(66 days)
Not Found
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.
No.
This device is a diagnostic test for detecting propoxyphene in urine, not a device used to provide therapy or treatment for a disease or condition.
Yes.
This device is designed to detect propoxyphene and norpropoxyphene in human urine, providing a "preliminary analytical result" for the "qualitative detection" of these substances. This aligns with the definition of a diagnostic device, which is used to identify or detect a particular condition or substance.
No
The device description clearly outlines a physical immunoassay test strip that utilizes chemical reactions and capillary action to produce a visual result. This involves hardware components (membrane strip, colloidal gold, antibodies, antigens) and is not solely software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the qualitative detection of propoxyphene and norpropoxyphene in human urine. This is a biological sample taken from the human body.
- Method: It uses a lateral flow immunoassay, which is a common method for in vitro diagnostic testing.
- Purpose: The test provides a preliminary result for use in determining the need for additional or confirmatory testing. This indicates it's used to diagnose or screen for the presence of a substance in a biological sample.
- Device Description: The description details the mechanism of the immunoassay, which involves reactions between antigens and antibodies in the urine sample. This is characteristic of IVD tests.
- Anatomical Site: The sample is human urine.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
'Rapid One'-Propoxyphene Test is used for the qualitative detection of propoxyphene and norpropoxyphene 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.)
'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.
'Rapid One'-Propoxyphene 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. 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 One'-Propoxyphene 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.
Product codes (comma separated list FDA assigned to the subject device)
JXN
Device Description
The assay employed in the 'Rapid One'-Propoxyphene 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 propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-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 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 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
Control urines containing concentrations above and below the stated cut-off were used. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days.
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 One'-Propoxyphene Test performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
'Rapid One'-Propoxyphene Test will detect propoxyphene or norpropoxyphene at 300 ng/ml.
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.
MedTox Diagnostics, Inc. 2-Panel Propoxyphene/MAMP-MDMA Test. (510 (k) No. K002141)
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
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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
MAY 22 2003
510 (k) Summary
Submitter's Name/Address:
American Bio Medica Corportion 122 Smith Road Kinderhook, NY 12106
Date of Preparation of this Summary:
Device Trade or Proprietary Name:
Contact Person:
Henry Wells VP Product Development Phone: 410 992-4734 Fax: 410 992-0328
March 12, 2003
'Rapid One'-Propoxyphene Test
Propoxyphene Test System
Classification Number/Class:
Classification Name:
Device Common/Usual Name or
{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: K030835
Predicate Device: MedTox Diagnostics, Inc. 2-Panel Propoxyphene/MAMP-MDMA Test. (510 (k) No. K002141).
Test Description:
The assay employed in the 'Rapid One'-Propoxyphene 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 propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-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 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 two colored bands, and a positive sample will produce only one band.
Intended use:
'Rapid One'-Propoxyphene Test is used for the qualitative detection of propoxyphene and norpropoxyphene 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:
'Rapid One'-Propoxyphene Test will detect propoxyphene or norpropoxyphene at 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 One'-Propoxyphene Test performance.
Conclusion:
'Rapid One'-Propoxyphene Test is substantially equivalent to the previously cleared propoxyphene section of MedTox 2 Panel PPX/MAMP-MDMA Test (510(k) No. K002141).
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Henry Wells Vice President Product Development American Bio Medica Corporation 9110 Red Branch Road Suite B Columbia, Maryland 21045
MAY 22 2003
Re: K030835
Trade/Device Name: Rapid One - Propoxyphene Test Regulation Number: 21 CFR § 862.3700 Regulation Name: Propoxyphene Test System Regulatory Class: II Product Code: JXN Dated: March 14, 2003 Received: March 17, 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 (OS) regulation (21 CFR Part 820). 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.
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Page 2 -
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
4
Page of
510(k) Number (if known):__
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
'Rapid One'-Propoxyphene Test
'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.
'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for i over-the-counter sales to nonprofessionals. The assay 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 One'-Propoxyphene 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | 510(k) |
| K030835 | |
|---|---|
| OR |
| Over-The-Counter Use | |
|---|---|
| -- | ---------------------- |
(Optional Format 1-2-96)