QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

K043051 · Phamatech, Inc. · DJG · Feb 7, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043051
• Device Name: QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
• Applicant: Phamatech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of the oxycodone in urine. The cutoff concentration for this test is 100 ng/ml. This assay is intended for professional use. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Device Story

QuickScreen™ Oxycodone Test is a rapid, qualitative, one-step lateral flow immunoassay for urine drug screening. Device utilizes visual color sandwich immunochemical technology to detect oxycodone presence at 100 ng/mL cutoff. Intended for professional use in clinical settings. Operator performs test by applying urine sample to device; results are interpreted visually by the clinician. Output is a preliminary qualitative result (positive/negative). Preliminary positive results require secondary confirmation via GC/MS or alternative chemical methods. Device assists healthcare providers in identifying potential oxycodone use, facilitating clinical decision-making regarding patient management.

Clinical Evidence

Clinical evidence includes a clinical sample correlation study and a blind labeled spiked study. Results demonstrated >99% correlation with predicate devices. No further clinical performance metrics (sensitivity/specificity) provided beyond correlation data.

Technological Characteristics

Lateral flow immunoassay; visual color sandwich technology; immunochemical principle (antibody/target analyte/antibody complex formation). Standalone, single-use test device. No electronic components, software, or external energy source required.

Indications for Use

Indicated for the qualitative detection of oxycodone in human urine at a cutoff concentration of 100 ng/mL. Intended for professional use as a preliminary screening test. Requires confirmatory testing via GC/MS or other chemical methods.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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

• American BioMedica Corporation RapidOne OXY Test (k014101)

Submission Summary (Full Text)

{0}------------------------------------------------

K 043051

## 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

QuickScreen™ Oxycodone Test (Models 9120, 9120T, 9120X and 9121) Identification:

Description: Immunoassay for the qualitative detection of Oxycodone in urine

Name Of Manufacturer:

Phamatech 10151 Barnes Canyon Road San Diego, California 92121, USA

Intended Use: The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of the oxycodone in urine. The cutoff concentration for this test is 100 ng/ml. This assay is intended for professional use.

The QuickScreen™ Oxycodone Test, like many commercially available Technology: oxycodone screening test kits, qualitatively measures the presence of oxycodone by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC RapidOne Oxycodone test (Kinderhook, NY). These devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibodv / target analyte / antibody / complexes.

The product performance characteristics of the QuickScreen™ Oxycodone Performance: Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the QuickScreen™ Oxycodone Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the oxycodone in urine. Laboratory studies, using clinical specimens, produced a >99% correlation when compared to the predicate devices.

For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen™ Oxycodone Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the professional user.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures connected by flowing lines, representing health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 7 2005

Mr. Carl Mongiovi Vice President Phamatech Inc. 10151 Barnes Canyon Road San Diego, CA 92121

Re: k043051

> Trade/Device Name: QuickScreen Oxycodone Test Model 9120, 9120T, 9120X, and 9121 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: January 5. 2005 Received: January 19, 2005

Dear Mr. Mongiovi:

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).

{2}------------------------------------------------

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,

Jean M. Cooper, MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number K043051:

Device Name: QuickScreen Oxycodone Test Model 9120, 9120T, 9120X and 9121 Indications for Use:

The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL.. This test is intended for professional use.

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Prescription Use: Over the Counter: AND/OR 21 CFR 807 Subpart C Part 21 CFR 801 Subpart D

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

41
(Division Sign-Off)
*pating*
Division of Clinical Laboratory Deviees
510(k) Number K043051