UCP DRUG SCREENING TEST CUPS

K110515 · Ucp Biosciences, Inc. · DIS · Apr 20, 2011 · Clinical Toxicology

Device Facts

• Record ID: K110515
• Device Name: UCP DRUG SCREENING TEST CUPS
• Applicant: Ucp Biosciences, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Apr 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Indications for Use

The UCP Home Drug Screening Test is intended for the qualitative detection of drugs of abuse in human urine. The test is intended for over-the-counter (OTC) use.

Device Story

UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for urine drug screening. Device accepts human urine samples; utilizes lateral flow immunoassay technology to detect presence of specific drugs/metabolites above defined cut-off concentrations. Output is visual (preliminary positive or negative result). Intended for OTC use by consumers (e.g., parents) and healthcare professionals. Provides preliminary analytical results; requires confirmatory testing via GC/MS or HPLC for clinical decision-making. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of competitive binding immunoassays.

Technological Characteristics

Lateral flow competitive binding immunoassay; urine-based; visual readout; multi-drug or single-drug configurations.

Indications for Use

Indicated for qualitative detection of drugs of abuse in human urine for over-the-counter (OTC) use.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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
OIVD Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER
k110515

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 included both a test cup and a test card format and 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 modification to the plastic strip holder in the collection cup so that the cup can hold up to 12 strips.

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

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.

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.