(58 days)
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No
The device description details a standard immunoassay based on competitive binding and colorimetric detection, with no mention of computational analysis or learning algorithms.
No
This device is a diagnostic tool used to screen urine for the presence of Benzodiazepine; it does not treat or cure any medical condition.
Yes
The device is described as a "rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine" and its intended use is to "screen urine for the presence of Benzodiazepine and its metabolites," which are actions typical 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 clearly states it's for the "determination of Benzodiazepine in urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Device Description: The description details a "chromatographic absorbent device" that performs a "competitive binding immunoassay." This is a common method used in IVD tests to detect specific substances in biological samples.
- Purpose: The test is designed to "screen urine for the presence of Benzodiazepine and its metabolites," which is a diagnostic purpose.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes. This device fits that description.
N/A
Intended Use / Indications for Use
Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: 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 that 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 indicated6. Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test is not intended to monitor drug levels, but only to screen urine for the presence of Benzodiazepine and its metabolites.
Product codes (comma separated list FDA assigned to the subject device)
JXM
Device Description
The trade name of the device is One Step™ Urine Drug of Abuse: Benzodiazenine Test having a designated common name of Benzodiazevine 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.
Technical Chemicals and Products. Inc.'s One Step™ Urine Drug of Abuse: 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
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Indicated Patient Age Range
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Intended User / Care Setting
medical/forensic screening
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 Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test yielded an agreement within positive samples of 1,000 and an agreement within negative samples of 0,9740 and an accuracy of 98.54% when tested against Syva EMIT II2200 ® on samples documented to be positive by GC/MS2200. A clinical trial consisting of 303 samples was run and the combined data yielded an agreement within positives of 100%, an agreement within negatives of 95,42% with an accuracy of 97,69% when compared to Emit II 200 ® run at 200 ng/ml. By non-parametric testing, the results are significantly different from one another. Emit II® yielded 7 false positives. GC/MSwoo 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 GC/MS 200. 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 200 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: agreement within positive samples of 1,000, agreement within negative samples of 0,9740, accuracy of 98.54%.
Clinical trial: agreement within positives of 100%, agreement within negatives of 95,42%, accuracy of 97,69%.
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).
0
K98076
510k Submission for
One Step™ Urine Drug of Abuse: Benzodiazepine Test
APR 2 9 1998
Technical Chemicals and Products, Inc.
Page 78 of 78
Revision A 1/15/98 Printed on 2/25/98
Summary of Safety and Effectiveness
The sponsor, Technical Chemicals and Products, Inc. (3341 SW 15th St., Pompano Beach. Fl. 33069), 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 One Step™ Urine Drug of Abuse: Benzodiazenine Test having a designated common name of Benzodiazevine 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.
Technical Chemicals and Products. Inc.'s One Step™ Urine Drug of Abuse: 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 Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test vielded an agreement within positive samples of 1,000 and an agreement within negative samples of 0,9740 and an accuracy of 98.54% when tested against Syva EMIT II2200 ® on samples documented to be positive by GC/MS2200. A clinical trial consisting of 303 samples was run and the combined data vielded an agreement within positives of 100%, an agreement within negatives of 95,42% with an accuracy of 97,69% when compared to Emit II 200 ® run at 200 ng/ml. By non-parametric testing, the results are significantly different from one another. Emit II® vielded 7 false positives. GC/MSwoo 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 GC/MS 200. 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 200 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.
TCPIbzd510alLH, Dr. Cleve W. Laird, 02/25/98 10:37 AM
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 1998
Technical Chemicals & Products, Inc. C/O Cleve W. Laird, Ph.D. Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065
K980776 Re: Benzodiazepine Assay One-Step™ Urine Drug of Abuse: Regulatory Class: II Product Code: JXM : February 25, 1998 Dated: March 2, 1998 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 realassified 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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 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 Gutman
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
Not vet Assigned 510(k) Number (if Known):
One Step™ Urine Drug of Abuse: Benzodiazepine assay Device Name:
Indications For Use:
INTENDED USE
Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: 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 that 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 indicated6. Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test is not intended to monitor drug levels, but only to screen urine for the presence of Benzodiazepine and its metabolites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
5100k) Number
(Division Sign-Off)
Division of Clinical Laboratory Devices
Prescription Use:
(Per 21 CFR 801.109
or
Over The Counter Use: (Optional Format 1-2-96)