The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.

The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/ml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone , oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

Device Description

AI/ML Overview

The Phamatech QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of various drugs or their metabolites in urine. This analysis focuses on the performance studies for the change to a 150 ng/ml cutoff concentration for cocaine (benzoylecgonine).

1. Acceptance Criteria and Reported Device Performance for Cocaine (150 ng/ml cutoff)

The acceptance criteria for the device performance are implicitly demonstrated by the reported agreement percentages with GC/MS results and the precision at various concentrations around the cutoff. While explicit numerical acceptance criteria are not stated as "thresholds," the reported performance values are presented to demonstrate substantial equivalence to predicate devices.

Category	Acceptance Criteria (Implicit)	Reported Device Performance (Cocaine 150 ng/ml cutoff)
Clinical Sample Correlation (Agreement with GC/MS)	High agreement percentage with GC/MS results for both positive and negative samples, particularly around the cutoff.	Dipcard: 98.75% agreement for positive results, 100% agreement for negative results. Cassette: 98.75% agreement for positive results, 100% agreement for negative results. Cup: 98.75% agreement for positive results, 100% agreement for negative results. Multi-dip: 97.5% agreement for positive results, 100% agreement for negative results.
Precision around Cutoff	Consistent and accurate detection of positive samples above the cutoff and negative samples below the cutoff.	At Cutoff (150 ng/ml): Multi Card: 12 positive, 68 negative Cup: 21 positive, 59 negative Cassette: 15 positive, 65 negative At 125% of Cutoff (187.5 ng/ml): 100% positive detection across all formats. At 75% of Cutoff (112.5 ng/ml): 100% negative detection across all formats.
Other Technical Performance Tests	Acceptable results for interference, lot-to-lot consistency, prozone response, and environmental factors.	"Other technical performance tests include: Assay Interference - Negative base, Assay Interference – Positive base, Lot to Lot Consistency, Prozone Response, Effect of Sample pH, Test Strip Dip Time Flex, Read Time Flex, Sample Temperature Flex, Specific Gravity Effects, Format Equivalency." (Results not detailed in provided text, but implied as acceptable).

2. Sample Size and Data Provenance for Test Set

Sample Size:
- Method Comparison (Clinical Samples): 80 unaltered clinical urine samples were tested.
- Precision around Cutoff (Spiked Samples): For each concentration level (Negative, -75%, -50%, -25%, Cutoff, 125%, 150%, 175%, 200%), samples were tested across 3 sites by 3 technicians for 20 days. The number of individual tests per concentration can be inferred. For example, at "Cutoff", 80 tests were performed (e.g., 20 days * 3 technicians * X number of tests per technician per day, or a total of 80 combined tests). The provided table lists a total of 80 observations (e.g., 12 pos + 68 neg = 80 for "Multi Card" at cutoff). This implies a total of 80 tests per concentration per format.
Data Provenance:
- Clinical Samples: Described as "unaltered clinical urine samples." The country of origin is not explicitly stated, but the submission is to the FDA in the USA, implying potential origin from the USA.
- Spiked Samples: "Standard drug solutions diluted in drug free urine." These are laboratory-prepared samples.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: For the method comparison study, "3 operators who are typical operators at this site" performed the tests on the QuickScreen devices.
Qualifications of Experts: Their specific qualifications (e.g., years of experience, professional titles) are not detailed beyond "typical operators at this site."
Ground Truth Qualification: The primary ground truth for the clinical samples was established by GC/MS results, which is a gold standard analytical method.

4. Adjudication Method for the Test Set

The adjudication method for the test set is not explicitly described in the provided text. The method comparison states that the 80 clinical samples were "blinded and sufficiently randomized and compared to GC/MS results." This indicates a direct comparison to the GC/MS reference, rather than an adjudication process between human readers or between a human reader and AI.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluates the performance of human readers with and without AI assistance. The QuickScreen Drug Screening Test System is an immunoassay device, not an AI-driven imaging or diagnostic software that assists human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The entire performance evaluation described in the document, including the clinical sample correlation study and the precision studies, represents the standalone performance of the QuickScreen device itself, without human interpretation in a diagnostic workflow (beyond the initial visual reading for qualitative results). The agreementpercentages and precision values directly reflect the device's ability to detect the analytes.

7. Type of Ground Truth Used

Clinical Samples: The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the confirmatory method and the "gold standard" for drug testing.
Spiked Samples: The ground truth for the precision studies was based on the known concentrations of standard drug solutions diluted in drug-free urine.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI development. The QuickScreen device is a lateral flow immunoassay. Thus, there is no AI algorithm that requires a separate training set. The performance studies mentioned are for validation of the chemical assay.

