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

Indications for 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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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k123863

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.)

The predicate device UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cup was cleared under k091588.

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:

a) The dimension of plastic housing in the test cards has a modification: the width of plastic housing in the modified device is reduced about 10% compared to the predicate device, whereas the length of the plastic housing in the modified device remains the same as that in the predicate device.

b) The plastic cup in the test cups has a modification: The shape of the plastic cup is changed to a cylindrical cone shape, in which the diameter of the bottom round surface is smaller than that of the upper round surface.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison analysis. Studies performed include cutoff, precision, inter lot reproducibility, interference, accuracy and lay user studies.

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

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

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6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.