(84 days)
No predicate device(s) are listed in the provided text.
Not Found
No
The device description clearly outlines a simple immunochromatographic assay based on antigen-antibody reactions, which is a standard chemical process and does not involve AI or ML. The performance studies describe comparisons to GC/MS and a predicate device, not the training or validation of an AI/ML model.
No
The device is described as a rapid immunochromatographic immunoassay for the qualitative detection of Buprenorphine in human urine. It is used for diagnostic purposes (drug screening) and does not provide any treatment or therapeutic function.
Yes
The device is described as an immunoassay for the qualitative detection of Buprenorphine in human urine. Its intended use is to obtain visual, qualitative results for drug screening, which falls under the definition of a diagnostic device.
No
The device description clearly outlines a physical immunochromatographic assay (dipstick and dipcard) that utilizes chemical reactions and visual interpretation, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the devices are "rapid immunochromatographic immunoassays for the qualitative detection of Buprenorphine in human urine". This clearly indicates the device is used to test a biological sample (human urine) in vitro (outside the body) to gain information about a person's health status (presence of Buprenorphine).
- Device Description: The description details the mechanism of action, which involves "immunochemical reactions between antigens and antibodies" and analyzing the presence or absence of a "purple-red band at the test region". This is a typical description of an immunoassay, a common type of IVD.
- Performance Studies: The document describes performance studies conducted on urine specimens to evaluate the device's accuracy, sensitivity, specificity, etc., which are standard evaluations for IVD devices.
- Professional Use Only: While not a definitive marker on its own, the restriction to "professional use only" is common for IVD devices used in clinical or laboratory settings.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fastect® II BUP Drug Screen Dipstick and the QuickTox® Drug Screen Dipcard devices are chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests are screening devices and provide only a preliminary result. All positive test results obtained should be confirmed by another test method, preferably GC/MS or LC/MS analysis. The Fastect® II BUP Drug Screen Dipstick and the QuickTox® Drug Screen Dipcard deviccs are intended for professional use only. They are not intended for over-the-counter sale to non-professionals.
Product codes
DJG
Device Description
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are based on the principle of highly specific immunochemical reactions between antigens and antibodies. Both devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. If Buprenorphine is present in the urine, it competes with the immobilized drug conjugate for the limited binding sites on the colored antibody colloidal gold conjugate. When a sufficient amount of drug is present, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug conjugate immobilized on the membrane. Thus, the absence of the purple-red band at the test region indicates a prcliminary positive result. However, if there is no drug present to compete for the binding sites of the colored colloidal gold conjugate, it binds to the immobilized drug conjugate to form a visible purple-red band at the test region of the membrane. Thus, the presence of a purple-red band at the test region indicates a negative result. The Fastect II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests can be performed without the use of any additional instruments.
A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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
A total of 90 urine specimens were evaluated with the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices. Of the 90 urine specimens, 50 urine samples were clinical specimens previously analyzed by GC/MS with known Buprenorphine concentrations. Approximately 10% were near-negative samples and at least 10% of the clinical urine samples were near-positive. When near-negative and near-positive clinical urine samples could not be easily obtained, more concentrated clinical urine samples were diluted to make these samples. Both the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices were compared with the ACON® BUP One Step Buprenorphine Test Device as well as against the values obtained through GC/MS analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Accuracy Study
Sample Size: 90 urine specimens
Key Results:
Fastect® II BUP Drug Screen Dipstick Test:
- Positive detections:
- Negative (+50%): 33
- % Agreement for Positive: 100%
- Negative detections:
- Negative (+50%): 0
- % Agreement for Negative: 94%
QuickTox® Drug Screen Dipcard Test:
- Positive detections:
- Negative (+50%): 33
- % Agreement for Positive: 100%
- Negative detections:
- Negative (+50%): 0
- % Agreement for Negative: 94%
The performance characteristics were also verified by sensitivity, precision, specificity, cross-reactivity, interference (pH and Specific Gravity), stability, and optimal read time studies. The results demonstrated substantial equivalency between the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices and ACON® BUP One Step Buprenorphine Test Device, both with a cut-off concentration of 10 ng/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement for Positive: 100%
Agreement for Negative: 94%
Predicate Device(s)
Not Found
Reference Device(s)
ACON® BUP One Step Buprenorphine Test Device
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
Image /page/0/Picture/0 description: The image shows a logo for BRANAN BMC MEDICAL CORP. The logo features the letters "BMC" in large, bold font, with the word "BRANAN" arched above it and "MEDICAL CORP" written below. The logo has a geometric shape surrounding the letters, giving it a structured and corporate appearance. The text and shapes are all in black and white.
