(487 days)
Not Found
Sigma SIA™ THC, Syva Emit, GC/MS, GC/MS
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 components.
No.
The device is described as a screening tool for urine drug testing (cannabinoids), not for treating or diagnosing a disease or condition in a patient.
Yes
The device performs "medical/forensic screening of urine" for drugs of abuse, specifically cannabinoids. This screening provides information about the presence or absence of a substance to assist in medical or forensic evaluations, which falls under 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 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 the presence of drugs or drug metabolites in a urine sample using chemical reactions (antibody-dye conjugate binding, competition with immobilized antigen conjugate). This is a typical description of an in vitro diagnostic test.
- Sample Type: The device uses urine, which is a biological specimen taken from the human body.
- Performance Studies: The performance studies involve testing the device against reference methods using individual urine samples. This is standard practice for evaluating the performance of IVD devices.
The core function of the device is to analyze a biological sample in vitro (outside the body) to provide information about the presence of substances (drugs or metabolites) within that sample. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for medical/forensic screening of urine.
Product codes
Not Found
Device Description
TCPI's One Step™ Urine Drug of Abuse Cannabinoids 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
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
Not Found
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
Not Found
Summary of Performance Studies
The sponsor subjected the final product to both in house testing of 249 individual urine samples using both the Sigma SIA™ THC, Syva Emit and GC/MS against the new product. The calculated sensitivity and specificity both equal 1.00 with the accuracy of 100%. Subsequently the device was subjected to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 1.00, the specificity equaled 0.9935 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference.
Key Metrics
In house testing: sensitivity = 1.00, specificity = 1.00, accuracy = 100%.
Clinical trial: sensitivity = 1.00, specificity = 0.9935, accuracy = 99.67%.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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510k Submission for
One Step™ Urine drug of abuse Cannabinoid Test (THC) - K951853
Technical Chemicals & Products, Inc.
Page 60 of 60
Revision A- 4/17/95, B-10/3195, C-3/20/96, printed on 3/20/96
Summary of Safety and Effectiveness 9.
The sponsor Technical Chemicals and Products Inc. (3340 S.W. 15th Street, Pompano Beach, Florida, 33069) 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. This summary was originally written in May of 1995 and has been updated as of March, 1996
The Trade name of the device is One Step™ Urine Drug of Abuse Cannabinoid Test (THC) 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.
TCPI's One Step™ Urine Drug of Abuse Cannabinoids 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 249 individual urine samples using both the Sigma SIA™ THC, Syva Emit and GC/MS against the new product. The calculated sensitivity and specificity both equal 1.00 with the accuracy of 100%. Subsequently the device was subjected to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 1.00, the specificity equaled 0.9935 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference.
Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, Exec Vice President, Technicals & Products Inc. at 954-979-0400 or by fax at 954-979-0009.