for IVD devices.

All these factors clearly indicate that the Healgen Multi-Drug Urine Test Cup and Dip Card are intended for in vitro diagnostic use.

N/A

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, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:

Drug(Identifier)Cut-off level
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Cannabinoids50 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL or 2000 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
Propoxyphene300 ng/mL
Nortriptyline1000 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, Nortriptyline, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Product codes (comma separated list FDA assigned to the subject device)

JXM, DJG, DIO, LDJ, LCM, LAF, DKZ, DIS, DJR, JXN, LFG

Device Description

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, Propoxyphene, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

A lay user study was performed at three intended user sites with 300 lay persons for each format of the device. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and Each participant was provided with the package insert, blind labeled samples and test blind-labeled. devices.

The test results were compared against GC/MS confirmed concentrations.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data of precision, cut-off, interference, specificity and method comparison of the devices were reported in K142280, K143187, K141647, K140546, K15079, K150096, K151348 and K152269.

A lay user study was performed for both the Dip Card and the Test Cup for drugs at specified percentages of cutoff concentrations.
For the Dip Card with MOP 300:

  • Methamphetamine: 90% to 100% agreement
  • Cocaine: 90% to 100% agreement
  • Cannabinoids: 90% to 100% agreement
  • Morphine: 85% to 100% agreement
  • Oxazepam: 85% to 100% agreement
  • Amphetamine: 90% to 100% agreement
  • Oxycodone: 90% to 100% agreement
  • Methadone: 85% to 100% agreement
  • Secobarbital: 95% to 100% agreement
  • Buprenorphine: 95% to 100% agreement
  • Phencyclidine: 90% to 100% agreement
  • MDMA: 90% to 100% agreement
  • Propoxyphene: 90% to 100% agreement
  • Tricyclic Antidepressants: 95% to 100% agreement

For the Dip Card with MOP 2000 (table labeled inconsistently, includes other drugs):

  • Methamphetamine: 90% to 100% agreement
  • Cocaine: 90% to 100% agreement
  • Cannabinoids: 90% to 100% agreement
  • Morphine: 90% to 100% agreement
  • Oxazepam: 90% to 100% agreement
  • Amphetamine: 85% to 100% agreement
  • Oxycodone: 85% to 100% agreement
  • Methadone: 95% to 100% agreement
  • Secobarbital: 90% to 100% agreement
  • Buprenorphine: 90% to 100% agreement
  • Phencyclidine: 90% to 100% agreement
  • MDMA: 90% to 100% agreement
  • Propoxyphene: 85% to 100% agreement
  • Tricyclic Antidepressants: 90% to 100% agreement

For the Cup with MOP 300:

  • Methamphetamine: 95% to 100% agreement
  • Cocaine: 90% to 100% agreement
  • Cannabinoids: 85% to 100% agreement
  • Morphine: 95% to 100% agreement
  • Oxazepam: 95% to 100% agreement
  • Amphetamine: 95% to 100% agreement
  • Oxycodone: 90% to 100% agreement
  • Methadone: 95% to 100% agreement
  • MDMA: 90% to 100% agreement
  • Secobarbital: 95% to 100% agreement
  • Buprenorphine: 90% to 100% agreement
  • Phencyclidine: 90% to 100% agreement
  • Propoxyphene: 90% to 100% agreement
  • Tricyclic Antidepressants: 90% to 100% agreement

For the Cup with MOP 2000:

  • Methamphetamine: 85% to 100% agreement
  • Cocaine: 90% to 100% agreement
  • Cannabinoids: 90% to 100% agreement
  • Morphine: 95% to 100% agreement
  • Oxazepam: 90% to 100% agreement (table contains this row under Amphetamine header for % cutoff, but refers to Oxazepam)
  • Amphetamine: 95% to 100% agreement
  • Oxycodone: 95% to 100% agreement
  • Methadone: 95% to 100% agreement
  • MDMA: 90% to 100% agreement
  • Secobarbital: 90% to 100% agreement
  • Buprenorphine: 90% to 100% agreement
  • Phencyclidine: 95% to 100% agreement
  • Propoxyphene: 90% to 100% agreement
  • Tricyclic Antidepressants: 95% to 100% agreement

All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

The key metric reported is "The percentage agreement (%)" comparing Lay person results to GC/MS, for various percentage of cutoff levels.
Range of agreements:
Dip Card MOP 300: 85% to 100%
Dip Card MOP 2000: 85% to 100%
Cup MOP 300: 85% to 100%
Cup MOP 2000: 85% to 100%

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.

