(75 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.
No
The device is described as a medical/forensic screening tool for urine, specifically a methamphetamine test, which is diagnostic in nature, not therapeutic.
Yes
The device is intended for "medical/forensic screening of urine" to detect methamphetamine or its metabolites, which is a diagnostic purpose. The description also mentions "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" and "will not produce a magenta color band when the drug is above the detection level", indicating it provides a result (positive/negative) based on a biological sample to diagnose the presence of a substance.
No
The device description clearly outlines a physical chromatographic absorbent device, which is a hardware component, not solely 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 that 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 "drug or drug metabolites in the sample." This is a typical description of an in vitro diagnostic test that analyzes a biological sample outside of the body.
- Mechanism of Action: The mechanism involves "drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites." This describes a biochemical reaction occurring with the sample, which is characteristic of an IVD.
- Performance Studies: The performance studies involve testing the device against other methods (Syva EMIT® II and GC/MS) using "samples" (urine). This further confirms that the device is used to analyze biological samples.
Therefore, based on the intended use, device description, and the nature of the performance studies, this device fits the definition of an In Vitro Diagnostic.
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 Methamphetamine 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 500 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
In-house testing of Syntron's QuikPac II One Step Methamphetamine Test vielded a relative sensitivity and specificity of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 305 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 97.7% with an accuracy of 98.68%. All positive samples by either screening method were confirmed by GC/MS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-house testing: relative sensitivity and specificity of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. Clinical trial: 305 samples, relative sensitivity of 100%, a relative specificity of 97.7% with an accuracy of 98.68%. The results on the 6 discrepant samples clearly demonstrated the specificity of the QuikPac II One Step Methamphetamine Test. Four of the 6 samples were negative for methamphetamine, but positive for Amphetamine by GC/MS. The other two were negative for methamphetamine but positive for pseudoephedrine and phenyl propanolamine (PPA) respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity of 1.00 (in-house), 100% (clinical). Relative specificity of 1.00 (in-house), 97.7% (clinical). Accuracy of 100% (in-house), 98.68% (clinical).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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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510k Submission for
QuikPac II One Step Methamphetamine Test
MAY 1 3 1997
Syntron Bioresearch, Inc.
Page 58 of 58 Pages
Revision C 4/11/97 Printed on 4/22/97
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 Methamphetamine and its metabolites in a screening format.
The trade name of the device is QuikPac II One Step Methamphetamine Test having a designated common name of Methamphetamine Test System and a classification as a class II device per 21 CFR 1 862.3610. This device is intended for medical/forensic screening of urine.
Syntron's QuikPac II One Step Methamphetamine 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 500 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 Methamphetamine Test vielded a relative sensitivity and specificity of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 305 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 97.7% with an accuracy of 98.68%.
All positive samples by either screening method were confirmed by GC/MS. The results on the 6 discrepant samples clearly demonstrated the specificity of the QuikPac II One Step Methamphetamine Test. Four of the 6 samples were negative for methamphetamine, but positive for Amphetamine by GC/MS. The other two were negative for methamphetamine but positive for pseudoephedrine and phenyl propanolamine (PPA) respectively.
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.