(169 days)
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No
The device description details a chromatographic immunoassay, which is a chemical reaction-based test, not an AI/ML system. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is described as a screening tool for the presence of Cannabinoids in urine, not for treating any medical condition.
Yes
Explanation: The device is described as "for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format" and "intended for medical/forensic screening of urine," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines a physical chromatographic absorbent device, which is a hardware component, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format." This involves testing a sample taken from the body (urine) in vitro (outside the body) to provide diagnostic information (presence of substances).
- Device Description: The description details a "chromatographic absorbent device" that performs a chemical reaction with the urine sample to detect the presence of specific substances. This is a typical mechanism for IVD tests.
- Performance Studies: The performance studies involve testing urine samples and comparing the results to established methods (Syva Emit and GC/MS) to evaluate the device's accuracy in detecting the target substances. This is a standard practice for validating IVD devices.
- Key Metrics: The reporting of metrics like sensitivity, specificity, and concordance are crucial for evaluating the performance of IVD tests.
The fact that it's intended for "medical/forensic screening of urine" further reinforces its classification as an IVD, as these are common applications for in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
This device is intended for medical/forensic screening of urine.
Product codes
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Device Description
The Trade name of the device is QuikStrip™ One Step Marijuana (THC) Test having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. Syntron's QuikStrip™ One Step Marijuana (THC) 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 50 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
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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
The sponsor subjected the final product to both in-house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product and an independent Clinical Trial.
Summary of Performance Studies
The sponsor subjected the final product to both in-house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product and an independent Clinical Trial. The calculated relative sensitivity compared to Emit was 99.3% and the calculated relative specificity against Emit was found to be 1.00 with concordance of 99.67%. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference between the reference method and the new Syntron method.
Key Metrics
relative sensitivity compared to Emit was 99.3%, relative specificity against Emit was found to be 1.00, concordance of 99.67%
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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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Summary of Safety and Effectiveness
FEB 28 1997
Karas Su
The sponsor Syntron Bioresearch Inc. (277 Loker Ave. West, Carlsbad, Ca., 92008) has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format.
The Trade name of the device is QuikStrip™ One Step Marijuana (THC) Test having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine.
Syntron's QuikStrip™ One Step Marijuana (THC) 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 50 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.
The sponsor subjected the final product to both in-house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product and an independent Clinical Trial. The calculated relative sensitivity compared to Emit was 99.3% and the calculated relative specificity against Emit was found to be 1.00 with concordance of 99.67%. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference between the reference method and the new Syntron method.
Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President of Drial Consultants Inc. at 805-522-6223 or by fax at 805-522-1526 who is Syntron's designated regulatory consultant. Specific Corporate information may be obtained from Dr. James Lee, President of Syntron Bioresearch at the address given in the first paragraph.