(13 days)
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Not Found
No
The device description details a chemical immunoassay based on competitive binding and colorimetric detection, with no mention of computational analysis or learning algorithms.
No.
The device is an in vitro diagnostic test used for screening purposes to detect the presence of Cocaine in urine, not to treat or cure a disease or condition.
Yes
The device is described as an "immunoassay for the determination of Cocaine in urine" and provides "preliminary data" for the presence of Cocaine, which is a form of diagnostic testing.
No
The device description clearly describes a physical chromatographic absorbent device and its chemical reaction process, indicating it is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "determination of Cocaine in urine." This involves testing a sample taken from the human body in vitro (outside the body).
- Device Description: The description details a "chromatographic absorbent device" that analyzes the chemical composition of the urine sample to detect the presence of cocaine or its metabolites. This is a typical characteristic of an IVD.
- Sample Type: The test is performed on "urine," which is a biological specimen.
- Purpose: The purpose is to "screen urines for the presence of Cocaine and its metabolites," which is a diagnostic function performed on a sample.
The information provided aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 300 ng/ml (NIDA screening cutoff is 300 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 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 QuikPac II 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 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 300 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
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
In-house testing of Syntron's QuikPac II One Step Cocaine Test yielded a relative sensitivity or agreement within positive samples of 1.000 and a relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against a commercial EIA test for Cocaine on samples documented to be positive by GC/MS. A clinical trial consisting of 318 samples was run and the combined data yielded a relative sensitivity of 99.89%, a relative specificity of 100% with an accuracy of 99.56% when compared to a commercial EIA test for Cocaine.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-house testing: relative sensitivity 1.000, relative specificity 1.000, accuracy 100% when tested against a commercial EIA test for Cocaine on samples documented to be positive by GC/MS.
Clinical trial: 318 samples, relative sensitivity 99.89%, relative specificity 100%, accuracy 99.56% when compared to a commercial EIA test for Cocaine.
All positive samples by either screening method were confirmed by GC/MS. The results on the 2 discrepant samples clearly demonstrated similar errors by the Emit II method. Two samples were positive by both GC/MS and QuikPac II, but negative for Cocaine by Emit II. Previous testing samples demonstrated to be adulterated with "Clean Jane", [sodium dodecylsulfate (Tide)], which is supposed to prevent a positive test tested positive by both screening tests (Emit II & QuikPac II). GC/MS analysis returned a negative for the drug (cocaine) with a specific signature for the adulterant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity, relative specificity, accuracy.
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
12992990
510k Submission for QuikPac II One Step Cocaine(300) Test
Syntron Bioresearch, Inc.
Page 105 of 105 Pages
Revision A 6/05/99, Printed on 08/20/1999
15.1.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 Cocaine and its metabolites in a screening format.
The trade name of the device is QuikPac II One Step Cocaine Test having a designated common name of Cocaine 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 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 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 300 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 Cocaine Test yielded a relative sensitivity or agreement within positive samples of 1.000 and a relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against a commercial EIA test for Cocaine on samples documented to be positive by GC/MS. A clinical trial consisting of 318 samples was run and the combined data yielded a relative sensitivity of 99.89%, a relative specificity of 100% with an accuracy of 99.56% when compared to a commercial EIA test for Cocaine.
All positive samples by either screening method were confirmed by GC/MS. The results on the 2 discrepant samples clearly demonstrated similar errors by the Emit II method. Two samples were positive by both GC/MS and QuikPac II, but negative for Cocaine by Emit II. Previous testing samples demonstrated to be adulterated with "Clean Jane", [sodium dodecylsulfate (Tide)], which is supposed to prevent a positive test tested positive by both screening tests (Emit II & QuikPac II). GC/MS analysis returned a negative for the drug (cocaine) with a specific signature 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 20 1999
Syntron Bioresearch, Inc. c/o Dr James M. Barquest California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, California 94234
Re: K992990
Trade Name: QuikPac II One Step Cocaine Assay Regulatory Class: II Product Code: DIO Dated: August 20, 1999 Received: September 7, 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.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Sutman
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
FOOD & DRUG BRANCH The States
510(k) Number (if Known): Not yet assigned
Device Name: QuikPac II One Step Cocaine assay
Indications For Use:
Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 300 ng/ml (NIDA screening cutoff is 300 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 Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Sean Cooper
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_k 99 2990
Prescription Use: (Per 21 CFR 801.109
or
Over The Counter Use: (Optional Format 1-2-96)