K142280, K143187, K141647, K140546, K150791, K150096, K151348, K152269

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

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

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

HEALGEN SCIENTIFIC LLC C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

August 2, 2017

Re: K163704

Trade/Device Name: Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, DJG, DIO, LDJ, LCM, LAF, DKZ, DIS, DJR, JXN, LFG Dated: June 26, 2017 Received: July 03, 2017

Dear Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (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 (QS) regulation (21 CFR Part 820); and if applicable, the

1

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Donald J. St Pierre -S

Donald J. St. Pierre Acting Director 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)

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. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:

Drug(Identifier)Cut-off level
Amphetamine500 ng/mL
Oxazepam300 ng/mL
Cocaine150 ng/mL
Cannabinoids50 ng/mL
Methamphetamine500 ng/mL
Morphine300 ng/mL or 2000 ng/mL
Oxycodone100 ng/mL
Secobarbital300 ng/mL
Buprenorphine10 ng/mL
Methylenedioxy-methamphetamine500 ng/mL
Phencyclidine25 ng/mL
Methadone300 ng/mL
Propoxyphene300 ng/mL
Nortriptyline1000 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, Nortriptyline, Propoxyphene 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 must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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    1. Date: December 18, 2016
    1. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401
    1. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
    1. Device Name: Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card

Classification: Class II

Product CodeRegulation SectionPanel
DKZ
Amphetamine21 CFR § 862.3100, Amphetamine Test SystemToxicology
LDJ
Cannabinoids21 CFR § 862.3870, Cannabinoids Test SystemToxicology
DIO
Cocaine21 CFR § 862.3250, Cocaine and Cocaine Metabolites
Test SystemToxicology
LAF
Methamphetamine21 CFR § 862.3610, Methamphetamine Test
SystemToxicology
DJG
Morphine21 CFR § 862.3650, Opiate Test SystemToxicology
JXM
Oxazepam21 CFR § 862.3170, Benzodiazepine Test SystemToxicology
DJG
Oxycodone21 CFR § 862.3650, Opiate Test SystemToxicology
DIS
Secobarbital21 CFR § 862.3150, Barbiturate Test SystemToxicology
DJG
Buprenorphine21 CFR § 862.3650, Opiate Test SystemToxicology
LAF
Methylenedioxy-
methamphetamine21 CFR § 862.3610, Methamphetamine Test SystemToxicology

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| LCM

PhencyclidineEnzyme Immunoassay PhencyclidineToxicology
DJR
Methadone21 CFR § 862.3620, Methadone Test SystemToxicology
JXN
Propoxyphene21 CFR § 862.3700, Propoxyphene Test SystemToxicology
LFG
Nortriptyline21 CFR, 862.3910 Tricyclic antidepressant drugs
test system Test SystemToxicology

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, Propoxyphene, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

6. Predicate Devices:

K142280; Healgen Oxazepam and Morphine Tests (Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Dip Card, Cup) K140546; Healgen Marijuana and Methamphetamine Tests (Dip Card, Cup) K150791; Healgen Secobarbital, Buprenorphine and Methadone Tests (Cup, Dip Card) K150096; Healgen Methylenedioxy-methamphetamine and Phencyclidine Tests (Dip Card, Cup) K151348; Healgen Nortriptyline and Propoxyphene Tests (DipCard, Cup) K152269; Healgen Amphetamine, Cocaine and Methamphetamine Tests (Dip Card, Cup)

    1. 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, Propoxyphene, Nortriptyline and Methadone in human urine at the cutoff concentrations of:
Drug(Identifier)Cut-off level
Amphetamine(AMP)500 ng/mL

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Oxazepam (OXA)300 ng/mL
Cocaine (COC)150 ng/mL
Cannabinoids (THC)50 ng/mL
Methamphetamine (MET)500 ng/mL
Morphine (MOR)300ng/mL or 2000 ng/mL
Oxycodone (OXY)100 ng/mL
Secobarbital (BAR)300 ng/mL
Buprenorphine (BUP)10 ng/mL
Methylenedioxy-methamphetamine (MDMA)500 ng/mL
Phencyclidine (PCP)25 ng/mL
Methadone (MTD)300 ng/mL
Propoxyphene300 ng/mL
Nortriptyline (TCA)1000 ng/mL

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

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. 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.

    1. 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, K151348,
K152269) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Indication(s) for use | For the qualitative determination of
Amphetamine, Oxazepam, Cocaine,
Cannabinoids, Methamphetamine, Morphine,
Oxycodone, Secobarbital, Buprenorphine,
Methylenedioxy-methamphetamine,
Phencyclidine, Propoxyphene, Nortriptyline
and Methadone in human urine.

The configurations of the New Devices are
available in any combination of the above
tests. | For the qualitative determination of
Amphetamine, Oxazepam, Cocaine,
Cannabinoids, Methamphetamine,
Morphine, Oxycodone,
Secobarbital, Buprenorphine,
Methylenedioxy-methamphetamine,
Phencyclidine, Propoxyphene,
Nortriptyline and Methadone in
human urine.