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

As there is no "training set" in the context of AI for this immunoassay device, this question is not applicable. The device's underlying chemical principles are developed and validated, not "trained" on data samples.

Summary

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K103295

FEB - 1 2012 Page 1 of 5

510 (k) SUMMARY AS REQUIRED BY SECTION 807,92(C)

Manufacturer & Submitter:

Contact:

Phamatech Inc. 10151 Barnes Canyon Road San Diego, California 92121, USA Cari A. Mongiovi Vice President Telephone 858 643 5555 Fax 858 635 5843

1/15/2011 Date Prepared

Proprietary Name: QuickScreen Drug Screening Test System

Common Name: Drug of Abuse Rapid Test System

Description: Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine

Classification Names:

The applicant test system regulatory classification is Class II, Classification Panel is Clinical Toxicology (91). Regulatory information applicable to this test system is provided below:

CFR section		Product Code
862.3100	Amphetamine test system	DKZ
862.3150	Barbiturate test system	DIS
862.3170	Benzodiazepine test system	JXM
862.3250	Cocaine/cocaine metabolite test system	DIO
862.3620	Methadone test system	DJR
862.3610	Methamphetamine test system	DJC
862.3650	Opiate test system	DJG
862.3650	Opiate test system (Oxycodone)	DJG
	Phencyclidine	LCM
862.3870	Cannabinoid test system	LDJ

Predicate Device: At Home Drug Test Models 9308T and 9308Z

Intended Use:

The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone,

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methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The cut-off concentrations of this test are as follows:

Analyte	Calibrator	Cutoff
Amphetamine	d amphetamine	1000 ng/ml
Cocaine	benzoylecgonine	150 ng/ml
• Methamphetamine	d methamphetamine	500 ng/ml
Opiates	morphine	300 ng/ml
PCP	phencyclidine	25 ng/ml
Barbiturates	Secobarbital	200 ng/ml
Benzodiazepines	Oxazepam	200 ng/ml
Methadone	Methadone	300 ng/ml
Oxycodone	Oxycodone	100 ng/ml
THC	Cannabinoids	50 ng/ml

The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.

Configurations of the QuickScreen Drug Screening Test System mav consist of any combination of the above listed and previously cleared drug. Refer to specific product labeling for the combination of drug tests included on that test device.

Similarities and differences to predicate device:

The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech QuickScreen At Home Drug Test and the Phamatech QuickScreen Pro Multi Drug Screening Test. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.

	At Home TestModel 9308T & 9308Z	QuickScreenTMDrug Screening Test System
510(k) #	K070009	K103295
Format	Integrated Cup/ Dip Card	Integrated Cup/Dip Card/Cassette
Use	In vitro diagnostic	In vitro diagnostic

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Intended Use
	Detection of:cocaine (benzoylecgonine)THC,opiates,amphetamine,methamphetamine,Benzodiazepines,barbiturates,methadonePCPOXY	Detection of:cocaine (benzoylecgonine)THC,opiates,amphetamine,methamphetamine,Benzodiazepines,barbiturates,methadonePCPOXY
Specimen	Urine	Urine
Methodology	Lateral flow Immunoassay	Lateral flow Immunoassay
Qualitative	YES	YES
Antibodies	Monoclonal / Polyclonal	Monoclonal / Polyclonal
Analyte's detected	10	10
Cutoffs (ng/ml)	Cocaine: 300THC: 50AMP 1000Opiates: 300PCP: 25MET: 500BZD: 200Barb: 200MTD: 300OXY 100	Cocaine: 150THC: 50AMP 1000Opiates: 300PCP: 25MET: 500BZD: 200Barb: 200MTD: 300OXY 100
Incubation	10 minutes	10 minutes
Control	Control Line	Control Line
Features	Test Expired Indicator	Test Expired Indicator
End User	Home (OTC) Use	Point of Care Use

The performance characteristics of the QuickScreen Drug Screening Test system for common analytes are exactly the same. They have not been altered by the change in cutoff concentration of the cocaine test.

See K070009 for amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites. Performance studies were conducted for the change to a 150ng/ml cutoff concentration for cocaine.

The following laboratory performance studies were performed to determine substantial equivalence of the QuickScreen Drug Screening Test system to the predicate:

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Performance: The performance characteristics of the QuickScreen Drug Screening Test system for common analytes was evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen Drug Screening Test system to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine.

