UCP Drug Test Mini Cups

K151213 · Ucp Biosciences, Inc. · DKZ · Aug 21, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151213
• Device Name: UCP Drug Test Mini Cups
• Applicant: Ucp Biosciences, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for the following drugs and their metabolites in human urine: Amphetamine (1000 ng/mL), Barbiturates (300 ng/mL), Benzodiazepines (300 ng/mL), Buprenorphine (10 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), Opiates (2000 ng/mL), Oxycodone (100 ng/mL), Phencyclidine (25 ng/mL), Propoxyphene (300 ng/mL), Tricyclic Antidepressant (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 - the second step in the process, along with the materials for shipping the urine speciment to the laboratory, is provided. The test is also intended for prescription use. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, 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 Cups; modified version of previously cleared test cups (K130463). Modification involves 12% reduction in cup diameter. Device utilizes lateral flow immunoassay technology for qualitative drug detection in urine. Intended for home use by consumers. Results provide preliminary analytical test results; clinical consideration and professional judgment required for confirmation. Modification assessed via design control activities and risk analysis to ensure fundamental scientific technology remains unchanged.

Clinical Evidence

Bench testing only. Verification studies conducted for the modified (smaller) test cup included precision, inter-lot reproducibility, sensitivity, pH and specific gravity interference, accuracy, and a lay-user study. Results demonstrated satisfactory performance consistent with the predicate device.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; visual qualitative readout; no energy source required; standalone device; smaller form factor compared to predicate.

Indications for Use

Indicated for the qualitative detection of drugs of abuse in human urine specimens for home use.

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

• k130463

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K151213

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

k130463:
UCP Home Drug Screening Test Cards
UCP Home Drug Screening Test Cups

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:
The dimension of the test cups has a modification: the diameter of the test cups is reduced about 12% compared to the predicate test cups.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and cutoffs.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.