The configurations of the Predicate
devices are only available in single
drug test. |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on
antigen- antibody interactions to indicate
positive or negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 500 ng/ml
Oxazepam (OXA):300 ng/ml
Cocaine(COC): 150 ng/ml
Cannabinoids (THC):50 ng/ml
Methamphetamine (MET): 500 ng/ml
Morphine (MOR): 300ng/mL or 2000 ng/ml
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-methamphetamine(MDMA):
500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml
Propoxyphene: 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml | Same |
| Configurations | Cup, Dip Card | Same |
| Intended Use | OTC Use & Prescription Use | Same |

7

8

Healgen Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 14 drugs of abuse tests while the predicate devices are single-drug test. And the Healgen Multi-Drug Urine Test Dip Card is the same as the test dip card format of the predicate devices except that the Healgen Multi-Drug Urine Test Dip Card is a multi-drug test that offers any combination from 2 to 14 drugs of abuse tests while the predicate devices are single-drug test.

9. Performance

Performance data of precision, cut-off, interference, specificity and method comparison of the devices were reported in K142280, K143187, K141647, K140546, K15079, K150096, K151348 and K152269.

10.Lay User Verification

A lay user study was performed at three intended user sites with 300 lay persons for each format of the device. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and Each participant was provided with the package insert, blind labeled samples and test blind-labeled. devices.

Drugs% of CutoffNumber of samplesLay person resultsThe percentage agreement (%)
No. of PositiveNo. of Negative
Methamphetamine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Cocaine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Cannabinoids-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
Morphine-25% Cutoff2031785%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
Oxazepam-25% Cutoff2011995%
+25% Cutoff2017385%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
Amphetamine-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
Oxycodone-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
Methadone-25% Cutoff2031785%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
Secobarbital-100%Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
Buprenorphine-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
Phencyclidine-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
MDMA-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
Propoxyphene-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
Tricyclic-50% Cutoff1600160100%
Antidepressants-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%

Comparison between GC/MS and Lav Person Results for Dip Card with MOP 300

9

10

11

+75% Cutoff20200100%
Drugs% of CutoffNumber of samplesLay person results No. of PositiveLay person results No. of NegativeThe percentage agreement (%)
Methamphetamine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Cocaine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Cannabinoids-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Morphine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Oxazepam-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Comparison between GC/MS and Lay Person Results for Dip Card with MOP 2000
Amphetamine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2031785%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Oxycodone-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2031785%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Methadone-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Secobarbital-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff20020100%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Buprenorphine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Phencyclidine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
MDMA-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
Propoxyphene-25% Cutoff2031785%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
Tricyclic
Antidepressants-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%

12

13

Comparison between GC/MS and Lay Person Results for Cup with MOP 300

| Drugs | % of Cutoff | Number
of samples | Lay person results | | The
percentage
agreement
(%) |
|------------------------------|--------------|----------------------|--------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| Methamphetamine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cocaine | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | | | | | |
| Cannabinoids | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 3 | 17 | 85% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| Morphine | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| Oxazepam | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| Amphetamine | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| Oxycodone | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| Methadone | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100% Cutoff | 20 | 0 | 20 | 100% |
| | -75% Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | | | | | |
| | -25% Cutoff | 20 | 1 | 19 | તેરજ |
| | +25% Cutoff | 20 | 1 d | l | તેરજ |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| MDMA | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | l | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી ત |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| Secobarbital | -25% Cutoff | 20 | 1 | 19 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી |
| | +25% Cutoff | 20 | 1 d | l | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| Buprenorphine | -25% Cutoff | 20 | 1 | 19 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 1 60 | 100% |
| Phencyclidine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | l | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી ત |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| Propoxyphene | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | તેરજ |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | | | | | |
| Tricyclic
Antidepressants | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 160 | 0 | 160 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 40 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |

14

15

16

Comparison between GC/MS and Lay Person Results for Cup with MOP 2000

Drugs% of CutoffNumber of samplesLay person resultsThe percentage agreement (%)
No. of PositiveNo. of Negative
Methamphetamine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2017385%
+50% Cutoff40400100%
+75% Cutoff20200100%
Cocaine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Cannabinoids-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Morphine-100% Cutoff20020100%
-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Oxazepam-100% Cutoff20020100%
-75% Cutoff20020100%
Amphetamine-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
-75% Cutoff20020100%
Oxycodone-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
Methadone-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
MDMA-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
-100% Cutoff20020100%
Secobarbital-75% Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Buprenorphine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Phencyclidine-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%
Propoxyphene-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2011995%
+25% Cutoff2018290%
+50% Cutoff40400100%
+75% Cutoff20200100%
Tricyclic
Antidepressants-100%Cutoff20020100%
-75%Cutoff20020100%
-50% Cutoff1600160100%
-25% Cutoff2021890%
+25% Cutoff2019195%
+50% Cutoff40400100%
+75% Cutoff20200100%

17

18

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

  • 11.Conclusion
    Verification studies were conducted in support of the modification to have a multi-drug test cup and test card test, including interference studies and a lay-user study. Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates.