(111 days)
Not Found
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
Explanation: The device is a qualitative drug screening immunoassay, providing preliminary analytical results for detecting abused substances in urine. It is used for diagnostic purposes (detection of drugs), not for treating or preventing disease.
Yes
The device is described as a "one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine," which provides a "preliminary analytical test result" to "determine the need for additional or confirmatory testing." This clearly indicates its use in identifying the presence of certain conditions (drugs of abuse) in a biological sample, which is the definition of a diagnostic device.
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 that the device is for the "simultaneous detection of 5 abused substances in urine." Urine is a biological specimen, and the test is performed in vitro (outside the body).
- Device Description: The description details a "lateral flow immunoassay" that analyzes a "urine sample." This is a common method for in vitro diagnostic testing.
- Purpose: The test is used to provide a "preliminary result for use in determining the need for additional or confirmatory testing." This aligns with the purpose of many IVD screening tests.
- Professional Use: While intended for professional use, this does not preclude it from being an IVD. Many IVDs are designed for use by trained healthcare professionals.
The information provided clearly indicates that this device is used to test a biological sample (urine) in vitro to diagnose or screen for the presence of specific substances, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
'Rapid Drug Screen'-5-Panel is used for the qualitative detection of d-amphetamine, benzoyl ecgonine, cannabinoids, opiates, and phencyclidine in human urine. This immunoassay system 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'-5-Panel is not for point of care uses.
'Rapid Drug Screen' 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). 'Rapid Drug Screen' 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels:
d-Amphetamine 1000 ng/ml
Benzoyl ecgonine 300 ng/ml
Cannabinoids 50 ng/ml
Opiates 300 ng/ml
Phencyclidine (PCP) 25 ng/ml
Product codes
DJG, DMY, DJF, DIO, LDJ, DKZ, DOD, LCL
Device Description
The assays employed in the 'Rapid Drug Screen' - 5-Panel 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 goldantibody 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 negative.
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-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 of 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
'Rapid Drug Screen' 5-Panel test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision.
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)
The same assay strips which are used in the single drug assays have been incorporated into the 'Rapid Drug Screen'-5-Panel format. The sensitivity, reproducibility and accuracy for each of the assays have cleared the 510(k) process. The independence of each channel has been demonstrated in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
'Rapid Drug Screen' - 5-Panel will detect the 5 drugs in urine at the following levels:
d-Amphetamine 1000 ng/ml
Benzoyl ecgonine (Cocaine Metabolite) 300 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Opiates 300 ng/ml
Phencyclidine (PCP) 25 ng/ml
Predicate Device(s)
K990820, K990822, K990822, K992452, K980084
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 0 2000
510(k) Summary
Submitter's Name/Address:
American Bio Medica Corporation 300 Fairview Avenue Hudson, N.Y. 12534
Contact Person:
November 2, 1999
Multidrug test system
Henry Wells Vice President of Product Development Phone: 518-822-8882 Fax: 518-822-0391
Date of Preparation of this Summary:
Device Trade of Proprietary Name:
Device Common/Usual Name or Classification Name:
Classification Number/Class
[no classification regulation]/Class II
'Rapid Drug Screen'-5-Panel
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: __K993151
| Predicate Device: | American Bio Medica 'RapidOne' Single Tests: | |
|---|---|---|
| Opiates | 510(k) No.K990820 | |
| Marijuana | 510(k) No.K990822 | |
| Cocaine | 510(k) No.K990822 | |
| Amphetamine | 510(k) No.K992452 | |
| And Forefront Diagnostics 'InstaCheck' | ||
| PCP | 510(k) No.K980084 |
Test Description:
The assays employed in the 'Rapid Drug Screen' - 5-Panel 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 goldantibody 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 negative.
1
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-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 of 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:
'Rapid Drug Screen'-5-Panel is used for the qualitative detection of d-amphetamine, benzoyl ecgonine, cannabinoids, opiates, and phencyclidine in human urine. This immunoassay system 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'-5-Panel is not for point of care uses.
Performance Characteristics:
'Rapid Drug Screen' - 5-Panel will detect the 5 drugs in urine at the following levels:
| d-Amphetamine | 1000 ng/ml |
|---|---|
| Benzoyl ecgonine (Cocaine Metabolite) | 300 ng/ml |
| Cannabinoids | |
| (11-nor-9-carboxy-delta-9-THC) | 50 ng/ml |
| Opiates | 300 ng/ml |
| Phencyclidine (PCP) | 25 ng/ml |
Conclusion
The same assay strips which are used in the single drug assays have been incorporated into the 'Rapid Drug Screen'-5-Panel format. The sensitivity, reproducibility and accuracy for each of the assays have cleared the 510(k) process. The independence of each channel has been demonstrated in this submission. 'Rapid Drug Screen'-5-Panel is substantially equivalent to a combination of the following:
| 'RapidOne' Opiates Test | K990820 |
|---|---|
| 'RapidOne' Cocaine Test | K990822 |
| 'RapidOne' Marijuana Test | K990818 |
| 'RapidOne' Amphetamine Test | K992452 |
| 'InstaCheck' PCP Test | K980084 |
30
2
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 head with three curved lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
'JAN 1 0 2000
American Bio Medica c/o Mr. John B. Dubeck, Esq. Keller and Heckman LLP 1001 G Street NW, Suite 500W Washington, DC 20001
Re: K993151
Trade Name: Rapid Drug Screen 5 Panel Test Regulatory Class: II Product Code: DJG, DMY, DJF, DIO, LDJ, DKZ, DOD, LCL Dated: November 23, 1999 Received: November 23, 1999
Dear Mr. Dubeck:
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.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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 Putman
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
4
510(k) Number (if known): 长 9 9 3 LSI
'Rapid Drug Screen' 5 - Panel Test Device Name:
Indications For Use:
'Rapid Drug Screen' 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). 'Rapid Drug Screen' 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels:
| d-Amphetamine | 1000 ng/ml |
|---|---|
| Benzoyl ecgonine | 300 ng/ml |
| Cannabinoids | 50 ng/ml |
| Opiates | 300 ng/ml |
| Phencyclidine (PCP) | 25 ng/ml |
'Rapid Drug Screen' 5-Panel test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy 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).
'Rapid Drug Screen' 5-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order 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.
Sean Cooper
Division Sign-Off
Laboratory Devices
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LIÑÈ-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)