UCP HOME DRUG SCREENING TESTS

K091588 · Ucp Biosciences, Inc. · DKZ · Sep 4, 2009 · Clinical Toxicology

Device Facts

• Record ID: K091588
• Device Name: UCP HOME DRUG SCREENING TESTS
• Applicant: Ucp Biosciences, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The UCP Home Drug Screening Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: Amphetamine (1000 ng/mL), Barbiturates (300 ng/mL), Benzodiazepines (300 ng/mL), Cocaine (300 ng/mL), Marijuana (50 ng/mL), Methadone (300 ng/mL), Methamphetamine (1000 ng/mL), MDMA (500 ng/mL), Morphine (300 ng/mL), Opiate 2000 (2000 ng/mL), Oxycodone (100 ng/mL), Phencyclidine (25 ng/mL), Tricyclic Antidepressant (1000 ng/mL). The tests contain two formats: 1) Test Card; 2) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing – the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

Device Story

UCP Home Drug Screening Test Cards and Cups are lateral flow, competitive binding immunoassays for qualitative drug detection in human urine. Device accepts urine sample directly; no instrumentation required. Principle of operation relies on competitive binding between drug in sample and drug-conjugate on membrane; visual result (colored lines) indicates presence or absence of drug. Used by OTC consumers (parents) or healthcare professionals for preliminary screening. Output is visual qualitative result; preliminary positive requires confirmatory testing via GC/MS or HPLC. Benefits include rapid, accessible initial screening for drug presence, facilitating subsequent clinical or personal decision-making regarding confirmatory testing.

Clinical Evidence

No clinical trials performed. Evidence consists of a lay user study (n=115 for cards, n=110 for cups) across three locations. Participants (ages 18-75) with varying education levels tested samples spiked with drugs at 0%, 50%, 75%, 125%, 150%, and 300% of cutoff concentrations. Results showed high agreement with expected values (96.9% to 99.1% correct). Post-study questionnaires confirmed 99.1% of participants understood instructions and results.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Card (up to 10 strips) and Test Cup (up to 5 strips). Urine matrix. Internal procedural control line on each strip. Read time: 5-10 minutes. No instrumentation required.

Indications for Use

Indicated for qualitative detection of drugs and metabolites in human urine for OTC consumers and healthcare professionals. Target drugs: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressants. Provides preliminary results; requires confirmatory testing (GC/MS or HPLC).

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

• UCP Rapid Drug Screening Tests (k050540)
• UCP Rapid Drug Screening Tricyclic Antidepressants Tests (k061457)
• UCP Multiple Drug Screen Test Cups (k072062)

Submission Summary (Full Text)

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# UCP 510K Submission (k091588) UCP Home Drug Screening Test

## 10. 510(K) SUMMARY

SEP 0 4 2009

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

The Assigned 510(k) number is k091588

#### Submitter:

UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: [phone] Fax: [phone]

Date:

May 28, 2009

### Contact Person:

Dr. Nancy Chen

#### Trade Name:

UCP Home"M Drug Screening Test Card UCP Home™ Drug Screening Test Cup

#### Common Name:

Amphetamine Test System Methamphetamine Test System Cocaine Test System Barbiturate Test System Benzodiazepine Test System Methamphetamine Test System (MDMA) Opiates Test System Methadone Test System Opiates Test System (Oxycodone) Phencyclidine Test (unclassified) Cannabinoid Test System Tricyclic Antidepressant Test System

#### Product Code:

DKZ, LAF, DIO, DIS, JXM, DJC, DMB, DJG, LCM, LDJ, LFG

#### Regulation Section:

CFR 21 § 862.3650 CFR 21 § 862.3100

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# UCP 510K Submission (k091588) UCP Home Drug Screening Test CFR 21 § 862.3100 CFR 21 § 862.3250 CFR 21 § 862.3150 CFR 21 § 862.3610 CFR 21 § 862.3620 CFR 21 § 862.3250

CFR 21 § 862.3250 CFR 21 § 862.3100 CFR 21 § 862.3870 CFR 21 § 862.3910

Panel: Toxicology (91)

Device Classification: II

### Substantially Equivalent Devices:

# UCP Rapid Drug Screening Tests UCP Rapid Drug Screening Tricyclic Antidepressants Tests UCP Multiple Drug Screen Test Cups

### Product Description:

UCP Home Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates. Benzodiapines. Cocaines. Marijuana. Methamphetamine. MDMA. Opiates, Morphine, Oxycodone, Phencyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

#### Intended Use:

# 2. UCP Home™ Drug Screening Tests:

UCP Home "10 Drug Screening Tests are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations:

| Marjuana: | 50 ng/mL |
|------------------|------------|
| Cocaine: | 300 ng/mL |
| Amphetamine: | 1000 ng/mL |
| Methamphetamine: | 1000 ng/mL |
| Opiates: | 2000 ng/mL |

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# UCP 510K Submission (k091588) UCP Home Drug Screening Test

| Morphine: | 300 ng/mL |
|----------------------------|------------|
| Phencyclidine: | 25 ng/mL |
| Barbiturares: | 300 ng/mL |
| Benzodiazepines: | 300 ng/mL |
| Methadone: | 300 ng/mL |
| Oxycodone: | 100 ng/mL |
| MDMA: | 500 ng/mL |
| Tricyclic Antidepressants: | 1000 ng/mL |

The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling.

