(139 days)
LC/MS results
Not Found
No
The device description details a standard lateral flow immunoassay based on antigen-antibody reactions, with no mention of computational analysis, algorithms, or learning processes. The performance studies focus on reproducibility of the immunoassay's chemical reaction.
No
This device is a diagnostic test for detecting buprenorphine in urine, not a therapeutic device used for treatment.
Yes
This device is a diagnostic device as it is intended for the qualitative detection of buprenorphine in human urine, which provides a preliminary analytical result to determine the need for additional or confirmatory testing. This aligns with the definition of a diagnostic device, which is used to detect or monitor diseases or conditions.
No
The device description clearly outlines a physical immunoassay test strip that utilizes chemical reactions and capillary action to detect substances in urine. This involves hardware components (membrane strip, colloidal gold-antibody complex, immobilized drug conjugate) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of 12.5 ng/ml of buprenorphine in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to gain information about a physiological state (presence of buprenorphine).
- Device Description: The description details a "lateral flow immunoassay" that uses "human urine" as the sample. This is a common format for IVD tests.
- Professional Use: While it's intended for professional use, this doesn't preclude it from being an IVD. Many IVDs are designed for use by healthcare professionals in a laboratory or clinical setting.
- Preliminary Result: The fact that it provides a preliminary result and requires confirmatory testing (like LC/MS) is also consistent with many IVDs, particularly screening tests.
The core function of analyzing a human sample in vitro to provide diagnostic information (even if preliminary) firmly places this device in the category of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
'RapidOne' - Buprenorphine Test is used for the qualitative detection of buprenomine and buprenorphine glucuronide in human urine. This immunoassay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing i.e. liquid chromatography/mass spectrometry (LC/MS).
'RapidOne'-Buprenorphine Test is a one-step lateral flow immunoassay for the qualitative detection of 12.5 ng/ml of buprenorphine in human urine.
'RapidOne'-Buprenorphine Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. liquid chromatography/mass spectrometry (LC/MS).
'RapidOne'-Buprenorphine Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. LC/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
The assay employed in the "RapidOne"-Buprenorphine Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of buprenorphine-and buprenorphine glucuronide in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex. is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur, forming visible lines in the "test" area. When drug is present in the urine sample, the drug or metabolite will compete with the drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug compage. An absence of a color band (Ime) in the "test" grea is indicative of a possive result. A control band (line), comprised of a different autibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present on all reactions. A negative will produce two colored bands, and a positive sample will produce only one band.
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
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)
Reproducibility was evaluated using control urmes containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days. The results confirmed the reproducibility of the 'RapidOne'-Bupremorphine Test performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
'RapidOne'-Buprenorphine Test will detect buyrenorphine at 12.5 ng/ml and bunrenorphine glucuronide at 10.0 ng/ml.
Predicate Device(s)
LC/MS results
Reference Device(s)
Not Found
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).
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
AUG - 7 2006
510(k) Summary
Submitter's Name/Address: American BioMedica Corporation 122 Smith Road Kinderhook, NY 12106
Date of Preparation of this Summary:
Device Trade or Proprietary Name:
Device Common/Ususal Name or Classification Name:
Contact Person: Herry Wells VP Product Development Phone: 410-992-4734 410-992-0328 Fax:
March 13, 2006
RapidOne-Buprenorphine Test
Opiate Test System
Classification Number/Class:
$862.3650 Class II
This 510(k) Summary is being submitted in accordance with the requirement of 21 CFR 807.92.
The assigned 510(k) number is: K 060760
Predicate Device: LC/MS results
Test Description:
The assay employed in the "RapidOne"-Buprenorphine Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of buprenorphine-and buprenorphine glucuronide in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex. is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur, forming visible lines in the "test" area
When drug is present in the urine sample, the drug or metabolite will compete with the drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug compage. An absence of a color band (Ime) in the "test" grea is indicative of a possive
1
result.
A control band (line), comprised of a different autibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present on all reactions.
A negative will produce two colored bands, and a positive sample will produce only one band.
Intended Use:
'RapidOne' - Buprenorphine Test is used for the qualitative detection of buprenomine and buprenorphine glucuronide in human urine. This immunoassay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing i.e. liquid chromatography/mass spectrometry (LC/MS).
Performance Characteristics:
'RapidOne'-Buprenorphine Test will detect buyrenorphine at 12.5 ng/ml and bunrenorphine glucuronide at 10.0 ng/ml.
Reproducibility was evaluated using control urmes containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days. The results confirmed the reproducibility of the 'RapidOne'-Bupremorphine Test performance.
Conclusion:
'RapidOne' - Buprenor phine Test is substantially equivalent to the results obtained with LC/MS.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 7 2006
Henry Wells, Ph.D. American BioMedica Corp. 9110 Red Branch Road Suite B Columbia, MD 21045
K060760 Re:
Trade/Device Name: 'RapidOne'- Buprenorphine Test Regulation Number: 21 CFR8862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: June 23, 2006 Received: June 28, 2006
Dear Dr. Wells:
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).
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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) 276-0484. 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 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 060760
'RapidOne' - Buprenorphine Test Device Name:
Indications For Use:
'RapidOne'-Buprenorphine Test is a one-step lateral flow immunoassay for the qualitative detection of 12.5 ng/ml of buprenorphine in human urine.
'RapidOne'-Buprenorphine Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. liquid chromatography/mass spectrometry (LC/MS).
'RapidOne'-Buprenorphine Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. LC/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.
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)
Carol Bernam
Livision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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