510(k) SUMMARY
NOV 21 2008
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K082508
Submitter
Branan Medical Corporation 140 Technology Dr., Suite 400 Irvine, CA 92618
Tel: (949) 598-7166 Fax: (949) 598-7167
Date Prepared
August 25, 2008
Contact Person
Raphacl Wong President
Product Names
Fastect® II BUP Drug Screen Dipstick QuickTox® Drug Screen Dipcard
Common Name
Immunochromatographic test for the qualitative detection of Buprenorphine in urine.
Classification Panel
Buprenorphine Test Systems
Product Code
DJG
Classification Number
21 CFR, 862.6350
1
Device Classification
The Buprenorphine test systems are classified as Class II devices with moderate complexity. These tests are used to provide only a preliminary result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis.
Intended Use
The Fastect® II BUP Drug Screen Dipstick and the QuickTox® Drug Screen Dipcard devices are chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests are screening devices and provide only a preliminary result. All positive test results obtained should be confirmed by another test method, preferably GC/MS or LC/MS analysis. The Fastect® II BUP Drug Screen Dipstick and the QuickTox® Drug Screen Dipcard deviccs are intended for professional use only. They are not intended for over-the-counter sale to non-professionals.
Description
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are based on the principle of highly specific immunochemical reactions between antigens and antibodies. Both devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. If Buprenorphine is present in the urine, it competes with the immobilized drug conjugate for the limited binding sites on the colored antibody colloidal gold conjugate. When a sufficient amount of drug is present, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug conjugate immobilized on the membrane. Thus, the absence of the purple-red band at the test region indicates a prcliminary positive result. However, if there is no drug present to compete for the binding sites of the colored colloidal gold conjugate, it binds to the immobilized drug conjugate to form a visible purple-red band at the test region of the membrane. Thus, the presence of a purple-red band at the test region indicates a negative result. The Fastect II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests can be performed without the use of any additional instruments.
A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.
2
Safety and Effectiveness Data
Accuracy
A total of 90 urine specimens were evaluated with the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices. Of the 90 urine specimens, 50 urine samples were clinical specimens previously analyzed by GC/MS with known Buprenorphine concentrations. Approximately 10% were near-negative samples and at least 10% of the clinical urine samples were near-positive. When near-negative and near-positive clinical urine samples could not be easily obtained, more concentrated clinical urine samples were diluted to make these samples. Both the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices were compared with the ACON® BUP One Step Buprenorphine Test Device as well as against the values obtained through GC/MS analysis. The following shows the results obtained from this study:
Fastcct® II BUP Drug Screen Dipstick Test
| | Negative
(+50%) | %
Agreement |
|--------------|--------------------|----------------------------------------|-----------------------------------------|-----------------------------------|----------------|
| Positive (+) | 0 | 3 | 6 | 33 | 100% |
| Negative (-) | 43 | 5 | 0 | 0 | 94% |
QuickTox® Drug Screen Dipcard Test
| | Negative
(+50%) | % Agreement |
|--------------|--------------------|----------------------------------------|-----------------------------------------|-----------------------------------|-------------|
| Positive (+) | 0 | 3 | 6 | 33 | 100% |
| Negative (-) | 43 | 5 | 0 | 0 | 94% |
Performance Characteristics and Other Information
The performance characteristics of the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices were verified by sensitivity, precision, specificity, cross-reactivity, interference (pH and Specific Gravity), stability, and optimal read time studies. Results from these studies show that the above-mentioned devices are reliable and meet performance claims when used according to the instructions provided in the Package Insert.
Conclusion
The performance characteristics studies performed demonstrate substantial equivalency between the Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices and ACON® BUP One Step Buprenorphine Test Device with the same cut-off concentration of 10 ng/ml. We have demonstrated that these tests are safe and effective in qualitatively detecting Burrenorphine at a cut-off concentration of 10 ng/ml. Therefore these tests are suitable for professional use only.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Branan Medical Corporation c/o Mr. Raphacl Wong President 140 Technology Drive, Suite 400 Irvine, CA 92618
NOV 21 2008
Re: K082508
Trade Name: Fastect® II BUP Drug Screen Dipstick QuickTox® Drug Screen Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: DJG Dated: August 25, 2008 Received: September 02, 2008
Dear Mr. Wong:
We have reviewed your Scction 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 vour 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 (OS) regulation (21 CFR Part 820).
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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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Fastect® II BUP Drug Screen Dipstick Device Name: QuickTox® Drug Screen Dipcard
Indications for Use:
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are rapid immunochromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. The devices are intended for professional use only. They are not intended for over-the-counter sale to non-professionals.
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard tests are used to obtain visual, qualitative results. A more specific alternate method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS are the preferred confirmatory methods.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In,Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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