UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS

K123863 · Ucp Biosciences, Inc. · DKZ · Jan 9, 2013 · Clinical Toxicology

Device Facts

• Record ID: K123863
• Device Name: UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
• Applicant: Ucp Biosciences, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cup are intended for the qualitative detection of drugs of abuse in human urine. The tests are intended for over-the-counter (OTC) use as 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.

Device Story

UCP Compact Drug Test Cards and Cups are lateral flow, competitive binding immunoassays for urine drug screening. Device accepts human urine sample; utilizes antibody-antigen binding principle to produce visual color change indicating presence or absence of specific drug metabolites. Used in OTC and clinical settings; operated by consumers or healthcare professionals. Provides preliminary qualitative results; positive results require secondary confirmation via GC/MS. Assists in identifying potential drug use; facilitates specimen transport for laboratory confirmation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow, competitive binding immunoassay. Qualitative visual readout. Form factor: test cards and cups. Analyte-specific cut-off concentrations range from 25 ng/mL to 2000 ng/mL.

Indications for Use

Indicated for qualitative detection of drugs of abuse in human urine for over-the-counter (OTC) home use as a preliminary screening tool. Requires confirmatory testing via GC/MS.

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).

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Q

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

# January 9, 2013

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

Re: k123863

Trade/Device Name: UCP Compact Drug Test Cards UCP Compact Drug Test Cups

Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System

Regulatory Class: II Product Code: DKZ, DIS, JXM, DIO, DJC, DMB, DJG, LCM, LDJ, LFG Dated: December 12, 2012

Received: December 14, 2012

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. 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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Carol C. Benson 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): k123863

# Device Name: UCP Compact Drug Test Cards UCP Compact Drug Test Cups

Indications for Use:

The UCP Compact Drug Test Cards, UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of 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 ng/mL |

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, 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.

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Conqurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Lois Huxable
Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health

510(k) K123863

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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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Almaxleyles
Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health

510(k) K123863