The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests provide only preliminary test results, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

For Over-The-Counter (OTC) use For In Vitro Diagnostics only

### Comparison to Predicate Devices:

When compared to the predicates, UCP Home Drug Screening Tests provide the qualitative determination of the same drugs in the same matrix, and utilizes the same cutoff concentrations. Both tests are immunochromatographic, lateral flow assays for the qualitative detection of drugs with visual, qualitative end results. Both tests are intended to provide preliminary analytical test results. The predicates are intended for professional use only, whereas UCP Home Drug Screening Tests are intended for OTC consumers use.

### Safety and Effectiveness Data:

Accuracy

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# UCP 510K Submission (k091588) UCP Home Drug Screening Test

A clinical comparison study for UCP Home Drug Screening Tests can be found in 510k submissions (k050540, k061457, k072062).

# Consumer Studies

The consumer study for UCP Home Drug Screening Test Cards was conducted among 115 lay persons in three geographic regions: Texas, Pennsylvania and California. Fifty eight females and fifty seven males from ages between 18 and 75 years have participated the studies. Fifty eight participants had high school education or less, fifty seven participants had finished college courses. None of the participants had experiences using drug testing products before. A separately consumer study for UCP Home Drug Screening Test Cups was conducted among 110 lay persons in three geographic regions: Texas, Pennsylvania and California. Fifty five females and fifty five males from ages between 18 and 77 years participated the study. Fifty five participants had high school education or less, fifty five participants had finished college courses. None of the participants had experiences using drug testing products before. The urine samples were prepared to contain strong negative (0% of cutoff), a very weak negative (50% of cutoff), a weak negative (75% of cutoff), a very weak positive (125% of cutoff), a weak positive (150% of cutoff) and high positive (300% of Cutoff), The urine samples with various drug concentrations were prepared by spiking pure drugs or drug metabolites into drug free human urine, the final drug concentrations in each urine sample were confirmed by GC/MS but TCA, TCA concentrations in the urine samples was confirmed by HPLC. The test results performed by the lay users showed 96.7% or above agreement rate with GC/MS results and indicate the lay users can perform UCP Home Drug Screening Test Card or Cup satisfactorily by following the test instruction. The post-study survey was conducted to determine if the lay users can understand the test instruction, the meaning of the test results and how to interpret the test results. Consumers were asked 9 questions including whether the test was easy to run, the results was easy to read, how to interpret the test results, importance of confirmatory test and some medicines and foods may affect the test results. Participant responses support that the lay users can understand how to run the test, interpret the test results, the importance of confirmatory test, and some issues concerning certain prescription medicines and foods may affect the test results.

## Other Information about Performance Characteristics:

The performance characteristics of UCP Home Drug Screening Tests including the precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study can be found in 510k submissions (k050540, k061457, k072062)

## Conclusion:

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# UCP Home Drug Screening Test

UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cups are substantially equivalent to UCP Rapid Drug Screening Tests, UCP Rapid Drug Screening Tricyclic Antidepressants, UCP Multiple Drug Screen Test Cups. .

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Image /page/5/Picture/12 description: The image shows a 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" is partially visible along the left side of the logo.

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SEP 0 4 2009

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

UCP Biosciences Inc. c/o Nancy Chen 1445 Koll Circle Suite 111 San Jose, CA 95112

Re: k091588

> Trade Name: UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cups Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DKZ, DIS, JXM, DIO, DJC, DMB, DJG, LCM, LDJ, LFG Dated: August 13, 2009 Received: August 13, 2009

Dear Ms. Chen:

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 [phone]. 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 [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

G.C.H

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k091588

Device Name: UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cups

Indications For Use:

The UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the following drugs and their metabolites in human urine:

| Test | Calibrator | Cut-off |
|--------------------------|-------------------|------------|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiate 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 pg/mL |

The tests contain two formats: 1) Test Card; 2) Test Cup. · The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users.

The tests will yield preliminary positive results when the prescription drugs Barbiturates. Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

Prescription Ues × AND/OR (Part 21 CFR 801 Subpart D)

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

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

| Division Sign-Off | |
|-------------------------------------------------------------------|---------|
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
| Office of In Vitro Diagnostic | |
| Device Evaluation and Safety | |
| 510(k) | k091588 |