DRUGCHECK X MULTIDRUG SCREENING DEVICE

K992748 · Syntron Bioresearch, Inc. · DIO · Sep 2, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992748
• Device Name: DRUGCHECK X MULTIDRUG SCREENING DEVICE
• Applicant: Syntron Bioresearch, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Sep 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide 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 DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.

Device Story

Device is a strip holder accommodating 2-8 chromatographic absorbent immunoassay strips for urine drug screening. Principle of operation: competitive binding immunoassay; drug/metabolites in urine compete with immobilized drug conjugate on porous membrane for limited antibody sites. If drug is present above cutoff, no magenta band forms in positive reaction zone; control zone produces magenta band if reagents function correctly. Used in medical/forensic settings; operated by clinicians/technicians. Provides qualitative visual output (presence/absence of color bands). Results are preliminary and require GC/MS confirmation. Benefits include rapid, simple screening for drugs of abuse.

Clinical Evidence

Clinical trial of 565 urine samples compared device results against Emit II and GC/MS. Results showed no inappropriate reactions or interference. All positive screening results were confirmed by GC/MS. Statistical analysis using non-parametric methods indicated no significant difference between the device and comparator methods.

Technological Characteristics

Strip holder device containing 2-8 chromatographic absorbent immunoassay strips. Employs competitive binding immunoassay on porous membrane support. Qualitative visual readout. No external energy source required. Standalone device.

Indications for Use

Indicated for the qualitative screening of urine for drugs of abuse and their metabolites in individuals suspected of drug use. Detects Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP) at SAMHSA-designated GC/MS cutoff levels. Provides preliminary results requiring 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

• Emit II

Submission Summary (Full Text)

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K992748

# 510k Submission for QuikStrip DrugCheck X Multidrug Screening Device Syntron Bioresearch, Inc.

Syntron Bioresearch, Inc.

Revision A 02/16/99 Printed on 6/11/99

Page 291 of 291

### 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 Strip Holder that will accommodate 2 to 8 of the company's cleared drugs of abuse strips for the qualitative detection in urine of drugs of abuse and their metabolites in a quick, simple, easy to read, screening format,

The trade name of the device is DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) having a designated common name of Strip Holder and a classification as a Class II device per FDA. This device is intended for the medical/forensic screening of urine for drugs of abuse.

Syntron's DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) consists of two to eight (2-8) individual chromatographic absorbent devices 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 for each drug. 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, different for each drug, 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 specified by SAMHSA for GC/MS. 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. Each of the test strips in the holder functions independently and is read independently.

In-house testing of DrugCheck X Multidrug Screening Device yielded no observations of inappropriate reactions or interference between tests on samples designed to test for interference and inappropriate reactions. A clinical trial consisting of 565 clinical samples was run and the results revealed no inappropriate reactions or interference. The observations were not significantly different from those obtained by either Emit II or GCMS. When tested by non parametric statistical methods the results are not significantly different from one another. All positive samples by either screening method were confirmed by GC/MS.

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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP -2 1999

Syntron Bioresearch. Inc. c/o Mr. James M. Barquest California Department of Health Food and Drug Branch 601 North Seventh Street (MS-357) P.O. Box 942732 Sacramento, California 94234

Re: K992748

> Trade Name: QuikStrip DrugCheck X Multidrug Screening Device Regulatory Class: II Product Code: DIO, LDJ, DKZ, DPK, LCM Dated: August 9, 1999 Received: August 16, 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

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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 Putman

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: DrugCheck X Multidrug Screening Device

### Indications For Use:

Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide 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 DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.

Deantosey
(Division Sign-Off)

Division of Clinical Laboratory Devices Kyo777 510(k) Number.

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use:
(Per 21 CFR 801.109

5000

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

FOOD & DRUG BRANCH JUN 1 8 1999

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