QUICKPAC II ONE STEP COCAINE TEST

K992990 · Syntron Bioresearch, Inc. · DIO · Sep 20, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992990
• Device Name: QUICKPAC II ONE STEP COCAINE TEST
• Applicant: Syntron Bioresearch, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Sep 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 300 ng/ml (NIDA screening cutoff is 300 ng/ml). The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.

Device Story

QuikPac II One Step Cocaine Test is a chromatographic absorbent device for qualitative urine drug screening. Input: urine sample. Principle: competitive binding immunoassay; drug/metabolites in sample compete with immobilized drug conjugate on porous membrane for limited antibody sites. Labeled antibody-dye conjugate binds to free drug, forming antibody-antigen complex. If drug concentration exceeds 300 ng/ml, complex competes with immobilized conjugate, preventing magenta color band formation in positive reaction zone. Control zone binds unbound dye conjugate to confirm device function. Output: visual magenta color band (negative) or absence of band (positive). Used in clinical/forensic settings by professionals. Results are preliminary and require GC/MS confirmation for clinical decision-making. Benefits: rapid screening for presence of Cocaine.

Clinical Evidence

Clinical trial of 318 urine samples compared QuikPac II to commercial EIA test and GC/MS. Results: relative sensitivity 99.89%, relative specificity 100%, accuracy 99.56%. In-house testing showed 100% sensitivity, 100% specificity, and 100% accuracy against GC/MS-confirmed samples. Discrepant analysis showed similar error profiles to Emit II method.

Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; competitive binding immunoassay principle. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for qualitative screening of urine for Cocaine and its metabolites at a 300 ng/ml cutoff. Intended for medical/forensic screening; not for monitoring drug levels. Preliminary results require GC/MS confirmation.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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).

Reference Devices

• Emit II

Submission Summary (Full Text)

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12992990

## 510k Submission for QuikPac II One Step Cocaine(300) Test

Syntron Bioresearch, Inc.

Page 105 of 105 Pages

Revision A 6/05/99, Printed on 08/20/1999

## 15.1.Summary of Safety and Effectiveness

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Cocaine and its metabolites in a screening format.

The trade name of the device is QuikPac II One Step Cocaine Test having a designated common name of Cocaine Test System and a · classification as a Class II device per 21 CFR ¶ 862.3250. This device is intended for the medical/forensic screening of urine.

Syntron's QuikPac II One Step Cocaine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 300 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

In-house testing of Syntron's QuikPac II One Step Cocaine Test yielded a relative sensitivity or agreement within positive samples of 1.000 and a relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against a commercial EIA test for Cocaine on samples documented to be positive by GC/MS. A clinical trial consisting of 318 samples was run and the combined data yielded a relative sensitivity of 99.89%, a relative specificity of 100% with an accuracy of 99.56% when compared to a commercial EIA test for Cocaine.

All positive samples by either screening method were confirmed by GC/MS. The results on the 2 discrepant samples clearly demonstrated similar errors by the Emit II method. Two samples were positive by both GC/MS and QuikPac II, but negative for Cocaine by Emit II. Previous testing samples demonstrated to be adulterated with "Clean Jane", [sodium dodecylsulfate (Tide)], which is supposed to prevent a positive test tested positive by both screening tests (Emit II & QuikPac II). GC/MS analysis returned a negative for the drug (cocaine) with a specific signature for the adulterant.

Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 20 1999

Syntron Bioresearch, Inc. c/o Dr James M. Barquest California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, California 94234

Re: K992990

> Trade Name: QuikPac II One Step Cocaine Assay Regulatory Class: II Product Code: DIO Dated: August 20, 1999 Received: September 7, 1999

Dear Dr. Barquest:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# FOOD & DRUG BRANCH The States

510(k) Number (if Known): Not yet assigned

### Device Name: QuikPac II One Step Cocaine assay

#### Indications For Use:

Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 300 ng/ml (NIDA screening cutoff is 300 ng/ml). The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Sean Cooper

Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_k 99 2990

Prescription Use: (Per 21 CFR 801.109

or

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