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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.

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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Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolite, THC metabolite, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of abuse samples. The detecting cut-off concentrations are as follows:

This assay provides only a preliminary analytical test result. A more specific alternate chemical method m ust be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/ MS)/High performance liquid chromatography (HPLC, for TCA) are the preferred confirmatory methods. Cl inical consideration and professional judgment should be applied to any drug of abuse test result, particula rly when preliminary positive results are obtained.

The AccuSign® RCDOA 10 test device is a simple immuno-chromatographic test for the rapid, qualitative detection of methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, amphetamine and/or their metabolites in human urine. The test result can be read visually or with DXpress reader (K050955).

Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and the study information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K983501: AccuSign® DOA10). Since the new device (AccuSign® RC-DOA 10) is stated to be "identical and use the same formula and manufacturing processes with the same reagents" as the predicate, and the key difference is the addition of a reader-compatible option, the acceptance criteria are effectively that its performance should be commensurate with the established performance of the predicate device.

The document directly states the detection cut-off concentrations for each substance as both the intended use and the "Detection Cutoff" in the substantial equivalence comparison table. This indicates that the device must accurately detect these substances at or above these specified cut-off levels.

Note on Reported Device Performance: The provided 510(k) summary does not contain specific performance metrics (e.g., sensitivity, specificity, accuracy) from a separate clinical study for the new device. Instead, the claim of substantial equivalence relies on the new device being "identical" to the predicate in its core biochemical function, with the only change being an additional reading method. Therefore, the "reported device performance" is essentially that it achieves the same detection capabilities as the legally marketed predicate device at the specified cut-off concentrations.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly detail a separate test set size or its data provenance (e.g., country of origin, retrospective/prospective). The submission relies heavily on the claim that the new device is "identical" to the predicate device in terms of its chemical components and manufacturing process. Therefore, the performance data from the predicate device's original clearance would be presumed to apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The 510(k) summary does not mention the use of experts for establishing ground truth for a test set for this specific submission. This is because the device is a diagnostic test kit for drugs of abuse, and the "ground truth" for such tests typically comes from validated analytical methods (like GC/MS). Expert consensus is usually more relevant for image-based diagnostic devices or complex clinical scenarios where subjective interpretation is involved.

4. Adjudication Method for the Test Set

No adjudication method is described, as no specific test set or study requiring adjudication is detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was mentioned or performed for this submission. MRMC studies are typically used for devices where human readers interpret diagnostic images or data, and the AI system is intended to assist or replace human interpretation. This device is a rapid immunoassay test where results are either visually read or read by a simple optical reader (DXpress). The 510(k) focuses on the "Reader reading compatible" aspect, implying it's an alternative to visual reading, not an AI assistance for human interpretive tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, a standalone performance is implied. The device, whether read visually or by the DXpress reader, functions as a standalone diagnostic tool for detecting the presence of drugs of abuse. The performance is based on its ability to react to specific concentrations of analytes, independent of human interpretive faculties beyond simply observing a line or reading a digital output. The "algorithm" here is the chemical reaction and optical detection mechanism. However, no specific separate standalone clinical study with new data is presented in this summary.

7. The Type of Ground Truth Used

The ground truth for this type of immunoassay is based on analytical chemical methods, specifically the concentration of the target drug or metabolite in urine samples. The document explicitly states that the test provides "only a preliminary analytical result" and that "a more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) (and for TCA, HPLC) is the gold standard used to establish definitive ground truth for drug presence and concentration.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set size. This is because the device is an immunoassay kit built on established chemical principles and reagents. It does not involve machine learning algorithms that require a training set in the conventional sense. The "training" in this context would refer to the development and optimization of the chemical formulations and reaction conditions, which were already established for the predicate device.

9. How the Ground Truth for the Training Set Was Established

As there is no conventional training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply here. The fundamental "ground truth" for the device's design and operation, derived from the predicate, would have been established through a combination of:

• Analytical validation: Testing the device with known concentrations of drug standards and interferences.
• Clinical correlation: Comparing test results with confirmed results from definitive analytical methods (like GC/MS) on patient samples during the development and validation of the predicate device.

