(48 days)
Not Found
Not Found
No
The device description details a competitive binding immunoassay based on chemical reactions and colorimetric detection, with no mention of computational analysis or learning algorithms.
No.
The device is an immunoassay for detecting cocaine in urine, providing preliminary data for screening purposes, not for therapeutic intervention.
Yes
The device is described as a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine, providing preliminary data used to screen for the presence of Cocaine and its metabolites. This function aligns with the definition of a diagnostic device.
No
The device description clearly describes a physical chromatographic absorbent device, which is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "determination of Cocaine in urine". Urine is a biological specimen taken from the human body.
- Device Description: The device description explains that it's a "chromatographic absorbent device" that uses a competitive binding immunoassay to detect the presence of a substance (Cocaine or its metabolites) in a sample. This is a common method used in IVD tests.
- Nature of the Test: The test is performed in vitro (outside the body) on a biological sample (urine).
- Purpose: The purpose is to provide "preliminary data" for "medical/forensic screening" for the presence of a drug of abuse. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
The fact that it's a rapid, qualitative test for screening purposes further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 150 mg/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 QuikStrip One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.
Product codes
DIO
Device Description
Syntron's QuikStrip One Step Cocaine 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 150 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: Not Found. Sample size not explicitly stated for in-house testing. Data source not explicitly stated for in-house testing. Annotation protocol not explicitly stated for in-house testing.
Clinical trial: 304 samples. Data source: Not found. Annotation protocol: All positive samples by either screening method were confirmed by GC/MS.
Summary of Performance Studies
In-house testing:
Study type: In-house testing
Sample size: Not explicitly stated.
Key results: yielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 0.9839 and an accuracy of 99.03% when tested against Syva EMIT® II on samples documented to be positive by GC/MS.
Clinical trial:
Study type: Clinical trial
Sample size: 304 samples
Key results: the combined data yielded a relative sensitivity of 99.49%, a relative specificity of 100% with an accuracy of 99.75% when compared to Emit II®.
Key Metrics
In-house testing: relative sensitivity 1.000, relative specificity 0.9839, accuracy 99.03%
Clinical trial: relative sensitivity 99.49%, relative specificity 100%, accuracy 99.75%
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
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Page 79 of 79
510k Submission for QuikStrip One Step Cocaine Test Syntron Bioresearch, Inc.
Revision A 4/17/97 Printed on May 22, 1997
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 Cocaine and its metabolites in a screening format.
The trade name of the device is QuikStrip One Step Cocaine Test having a designated common name of Cocaine Test System and a classification as a Class II device per 21 CFR 9 862.3250. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Cocaine 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 150 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 Cocaine Test yielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 0.9839 and an accuracy of 99.03% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 304 samples was run and the combined data yielded a relative sensitivity of 99.49%, a relative specificity of 100% with an accuracy of 99.75% when compared to Emit II®.
All positive samples by either screening method were confirmed by GC/MS. The results on the 3 discrepant samples clearly demonstrated similar errors by both methods. Three samples were positive by both Emit II® and QuikStrip, but negative for Cocaine by GC/MS. All three samples were demonstrated to be adulterated with "Clean Jane" [sodium dodecylsulfate (Tide)] which is supposed to interfere with positive testing. but causes both screening tests to return positive results. GC/MS analysis will return a negative for the drug, but a positive for the adulterant.
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 a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings forming a diagonal line. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUM SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Cleve W. Laird President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065
JUL 1 4 1997
Re: K971926 QuikStrip One Step Cocaine Test Regulatory Class: II Product Code: DIO Dated: May 22, 1997 Received: May 27, 1997
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 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory 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 Requlations.
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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 (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/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
3
510(k) Number (if Known): Initial Submission
Device Name: QuikStrip One Step Cocaine Assay
Indications For Use:
Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 150 mg/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 Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.