QUIKSTRIP ONE STEP AMPHETAMINE TEST

K971218 · Drial Consultants, Inc. · DKZ · May 30, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971218
• Device Name: QUIKSTRIP ONE STEP AMPHETAMINE TEST
• Applicant: Drial Consultants, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

Syntron's QuikStrip One Step Amphetamine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Amphetamine in urine. 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 indicated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.

Device Story

Chromatographic absorbent device for qualitative urine drug screening. 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 free drug; complex competes with immobilized antigen in positive reaction zone. Result: absence of magenta band indicates drug level >500 ng/ml; presence of magenta band in control zone confirms test validity. Used in clinical/forensic settings; operated by laboratory personnel. Output: visual colorimetric result. Clinical decision-making: preliminary screening tool requiring GC/MS confirmation for positive results.

Clinical Evidence

Clinical trial of 308 urine samples compared QuikStrip to Syva EMIT® II. Results showed 100% relative sensitivity, 100% relative specificity, and 100% accuracy. All positive samples confirmed by GC/MS. 13 discrepant samples (positive by both screening methods, negative by GC/MS) were identified as containing ephedrine or Phenyl Propanolamine (PPA).

Technological Characteristics

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

Indications for Use

Indicated for qualitative screening of human urine for amphetamine and its metabolites. Intended for medical/forensic screening; not for monitoring drug levels. Preliminary results require GC/MS confirmation.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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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510k Submission for MAY 30 1997
QuikStrip One Step Amphetamine Test K971218
Syntron Bioresearch, Inc.
Revision B 4/21/97 Printed on 5/8/97
Page 58 of 56

# 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 Amphetamine and its metabolites in a screening format.

The trade name of the device is QuikStrip One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3610. This device is intended for the medical/forensic screening of urine.

Syntron's QuikStrip One Step Amphetamine 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 500 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 Amphetamine Test yielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 308 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II®.

All positive samples by either screening method were confirmed by GC/MS. The results on the 13 discrepant samples clearly demonstrated the same errors by both methods. Thirteen Samples were positive by both Emit II® and QuikStrip, but negative for amphetamine by GC/MS. Of these thirteen (13) samples, twelve (12) were positive for ephedrine by GC/MS. The other one (1) was negative for Amphetamine but positive for Phenyl Propanolamine (PPA).

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

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

MAY 30 1997

Re: K971218
QuikStrip One Step Amphetamine Test
Regulatory Class: II
Product Code: DKZ
Dated: March 24, 1997
Received: April 2, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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/dsmamain.html".

Sincerely yours,

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): K971218

Device Name: QuikStrip One Step Amphetamine Test

Indications For Use:

Syntron's QuikStrip One Step Amphetamine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Amphetamine in urine. 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 QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Perscription Use:
(Per 21 CFR 801.109)

or

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