(189 days)
Not Found
No
The device description details a lateral flow immunoassay based on antigen-antibody reactions, which is a traditional biochemical method and does not involve AI or ML. The performance studies described are standard reproducibility tests for this type of assay. There is no mention of AI, ML, or related concepts in the provided text.
No
This device is a diagnostic tool for detecting benzoyl ecgonine (a cocaine metabolite) in urine, not a device used to provide therapy or treatment.
Yes
This device is a lateral flow immunoassay used for the qualitative detection of benzoyl ecgonine (cocaine metabolite) in human urine, providing a preliminary screening result for diagnostic purposes.
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, etc.) 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 benzoyl ecgonine in human urine." This is a test performed on a sample taken from the human body (urine) to provide information about a physiological state (presence of a drug metabolite).
- Device Description: The description details a "lateral flow immunoassay" that uses biological components (antigens and antibodies) to analyze the urine sample. This is a common method for in vitro diagnostic tests.
- Anatomical Site: The test is performed on "human urine," which is a biological specimen.
- Performance Studies: The document describes reproducibility studies using "control urines" and verification by "GC/MS," which are standard practices for evaluating the performance of diagnostic tests.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
'RapidOne'-Cocaine-150 Test is used for the qualitative detection of benzoyl ecgonine 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. gas chromatography/mass spectrometry (GC/MS).
'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine.
'RapidOne'-Cocaine-150 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. gas chromatography/mass spectrometry (GC/MS),
'RapidOne'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. 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 (comma separated list FDA assigned to the subject device)
DIO
Device Description
The assay employed in the 'RapidOne-Cocaine-150 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 benzoyl ecgonine 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 goldantibody 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. conjugate. An absence of a color band (line) in the "test" area is indicative of a positive.
A control band (line), comprised of a different antibody/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 urine 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 urines 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'-Cocaine-150 Test performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
'RapidOne'-Cocaine-150 Test will detect benzoyl ecgonine at 150 ng/ml.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
'RapidOne'-Cocaine Test (510(k) No. K990822)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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
JUN 16 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:
Classification Number/Class:
Contact Person:
Henry Wells VP Product Development Phone: 410-992-4734 410-992-0328 Fax:
December 2, 2005
'RapidOne-Cocaine-150 Test
Cocaine Test System
8862.3250 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: No. K 053422.
Predicate Device: 'RapidOne'-Cocaine Test (510(k) No. K990822).
Test Description:
The assay employed in the 'RapidOne-Cocaine-150 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 benzoyl ecgonine 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 goldantibody 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. conjugate. An absence of a color band (line) in the "test" area is indicative of a positive
1
A control band (line), comprised of a different antibody/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 urine will produce two colored bands, and a positive sample will produce only one band.
Intended Use:
'RapidOne'-Cocaine-150 Test is used for the qualitative detection of benzoyl ecgonine 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. gas chromatography/mass spectrometry (GC/MS).
Performance Characteristics:
'RapidOne'-Cocaine-150 Test will detect benzoyl ecgonine at 150 ng/ml.
Reproducibility was evaluated using control urines 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'-Cocaine-150 Test performance.
Conclusion:
'RapidOne'-Cocaine-150 Test is substantially equivalent to the previously cleared 'RapidOne'-Cocaine Test 510(k) No. K990822.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular border containing the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Henry Wells V.P. Product Development American BioMedica Corp. 9110 Red Branch Road Suite B Columbia, MD 21045
JUN 15 2006
Re: K053422
Trade/Device Name: 'RapidOne'- Cocaine-150 Test Regulation Number: 21 CFR§862.3250 Regulation Name: Cocaine & cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: June 6, 2006 Received: June 7, 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, Inting 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 artecting your device
may publich further a 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 At 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), and good manufacturing practi
3
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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 10gally 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 nother 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 tolloffree 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 Gatti
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 O 5 3422
'RapidOne'- Cocaine-150 Test Device Name:
Indications For Use:
'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine.
'RapidOne'-Cocaine-150 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. gas chromatography/mass spectrometry (GC/MS),
'RapidOne'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. 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.
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)
sion Sign-Off
f In Vitro Diagnostic Device
and Safety
LAS3422
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