(212 days)
Not Found
No
The device description details a lateral flow immunoassay based on antigen-antibody reactions and capillary action, with visual interpretation of colored lines. There is no mention of computational analysis, algorithms, or learning processes.
No
The device is described as an immunoassay for the detection of drugs in urine, intended for screening purposes to identify the need for further confirmatory testing, not for treatment.
Yes
Explanation: The device is intended for the "simultaneous detection of abused drugs in urine" and provides a "qualitative detection" of various drugs, which are clear indications of a diagnostic purpose. It specifically states "This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing."
No
The device is a physical immunoassay contained within a polypropylene cup, relying on chemical reactions and visual interpretation of lines on a membrane strip, not 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 of abused drugs in urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Sample Type: The device uses human urine, which is a biological specimen.
- Method: It employs a "lateral flow immunoassay," which is a common method used in IVD tests to detect specific substances in a sample.
- Purpose: The purpose is to qualitatively detect the presence of specific drugs of abuse, which is a diagnostic function.
- Professional Use: While it's intended for professional use and not over-the-counter, this doesn't preclude it from being an IVD. Many IVDs are designed for use by healthcare professionals.
- Preliminary Result: Even though it provides a preliminary result and requires confirmatory testing, it is still performing an initial diagnostic screening.
The description clearly aligns 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 Tox Cup'-is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for professional use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
Amphetamine 500 ng/mL, Amphetamine 1000 ng/mL, Methamphetamine 500 ng/mL, Methamphetamine 1000 ng/mL, 3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL, 3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL, Buprenorphine 12.5 ng/mL, Benzodiazepines (Oxazepam) 300 ng/mL, Barbiturates (Butalbital) 300 ng/mL, Oxycodone 100 ng/mL, Methadone 300 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 ng/mL, Opiates 300 ng/mL, Opiates 2000 ng/mL, Cocaine, (Benzoylecgonine 300 ng/mL, Cocaine, (Benzoylecgonine) 150 ng/mL, Tricyclic Antidepressants, (Nortriptyline) 1000 ng/mL, THC/ Cannabinoids (11 nor△9-THC-9-carboxylic 50 ng/mL.
Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels: Amphetamine 1000 ng/mL, Amphetamine 500 ng/mL, Methamphetamine 1000 ng/mL, Methamphetamine 500 ng/mL, 3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL, 3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL, Buprenorphine 12.5 ng/mL, Benzodiazepines (Oxazepam) 300 ng/mL, Barbiturates (Butalbital) 300 ng/mL, Oxycodone 100 ng/mL, Methadone 300 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 ng/mL, Opiates 300 ng/mL, Opiates 2000 ng/mL, Cocaine (Benzoylecgonine) 300 ng/mL, Cocaine (Benzoylecgonine) 150 ng/mL, Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL, THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) 50 ng/mL.
Product codes (comma separated list FDA assigned to the subject device)
LAG, DJG, DIO, DKE, LCM, DKZ, JXM, DJR, LFI, JXN
Device Description
The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the highly specific reaction between antigens and antibodies.
Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all "test" areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled 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 binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a colored line in any of the test areas is indicative of a presumptive positive result. A control 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 a drug in the urine, and therefore, should be present in all reactions. A negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample.
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 commercially available 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 4 times, twice daily, for 5 days. The results demonstrate the reproducibility of the 'Rapid Tox Cup' performance.
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.
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
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
MAY 3 0 2008
Submitters Name/Address: American Bio Medica Corporation 122 Smith Road Kinderhook, NY 12106
Contact Person:
Richard Reilly QA/RA Manager Phone: 856 241 2320 Fax: 856 241 2343
Date of Preparation of this Summary
Device Trade or Proprietary Name:
Device Common/Usual_Name_or Classification Name:
Classification Number/Class:
Fax: 856 241 2
"Rapid Tox Cup"
May 7, 2008
^
^
Multi-Drug Test System
(No classification Regulation) / Class II
This 510 (k) summary is being submitted in accordance with requirement of 21 CFR 807.92.
The assigned 510 (k) number is:
Predicate Device:
The Technology utilized in the 'Rapid Tox Cup' is based on the same principle as that utilized in both "Rapid Tec 4,' 510(k) No. K041712, 'Rapid Tec 5'' 510(k) No K023869, and 'Rapid Tox' 510 (k) No. K053359.
Test Description:
The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the highly specific reaction between antigens and antibodies.
Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all "test" areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled 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 binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a colored line in any of the test areas is indicative of a presumptive positive result.
1
A control 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 a drug in the urine, and therefore, should be present in all reactions.
A negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample.
INTENDED USE
'Rapid Tox Cup'-is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for professional use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will vield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results.
