(161 days)
No
The device description details a lateral flow immunoassay based on antigen-antibody reactions, which is a purely chemical and physical process. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No.
The device is an immunoassay for detecting abused substances in urine, providing diagnostic information but not directly treating any condition.
Yes
Explanation: The device is used for the qualitative detection of abused substances in human urine, providing preliminary results to determine the need for additional or confirmatory testing. This diagnostic function is explicitly stated in the "Intended Use / Indications for Use" section.
No
The device description clearly outlines a physical immunoassay test strip with a membrane, immobilized drug conjugates, and a colloidal gold-multi-antibody complex. This involves physical components and chemical reactions, not just software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the "qualitative detection of the following abused substances in human urine". This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Device Description: The description details an immunoassay that analyzes a urine sample to detect the presence of specific substances. This is a classic example of an in vitro diagnostic test.
- Intended User / Care Setting: While intended for professional use, this still falls under the umbrella of IVD devices used in a healthcare or laboratory setting.
The core function of the device is to analyze a biological sample (urine) outside of the body to provide diagnostic information (presence or absence of drugs), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
'RapidTec'-5M-Multiple Drug Test is used for the qualitative detection of the following abused substances in human urine: methamphetamines, benzoyl ecgonine, phencyclidine, opiates and cannabinoids. 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.)
Product codes
DJR, JXM, LDJ, DIG, LCM
Device Description
The assays employed in the 'RapidTec'-5M-Multiple Dip 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 marijuana, opiates, phencyclidine, cocaine and methamphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex 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 conjugates. 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 its corresponding 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 result. 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 or absence of drug in the urine, and therefore, should be present on all reactions. A negative urine will produce six colored bands, and a positive sample will produce only one band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
'Rapid Tec'-5M-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sale to nonprofessionals. The ussay is casy to perform, but should not be used without proper supervision.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 'RapidTec' -5M-Multiple Dip Test performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).
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APR 3 0 2003
510 (k) Summary
Submitter's Name/Address: American Bio Medica Corportion 122 Smith Road
Kinderhook, NY 12106
Contact Person:
Henry Wells VP Product Development Phone: 410 992-4734 Fax: 410 992-0328
Date of Preparation of this Summary:
Device Trade or Proprietary Name:
Device Common/Usual Name or Classification Name:
November 14, 2002
'RapidTec'-5M-Multiple Dip Test
Multi Drug Test System
Classification Number/Class:
[no classification regulation]/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:
Predicate Device: American Bio Medica Corp. 'Rapid Drug Screen'-9-Panel. (510(k) No. K012159.)
Test Description:
The assays employed in the 'RapidTec'-5M-Multiple Dip 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 marijuana, opiates, phencyclidine, cocaine and methamphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex 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 conjugates. 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 its corresponding 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 result.
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 or absence of drug in the urine, and therefore, should be present on all reactions.
A negative urine will produce six colored bands, and a positive sample will produce only one band.
Intended use:
'RapidTec'-5M-Multiple Drug Test is used for the qualitative detection of the following abused substances in human urine: methamphetamines, benzoyl ecgonine, phencyclidine, opiates and cannabinoids. 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:
'RapidTec' - 5M-Multiple Dip Test will detect drugs of abuse in human urine at the following levels:
| Methamphetamine | 1000 ng/ml |
|---|---|
| Benzoyl ecgonine | 300 ng/ml |
| Cannabinoids | 50 ng/ml |
| Phencyclidine | 25 ng/ml |
| Opiates | 2000 ng/ml |
| 300 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 'RapidTec' -5M-Multiple Dip Test performance.
Conclusion:
'RapidTec'-5M-Multiple Dip Test is substantially equivalent to the previously cleared 'Rapid Drug screen' - 9-Panel (510(k) No. K012159). Both systems utilize the same antibodies. The only difference is that in 'Rapid Drug Screen'-9-Panel, each assay occupies a separate channel, while in 'RapidTec'-5M-Multiple Dip Test each independent assay is 'stacked' in separate lines, one above the other.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is made up of three curved lines that converge at the bottom.
APR 3 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Henry Wells, Ph.D. V.P. Product Development American Bio Medica Corporation 9110 Red Branch Road Columbia, MD 21045
K023869 Re:
Trade/Device Name: 'RapidTec'-5M-Multiple Dip Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: DJR, JXM, LDJ, DIG, LCM Dated: February 24, 2003 Received: February 25, 2003
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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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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K023869 SIO(K) NUMBER (IF KNOWN) :
DEVICE NAME : 'RapidTec'-5M-Multiple Dip Test
INDICATIONS FOR USE:
'RapidTec'-5M-Multiple Dip Test is a onc-step lateral flow immunoassay for the simultaneous qualitative detection of methamphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine.
'RapidTec'-5Mmultiple Dip Test will dctect these analytes at the following concentrations:
| Methamphetamines: | 1000 ng/ml |
|---|---|
| Benzoyl ecgonine | 300 ng/ml |
| Cannabinoids | 50 ng/ml |
| Phencylidine | 25 ng/ml |
| Opiates | 2000 ng/ml |
'Rapid Tec'-5M-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sale to nonprofessionals. The ussay is casy to perform, but should not be used without proper supervision. This 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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
. シ
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Han Cooper | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023869 |
| Prescription Use | |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter-Use | |
| (Optional Format 1-2-96) |
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'RapidTec'-5M-Multiple Dip Test provides only a preliminary analytical result. A more specific alternate 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.