(189 days)
'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.
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.
The 'RapidOne'-Cocaine-150 Test is a qualitative immunoassay for detecting benzoyl ecgonine in human urine. The study presented a limited set of performance data primarily focused on reproducibility, as the device was deemed "substantially equivalent" to a previously cleared device. Due to the nature of the submission (510(k) for substantial equivalence and the limited information provided in the summary), a full, detailed study report with all the requested information is not present. The information below is extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Detection Limit | Not explicitly stated as a separate criterion; implied to be 150 ng/ml for benzoyl ecgonine. | 'RapidOne'-Cocaine-150 Test will detect benzoyl ecgonine at 150 ng/ml. |
| Reproducibility | Consistent and accurate results across multiple tests, across concentrations above/below cutoff. | Confirmed by testing control urines (above/below cutoff and negative) four times daily for five days. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The study mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls were also used." It also states "Each sample was tested four times, twice daily, for five days," which implies repeat testing of a smaller set of samples rather than a large test set for overall performance.
- Data Provenance: Not specified. The summary does not provide details about the origin of the urine samples (e.g., country of origin, retrospective or prospective collection).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable/not stated.
- Qualifications of Experts: Not applicable/not stated. Ground truth for performance was established using GC/MS.
4. Adjudication Method
- Adjudication Method: Not applicable. Human experts were not involved in establishing the ground truth for this performance study; GC/MS was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a standalone in-vitro diagnostic test.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the described performance relates to the standalone performance of the device without human-in-the-loop assistance beyond the usual interpretation of a qualitative test result (presence/absence of a line). The study focuses on the device's ability to detect the analyte at a specified concentration.
7. Type of Ground Truth Used
- Ground Truth Type: Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "All concentrations were verified by GC/MS." and "GC/MS is the preferred confirmatory method."
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not stated. This type of immunoassay device does not typically involve a "training set" in the context of machine learning algorithms. Its design and cutoff are based on established biochemical principles and often validated against known concentrations.
9. How Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. As mentioned above, a training set is not relevant for this immunoassay's development. The cutoff and performance characteristics are based on the immunoassay's design and validated using reference methods like GC/MS.
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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
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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.
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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
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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 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
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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
Page 1 of
§ 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).