QUIKPAC II ONE STEP COCAINE TEST

K972059 · Drial Consultants, Inc. · DIO · Aug 28, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972059
• Device Name: QUIKPAC II ONE STEP COCAINE TEST
• Applicant: Drial Consultants, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Aug 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

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 150 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 immunoassay for urine drug 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; if drug concentration exceeds 150 ng/ml, no magenta band forms in positive reaction zone. Control zone produces magenta band to verify reagent/device function. Used in clinical/forensic settings; interpreted by healthcare providers or technicians. Output: visual qualitative result (presence/absence of color band). Results are preliminary; require GC/MS confirmation for clinical decision-making. Benefits: rapid screening for cocaine presence.

Clinical Evidence

Clinical trial of 304 samples compared QuikPac II to commercial EIA test. Results: 99.49% relative sensitivity, 100% relative specificity, 99.75% accuracy. In-house testing (n=not specified) showed 100% relative sensitivity, 98.39% relative specificity, 99.03% accuracy vs EIA. Discrepant samples (n=3) were identified as adulterated with sodium dodecylsulfate (Tide), which caused false positives in both the subject device and the comparator (Emit II).

Technological Characteristics

Chromatographic absorbent device; porous membrane support; competitive binding immunoassay; visual colorimetric readout (magenta band). Qualitative detection at 150 ng/ml cutoff.

Indications for Use

Indicated for qualitative screening of urine for cocaine and its metabolites at a 150 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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AUG 28 1997

510k Submission for QuikPac II One Step Cocaine Test

Syntron Bioresearch, Inc.

Page 80 of 80 Pages

K972050

Revision d 5/17/97, 7/26/97 Printed on 8/11/97

## 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 9 862.3250. 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 150 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 vielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 0.9839 and an accuracy of 99.03% when tested against a commercial EIA test for Coacaine on samples documented to be positive by GC/MS. A clinical trial consisting of 304 samples was run and the combined data yielded a relative sensitivity of 99.49%, a relative specificity of 100% with an accuracy of 99.75% when compared to a commercial EIA test for Coacaine.

All positive samples by either screening method were confirmed by GC/MS. The results on the 3 discrepant samples clearly demonstrated similar errors by both methods. Three samples were positive by both Emit II® and QuikPac II, but negative for Cocaine by GC/MS. All three samples were demonstrated to be adulterated with "Clean Jane" [sodium dodecylsulfate (Tide)] which is supposed to interfere with positive testing, but causes both screening tests to return positive results. GCMS analysis will return a negative for the drug, but a positive 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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Food and Drug Administration ¨¨ 2098 Gaither Road Rockville MD 20850

Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue Suite 201 Stmi Valley, California 93065

AUG 28 1997

K972059/S1 Re: QuikPac II One Step Cocaine Assay Trade Name: Requlatory Class: II Product Code: DIO Dated: Auqust 11, 1997 Received: August 12, 1997

Dear Dr. Laird:

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 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 requlations 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 requirement, as set forth in the Quality System Requlation (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 requlatory 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 Requlations.

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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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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## 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 150 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)

## (Division Sign-Off) wision of Clinical Labor. (k) Number Perscription Use: Over The Counter Use: or (Per 21 CFR 801.109 (Optional Format 1-2-96)

Concurance of CDRH, Office of Device Evaluation (ODE)