(14 days)
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 indicated. 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.
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.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the QuikPac II One Step Opiate Test:
Acceptance Criteria and Device Performance for QuikPac II One Step Opiate Test
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Relative Sensitivity (Positive Agreement) | 100% |
| Relative Specificity (Negative Agreement) | 100% |
| Accuracy | 100% |
2. Sample Size and Data Provenance
- Sample Size (Test Set): 829 samples were used in clinical trials.
- Data Provenance: The text does not explicitly state the country of origin. It conducted "in-house testing" and "clinical trials," and mentions "independent clinical trial." It does not specify whether the data was retrospective or prospective, though clinical trials typically imply prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
- The text does not explicitly state the number of experts used.
- Qualifications of Experts: Not specified. The reference methods (Syva EMIT® II and GC/MS) serve as the primary ground truth, which are laboratory methods rather than expert human interpretation in this context.
4. Adjudication Method for the Test Set
- None directly applicable. For this type of chemical assay, adjudication methods like 2+1 or 3+1 are not typically used for establishing ground truth. The ground truth was established by objective laboratory methods (Syva EMIT® II and GC/MS). The text states: "All positive samples by either screening method were confirmed by GC/MS." This implies a confirmatory approach rather than expert adjudication of the screening results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This device is a standalone diagnostic test for chemical analysis (drug detection), not an imaging or interpretive device that would involve human readers.
6. Standalone Performance Study
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The performance metrics (sensitivity, specificity, accuracy) are for the device itself when compared against established laboratory methods.
7. Type of Ground Truth Used
- Laboratory Reference Methods: The primary ground truth was established by:
- Syva EMIT® II (Enzyme Multiplied Immunoassay Technique)
- Gas Chromatography/Mass Spectrophotometry (GC/MS) – specifically used to confirm all positive samples from either screening method.
8. Sample Size for the Training Set
- Not specified. The document mentions "in-house testing" but does not detail a separate training set size. For this type of immunoassay, extensive "training set" data for algorithm development in the modern sense is less common; rather, the device is developed and optimized based on biochemical principles and then validated.
9. How the Ground Truth for the Training Set Was Established
- Not specified as a distinct training set. The development and calibration would typically rely on known positive and negative samples, likely characterized by reference laboratory methods similar to those used for validation (e.g., GC/MS). The text focuses on the performance of the final device, implying that any internal development or "training" would have used similarly robust methods for ground truth if applicable.
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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
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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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, resembling a bird or flowing water.
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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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)
§ 862.3650 Opiate test system.
(a)
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.(b)
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).