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Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressans, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection cut-off concentrations are as follows:

Not Found

This document is a 510(k) clearance letter from the FDA for a qualitative immunoassay device, the AccuSign® DOA 10, for the detection of various drugs of abuse in human urine. It does not contain detailed information on the acceptance criteria and study results in the format requested.

The provided text only includes:

• The trade name and regulatory class of the device.
• The product codes and indications for use.
• The detection cut-off concentrations for each drug.
• A confirmation of substantial equivalence to predicate devices.

Therefore, I cannot provide the structured information about acceptance criteria and study details based on the given document. The document is essentially a clearance letter, not a detailed study report.

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Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows:

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "AccuSign® DOA 10" and related products. It outlines the FDA's determination of substantial equivalence to legally marketed predicate devices. However, this document primarily grants market authorization and does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness data (SSED).

Therefore, I cannot fulfill all parts of your request with the information provided. Specifically, the document does not include:

• A table of acceptance criteria and reported device performance (beyond the cut-off concentrations listed for each substance).
• Sample sizes used for test sets.
• Data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• Type of ground truth used (beyond implying chemical analysis for cut-off concentrations).
• Sample size for the training set.
• How ground truth for the training set was established.

What can be extracted from the provided document is the stated indications for use and the cut-off concentrations, which serve as a foundational aspect of the device's intended performance.

Here's the closest I can get to your request using the available information:

Device Description and Intended Use:

The AccuSign® DOA 10 (and related AccuSign DOA Panel, AccuSign MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) is an immunoassay for the qualitative detection of various drugs of abuse and their metabolites in samples. It is intended to assist in the screening of drug of abuse samples.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" presented in this document relate to the cut-off concentrations at which the device is designed to qualitatively detect the various substances. These cut-off concentrations define the threshold for a positive result.

Note: The document states "The detecting cut-off concentrations are as follows:" implying these are the performance targets the device aims to meet. Actual reported performance metrics like sensitivity, specificity, accuracy, or concordance with a reference method are not detailed in this document. Such information would typically be found in the device's intended use instructions or 510(k) summary (which is not this letter).

Missing Information and Limitations:

Based solely on the provided FDA 510(k) letter, the following information required by your request is not available:

1. Sample size used for the test set: Not mentioned.
2. Data provenance (e.g., country of origin, retrospective/prospective): Not mentioned.
3. Number of experts used to establish ground truth & qualifications: Immunoassay performance is typically validated against laboratory reference methods (e.g., GC/MS), not through expert consensus in the same way as image interpretation. The concept of "experts" for ground truth as traditionally applied to image analysis or clinical diagnosis is not directly applicable here. The "ground truth" for these devices is usually the precise chemical concentration determined by a more definitive laboratory method.
4. Adjudication method for the test set: Not applicable for this type of test (validation against a reference method).
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a diagnostic assay, not an AI interpretation of complex data by human readers.
6. Standalone (algorithm only) performance: This device is a standalone diagnostic assay. Its performance would be assessed directly without human interpretation as part of the "device performance" (e.g., accuracy against a gold standard). However, the specific metrics (sensitivity, specificity) are not provided in this letter.
7. Type of ground truth used: Implied to be quantitative chemical analysis (e.g., GC/MS) to establish the true concentration of drug metabolites, which then determines if it's above or below the cut-off. This document does not explicitly state the method.
8. Sample size for the training set: Not applicable in the context of an immunoassay. The "training" for such devices involves assay development and calibration, not machine learning on a distinct training set.
9. How the ground truth for the training set was established: See point 8.

Conclusion:

This FDA 510(k) letter confirms the market clearance of the AccuSign® DOA 10 device based on substantial equivalence to existing devices. It defines the substances detected and their respective cut-off concentrations, which are fundamental to the device's intended performance. However, it does not include the detailed performance study results or methodologies (like expert adjudication, sample sizes, provenance, or specific validation metrics) that would typically be found in a comprehensive technical report or FDA's decision summary for substantial equivalence. For those details, one would need to consult the full 510(k) submission summary, if publicly available.

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