QUICKPAC II ONE STEP OPIATES TEST

K993491 · Syntron Bioresearch, Inc. · DJG · Oct 29, 1999 · Clinical Toxicology

Device Facts

• Record ID: K993491
• Device Name: QUICKPAC II ONE STEP OPIATES TEST
• Applicant: Syntron Bioresearch, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Oct 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Syntron's QuikPac II One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 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 Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.

Device Story

Chromatographic absorbent immunoassay; detects opiates in urine. Sample flows through membrane; drug/metabolites compete with immobilized drug conjugate for limited antibody sites. Labeled antibody-dye conjugate binds free drug; complex competes with immobilized antigen in positive reaction zone. Absence of magenta band at 2000 ng/ml cutoff indicates positive result; presence of band in control zone confirms reagent/device function. Used in clinical/forensic settings; operated by laboratory personnel. Provides qualitative visual readout; assists in preliminary screening for drug presence; requires GC/MS confirmation for clinical decision-making.

Clinical Evidence

Bench testing and clinical trials evaluated 829 samples. Results compared against Syva EMIT® II and GC/MS. Reported 100% relative sensitivity, 100% relative specificity, and 100% accuracy at 2000 ng/ml cutoff. No false positives or negatives observed.

Technological Characteristics

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

Indications for Use

Indicated for qualitative screening of human urine for opiates and metabolites at a 2000 ng/ml cutoff. Intended for medical/forensic screening; not for monitoring drug levels. Preliminary results require GC/MS confirmation.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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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OCT 2 9 1999

510k Submission for

QuikPac II One Step Opiate (2000) Test

Syntron Bioresearch, Inc.

Page 104 of 104 Pages

K993491

Revision A 615/99, Cleared XX/XX/99, Printed on 08/12/1999

## 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 Opiates and its metabolites in a screening format.

The trade name of the device is QuikPac II One Step Opiate Test having a designated common name of Opiate Test System and a classification as a Class II device per 21 CFR ¶ 862.3250. This device is intended for the medical/forensic screening of urine.

Syntron's QuikPac II One Step Opiate 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 2000 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 Opiate Test yielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. In clinical trials 829 samples were 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®or GC/MS run at 2000 ng/ml.

All positive samples by either screening method were confirmed by GC/MS. There were no false positive or negative results observed in either the in-house clinical trial or the independent clinical trial.

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

## OCT 2 9 1999

Syntron Bioresearch, Inc. c/o James Barquest, Ph.D. California Department of Health Food and Drug Branch 601 North Seventh Street (MS-357) P.O. Box 942732 Sacramento, California 94234-7320

K993491 Re:

> Trade Name: QuikPac II One Step Opiates Test Regulatory Class: II Product Code: DJG Dated: October 8, 1999 Received: October 15, 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 (OS) 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 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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## 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/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): To Be Assigned

Device Name: OuikPac II One Step Opiates assay

## Indications For Use:

Syntron's QuikPac II One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 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 Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dean Coopy

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 1x993491

Prescription Use: (Per 21 CFR 801.109

of

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