UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS

K061457 · Ucp Biosciences, Inc. · LFG · Aug 21, 2006 · Clinical Toxicology

Device Facts

• Record ID: K061457
• Device Name: UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS
• Applicant: Ucp Biosciences, Inc.
• Product Code: LFG · Clinical Toxicology
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3910
• Device Class: Class 2

Intended Use

UCP Rapid "" Drug Screening Tricyclic Antidepressant, Propoxyphene Test are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection Tricyclic Antidepressant, Propoxyphene and their metabolites in human urine at the following cut-off concentrations: Tricyclic Antidepressant 1000 ng/mL Propoxyphene 300 ng/mL The tests provide only preliminary test results, 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 result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drugs levels.

Device Story

UCP Rapid Drug Screening tests are lateral flow immunochromatographic assays for qualitative detection of Tricyclic Antidepressants and Propoxyphene in human urine. Device utilizes competitive binding principle; drug in sample competes with drug conjugate for limited antibody binding sites. Visual output indicates presence or absence of drug at specified cut-off concentrations. Tests are performed without instrumentation; intended for professional use. Results are preliminary; clinical judgment and confirmatory testing (GC/MS) required for positive results. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

Clinical comparison study using 128 urine specimens per drug (64 positive, 64 negative). Specimens included 10% concentrations between -50% cutoff to cutoff and 10% between cutoff to +50% cutoff. Results compared against predicate devices and confirmed via HPLC or GC/MS. Performance demonstrated ≥ 98% agreement for all drugs. Additional bench testing included precision, sensitivity, specificity, cross-reactivity, interference, and stability studies.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format. Visual, qualitative end-result. No instrumentation required. Standalone test strips or devices. Evaluated for precision, sensitivity, specificity, cross-reactivity, interference, and stability.

Indications for Use

Indicated for qualitative detection of Tricyclic Antidepressants and Propoxyphene and their metabolites in human urine at 1000 ng/mL and 300 ng/mL cut-offs, respectively. Intended for preliminary screening; results require confirmation by GC/MS. Not for monitoring drug levels.

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).

Predicate Devices

• ACON TCA One Step Tricyclic Antidepressant Test Strip and Device (k021526)
• Instant-View Propoxyphene Urine Test and Cassette (k022915)

Submission Summary (Full Text)

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# 510(K) Submission for UCP Rapid™ Drug Screening TCA, PPX Tests

# 10. 510(K) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

The Assigned 510(k) number is K061457

#### Submitter:

UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: [phone] Fax: [phone]

#### Date:

May 22, 2006

#### Contact Person:

Dr. Nancy Chen

#### Trade Name:

UCP Rapid TM Drug Screening Tricyclic Antidepressant Test Strips UCP Rapid™ Drug Screening Tricyclic Antidepressant Test Devices UCP Rapid™ Drug Screening Propoxyphene Test Strips UCP Rapid™ Drug Screening Propoxyphene Test Devices

#### Common Name:

Tricyclic Antidepressant Test System Propoxyphene Test System

#### Product Code:

AFG (Tricyclic Antidepressant Test System) JXN (Propoxyphene Test System)

#### Regulation Section:

21 CFR 8628 3910 21 CFR 862§3700

Panel: Toxicology (91)

# PROPRIETARY INFORMATION

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# 510(K) Submission for UCP Rapid™ Drug Screening TCA, PPX Tests

# Device Classification: II

## Substantially Equivalent Devices:

ACON TCA One Step Tricyclic Antidepressant Test Manufactured by ACON Laboratories

Instant - View® Propoxyphene (PPX) Urine Test Manufactured by Alfa Scientific Designs, Inc

## Product Description:

UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

## Intended Use:

UCP Rapid "" Drug Screening Tricyclic Antidepressant, Propoxyphene Test are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection Tricyclic Antidepressant, Propoxyphene and their metabolites in human urine at the following cut-off concentrations:

| Tricyclic Antidepressant | 1000 ng/mL |
|--------------------------|------------|
| Propoxyphene | 300 ng/mL |

The tests provide only preliminary test results, 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 result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drugs levels.

# Comparison to Predicate Devices:

When compared to the predicates, UCP Rapid™ Drug Screening Tricyclic Antidepressant and Propoxyphene Tests provide the qualitative determination of the same drugs in the same matrix, and utilizes the same cutoff concentrations. Both tests are immunochromatographic, lateral flow assays for the qualitative detection of drugs with visual, qualitative end results. Both tests are intended to provide preliminary analytical test results.

# Safety and Effectiveness Data: Accuracy

PROPRIETARY INFORMATION PAGE A STATE

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# 510(K) Submission for UCP Rapid™ Drug Screening TCA, PPX Tests

A clinical comparison study was conducted using 128 clinical urine specimens per each drug including approximately 10% of the specimens containing one type drug at concentrations between -50% cutoff to cutoff ranges, another 10% of the specimens containing one type drug at concentrations between cutoffs to +50% cutoff ranges. The study was compared the test results between UCP RapidTM Drug Screening Tricyclic Antidepressant Tests with ACON TCA One Step Tricyclic Antidepressant Tests, UCP Rapid 110 Drug Screening Propoxyphene Test with Instant-View® Propoxyphene Urine test. Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug. All test results were confirmed with HPLC or GC/MS analysis. UCP Rapid11M Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test demonstrated performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS.

#### Other Information about Performance Characteristics:

The performance characteristics of UCP Rapid™ Drug Screening Tricyclic Antidepressant Test, UCP Rapid™ Drug Screening Propoxyphene Test was evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP Rapid 100 Drug Screening Tricyclic Antidepressant Test, UCP Rapid 100 Drug Screening Propoxyphene Test performs satisfactorily when used according to the package inserts.

#### Conclusion:

UCP Rapid™ Drug Screening Tricyclic Antidepressant Test is substantially equivalent to ACON TCA One Step Tricyclic Antidepressant Test, UCP Rapid™ Drug Screening Propoxyphene Test is substantially equivalent to Instant-View® Propoxyphene (PPX) Urine Test.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

AUG 2 1 2006

Re: k061457

Trade/Device Name: UCP Rapid™ Drug Screening Tricyclic Antidepressant Test UCP Rapid™ Drug Screening Propoxyphene Test Regulation Number: 21 CFR 8862.3910 Regulation Name: Tricyclic antidepressant drugs test system Regulatory Class: Class II Product Code: LFG, JXN Dated: August 10, 2006 Received: August 11, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Garcia

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K061457

Device Name: UCP Rapid™ Drug Screening Tricyclic Antidepressant Test UCP Rapid™ Drug Screening Propoxyphene Test

Indications For Use:

The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:

Test

Tricyclic Antidepressant Propoxyphene

Calibrator Nortriptyline Propoxyphene

Cut-off 1000 ng/mL 300 ng/mL

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 either single drug test or in combination with multiple other drug 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k061457