(14 days)
Not Found
Not Found
No
The device description details a standard immunoassay based on competitive binding and colorimetric detection, with no mention of AI or ML components. The performance studies describe traditional analytical validation methods.
No
The device is described as an immunoassay for screening the presence of Opiates in urine, providing preliminary data, and is not intended to monitor drug levels or provide therapy.
Yes
The device is intended to screen urine for the presence of Opiates and its metabolites, providing preliminary data for the determination of Opiates, which is a diagnostic function. The document explicitly states "The test provides only preliminary data which should be confirmed by other methods".
No
The device description clearly describes a physical chromatographic absorbent device (a "strip") that utilizes chemical reactions and visual color changes to determine the presence of opiates. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of Opiates in urine." This involves testing a sample taken from the body (urine) in vitro (outside the body) to provide information about a physiological state (presence of opiates).
- Device Description: The description details a "chromatographic absorbent device" that performs a "competitive binding immunoassay." This is a common method used in IVD tests to detect specific substances in biological samples.
- Sample Type: The test uses "urine," which is a biological specimen.
- Purpose: The purpose is to "screen urines for the presence of Opiates and its metabolites," which is a diagnostic purpose.
- Intended User/Care Setting: It is "intended for the medical/forensic screening of urine," indicating use in a healthcare or related setting for diagnostic purposes.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Syntron's QuikStrip 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 QuikStrip One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.
Product codes
DJG
Device Description
Syntron's QuikStrip One Step Opiates 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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical/forensic screening of urine
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
In-house testing of Syntron's QuikStrip One Step Opiates Test vielded 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 either Emit II® or GC/MS run at 2000 ng/ml.
Summary of Performance Studies
The sponsor performed in-house testing and clinical trials. For in-house testing, the device was tested against Syva EMIT® II on samples documented to be positive by GC/MS. For clinical trials, 829 samples were run and compared to either Emit II® or GC/MS run at 2000 ng/ml.
Key Metrics
Relative sensitivity: 1.000 (in-house), 100% (clinical trials)
Relative specificity: 1.000 (in-house), 100% (clinical trials)
Accuracy: 100% (in-house), 100% (clinical trials)
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510k Submission for
QuikStrip One Step Opiates(2000) Test
Syntron Bioresearch, Inc.
Page 101 of 101
Revision A 6/18/99, Printed on 07/22/1999
14.1. 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 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 QuikStrip One Step Opiates Test having a designated common name of Opiates 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 QuikStrip One Step Opiates 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 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 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 QuikStrip One Step Opiates Test vielded 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 either Emit II® or GC/MS run at 2000 ng/ml.
All positive samples by either screening method were confirmed by GC/MS. The testing performed by both the sponsor and the Clinical Trial site did not find any false positives or false negatives in the samples tested.
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.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 9 1999
Syntron Bioresearch, Inc. c/o James M. Barquest, Ph.D. California Department of Health Food & Drug Branch 601 North Seventh Street (MS-357) P.O. Box 942732 Sacramento, California 94234-7320
- Re: K993490
Trade Name: QuikStrip One Step Opiate Assay Regulatory Class: II Product Code: DJG Dated: October 8, 1999 Received: October 15, 1999
Dear Dr. 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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
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
3
510(k) Number (if Known): To Be Assigned
Device Name: OuikStrip One Step Opiates assay
Indications For Use:
Syntron's QuikStrip 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 QuikStrip 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)
Alan Cooper
(Division Sign-Off) Wision of Clinical Laboratory Deviews 90 510(k) Number Lagg 3
Prescription Use:
(Per 21 CFR 801.109
or
Over The Counter Use: (Optional Format 1-2-96)