INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST

K022915 · Alfa Scientific Designs, Inc. · JXN · Nov 29, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022915
• Device Name: INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: JXN · Clinical Toxicology
• Decision Date: Nov 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3700
• Device Class: Class 2

Indications for Use

The Instant-View™ Propoxyphene (PPX) Urine Test is a rapid one-step immunoassay intended for use in the qualitative detection of propoxyphene in human urine at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

Instant-View™ Propoxyphene (PPX) Urine Test is a rapid, one-step lateral flow immunoassay for qualitative detection of propoxyphene in human urine. Designed for healthcare professional use in clinical settings. Device utilizes competitive binding principle; drug in urine competes with drug-conjugate for limited antibody binding sites. Visual readout provided on test strip; presence or absence of colored lines indicates result. Preliminary positive results require confirmation via Gas Chromatography/Mass Spectrometry (GC/MS). Assists clinicians in identifying potential drug abuse; results intended to support clinical decision-making alongside professional judgment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; 300 ng/ml cutoff concentration. Standalone, non-electronic, single-use test device.

Indications for Use

Indicated for qualitative detection of propoxyphene in human urine at 300 ng/ml cutoff. For healthcare professional use only. Requires confirmatory testing via GC/MS for preliminary positive results.

Regulatory Classification

Identification

A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A propoxyphene 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064

Re:

k022915 Trade/Device Name: Instant-View™ Propoxyphene (PPX) Urine Test Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: August 26, 2002 Received: September 3, 2002

Dear Dr. Wang:

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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# 510 (K) NUMBER (IF KNOWN): HO32915

## DEVICE NAME: Instant-View™ Propoxyphene (PPX) Urine Test

### INDICATIONS FOR USE:

The Instant-View™ Propoxyphene (PPX) Urine Test is a rapid one-step immunoassay intended for use in the qualitative detection of propoxyphene in human urine at a cutoff concentration of 300 ng/ml. It is for health care professional use only.

This test provides only 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Tam Cooper

(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number _