QuickScreen Pro Multi Drug Screening Test, Model 9395Z

K181945 · Phamatech, Inc. · DKZ · Oct 18, 2018 · Clinical Toxicology

Device Facts

• Record ID: K181945
• Device Name: QuickScreen Pro Multi Drug Screening Test, Model 9395Z
• Applicant: Phamatech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Oct 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.

Device Story

Single-use, cup-format lateral flow immunoassay; detects drugs of abuse in urine. Input: urine sample; mechanism: competitive immunoassay using monoclonal/polyclonal antibodies on porous membrane; drug/metabolites compete with drug/protein conjugate for binding sites. Output: visual qualitative result indicated by self-timer. Used in professional point-of-care settings; interpreted by healthcare professionals. Provides preliminary results; requires confirmation via GC/MS or other methods. Benefits: rapid screening for clinical decision-making.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data including precision/reproducibility studies (n=80 per level) and method comparison studies against GC/MS reference method. Method comparison conducted at multiple POC sites using unaltered clinical urine samples. Results demonstrated high concordance with GC/MS; discrepant results were observed near the cut-off concentrations. Analytical specificity (cross-reactivity and interference) and stability (22-month claim) were also evaluated.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: monoclonal anti-drug antibody/colloidal gold conjugate, drug derivative/protein conjugate, goat anti-rabbit antibody. Format: single-use disposable cup with 12 test strips. No external controls. No electronic components; visual readout.

Indications for Use

Indicated for professional, prescription-only qualitative screening of urine for amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy (MDMA), methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (Imipramine), and buprenorphine.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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

• At Home Drug Test 12: Model 9308Z (k070009)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2018

Phamatech Inc. % Korina Akhondzadeh Sr. Regulatory Consultant to Phamatech Kara & Associates 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009

Re: k181945

Trade/Device Name: QuickScreen Pro Multi Drug Screening Test, Model 9395Z Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, JXM, DJC, LFG, DIS, DIO, DJR, LDJ, LCM, DJG Dated: July 16, 2018 Received: July 20, 2018

Dear Korina Akhondzadeh:

We have reviewed vour 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. 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 located 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.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Kellie B. Kelm -S

for 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) k181945

### Device Name

QuickScreen Pro Multi Drug Screening Test Model 9395Z

## Indications for Use (Describe)

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.

| Analyte | Abbreviation | Cut-off Concentration (ng/ml) |
|-------------------------------------------|------------------|-------------------------------|
| Amphetamines | AMP | 1000 |
| Barbiturates | BAR | 200 |
| Benzodiazepines | BZD | 200 |
| Cocaine | COC | 300 |
| Ecstasy | MDMA | 500 |
| Methadone | MTD | 300 |
| Methamphetamine | MET | 500 |
| Opiates | OPI | 300 |
| Oxycodone | OXY | 100 |
| Phencyclidine | PCP | 25 |
| Marijuana | THC | 50 |
| Tricyclic Antidepressants<br>(Imipramine) | TCA (Imipramine) | 1000 |
| Buprenorphine | BUP | 10 |

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/4/Picture/0 description: The image shows the logo for "PHAMATECH LABORATORIES & DIAGNOSTICS". The logo consists of the letters "PT" in a large, bold, sans-serif font, with the word "PHAMATECH" in a smaller, sans-serif font to the right of the letters. Below the word "PHAMATECH" is the phrase "LABORATORIES & DIAGNOSTICS" in an even smaller, sans-serif font. The letters and words are all in a blue color.

## k181945 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### l. SUBMITTER

Phamatech, Inc. 15175 Innovation Drive San Diego, CA

Phone: Contact at Phamatech: 858-643-5555 Robert A. Merlock QA/QC Manager

## Official Correspondent

Korina A. Akhondzadeh KARA & Associates - Regulatory Consultant to Phamatech 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009

Phone: [phone] Fax: [phone]

Date Prepared: October 15, 2018

#### II. DEVICE

Device Name: QuickScreen Pro Multi Drug Screening Test, Model 9395Z Common/Usual Name: Multi-Drug Urine Test Panel Class: ll

Product Code and Regulation:

| Product<br>Code | Regulation<br>Number | Regulation Description |
|-----------------|----------------------|--------------------------------------------|
| DKZ | 862.3100 | Amphetamine test system |
| DIS | 862.3150 | Barbiturate test system |
| JXM | 862.3170 | Benzodiazepine test system |
| DIO | 862.3250 | Cocaine and cocaine metabolite test system |
| DJC | 862.3610 | Methamphetamine test system |
| DJR | 862.3620 | Methadone test system |
| DJG | 862.3650 | Opiate test system |
| LCM | Unclassified | Phencyclidine |
| LDJ | 862.3870 | Cannabinoid test system |
| LFG | 862.3910 | Tricyclic antidepressant drugs test system |

