(67 days)
K-964900
Phamatech K-972556
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 are based on comparisons to other immunoassay methods and GC/MS, without mention of AI/ML model training or evaluation.
No
This device is a diagnostic tool used for qualitative detection of various drugs in urine; it does not provide any therapeutic benefit or treatment.
Yes
The device is intended for the qualitative detection of five abused drugs in urine, providing a preliminary analytical test result that indicates the potential presence of these substances. This aligns with the definition of a diagnostic device, which is used to identify diseases or conditions.
No
The device description clearly outlines a physical lateral flow immunoassay strip with a membrane, immobilized drug conjugate, and colloidal gold-antibody complex, indicating it is a hardware-based test kit, not software only.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "simultaneous detection in urine of five abused drugs". This indicates it's used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (screening for 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 drugs in a urine sample. This is a typical format for in vitro diagnostic tests.
- Performance Studies: The document includes performance studies comparing the device's results to other commercially available immunoassays and confirmatory methods (GC/MS), which are standard practices for evaluating IVD performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K-964900) strongly suggests that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the 510(k) submission process for medical devices, including IVDs.
- Intended User: The intended user is "professional laboratories," which is a common setting for performing IVD tests.
The device is designed to be used in vitro (outside the body) to analyze a human specimen (urine) to provide information about a person's health status (presence of drugs). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Rapid Drug Screen" with methamphetamine is a one-step , lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (750 ng/ml), Benzoyl ecgonine (225 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (225 ng/ml).
"Rapid Drug Screen" is intended for use by professional laboratories. The assays are easy to perform, but should not be used without proper supervision. These immunoassay is a simplified qualatative screening method that provides only a preliminary result for use in the need for aditional 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 judgement should be applied to any drug of abuse test result, particulary when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, LAF, LDJ, DJG, DIO
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 possitive 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 laboratories
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
Accuracy for amphetamines, benzoyl ecgonine, cannabinoids, and opiate was determined by comparison to a commercially available immunoassay ( 'microLINE', DSSI, Blackwood, N. J. The clinical specimens were determined to be positive or negative by Syva EMIT II.
Amphetamines (75 negative, 40 positive): RDS and microLINE agreement: 114/115 specimens. (One discordant sample was EMIT II positive, RDS negative. It contained 279 ng/ml of amphetamine and 585 ng/ml of methamphetamine). GC/MS range of positive samples showed amphetamine ranges of 279 to 24.113 ng/ml.
Benzoyl ecgonine (cocaine) (75 negative, 40 positive): RDS and microLINE agreement: 115/115 specimens. GC/MS analyses of positive samples showed cocaine ranges of 249 to>1,000,000 ng/ml.
Cannabinoids (THC) (75 negative, 40 positive): RDS and microLDNE agreement: 114/115 specimens. (One discordant sample was EMIT II negative, RDS positive. It contained 7 ng/ml of THC). GC/MS analyses of the positive specimens showed THC ranges of 39 to 620 ng/ml.
Quiates (75 negative, 40 positive): RDS and microLINE agreement: 115/115 specimens. GC/MS analyses showed morphine concentrations of 353 to > 48,000 ng/ml.
Accuracy for methamphetamines was determined by comparison to Syva EMIT II using clinical specimens as follows:.
Methamphetamines (454 specimens): RDS and EMIT II agreement with specimens below the cut-off (negative): 256/256. RDS detected 193/198 specimens reported positive by EMIT II.
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 three times daily, in duplicate, for five days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Accuracy and Reproducibility
Sample Size:
- Amphetamines: 115 specimens (75 negative, 40 positive)
- Benzoyl ecgonine: 115 specimens (75 negative, 40 positive)
- Cannabinoids: 115 specimens (75 negative, 40 positive)
- Opiates: 115 specimens (75 negative, 40 positive)
- Methamphetamines: 454 specimens
Key Results:
- Amphetamines: RDS and microLINE agreement: 114/115 specimens. One discordant sample was EMIT II positive, RDS negative (contained 279 ng/ml amphetamine and 585 ng/ml methamphetamine). GC/MS range of positive samples: 279 to 24,113 ng/ml.
- Benzoyl ecgonine: RDS and microLINE agreement: 115/115 specimens. GC/MS analyses of positive samples: 249 to >1,000,000 ng/ml.
- Cannabinoids: RDS and microLDNE agreement: 114/115 specimens. One discordant sample was EMIT II negative, RDS positive (contained 7 ng/ml THC). GC/MS analyses of positive specimens: 39 to 620 ng/ml.
- Opiates: RDS and microLINE agreement: 115/115 specimens. GC/MS analyses showed morphine concentrations of 353 to > 48,000 ng/ml.
- Methamphetamines: RDS and EMIT II agreement with specimens below the cut-off (negative): 256/256. RDS detected 193/198 specimens reported positive by EMIT II.
