(63 days)
K-984525
Not Found
No
The device description details a lateral flow immunoassay based on antigen-antibody reactions. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The results are determined by the presence or absence of visible lines, a purely chemical and physical process.
No
Explanation: A therapeutic device is used for treating or preventing diseases. This device is an in-vitro diagnostic device used for drug screening, which aids in diagnosis but does not provide therapy.
Yes
Explanation: The "Rapid Drug Screen" device falls under the definition of a diagnostic device as it is intended for the "qualitative detection of Cocaine (Benzoyl ecgonine), THC (Cannabinoids) and Opiates" in urine. This detection of substances in a biological sample is a characteristic function of a diagnostic device, providing preliminary analytical test results relevant to health status or disease.
No
The device description clearly details a physical immunoassay test strip that uses chemical reactions and visual interpretation of lines to detect drugs in urine. This involves hardware components (the test strip itself) and is not solely software.
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 "simultaneous detection in urine of three abused drugs". This indicates that it is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting the presence of drugs).
- Device Description: The description details a "lateral flow immunoassay" that uses a "membrane strip" and "colloidal gold-antibody complex" to detect the presence of specific substances (drugs) in a sample (urine). This is a common format for in vitro diagnostic tests.
- Sample Type: The device is designed to be used with "urine", which is a human specimen.
- Purpose: The purpose is to provide a "preliminary analytical test result" for the presence of drugs, which is a diagnostic step.
The fact that it's intended for professional use and requires confirmatory testing does not negate its classification as an IVD. It is still a test performed in vitro on a human specimen to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Rapid Drug Screen 3-Panel test for CTO is used for the qualitative detection of the following abused substances in human urine: Cocaine (Benzoyl ecgonine), THC (Cannabinoids) and Opiates. 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).
"Rapid Drug Screen" 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml.
"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
"Rapid Drug Screen" provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more 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 positive results are used.
"Rapid Drug Screen" is not intended for use as a Point of Care test.
Product codes (comma separated list FDA assigned to the subject device)
LDJ, DIO, DJG
Device Description
All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between antigens and antibodies.
Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. 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. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of a visible line in the test area occurs when the test is below the cut-off for the drug.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized 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 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 in 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
Not Found
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 Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K-984525
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
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
JAN 2 4 2000
American Bio Medica Corporation Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates
510(k) Summary
| Submitter's Name/Address: | Contact Person: |
|---|---|
| American Bio Medica Corporation | Henry J. Wells |
| 122 Smith Road | Vice President of Product |
| Kinderhook, N.Y. 12106 | Development |
| Phone: 800-227-1243 | |
| Fax: 518-822-0391 | |
| Date of Preparation of this Summary: | November 1999 |
| Device Trade or Proprietary Name: | Rapid Drug Screen 3-Panel Test |
| for CTO | |
| Device Common/Usual Name or | |
| Classification Name: | Rapid Drug Screen 3-Panel for |
| for Cocaine, Marijuana | |
| (THC) (Cannabinoids) and | |
| Opiates | |
| Classification Number/Class: | [no classification number]/Class I |
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
14993961 The assigned 510(k) is:
Predicate Device: American Bio Medica "Rapid Drug Screen" 5-Panel Test Kit with Methamphetamine (K-984525).
Test Description:
All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between antigens and antibodies.
Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. 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. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of a visible line in the test area occurs when the test is below the cut-off for the drug.
1
American Bio Medica Corporation Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized 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 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 in all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
Intended Use:
The Rapid Drug Screen 3-Panel test for CTO is used for the qualitative detection of the following abused substances in human urine: Cocaine (Benzoyl ecgonine), THC (Cannabinoids) and Opiates. 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).
Performance Characteristics:
This Rapid Drug Screen 3-Panel test will detect drugs of abuse in human urine at the following levels:
| Benzoyl ecgonine | 300 ng/ml |
|---|---|
| THC (Cannabinoids) | 50 ng/ml |
| Opiates | 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 Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates.
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American Bio Medica Corporation Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates
Conclusion:
The Rapid Drug Screen 3-Panel for CTO is substantially equivalent to the Rapid Drug Screen 5-Panel with Methamphetamines demonstrated by results obtained in the studies. The three analytes in the kit have been cleared by the 510(k) process (K-984525). There is no evidence of cross-reactivity when the three colloidal gold-antibody complexes are mounted in a common device side-by-side with physical separation of the individual channels.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The caduceus is a common symbol for healthcare and medicine, and the text identifies the organization as a U.S. government agency.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 4 2000
Mr. Henry Wells Vice President, Product Development American Bio Medica Corporation 300 Fairview Avenue Hudson, New York 12534
Re: K993961
Trade Name: Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates Regulatory Class: II Product Code: LDJ, DIO, DJG Dated: November 15, 1999 Received: November 22, 1999
Dear Mr. Wells:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known)
K 993961
Device Name: Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates
Indications For Use:
"Rapid Drug Screen" 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml.
"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
"Rapid Drug Screen" provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more 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 positive results are used.
"Rapid Drug Screen" is not intended for use as a Point of Care test.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| 510(k) Number | K993961 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Formal 1-2