QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE

K990325 · Syntron Bioresearch, Inc. · DKZ · Jun 24, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990325
• Device Name: QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
• Applicant: Syntron Bioresearch, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jun 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced by 2, 3, 4, 5, or 6) is a holder for up to six 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 DipScan 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 spectrometry (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 DipScan X Multidrug Screening Device is not intended to monitor drug levels, but only to screen for drugs of abuse and their metabolites.

Device Story

Device consists of a holder accommodating 2-6 individual chromatographic absorbent test strips; each strip contains immobilized antibodies specific to a drug or metabolite. Urine sample flows up the strip; labeled antibody-dye conjugate binds to free drug in specimen, forming antibody-antigen complex. Complex competes with immobilized antigen conjugate on membrane; absence of magenta color band indicates drug presence above SAMHSA-specified cutoff levels. Control zone produces magenta band to verify reagent/device function. Used for medical/forensic screening; operated by healthcare professionals or technicians. Results are visually interpreted by the user to provide preliminary screening data; positive results require confirmatory testing via GC/MS. Benefits include rapid, simple, qualitative detection of multiple drugs of abuse simultaneously.

Clinical Evidence

Bench testing only. In-house testing demonstrated no inappropriate reactions or interference between tests when using the multi-strip format.

Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; competitive binding immunoassay principle. Form factor: holder accommodating 2-6 independent test strips. No electronic components or software.

Indications for Use

Indicated for the qualitative screening of urine for drugs of abuse (Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana, Opiates, PCP) in individuals. Provides preliminary results requiring GC/MS confirmation. Not for monitoring drug levels.

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).

Submission Summary (Full Text)

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K990335

## 510k Submission for QuikStrip DipScan X Multidrug Screening Device

Syntron Bioresearch. Inc.

Page 122 of 122

## Revision d 06/17/99 Printed on 06/17/1999

#### Summary of Safety and Effectiveness 18.1

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlishad, The sponsor, Syntrol Diotesearch, roured, and tested under GMP/GLP
California, 92008), has developed, manufactured, and the company's clearly California, 92005), has developed, mannovate 2 to 6 of the company's cleared
guidelines a Strip Holder that will accommodate 2 to 6 of drugs of shuge and guidelines a Strip Holder that will accomments of or vine of drugs of abuse and drugs of abuse strips for the quallative ato to read, screening format. Test strips
their metabolites in a quick, simple, success staming, Mathamphetamine their metabolizes in a quick, suippe, easy to roughetamine, Methampbetamine, a valiable for Inclusion in the Dipecal H allo imprises (THC), Opiates (300), and Phencyclidine (PCP).

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

Syntron's QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) consists of two to six (2-6) individual replaced by 2, 3, 4, 0, or of consisted or which the drug or drug metabolites in the chromatograppine absorbent ac vives in immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up a support the absorbent device, the labeled antibody-dye conjugate binda 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 officition of case and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS (Note the cutoff for 18 above used in the opiate test strips was 300 ng/ml instead of the new cutoff of opiaces and in the 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. Test strips available for inclusion in the DipScan X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

In-house testing of QuikStrip DipScan X Multidrug Screening Device yielded no observations of inappropriate reactions or interference between tosts.

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/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a person with outstretched arms, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 1999

Syntron Bioresearch, Inc. c/o Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Ave. Suite 201 Simi Valley, California 93065

K990325 Re: 15770729
Trade Name: QuikStrip DipScan X Multidrug Screening Device Regulatory Class: II Product Code: DKZ, DJC, DIS, JXM, LDJ, DIO, LCM, DJG Dated: May 11, 1999 Received: May 13, 1999

Dear Dr. Laird:

This letter corrects our substantially equivalent letter of June 24, 1999 regarding the incorrect trade name, QuikScan Drug Test X Multidrug Screening Device. Your June 7, mooreet trade name, Quikscan DipScan X Multidrug Scan X Multidrug Screening Device as the trade name.

We have reviewed your Section 510(k) notification of intent to market the device we nave it viewed your books armined 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 ni meetstate commerce provise has been reclassified in accordance with the provisions of Amendments of to de reeds and Cometic Act (Act). You may, therefore, market the device, the i cucral I ood, Drag, and Controls of the Act. The general controls provisions of the subject to the general email 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 (1 cinance rippro rar) it normaling can be found in the Code of Federal Regulations, Title 10 Parts 800 to 895. A substantially equivalent determination assumcs compliance with 21, I arts ooo to 0701 ing Practice requirements, as set forth in the Quality System the 000d Manatalians and Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug with the Citil Togalation in ther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission docs not affect any obligation you might have under sections 531 through 542 of the Act

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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 [phone], or at its internet address "http://www.fda.gov/cdrl/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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## 510(k) Number (if Known): K990325

# Device Name: QuikStrip DipScan X Multidrug Screening Device

### Indications For Use:

Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced
) in the first and the commission will avolitative, competitive Syntron's QuikStrip DipScall a Michael ages common
by 2, 3, 4, 5, or 6) is a holder for up to six rapid, qualitative, competitive, in urine by 2, 3, 4, 5, or 6) is a notder for the decection of drugs of abserin urine at the
binding immunoassay strips for the detection of drugs of able for binding immunoassay strips for the access. The test strips available for
SAMHSA designated GCMS cutoff levels. The test strips available for SAMHSA designated GC/Mc Catch Promine, Methamphetamine,
inclusion in the DipScan are Amphetamine, Methamphetamine, inclusion in the Dipocan are Ampheraminer install (THC), Opiates, and Benzodiazepine, Barbiturates, Cocani, Marly preliminary data which
Phencyclidine (PCP).The tests provide only proliminary data which Phencychume (f Of ). Inter methods such as gas should be confirmed by oencr montometry (GCMS). Clinical chromatographymass spectryphisoment should be applied to any
considerations and professional judgment should minory positive considerations and professionial Jarga when preliminary positive
drug of abuse test result, particularly when DirScop X Multidrug drug of abuse test result, partics QuikStrip DipScan X Multidrug
results are indicated6. Syntron's QuikStrip drug levels, but only results are indicated. Syntron's camentor drug levels, but only to
Screening Device is not intended to monitor drugs and their Screening Device is not intended to misimaly of abuse and their metabolites.

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

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

Dean Cooper

ion Sign-Off) Division of Clinical Laboratory ... vices 90325 510(k) Number

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

Or

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