- Reproducibility: Confirmed by testing control urines multiple times daily for five days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Agreement rates are provided.
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-964900
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.
Phamatech K-972556
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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
510(k) Summary
Submitter's Name/Address:
American Bio Medica Corporation 300 Fairview Avenue Hudson, N. Y. 12534
Contact Person:
Henry J. Wells Vice President of Product Development Phone: 800-227-1243 Fax: 518-822-0391
Date of Preparation of this Summary:
Device Trade or Proprietary Name:
Device Common/Usual Name or Classification Name:
Classification Number/Class:
December 1998
Rapid Drug Screen 5-Panel with Methamphetamine Rapid Drug Screen 5-Panel with Methamphetamine
[no classification number]/Class II
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) is:_____________________
Predicate Devices: American Bio Medica "Rapid Drug Screen" 5-Panel test kit with PCP (510(k) No. K-964900).
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
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 possitive sample will produce only one band.
Intended Use:
The Rapid Drug Screen 5-Panel test with Methamphetamine is used for the qualitative detection of the following abused substances in human urine: d-Amphetamine, Benzoyl ecgonine, Cannabinoids, Opiates and Methamphetamines. 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:
The Rapid Drug Screen S-Panel test will detect drugs of abuse in human urine at the following levels:
| d-Amphetamine | 750 ng/ml |
|---|---|
| Benzoyl ecgonine | 225 ng/ml |
| Cannabinoids | 50 ng/ml |
| Methamphetamines | 1000 ng/ml |
| Opiates | 300 ng/ml |
Accuracy for amphetamines, benzoyl ecgonine, cannabinoids, and opiate was determined by comparison to a commercially available immunoassay ( 'microLINE', DSSI, Blackwood, N. J. The clinical specimens were determined to be positive or negative by Syva EMIT II.
Amphetamines (75 negative, 40 positive): RDS and microLINE agreement: 114/115 specimens. (One discordant sample was EMIT II positive, RDS negative. It contained 279 ng/ml of amphetamine and 585 ng/ml of methamphetamine). GC/MS range of positive samples showed amphetamine ranges of 279 to 24.113 ng/ml.
2
Benzoyl ecgonine (cocaine) (75 negative, 40 positive): RDS and microLINE agreement: 115/115 specimens. GC/MS analyses of positive samples showed cocaine ranges of 249 to>1,000,000 ng/ml.
Cannabinoids (THC) (75 negative, 40 positive): RDS and microLDNE agreement: 114/115 specimens. (One discordant sample was EMIT II negative, RDS positive. It contained 7 ng/ml of THC). GC/MS analyses of the positive specimens showed THC ranges of 39 to 620 ng/ml.
Quiates (75 negative, 40 positive): RDS and microLINE agreement: 115/115 specimens. GC/MS analyses showed morphine concentrations of 353 to > 48,000 ng/ml.
Accuracy for methamphetamines was determined by comparison to Syva EMIT II using clinical specimens as follows:.
Methamphetamines (454 specimens): RDS and EMIT II agreement with specimens below the cut-off (negative): 256/256. RDS detected 193/198 specimens reported positive by EMIT II.
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 three times daily, in duplicate, for five days. The results confirmed the reproducibility of the Rapid Drug Screen 5-Panel with Methamphetamine performance.
Conclusion:
The Rapid Drug Screen 5-Panel with Methamphetamine is substantially equivalent to the Rapid Drug Screen 5-Panel with PCP test kit as demonstrated by results obtained in the studies. Four of the five analytes in the kit have been cleared by the 510(k) process (K-964900). The methamphetamine analyte has been cleared under our vendor's 510(k) (Phamatech K-972556). There is no evidence of cross-reactivity when the five colloidal gold-antibody complexes are mounted in a common device side-by-side with physical separation of the individual channels.
3
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 6 1999
Henry Wells Vice President, Product Development American Bio Medica Corporation 300 Fairview Avenue Hudson, NY 12534
K984525 Re: Trade Name: "Rapid Drug Screen" 5-Panel with Methamphetamine Test Regulatory Class: II Product Code: DKZ, LAF, LDJ, DJG, DIO Dated: December 18, 1998 Received: December 21, 1998
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.
Image /page/3/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
4
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely vours,
Steven Autman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: Rapid Drug Screen 5-Panel with Methamphetamine
Indications For Use:
"Rapid Drug Screen" with methamphetamine is a one-step , lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (750 ng/ml), Benzoyl ecgonine (225 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (225 ng/ml).
"Rapid Drug Screen" is intended for use by professional laboratories. The assays are easy to perform, but should not be used without proper supervision. These immunoassay is a simplified qualatative screening method that provides only a preliminary result for use in the need for aditional 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 judgement should be applied to any drug of abuse test result, particulary when preliminary positive results are used.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number X984525
F1
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use