Method Comparison - The performance of the QuickScreen™ devices was evaluated with 3 operators who are typical operators at this site. Operators tested 80 unaltered clinical urine samples The samples were blinded and sufficiently randomized and compared to GC/MS results. The results are presented below:

COC 150		Negative<50% ofcutoff	NearCutoff50% tocutoff	NearCutoffPositive to+ 50 %	HighPositive>50% ofcutoff	%Agreement
Dipcard	+		1	17	28	98.75
	-	20	19			100
Cassette	+		1	16	28	98.75
	-	20	19			100
Cup	+		1	16	28	98.75
	-	20	19			100
Multi-dip	+		2	16	28	97.5
	-	24	18			100

Cutoff Value(ng/ml)	Phamatech COC150(Pos/Neg)	Drug/MetaboliteGC/MS value (ng/ml)
150	Positive (card)	147.1
		148.16
150	Positive (cup)	144
150	Positive (card)	144

Performance of the QuickScreen Drug Screening Test system around cutoff for cocaine (benzoylecgonine) was evaluated by testing standard drug solutions diluted in drug free urine at 3 sites by 3 technicians in card, cup and cassette formats for a period of 20 days. The results are summarized below:

CONCENTRATION(ng/ml)	Multi Card	Cup	Cassette
Negative	40	40	40
-75%	80	80	80
-50%	80	80	80

Sensitivity / Precision at 4 sites:

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-25%	80	0	80	0	80	0
Cutoff	12	68	21	59	15	65
125%	0	80	0	80	0	80
150%	0	80	0	80	0	80
175%	0	80	0	80	0	80
200%	0	80	0	80	0	80

Other technical performance tests include:

Assay Interference - Negative base Assay Interference – Positive base Lot to Lot Consistency Prozone Response Effect of Sample pH Test Strip Dip Time Flex Read Time Flex Sample Temperature Flex Specific Gravity Effects Format Equivalency

For the reasons mentioned above, it may be concluded that Conclusion: Phamatech's QuickScreen Drug Test system is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the point of care technician.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.

10903 New Hampshire Avenue Silver Spring, MD 20993

FEB 0 1 2012

PHAMATECH INC

c/o Carl Mongiovi 10151 Barnes Canyon Rd San Diego. CA 92121

Re: K103295

Trade Name: Quickscreen Cocaine 150 Test, Quickscreen Multi Drug Screening Test, Quickscreen Drug Cup Test Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Codes: DIO Dated: September 14, 2011 Received: January 18, 2012

Dear Mr. Mongiovi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

signature

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known): _K_103295 . _

Device Name: QuickScreen™ Cocaine 150 Test Model 9050T Dip Card and 9051 Cassette

Indications for Use:

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.

AND/OR X Prescription Use: (Part 21 CFR 801 Subpart D

Over the Counter Use: (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of the CDRH Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

513(a) K103295

175

ા W

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Page 1 of 1

INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known): _K_103295 .

Device Name: QuickScreen™ Multi Drug Screening Test Model 9339T Dip Card

Indications for Use:

Analyte	Calibrator	Cutoff
Amphetamine	d amphetamine	1000 ng/ml
Cocaine	benzoylecgonine	150 ng/ml
Methamphetamine	d methamphetamine	500 ng/ml
Opiates	morphine	300 ng/ml
PCP	phencyclidine	25 ng/ml
Barbiturates	Secobarbital	200 ng/ml
Benzodiazepines	Oxazepam	200 ng/ml
Methadone	Methadone	300 ng/ml
Oxycodone	Oxycodone	100 ng/ml
THC	Cannabinoids	50 ng/ml

Prescription Use: AND/OR X (Part 21 CFR 801 Subpart D

Over the Counter Use: (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of the CDRH Office of In Vitro Diagnostic Devices (OIVD)

Division Sian-Off

Office of In Vitin Diagnostic Device Evaluation and Safety

57021 K103295

176

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Page 1 of 1

INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known): _K 103295

Device Name: QuickScreen™ Drug Cup Model 9339Z

Indications for Use:

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone, oxycodone and THC in urine. Tests for barbiturates camot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

Analyte	Calibrator	Cutoff
Amphetamine	d amphetamine	1000 ng/ml
Cocaine	benzoylecgonine	150 ng/ml
Methamphetamine	d methamphetamine	500 ng/ml
Opiates	morphine	300 ng/ml
PCP	phencyclidine	25 ng/ml
Barbiturates	Secobarbital	200 ng/ml
Benzodiazepines	Oxazepam	200 ng/ml
Methadone	Methadone	300 ng/ml
Oxycodone	Oxycodone	100 ng/ml
THC	Cannabinoids	50 ng/ml

X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use: AND/OR (Part 21 CFR 801 Subpart D

Over the Counter Use: (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of the CDRH Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off
Office of in Vitro Diagnostic
Device Evaluation and Safety
510(k)	K103295

3 of 3177

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).