Performance Characteristics:
| Amphetamine | 500 ng/mL |
|---|---|
| Amphetamine | 1000 ng/mL |
| Methamphetamine | 500 ng/mL |
| Methamphetamine | 1000 ng/mL |
| 3,4-methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| 3,4-methylenedioxymethamphetamine (MDMA) | 1000 ng/mL |
| Buprenorphine | 12.5 ng/mL |
| Benzodiazepines (Oxazepam) | 300 ng/mL |
| Barbiturates (Butalbital) | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Methadone | 300 ng/mL |
| Phencyclidine | 25 ng/mL |
| Propoxyphene | 300 ng/mL |
| Opiates | 300 ng/mL |
| Opiates | 2000 ng/mL |
| Cocaine, (Benzoylecgonine | 300 ng/mL |
| Cocaine, (Benzoylecgonine) | 150 ng/mL |
| Tricyclic Antidepressants, (Nortriptyline) | 1000 ng/mL |
| THC/ Cannabinoids (11 nor△9-THC-9-carboxylic | 50 ng/mL |
2
Reproducibility was evaluated using commercially available 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 4 times, twice daily, for 5 days. The results demonstrate the reproducibility of the 'Rapid Tox Cup' performance.
Conclusion:
'Rapid Tox Cup' is performs equivalent to 'Rapid Tec,' and 'Rapid Tox' products previously cleared under listed 510k numbers above. The device in (Cup) form houses the identical strips used in these predicate cleared devices which are cassettes or test cards. Testing of the identical strips housed in the Rapid Tox Cup device performed as expected and showed no difference relative to results from the Rapid Tec or Rapid Tox products.
| Rapid Tox Cup | Rapid Tox | Rapid Tec | |
|---|---|---|---|
| Device Housing | Cup Format | Cassette Format | Card Format |
| Sampling Method | Fill Cup | Dip or Pipette | Dip or Pipette |
| Device Test Strips | Identical Strips | Identical Strips | Identical Strips |
| Results Reading | Identical | Identical | Identical |
| Time to Results | 3-5 minutes | 3-5 minutes | 5-7 minutes |
| Confirmation | Sample can be sent in | ||
| the cup itself or in a | |||
| separate container. | Sample sent out in | ||
| separate container. | Sample sent out in | ||
| separate container. | |||
| Quality Control | Control Line | ||
| Observation for valid | |||
| test | Control Line | ||
| Observation for | |||
| valid test | Control Line | ||
| Observation for | |||
| valid test | |||
| Drug Testing | |||
| Quantity | Can test for greater | ||
| than 10 drugs if | |||
| desired | Can test up to 10 | ||
| drugs | Can test up to 5 | ||
| drugs | |||
| Storage | Identical | Identical | Identical |
| Shelf Life | 2 years | 2 years | 2 years |
| Rapid Reader | |||
| compatible | No | Yes | Yes |
| Calibration | |||
| Required | No | No | No |
| User interaction | |||
| once sampled | None | None | None |
| Stability Test | |||
| Result | 8 hours | 8 hours | 1 hour |
| Minimum Sample | |||
| Volume | 5 mL | 100 μl | 100 μl |
| Cross Reactivity | Over 500 drugs | ||
| tested, same results | Over 500 drugs | ||
| tested, same results | Over 500 drugs | ||
| tested, same results | |||
| Drug ID being | |||
| tested | Drug abbreviation | ||
| adjacent to test line | Drug abbreviation | ||
| adjacent to test line | Drug abbreviation | ||
| adjacent to test line |
Similarities and Differences between the predicate devices and the Rapid Tox Cup:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
American Bio Medica Corp. c/o Rich Reilly 603 Heron Dr. Logan Township, NJ 08085
MAY 3 0 2008
K073078/S001 Trade Name: Rapid Tox Cup Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Codes: LAG, DJG, DIO, DKE, LCM, DKZ, JXM, DJR, LFI, JXN Dated: May 13, 2008 Received: May 14, 2008
Dear Mr. Reilly:
Re:
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).
4
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K073078
Device Name: Rapid Tox Cup
Indications For Use
Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels:
| Amphetamine | 1000 ng/mL |
|---|---|
| Amphetamine | 500 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Methamphetamine | 500 ng/mL |
| 3,4-methylenedioxymethamphetamine (MDMA) | 1000 ng/mL |
| 3,4-methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Buprenorphine | 12.5 ng/mL |
| Benzodiazepines (Oxazepam) | 300 ng/mL |
| Barbiturates (Butalbital) | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Methadone | 300 ng/mL |
| Phencyclidine | 25 ng/mL |
| Propoxyphene | 300 ng/mL |
| Opiates | 300 ng/mL |
| Opiates | 2000 ng/mL |
| Cocaine (Benzoylecgonine) | 300 ng/mL |
| Cocaine (Benzoylecgonine) | 150 ng/mL |
| Tricyclic Antidepressants (Nortriptyiline) | 1000 ng/mL |
| THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) | 50 ng/mL |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073078
6
'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay 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).
The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results.
There is no calibration necessary and therefore no calibrator needed for this device.
'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benom
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073078