(189 days)
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No
The device description details a chromatographic absorbent device that relies on chemical reactions and competitive binding for detection, with no mention of AI or ML technologies. The performance studies describe standard analytical comparisons, not AI/ML model validation.
No
The device is described as a diagnostic test for screening urine, not for treating or monitoring a disease.
No
Explanation: The device is intended for screening of urine for drugs or drug metabolites, indicating it is used for investigative or screening purposes, rather than diagnosing a medical condition.
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 is "medical/forensic screening of urine." This clearly indicates the device is used to examine a sample taken from the human body (urine) to provide information for medical or forensic purposes.
- Device Description: The description details a "chromatographic absorbent device" that analyzes components within a "test sample" (urine). This process of analyzing a biological sample outside of the body is the core function of an IVD.
- Classification: The device is classified as a "class II device per 21 CFR 862.3870," which is the regulation for Cannabinoid Test Systems. This classification falls under the umbrella of IVD devices.
- Performance Studies: The performance studies involve testing "individual urine samples" and comparing the results to "reference methods" like Syva Emit and GC/MS, which are also methods for analyzing biological samples.
All of these points strongly indicate that the device is designed and used for in vitro diagnostic purposes.
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
"Syntron's QuikPac II™ 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
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 QuikPac II™ 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 QuikPac II™ 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 415-688-0100 or by fax at 415-688-0104 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
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