(49 days)
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No
The device description details a chromatographic absorbent device that relies on chemical reactions and color changes to detect the presence of a substance. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is described as an "Amphetamine Test System" intended for "professional medical/forensic screening of urine," which indicates a diagnostic rather than a therapeutic purpose. It identifies the presence of drugs but does not treat any condition.
Yes
The device is intended for "medical/forensic screening of urine" for Amphetamine, which is a diagnostic purpose to detect the presence of a drug or drug metabolites in a sample.
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 "professional medical/forensic screening of urine." This clearly indicates that the device is used to examine a specimen (urine) from the human body 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. This is a typical description of an in vitro diagnostic test.
- Anatomical Site: The anatomical site is "urine," which is a human specimen.
- Classification: The device is classified as a Class II device per 21 CFR paragraph 862.3100, which is the regulation for Amphetamine Test Systems. This classification falls under the umbrella of IVD devices.
- Performance Studies: The performance studies describe testing the device against urine samples and comparing the results to other diagnostic methods (Syva EMIT® II, Emit® II, and GC/MS). This is characteristic of performance evaluation for IVD devices.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended for professional medical/forensic screening of urine.
Product codes
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Device Description
The trade name of the device is QuikPac II One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3100. This device is intended for professional medical/forensic screening of urine.
Syntron's QuikPac II One Step Amphetamine 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
professional medical/forensic
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-house testing of Syntron's QuikPac II One Step Amphetamine 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 308 samples was run and the combined data vielded a relative sensitivity of 100%, a relative specificity of 100%, and an accuracy of 100% when compared to Emit® II.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
relative sensitivity and specificity of 1.00 and an accuracy of 100%
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
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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 Amphetamine Test
Syntron Bioresearch. Inc.
MAY Page 54 of 54 Pages 1997
Revision B 2/17/97 Printed on 3/24/97
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 Amphetamine and its metabolites in a screening format.
The trade name of the device is QuikPac II One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3100. This device is intended for professional medical/forensic screening of urine.
Syntron's QuikPac II One Step Amphetamine 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 Amphetamine 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 308 samples was run and the combined data vielded a relative sensitivity of 100%, a relative specificity of 100%, and an accuracy of 100% when compared to Emit® II.
All positive samples by either screening method were confirmed by GC/MS. The results on the 13 discrepant samples clearly demonstrate the same errors by both. Thirteen (13) of the samples were positive for Amphetamine by either Emit® II or QuikPac II, but negative for Amphetamine by GC/MS. Of these 13 false positives twelve (12) were positive for Ephedrine by GC/MS and one (1) was positive for Phenyl PropanolAmine (PPA) by GC/MS.
Additional information pertaining to 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.