QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM

K992207 · Syntron Bioresearch, Inc. · DIO · Jul 22, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992207
• Device Name: QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
• Applicant: Syntron Bioresearch, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jul 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 300 ng/ml by GC/MS. (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 indicatedf. Syntron's QuikStrip 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

QuikStrip One Step Cocaine Test is a chromatographic absorbent immunoassay for urine screening. Input: urine sample. Principle: competitive binding; 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; complex competes with immobilized antigen in positive reaction zone. Result: absence of magenta color band at 300 ng/ml cutoff indicates positive; presence of magenta band in control zone confirms reagent/device function. Used in clinical/forensic settings; operated by healthcare professionals/technicians. Output: visual colorimetric result. Clinical decision-making: preliminary screening result requires GC/MS confirmation; clinical judgment applied to results. Benefit: rapid, qualitative detection of cocaine presence.

Clinical Evidence

Clinical trial of 318 urine samples compared QuikStrip One Step Cocaine Test against Syva EMIT® II, with all positive results confirmed by GC/MS. Results: relative sensitivity 99.89%, relative specificity 100%, accuracy 99.56%. In-house testing showed 100% accuracy compared to EMIT II on GC/MS-documented samples.

Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; immobilized drug conjugate. Qualitative visual readout. Standalone test format.

Indications for Use

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

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

• Syva EMIT® II

Submission Summary (Full Text)

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K99207

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

Syntron Bioresearch, Inc.

Page 101 of 101

Revision A 05/19/1999 Printed on 05/28/1999

### 13.1.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 QuikStrip 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 QuikStrip 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 up 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 QuikStrip One Step Cocaine Test vielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when compared against Syva EMIT® II 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 Emit II®.

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 Emitt II method. Two samples were positive by both GC/MS and QuikStrip, but negative for Cocaine by Emit II®.

Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or bv 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 1999

Syntron Bioresearch, Inc. c/o Mr. James M. Barquest California Department of Health Services Food & Drug Branch 601 N. Seventh Street P.O. Box 942732, MS-357 Sacramento, California 94234-7320

Re: K992207

> Trade Name: OuikStrip One Step Cocaine Assay Regulatory Class: II Product Code: DIO Dated: June 29, 1999 Received: June 30, 1999

Dear Mr. 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 Flectronic Product

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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 [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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# FOOD & DRUG BRANCH JUN 0 9 1999

510(k) Number (if Known): To be assigned

Device Name: QuikStrip One Step Cocaine

Indications For Use:

#### INTENDED USE

Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 300 ng/ml by GC/MS. (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 indicatedf. Syntron's QuikStrip 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)

or

Dran Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992207

**Prescription Use:**
(Per 21 CFR 801.109)

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