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Image /page/5/Picture/0 description: The image contains the logo for "PHAMATECH LABORATORIES & DIAGNOSTICS". The logo consists of the letters "PT" in a stylized font on the left, followed by the word "PHAMATECH" in a larger, bolder font. Below "PHAMATECH" is the phrase "LABORATORIES & DIAGNOSTICS" in a smaller font. The color scheme is primarily blue.

#### lll. PREDICATE DEVICE

## Primary Predicate Device

At Home Drug Test 12: Model 9308Z, K070009

The predicate device has not been subject to a recall.

#### IV. DEVICE DESCRIPTION

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the rapid detection of the following drugs in urine at the cut-off concentrations listed in Table 1. It is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a single-use device utilizing a cup format.

The device is based upon the Phamatech At Home 12 Drug Test Models 9308Z cleared in K070009 for home use for the detection of amphetamines(AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine(MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) in urine samples. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z adds testing for tricyclic antidepressants (TCA) (imipramine) and buprenorphine (BUP).

The QuickScreen Pro Multi-Drug Screening Test System is intended for use in prescription point-of-care settings.

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a chromatographic absorbent device in which drugs or drug metabolites in a urine sample compete with drug / protein conjugate immobilized on a porous membrane of the test device for a limited number of antibody / dye conjugate binding sites. The test device employs a unique combination of monoclonal and polyclonal antibodies to selectively identify drugs of abuse in urine. The test device also contains a self-timer that indicates when test results are ready to be interpreted.

#### > INDICATIONS FOR USE

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.

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Image /page/6/Picture/0 description: The image shows the logo for "PHAMATECH LABORATORIES & DIAGNOSTICS". The logo consists of the letters "PT" in a stylized font on the left, with the word "PHAMATECH" in a larger, bolder font to the right. Below "PHAMATECH" are the words "LABORATORIES & DIAGNOSTICS" in a smaller font. The logo is in a blue color scheme.

| Analyte | Abbreviation | Cut-off<br>Concentration<br>(ng/ml) |
|-------------------------------------------|------------------|-------------------------------------|
| Amphetamines | AMP | 1000 |
| Barbiturates | BAR | 200 |
| Benzodiazepines | BZD | 200 |
| Cocaine | COC | 300 |
| Ecstasy | MDMA | 500 |
| Methadone | MTD | 300 |
| Methamphetamine | MET | 500 |
| Opiates | OPI | 300 |
| Oxycodone | OXY | 100 |
| Phencyclidine | PCP | 25 |
| Marijuana | THC | 50 |
| Tricyclic Antidepressants<br>(Imipramine) | TCA (Imipramine) | 1000 |
| Buprenorphine | BUP | 10 |

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is substantially equivalent to the predicate At Home Drug Test 12: Model 9308Z based upon the same technological characteristics identified in Table 5-1 Comparison of the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z to the Predicate Device and as discussed below

## Comparison of Technological Characteristics

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z and its predicate device, At Home Drug Test 12: Model 9308Z, are qualitative lateral flow immunoassays based upon the principle of antigen and antibody immunochemistry for the detection of the identified drug analytes. Both devices test in urine using a cup format.

The predicate device, At Home Drug Test 12: Model 9308Z, tests for the same drugs as the subject device, QuickScreen™ Pro Multi Drug Screening Test Model 9395Z with the exception of buprenorphine and tricyclic antidepressants (imipramine).

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Image /page/7/Picture/0 description: The image shows the logo for PHAMATECH Laboratories & Diagnostics. The logo consists of the letters "PT" in a stylized font, with the word "PHAMATECH" in a larger, sans-serif font to the right. Below "PHAMATECH" are the words "LABORATORIES & DIAGNOSTICS" in a smaller font. The colors used in the logo are blue and light green.

#### VII. PERFORMANCE DATA

Performance testing was conducted for the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z. Studies focused on performance testing for the addition of the TCA and BUP tests. Performance testing for the other drugs was reported in K070009 (Phamatech At Home Drug Test 12: Model 9308Z).

