UCP MULTIPLE DRUG SCREEN TEST CUPS

K072062 · Ucp Biosciences, Inc. · LFG · Sep 20, 2007 · Clinical Toxicology

Device Facts

• Record ID: K072062
• Device Name: UCP MULTIPLE DRUG SCREEN TEST CUPS
• Applicant: Ucp Biosciences, Inc.
• Product Code: LFG · Clinical Toxicology
• Decision Date: Sep 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3910
• Device Class: Class 2

Indications for Use

The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels: [Table of cutoffs provided]. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. 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 Multiple Drug Screen Test Cups are lateral flow, competitive binding immunoassays for urine drug screening. Device detects Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, and Propoxyphene. User collects urine sample in cup; device provides visual qualitative results based on presence/absence of drug at specified cutoff concentrations. Intended for preliminary screening; positive results require confirmatory testing via GC/MS. Used in clinical or professional settings to assist in drug abuse assessment. Results interpreted by healthcare providers to guide clinical decision-making.

Clinical Evidence

Bench testing only. Submitter provided design control activities summary, risk analysis, and verification/validation results demonstrating that predetermined acceptance criteria were met for the modified collection cup design.

Technological Characteristics

Qualitative immunoassay test strips housed in a collection cup with integrated test chamber. Fundamental scientific technology remains consistent with predicate devices. No changes to assay chemistry or detection principle.

Indications for Use

Indicated for the qualitative detection of drugs of abuse and their metabolites in human urine. Target population includes individuals undergoing drug screening. Not for monitoring drug levels. Preliminary results require GC/MS confirmation.

Regulatory Classification

Identification

A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A tricyclic antidepressant drugs 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

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k072062

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.) k050540, k061457
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 addition of a collection cup with a test chamber to hold the test strips for qualitative drugs of abuse immunoassays.

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