(212 days)
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
'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.
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.
The device is contained in a polypropylene cup.
The provided document describes the "Rapid Tox Cup," a one-step, lateral flow immunoassay for the simultaneous detection of abused drugs in urine.
1. Acceptance Criteria and Reported Device Performance
The document presents targeted drug concentrations (cut-off levels) for detection. These can be considered the acceptance criteria for individual drug detection sensitivity. The study claims the device's performance is reproducible and equivalent to its predicate devices.
| Analyte (Drug) | Acceptance Criteria (Cut-off level) | Reported Device Performance (Specificity/Sensitivity) |
|---|---|---|
| Amphetamine | 500 ng/mL | Reproducible, equivalent to predicate devices |
| Amphetamine | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| Methamphetamine | 500 ng/mL | Reproducible, equivalent to predicate devices |
| Methamphetamine | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| 3,4-methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Reproducible, equivalent to predicate devices |
| 3,4-methylenedioxymethamphetamine (MDMA) | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| Buprenorphine | 12.5 ng/mL | Reproducible, equivalent to predicate devices |
| Benzodiazepines (Oxazepam) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Barbiturates (Butalbital) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Oxycodone | 100 ng/mL | Reproducible, equivalent to predicate devices |
| Methadone | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Phencyclidine | 25 ng/mL | Reproducible, equivalent to predicate devices |
| Propoxyphene | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Opiates | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Opiates | 2000 ng/mL | Reproducible, equivalent to predicate devices |
| Cocaine (Benzoylecgonine) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Cocaine (Benzoylecgonine) | 150 ng/mL | Reproducible, equivalent to predicate devices |
| Tricyclic Antidepressants (Nortriptyline) | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| THC/ Cannabinoids (11 nor△9-THC-9-carboxylic) | 50 ng/mL | Reproducible, equivalent to predicate devices |
Note: The performance is described as "reproducible" and "equivalent to predicate devices," but specific accuracy metrics (e.g., sensitivity, specificity, PPV, NPV) from the study are not provided in this summary. The performance is inferred from the demonstration of reproducibility and equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The reproducibility study used commercially available control urines.
- Sample Size: Each sample was tested 4 times, twice daily, for 5 days, for a total of 40 tests per sample. The specific number of distinct control urine samples (e.g., negative controls, above cut-off, below cut-off) used is not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be from a prospective study conducted for validation purposes, given the controlled testing conditions (commercially available control urines, specific testing regimen).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set (control urines) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a laboratory analytical method, not by human experts. Therefore, the information about the number and qualifications of experts is not applicable in this context.
4. Adjudication Method for the Test Set
Since the ground truth was established by GC/MS and the device provides a direct qualitative result (visible line or no line), there was no adjudication method described for resolving discrepancies in the test set. The results from the device were compared against the GC/MS verified concentrations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is an immunoassay that provides a direct qualitative result, not an imaging device requiring human interpretation, so such a study would not be typically applicable. The comparison was the device's performance against GC/MS-verified samples.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The reproducibility study evaluated the performance of the "Rapid Tox Cup" by testing control urines multiple times and verifying concentrations by GC/MS. This assesses the algorithm's (or, in this case, the immunoassay's) performance without human-in-the-loop interpretation beyond reading the visible lines. It also explicitly states that the device in cup form houses identical strips used in predicate devices, and testing showed "no difference relative to results from the Rapid Tec or Rapid Tox products."
7. The Type of Ground Truth Used
The ground truth used for the test set was laboratory analytical confirmation by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted method for drug concentration verification.
8. The Sample Size for the Training Set
The document does not specify a distinct training set sample size. The description of the device's technology (immunoassay with immobilized drug conjugates and colloidal gold-antibody complex) suggests that its "training" or development involved setting up the specific chemical reactions and cutoff concentrations. While this process would involve extensive testing and optimization, the document refers to validation studies rather than a formal "training set" in the machine learning sense. The performance characteristics were evaluated using commercially available control urines for reproducibility.
9. How the Ground Truth for the Training Set Was Established
As with the test set, the ground truth for optimizing or validating the device's detection capabilities (analogous to a training set's ground truth in AI) would have been established through laboratory analytical methods, most likely GC/MS, to accurately determine drug concentrations in samples used during the development and optimization phases. The summary states that "All concentrations were verified by GC/MS" for the reproducibility study, indicating this method for ground truth establishment.
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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.
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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 |
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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 inthe cup itself or in aseparate container. | Sample sent out inseparate container. | Sample sent out inseparate container. |
| Quality Control | Control LineObservation for validtest | Control LineObservation forvalid test | Control LineObservation forvalid test |
| Drug TestingQuantity | Can test for greaterthan 10 drugs ifdesired | Can test up to 10drugs | Can test up to 5drugs |
| Storage | Identical | Identical | Identical |
| Shelf Life | 2 years | 2 years | 2 years |
| Rapid Readercompatible | No | Yes | Yes |
| CalibrationRequired | No | No | No |
| User interactiononce sampled | None | None | None |
| Stability TestResult | 8 hours | 8 hours | 1 hour |
| Minimum SampleVolume | 5 mL | 100 μl | 100 μl |
| Cross Reactivity | Over 500 drugstested, same results | Over 500 drugstested, same results | Over 500 drugstested, same results |
| Drug ID beingtested | Drug abbreviationadjacent to test line | Drug abbreviationadjacent to test line | Drug abbreviationadjacent to test line |
Similarities and Differences between the predicate devices and the Rapid Tox Cup:
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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).
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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
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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
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'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
§ 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).