(195 days)
Not Found
No
The device description details a standard immunochromatographic assay based on chemical reactions and visual interpretation of color bands. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is described as an immunochromatographic enzyme immunoassay for qualitative determination of buprenorphine in human urine. It is used for detection and screening, not for treatment or therapy.
Yes
The device is described as an "immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine," which functions as a "preliminary analytical test." This indicates its use in identifying a medical condition (presence of buprenorphine), thus qualifying it as a diagnostic device.
No
The device description clearly describes a physical immunochromatographic test card with absorbent material, membranes, and reagents. This is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "qualitative determination of the presence of buprenorphine in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of a drug).
- Device Description: The description details a "chromatographic absorbent device" that uses an "immunochromatographic enzyme immunoassay" to detect the drug. This is a common method used in IVD tests.
- Biological Sample: The test is performed on "human urine," which is a biological specimen.
- Analysis Outside the Body: The test is conducted on the urine sample, not directly on the patient's body.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Sure Buprenorphine Rapid Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
Product codes
DJG
Device Description
For Sure Buprenorphine Rapid Test Card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate in whilel the arag of aring membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibodysample from and ages free drug in the specimen forming an antibody-antigen complex. conjugate onlike to the from bilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 will of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen unor color band in the control area. There is no meaning attributed to color produces only one other line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
March 30th, 2005 SECTION II 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
51O}k) Number: Design K # 042988
Submitter:
Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Rodrigo Berlie Marketing Director Telephone: (760) 602-2929 Facsimile: (760) 602-2999
Preparation Date:
March 30, 2005
Device Information:
Device Classification Name: Immunoassay, Buprenorphine Common/Usual Name: Immunoassay Test System for detection of Buprenorphine in Human Urine Proprietary Name: Rapid One Step Buprenorphine Test Card, For Sure Buprenorphine Rapid Test Card Regulation Number: 21 CFR§862.3650 Regulatory Name: Buprenorphine test system Product Code: DJG Regulatory Class: Class II
Predicate Devices:
For Sure Buprenorphine Rapid Test Card is substantially equivalent to The CEDIA® Buprenorphine Assay cleared by FDA (K040316), and GC/MS for its stated intended use.
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Device Description:
For Sure Buprenorphine Rapid Test Card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate in whilel the arag of aring membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibodysample from and ages free drug in the specimen forming an antibody-antigen complex. conjugate onlike to the from bilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 will of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen unor color band in the control area. There is no meaning attributed to color produces only one other line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Intended Use:
For Sure Buprenorphine Rapid Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
Comparison to Predicate Device(s):
For Sure Buprenorphine Test Card is substantially equivalent to CEDIA buprenorphine test system cleared by FDA, e.g., the CEDIA Buprenorphine Assay (K040316) and GC/MS for its stated intended use.
| Device Characteristics | Subject Device (For Sure
Buprenorphine Test Card) | Predicate Device(s)
CEDIA Buprenorphine Assay
(K040316) and GC/MS |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Buprenorphine one-step
Immunochromatographic test card
with 10 ng/ml cutoff. The assay
provides a simple and rapid
analytical screening procedure to
detect buprenorphine in human urine | The CEDA® Buprenorphine assay is
homogenous enzyme immunoassay
for qualitative or semi-quantitative
determination of the presence of
buprenorphine in human urine at
cutoff concentration of 5 ng/ml. |
| Analyte | Buprenorphine | Buprenorphine |
| Cutoff | 10 ng / ml | 5 ng/ml |
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| Matrix | Urine | Urine |
|---|---|---|
| Calibrator | None | 5 levels (0,5,20,50 and 75 mg/ml |
| Instrument | None, Visual read single use | Expensive Auto-analyzer |
| Calibration of Reagent | None | Yes, multiple reagents require |
| calibration. | ||
| Storage | Below 28 ℃ until expiration | 2℃ - 8℃ until expiration date |
Summary:
The information provided in this pre-market notification demonstrates that the Rapid One The Information provine Test Card is substantially equivalent to CEDIA Buprenorphine test assay system and GC/MS.
assay system and OCAND.
Substantial equivalence was demonstrated through comparison of intended use and Davical properties to the commercially available and analytical predicate devices. The physiour property to this pre-market notification provides reasonable assurance that mormation bappired in neworphine Test Card is safe and effective for its stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlie Marketing Director Aviara Biotech, LLC. 2720 Loker Ave-West Suite U Carlsbad, CA 92008
Re: K042988
Trade/Device Name: For Sure One Step Buprenorphine Test Card Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: April 28, 2005 Received: May 2, 2005
MAY 1 2 2005
Dear Mr. Berlie:
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 for are version 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 or any 1 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).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will anon your your of substantial equivalence of your device to a legally premarket notification - 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 of questions on the promotion and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may 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/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K042988
Device name: For Sure One Step Buprenorphine Test Card Device
Indications for Use:
For Sure One Step Buprenorphine Test Card is an immunochromatographic immunoassay for qualitative determination of the presence of buprenorphine in human minutioassay for qualitative of 10 ng/ml. The assay provides a simple and rapid urine at catorr oonoonareedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative The assay provides ost be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test results particularly when preliminary results are used.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Allent Catz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): K04298
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