QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST

K981292 · Syntron Bioresearch, Inc. · LCM · May 26, 1998 · TX

Device Facts

• Record ID: K981292
• Device Name: QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
• Applicant: Syntron Bioresearch, Inc.
• Product Code: LCM · TX
• Decision Date: May 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Syntron's QuikPac II One Step Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 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 Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Device Story

QuikPac II One Step Phencyclidine (PCP) Test is a chromatographic absorbent immunoassay for urine screening. Input: urine sample. Principle: competitive binding immunoassay; drug/metabolites in sample compete with immobilized drug conjugate on a porous membrane for limited antibody sites. Labeled antibody-dye conjugate binds to free drug, forming antibody-antigen complex. If drug concentration exceeds 25 ng/ml, complex competes with immobilized conjugate, preventing magenta color band formation in positive reaction zone. Unbound dye binds to control zone reagent, producing control band. Output: visual qualitative result (presence/absence of color band). Used in clinical/forensic settings by laboratory personnel. Results are preliminary; require GC/MS confirmation. Benefits: rapid screening for PCP presence to inform clinical/forensic decision-making.

Clinical Evidence

Bench testing and clinical trial data provided. In-house testing on 227 samples showed 100% accuracy, 1.00 relative sensitivity, and 1.00 relative specificity compared to Syva EMIT II. A clinical trial of 286 samples yielded 100% agreement (specificity/sensitivity/accuracy) compared to Emit II at 25 ng/ml. Two false positives were identified and confirmed by GC/MS as being below the 25 ng/ml cutoff; no false negatives were reported.

Technological Characteristics

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

Indications for Use

Indicated for the qualitative screening of human urine for Phencyclidine (PCP) and its metabolites at a 25 ng/ml cutoff level. Intended for medical/forensic screening; not for monitoring drug levels.

Reference Devices

• Syva EMIT® II

Submission Summary (Full Text)

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MAY 2 6 1998

498129 510k Submission for QuikPac II One Step Phencyclidine Test

Syntron Bioresearch, Inc.

Page 83 of 78 Pages

Revision A 03/21/98, Cleared XX/XX/98, Printed on 5/4/98

# 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 Phencyclidine (PCP) and its metabolites in a screening format.

The trade name of the device is QuikPac II One Step Phencyclidine (PCP) Test having a designated common name of Phencyclidine (PCP) Test System and a classification as a Class II device. This device is intended for the medical/forensic screening of urine.

Syntron's QuikPac II One Step Phencyclidine (PCP) 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 25 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 Phencyclidine (PCP) Test on 227 samples vielded an a relative specificity of 1.00 and an relative sensitivity of 1.00 and an accuracy of 100% when compared against Syva EMIT® IIm . A clinical trial consisting of 286 samples was run and the data vielded an agreement within positive samples or relative specificity of 100%, an agreement within negative or relative specificity of 100% with an accuracy of 100% when compared to Emit II® run at 25 ng/ml. By non parametric testing the results are not significantly different from one another. Emit II compared to GC/MS as results indicated the presence of drugs in two (2) cases but at a level below the cutoff of 25 ng/ml.

All positive samples by either screening method were confirmed by GC/MScs. The testing performed by both the sponsor and the Clinical Trial site did find 2 false positives and no false negatives in the samples tested. GC/MScs confirmed the presence of Phencyclidine (PCP) but at levels below the cutoff of 25 ng/ml.

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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 26 1998

Syntron Bioresearch, Inc. Cleve W. Laird, Ph.D. C/O Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065

Re : K981292 QuikPac II One Step Phencyclidine (PCP) Test Regulatory Class: II Product Code: LCM Dated: April 6, 1998 Received: April 9, 1998

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 The general controls provisions of the Act 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. ਰੋ 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 In addition, FDA may publish further announcements action. 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 Litman

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): To Be Assigned

## Device Name: QuikPac II One Step Phencyclidine (PCP) Test

### Indications For Use:

#### INTENDED USE

Syntron's QuikPac II One Step Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 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 Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

(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 Labora 510(k) Number Prescription Use: ! Over The Counter Use: or (Per 21 CFR 801.109 (Optional Format 1-2-96)