(180 days)
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No
The device description details a simple immunoassay based on competitive binding and colorimetric detection, with no mention of computational analysis or learning algorithms.
No.
The device is a rapid, qualitative immunoassay for screening benzodiazepine in urine, providing only preliminary data and is not intended to monitor drug levels or treat any condition.
Yes
This device is a rapid, qualitative immunoassay for the determination of Benzodiazepine in urine, providing preliminary data for the presence of the substance. This falls under diagnostic testing as it aims to identify the presence of a specific condition (benzodiazepine use) in a sample.
No
The device description clearly describes a physical chromatographic absorbent device, which is a hardware component, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of Benzodiazepine in urine." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of a drug).
- Device Description: The description details a "chromatographic absorbent device" that analyzes a "test sample" (urine) using chemical reactions (competitive binding immunoassay) to detect the presence of a substance. This is a typical description of an IVD test.
- Performance Studies: The performance studies involve testing human urine samples and comparing the results to other diagnostic methods (GC/MS and Syva EMIT® II). This is characteristic of the validation process for an IVD.
- Key Metrics: The reporting of metrics like sensitivity, specificity, and accuracy are standard for evaluating the performance of IVD devices.
The fact that it's a "rapid, qualitative, competitive binding immunoassay" for detecting a substance in a bodily fluid (urine) firmly places it within the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Syntron's QuikStrip One Step Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites:
Product codes (comma separated list FDA assigned to the subject device)
JXM
Device Description
Syntron's QuikStrip One Step Benzodiazepine 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 200 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
Urine
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 Benzodiazepine Test yielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of .9740 and an accuracy of 98.54% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 303 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 95.42% with an accuracy of 97.69% when compared to Emit II® run at 200 ng/ml. By non parametric testing the results are significantly different from one another. Emit II yielded 7 false positives. GC/MS results indicated the presence of drugs, but at a level below the cutoff of 200 ng/ml. All positive samples by either screening method were confirmed by GCMS. The testing performed by both the sponsor and the Clinical Trial site did find 2 and 7 respectively false positives and no false negatives in the samples tested. GC/MS confirmed the presence of benzodiazenines but at levels below the cutoff of 200 ng/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
In-house testing: relative sensitivity 1.000, relative specificity 0.9740, accuracy 98.54%.
Clinical trial (303 samples): relative sensitivity 100%, relative specificity 95.42%, accuracy 97.69%.
False positives: In-house testing 2, Clinical trial 7.
False negatives: 0 in both.
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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§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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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FEB 2 5 1998
510k Submission for
QuikStrip One Step Benzodiazepine Test
Syntron Bioresearch, Inc.
Page 77 of 77
Revision A 8/18/97 Printed on 8/26/97
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 Benzodiazepine and its metabolites in a screening format.
The trade name of the device is QuikStrip One Step Benzodiazepine Test having a designated common name of Benzodiazepine Test System and a classification as a Class II device per 21 CFR ¶ 862.3170. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Benzodiazepine 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 200 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 Benzodiazepine Test vielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of .9740 and an accuracy of 98.54% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 303 samples was run and the combined data vielded a relative sensitivity of 100%, a relative specificity of 95.42% with an accuracy of 97.69% when compared to Emit II® run at 200 ng/ml. By non parametric testing the results are significantly different from one another. Emit II vielded 7 false positives. GC/MS results indicated the presence of drugs, but at a level below the cutoff of 200 ng/ml.
. All positive samples by either screening method were confirmed by GCMS. The testing performed by both the sponsor and the Clinical Trial site did find 2 and 7 respectively false positives and no false negatives in the samples tested. GC/MS confirmed the presence of benzodiazenines but at levels below the cutoff of 200 ng/ml.
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 is circular and features the department's name around the perimeter. In the center is a stylized eagle symbol, which is a common emblem associated with the United States.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065
FEB 25 1998
Re : K973269 QuikStrip One Step Benzodiazepine Test Requlatory Class: II Product Code: JXM Dated: January 15, 1998 Received: January 16, 1998
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. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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
3
510(k) Number (if Known): Has Yet to be assigned
Device Name: Syntron's QuikStrip One Step Benzodiazepine assay
Indications For Use:
Syntron's QuikStrip One Step Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites: …………………………………………………
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
Concurance of CDRH, Office of Device Evaluation (ODE)
Perscription Use: (Per 21 CFR 801.109 or
Over The Counter Use: (Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K973269