(58 days)
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No
The device description details a chemical immunoassay process, and there are no mentions of AI, ML, or image processing.
No
The device is described as a diagnostic tool for screening urine for the presence of amphetamine and its metabolites; it does not treat or alleviate a medical condition.
Yes
Explanation: The device is an immunoassay for determining the presence of amphetamines in urine samples, which is a form of diagnostic screening. The intended use states it is for screening and provides preliminary data on the presence of substances.
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 clearly states it's for the "determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS)." This indicates it's used to test a sample (urine) in vitro (outside the body) to provide information about a patient's condition (presence of amphetamine).
- Device Description: The description details a "chromatographic absorbent device" that interacts with a "test sample" (urine) to detect the presence of a substance (drug or drug metabolites). This is a typical description of an in vitro diagnostic test.
- Intended User / Care Setting: It's intended for "medical/forensic screening of urine," which aligns with the use of IVDs in healthcare and forensic settings.
- Performance Studies: The performance studies involve testing "samples" (urine) and comparing the results to other diagnostic methods (Syva EMIT® II and GC/MS). This is characteristic of the validation process for IVDs.
The core function of the device is to analyze a biological sample (urine) in vitro to provide diagnostic information (presence of amphetamine), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The trade name of the device is QuikStrip One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR paragraph 862.3610. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
Product codes (comma separated list FDA assigned to the subject device)
DKZ
Device Description
Syntron's QuikStrip 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 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 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
medical/forensic screening of urine
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 QuikStrip One Step Amphetamine Test vielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples 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 yielded a relative sensitivity of 100%, a relative specificity of 100% with 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 demonstrated the same errors by both methods. Thirteen Samples were positive by both Emit II® and QuikStrip, but negative for amphetamine by GC/MS. Of these thirteen (13) samples, twelve (12) were positive for ephedrine by GC/MS. The other one (1) was negative for Amphetamine but positive for Phenvl Propanolamine (PPA).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity or agreement within positive samples of 1.00, relative specificity or agreement within negative samples of 1.00, accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS.
Relative sensitivity of 100%, relative specificity of 100% with an accuracy of 100% when compared to Emit II® for a clinical trial of 308 samples.
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 MAY 30 1997
QuikStrip One Step Amphetamine Test K971218
Syntron Bioresearch, Inc.
Page 58 of 56
Revision B 4/21/97 Printed on 5/8/97
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 QuikStrip One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3610. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip 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 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 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 QuikStrip One Step Amphetamine Test vielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples 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 yielded a relative sensitivity of 100%, a relative specificity of 100% with 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 demonstrated the same errors by both methods. Thirteen Samples were positive by both Emit II® and QuikStrip, but negative for amphetamine by GC/MS. Of these thirteen (13) samples, twelve (12) were positive for ephedrine by GC/MS. The other one (1) was negative for Amphetamine but positive for Phenvl Propanolamine (PPA).
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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the left side of the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Cleve W. Laird President and CEO Drial Consultants, Inc. . ... 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065
MAY 30 1097
Re : K971218 QuikStrip One Step Amphetamine Test Requlatory Class: II Product Code: DKZ March 24, 1997 Dated: April 2, 1997 Received:
Dear Dr. Laird:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known): K971218
Device Name: QuikStrip One Step Amphetamine Test
Indications For Use: .
Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
Concurance of CDRH, Office of Device Evaluation (ODE)
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