(143 days)
Not Found
No
The device description and performance studies focus on immunochromatography and chemical reactions, with no mention of AI or ML.
No.
The device is an in vitro diagnostic test for qualitative determination of Barbiturate and its metabolites in human urine, providing a preliminary analytical test result. It is not designed for diagnosis, cure, mitigation, treatment, or prevention of disease.
Yes
This device is designed for the "qualitative determination of Barbiturate and its metabolites in human urine specimens" to indicate the "presence of secobarbital." This falls under the definition of a diagnostic device as it aims to identify a specific substance in a biological sample to aid in diagnosis. While it provides only a preliminary result, it is still a diagnostic tool.
No
The device description clearly indicates it is an immunochromatography-based test kit that uses physical test strips and cards to detect substances in urine specimens. This involves physical components and chemical reactions, not solely software.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "in vitro test" and describes the determination of substances in a human specimen (urine).
- Device Description: Details the mechanism of action which involves a chemical reaction between antibodies and antigens to analyze compounds in a human urine specimen.
- Performance Studies: Describes testing using "urine control specimen and clinical urine specimen," which are samples taken from the human body.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The RapidBarbiturate Tests are immunochromatography based one step in vitro test. It is designed for qualitative determination of secobarbital in human urine specimen above the cutoff level of 300 ng/ml.
Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Product codes
DKX
Device Description
Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card
The RapidBAR test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-barbiturate antibody between barbiturate-protein conjugate and free drug which may be present in the urine specimen being tested.
When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine specimen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The studies performed are listed below:
Rapid Barbiturate Test Strip Sensitivity Accuracy (comparison study of clinical urine specimens)
Stability - Specimen Stability - Product Precision Reproducibility Specificity Interference
Rapid Barbiturate Test Card Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Barbiturate Test Strip and Test Card
Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card.
The results of performance characteristics demonstrate Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card to be substantially equivalent to the Applied Biotech SureStep ™ Drug Screen Test Barbiturate, which received 510 (k) approval.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Applied Biotech SureStep ™ Drug Screen Test Barbiturate
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Ko3021L
JUN 1 3 2003
510 (k) SUMMARY (21 CFR PART 807.92)
Product
Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card
Name of Manufacturer
Rapid Diagnostics, Division of ICN BIOmedicals Inc. 1429 Rollins Road, Burlingame, CA 94010, U.S.A.
Principle
The RapidBAR test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-barbiturate antibody between barbiturate-protein conjugate and free drug which may be present in the urine specimen being tested.
When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
Intended Use
The RapidBarbiturate Tests are immunochromatography based one step in vitro test. It is designed for qualitative determination of secobarbital in human urine specimen above the cutoff level of 300 ng/ml.
Performance
The studies performed are listed below:
Rapid Barbiturate Test Strip Sensitivity Accuracy (comparison study of clinical urine specimens)
1
Stability - Specimen Stability - Product Precision Reproducibility Specificity Interference
Rapid Barbiturate Test Card Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Barbiturate Test Strip and Test Card
Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card.
The results of performance characteristics demonstrate Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card to be substantially equivalent to the Applied Biotech SureStep ™ Drug Screen Test Barbiturate, which received 510 (k) approval.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2003
Mr. Charles Yu Director of Technical Operation ICN Biomedicals, Inc. 1429 Rollins Road Burlingame, CA 94010
Re: K030211
Trade/Device Name: Rapid Barbiturate Test Strip Rapid Barbiturate Test Card Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate Test System Regulatory Class: Class II Product Code: DKX Dated: April 11, 2003 Received: April 16, 2003
Dear Mr. Yu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510 (K) number (if known):__ K0 302 (1
Device Name: Rapid Barbiturate Test Strip
Indications for Use:
Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Jean Cooper
((Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030211
)
Prescription Use: (Per 21 CFR 801.109)
OR
Over the Counter Use: ______
5
INDICATIONS FOR USE STATEMENT
510 (K) number (if known): _ KO30 Al |______
Device Name: Rapid Barbiturate Test Card
Indications for Use:
Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Jean Cooper
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use: _ (Per 21 CFR 801.109)
OR
Over the Counter Use:
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