Performance testing was conducted to establish the substantial equivalence of the device:

- Method Comparison Studies .
- . Assay Interference Studies
- Assay Precision/Sensitivity Studies .
- Prozone Response ●
- Sample pH
- Read Time
- Sample Temperature
- . Specific Gravity

#### CONCLUSIONS VIII.

The testing conducted supports the safety and effectiveness of the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z and demonstrates the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z performs as intended. The performance testing conducted demonstrates that the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z performs substantially equivalent to the predicate device. Both the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z and the predicate device have the same intended use and technological characteristics.

## Table 5-1 Comparison of the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z to the Predicate Device

| Feature | QuickScreen™ Pro Multi Drug<br>Screening Test Model 9395Z | At Home Drug Test 12: Model 9308Z<br>(K070009)<br>Predicate Device |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The QuickScreen™ Pro Multi Drug<br>Screening Test Model 9395Z is an<br>screening test for the qualitative<br>detection of amphetamines,<br>barbiturates, benzodiazepines,<br>cocaine, ecstasy, methadone,<br>methamphetamine, opiates,<br>oxycodone, phencyclidine, marijuana,<br>(imipramine) antidepressants and<br>buprenorphine in urine at the cut-off<br>concentrations listed. | The Phamatech At Home 12 Drug Test:<br>Model 9308Z for amphetamines (AMP),<br>barbiturates (BAR), benzodiazepines<br>(BZD), cocaine (COC), ecstasy<br>(MDMA), methadone (MTD),<br>methamphetamine (MET), opiates<br>(OPI), oxycodone (OXY), phencyclidine<br>(PCP) and marijuana (THC) is a<br>screening test for the rapid detection of<br>the drugs listed above in urine. |
| Intended Use | Professional | OTC |
| 510(k) Number | N/A | K070009 |
| Feature | QuickScreen™ Pro Multi Drug<br>Screening Test Model 9395Z | At Home Drug Test 12: Model 9308Z<br>(K070009)<br>Predicate Device |
| Classification | Class II | Class II |
| Product Code<br>Regulation No.<br>Drug | DKZ<br>862.3100<br>(AMP)<br>DIS<br>862.3150 (BAR)<br>JXM<br>862.3170 (BZD)<br>DIO<br>862.3250 (COC)<br>DJC<br>862.3610<br>(MET/MDMA)<br>DJR<br>862.3620 (MTD)<br>DJG<br>862.3650<br>(OPI/BUP/OXY)<br>LCM<br>Pre-amendment<br>(PCP)<br>LDJ<br>862.3870 (THC)<br>LFG<br>862.3910 (TCA) | DKZ<br>862.3100<br>(AMP/MDA)<br>DIS<br>862.3150 (BAR)<br>JXM<br>862.3170 (BZD)<br>DIO<br>862.3250 (COC)<br>DJC<br>862.3610<br>(MET/MDMA)<br>DJR<br>862.3620 (MTD)<br>DJG<br>862.3650<br>(OPI/OXY)<br>LCM<br>Pre-amendment<br>(PCP)<br>LDJ<br>862.3870 (THC) |
| Methodology | Lateral flow immunoassay based on the<br>principle of antigen and antibody<br>immunochemistry | Lateral flow immunoassay based on the<br>principle of antigen and antibody<br>immunochemistry |
| Results | Qualitative | Qualitative |
| Analyte Cut-off | Amphetamines (AMP): 1000 ng/ml<br>Barbiturates (BAR): 200 ng/ml<br>Benzodiazepines: (BZD): 200 ng/ml<br>Cocaine (COC): 300 ng/ml<br>Ecstasy (MDMA): 500 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Methamphetamine (MET): 500 ng/ml<br>Opiates (OPI): 300 ng/ml<br>Oxycodone (OXY): 100 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Marijuana (THC): 50 ng/ml<br>Tricyclic Antidepressants (TCA)<br>(Imipramine): 1000 ng/ml<br>Buprenorphine (BUP): 10 ng/ml | Amphetamines (AMP): 1000 ng/ml<br>Barbiturates (BAR): 200 ng/ml<br>Benzodiazepines: (BZD): 200 ng/ml<br>Cocaine (COC): 300 ng/ml<br>Ecstasy (MDMA): 500 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Methamphetamine (MET): 500 ng/ml<br>Opiates (OPI): 300 ng/ml<br>Oxycodone (OXY): 100 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Marijuana (THC): 50 ng/ml |
| Configuration | Cup | Cup |
| Specimen Type | Urine | Urine |
| Use | Single-use | Single-use |

Phamatech QuickScreen Pro Multi Drug Screening Test Model 9395Z

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