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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QuickScreen Pro Multi Drug Screening Test, Model 9395Z, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the performance characteristics beyond the cut-off concentrations. Instead, it describes the established cut-off concentrations for each analyte and implies that the device's performance (sensitivity/precision) was evaluated against these cut-offs. The study focused on proving substantial equivalence to a predicate device, particularly for the newly added analytes (TCA and BUP).

Therefore, the "acceptance criteria" can be inferred to be the ability of the device to qualitatively detect the analytes in urine at or around the specified cut-off concentrations with acceptable precision/sensitivity. The "reported device performance" is a general statement that the device performs as intended and is substantially equivalent to the predicate for all analytes, with specific studies for TCA and BUP.

Analyte	Abbreviation	Cut-off Concentration (ng/ml) (Acceptance Criteria)	Reported Device Performance
Amphetamines	AMP	1000	Performs as intended, substantially equivalent to predicate
Barbiturates	BAR	200	Performs as intended, substantially equivalent to predicate
Benzodiazepines	BZD	200	Performs as intended, substantially equivalent to predicate
Cocaine	COC	300	Performs as intended, substantially equivalent to predicate
Ecstasy	MDMA	500	Performs as intended, substantially equivalent to predicate
Methadone	MTD	300	Performs as intended, substantially equivalent to predicate
Methamphetamine	MET	500	Performs as intended, substantially equivalent to predicate
Opiates	OPI	300	Performs as intended, substantially equivalent to predicate
Oxycodone	OXY	100	Performs as intended, substantially equivalent to predicate
Phencyclidine	PCP	25	Performs as intended, substantially equivalent to predicate
Marijuana	THC	50	Performs as intended, substantially equivalent to predicate
Tricyclic Antidepressants(Imipramine)	TCA (Imipramine)	1000	Performance testing conducted, performs as intended
Buprenorphine	BUP	10	Performance testing conducted, performs as intended

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the test sets for each type of performance study (Method Comparison, Assay Interference, Assay Precision/Sensitivity, Prozone Response, Sample pH, Read Time, Sample Temperature, Specific Gravity).

Data provenance is not explicitly stated regarding country of origin; however, the manufacturer is Phamatech, Inc. in San Diego, CA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve testing the device to demonstrate its performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set. For a drug screening test, the ground truth is typically established by analytical methods (like GC/MS) or by spiking urine samples with known concentrations of analytes.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method by human readers for the test set. For a qualitative immunoassay, the result is read directly from the test lines (presence or absence), and the comparison is to the confirmed analytical result.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done, nor does the document describe any AI component to the device. This is a point-of-care, qualitative immunoassay designed for direct interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is not an algorithm-only device. It is a physical immunoassay kit that produces a visual result. The "standalone" performance would refer to the device itself providing a result that is then compared to an analytical standard, which is implied by the performance studies (e.g., precision/sensitivity). There are no "human-in-the-loop" aspects in terms of interpretation algorithms to evaluate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of device is established by analytical methods, specifically by preparing urine samples with known concentrations of the analytes (e.g., using fortified samples at various concentrations around the cut-off) and comparing the device's results to these known concentrations, or by confirming positive results with a gold standard like Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating this is the expected ground truth for confirmation.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is common for immunoassay devices, where performance is typically established through analytical validation studies rather than machine learning training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described for a machine learning algorithm, the concept of establishing ground truth for a training set does not apply here. The device's performance is validated against analytical standards and comparative methods.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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(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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: 760-798-9642 Fax: 760-798-9643

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:

ProductCode	RegulationNumber	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 System is intended for use in prescription point-of-care settings.

> INDICATIONS FOR USE

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Analyte	Abbreviation	Cut-offConcentration(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(Imipramine)	TCA (Imipramine)	1000
Buprenorphine	BUP	10

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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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 DrugScreening Test Model 9395Z	At Home Drug Test 12: Model 9308Z(K070009)Predicate Device
Indications forUse	The QuickScreen™ Pro Multi DrugScreening Test Model 9395Z is anscreening test for the qualitativedetection of amphetamines,barbiturates, benzodiazepines,cocaine, ecstasy, methadone,methamphetamine, opiates,oxycodone, phencyclidine, marijuana,(imipramine) antidepressants andbuprenorphine in urine at the cut-offconcentrations listed.	The Phamatech At Home 12 Drug Test:Model 9308Z for amphetamines (AMP),barbiturates (BAR), benzodiazepines(BZD), cocaine (COC), ecstasy(MDMA), methadone (MTD),methamphetamine (MET), opiates(OPI), oxycodone (OXY), phencyclidine(PCP) and marijuana (THC) is ascreening test for the rapid detection ofthe drugs listed above in urine.
Intended Use	Professional	OTC
510(k) Number	N/A	K070009
Feature	QuickScreen™ Pro Multi DrugScreening Test Model 9395Z	At Home Drug Test 12: Model 9308Z(K070009)Predicate Device
Classification	Class II	Class II
Product CodeRegulation No.Drug	DKZ862.3100(AMP)DIS862.3150 (BAR)JXM862.3170 (BZD)DIO862.3250 (COC)DJC862.3610(MET/MDMA)DJR862.3620 (MTD)DJG862.3650(OPI/BUP/OXY)LCMPre-amendment(PCP)LDJ862.3870 (THC)LFG862.3910 (TCA)	DKZ862.3100(AMP/MDA)DIS862.3150 (BAR)JXM862.3170 (BZD)DIO862.3250 (COC)DJC862.3610(MET/MDMA)DJR862.3620 (MTD)DJG862.3650(OPI/OXY)LCMPre-amendment(PCP)LDJ862.3870 (THC)
Methodology	Lateral flow immunoassay based on theprinciple of antigen and antibodyimmunochemistry	Lateral flow immunoassay based on theprinciple of antigen and antibodyimmunochemistry
Results	Qualitative	Qualitative
Analyte Cut-off	Amphetamines (AMP): 1000 ng/mlBarbiturates (BAR): 200 ng/mlBenzodiazepines: (BZD): 200 ng/mlCocaine (COC): 300 ng/mlEcstasy (MDMA): 500 ng/mlMethadone (MTD): 300 ng/mlMethamphetamine (MET): 500 ng/mlOpiates (OPI): 300 ng/mlOxycodone (OXY): 100 ng/mlPhencyclidine (PCP): 25 ng/mlMarijuana (THC): 50 ng/mlTricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mlBuprenorphine (BUP): 10 ng/ml	Amphetamines (AMP): 1000 ng/mlBarbiturates (BAR): 200 ng/mlBenzodiazepines: (BZD): 200 ng/mlCocaine (COC): 300 ng/mlEcstasy (MDMA): 500 ng/mlMethadone (MTD): 300 ng/mlMethamphetamine (MET): 500 ng/mlOpiates (OPI): 300 ng/mlOxycodone (OXY): 100 ng/mlPhencyclidine (PCP): 25 ng/mlMarijuana (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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Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
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.(b)
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).