(48 days)
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No
The device description details a competitive binding immunoassay based on chemical reactions and colorimetric detection, with no mention of AI or ML. The performance studies describe standard analytical and clinical validation methods for this type of assay.
No
The device is a rapid, qualitative immunoassay for the determination of Barbiturates in urine. It is used for screening purposes and provides preliminary data, not for monitoring drug levels or treating a condition.
Yes
The device is a rapid, qualitative immunoassay for the determination of Barbiturates in urine, providing preliminary data for screening purposes. This aligns with the definition of a diagnostic device, which is used to identify the presence of specific substances or conditions to aid in diagnosis.
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 Barbiturates in urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body).
- Device Description: The description details a "chromatographic absorbent device" that performs an "immunoassay" on a "test sample" (urine). This is a typical description of an IVD device used for analyzing biological samples.
- Performance Studies: The document describes performance studies using "samples documented to be positive by GC/MS" and a "Clinical trial" with "296 samples." These studies are conducted to evaluate the performance of the device in detecting the target analyte in biological samples, which is characteristic of IVD testing.
- Key Metrics: The document provides metrics like "Relative sensitivity," "Relative specificity," and "Accuracy," which are standard performance indicators for IVD devices.
- Intended User / Care Setting: The intended user is for "medical/forensic screening of urine," which aligns with the use of IVD devices in clinical and forensic settings.
The device is designed to perform a test on a biological sample (urine) outside of the body to provide information about the presence of a substance (Barbiturates). This directly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TCPI's One Step™ Urine Drug of Abuse Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates 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 indicated6. TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.
Product codes
DIS
Device Description
TCPI's One Step™ Urine Drug of Abuse: Barbiturate 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 cutoff 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
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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
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Summary of Performance Studies
In-house testing of TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives 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 296 samples was run and the combined data yielded a relative sensitivity or agreement within positives of 97.96%, a relative specificity or agreement within negatives of 100% with an accuracy of 98.99%. All positive samples by either screening method were confirmed by GC/MS. Four of the 3 samples were negative for Barbiturate, but positive for other drugs by GC/MS. The three samples were positive for either Bromocriptine or Zoloft.
Key Metrics
Relative sensitivity or agreement within positives of 1.00, relative specificity or agreement within negatives of 1.00, accuracy of 100% (in-house testing).
Relative sensitivity or agreement within positives of 97.96%, relative specificity or agreement within negatives of 100%, accuracy of 98.99% (clinical trial of 296 samples).
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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
OCT - 2 1997
510k Submission for One Step™ Urine Drug of Abuse Barbiturate Technical Chemicals and Products, Inc. (TCPI).
Revision A 7/10//97 Printed on 8/13/97
Page 69 of 69
Summary of Safety and Effectiveness
The sponsor, Technical Chemicals and Products, Inc. (TCPI) (3341 S.W. 15th Street, 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 Barbiturate and its metabolites in a screening format.
The trade name of the device is One Step™ Urine Drug of Abuse: Barbiturate Test having a designated common name of Barbiturate Test System and a classification as a Class II device per 21 CFR ¶ 862.3150. This device is intended for the medical/forensic screening of urine.
TCPI's One Step™ Urine Drug of Abuse: Barbiturate 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 cutoff 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 TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives 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 296 samples was run and the combined data yielded a relative sensitivity or agreement within positives of 97.96%, a relative specificity or agreement within negatives of 100% with an accuracy of 98.99%.
All positive samples by either screening method were confirmed by GC/MS. Four of the 3 samples were negative for Barbiturate, but positive for other drugs by GC/MS. The three samples were positive for either Bromocriptine or Zoloft.
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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 2 1997
Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 93065 Simi Valley, California
K973047 Re : OneStep™ Urine Drug of Abuse: Barbiturate Test Requlatory Class: II Product Code: DIS Dated: August 13, 1997 Received: August 15, 1997
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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 requlation (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): Not yet Assigned
Device Name: One Step™ Urine Drug of Abuse Barbiturate Test
Indications For Use:
INTENDED USE
TCPI's One Step™ Urine Drug of Abuse Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates 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 indicated6. TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.
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