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The ABM Rapid Drug Screen™ is for the determination of Cocaine, Triavelier, Opiates, Marijuana, PCF, Barontales, Donzoulasspance, Barry, Tricyclics, Methampletamine and Ecstasy in human urine. The device provides only qualitative results and is intended for professional use only.

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The provided document is a 510(k) premarket notification letter from the FDA to American Bio Medica Corporation regarding their Rapid Drug Screen™ device. It confirms the device's substantial equivalence to other legally marketed devices and permits marketing.

Unfortunately, the document does not contain the detailed information necessary to answer the specific questions about the acceptance criteria and the study proving the device meets those criteria. The provided text is a regulatory approval letter, not a scientific study report or a summary of performance data.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

To obtain this information, one would typically need to consult the full 510(k) submission, including the detailed performance studies, which are usually much more extensive than the approval letter itself.

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"Rapid Drug Screen" 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml.

"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional 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 judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

"Rapid Drug Screen" is not intended for use as a Point of Care test.

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 positive sample will produce only one band.

Here's an analysis of the provided text regarding the Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates, focusing on acceptance criteria and study information:

Description of Acceptance Criteria and Proving Device Performance

The provided document describes a reproducibility study as the primary method used to demonstrate the device's performance against its claimed detection levels (acceptance criteria). The study aimed to show that the device consistently produces the expected results (positive for drug presence above the cut-off, negative below) when tested multiple times.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "The results confirmed the reproducibility of the Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates." but does not provide specific metrics like sensitivity, specificity, accuracy, or concordance rates from this reproducibility study. It only confirms that the reproducibility was demonstrated.

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

• Sample Size: Each sample was tested four times, twice daily, for five days. The exact number of "control urines" used (i.e., distinct samples at specific concentrations) is not explicitly stated. It's implied there were samples above, below, and negative for each analyte. If we assume at least one unique sample for each category (above, below, negative) for each of the 3 analytes, that would be 9 initial control urine samples, each tested 20 times (4 times/day * 5 days).
• Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the control urines or if they were clinical samples. It uses the term "control urines," suggesting they were prepared samples with known concentrations. The study is presented as evidence for the premarket notification (510(k)), implying it was conducted as part of the device's development/validation. It would be considered a prospective study in the sense it was designed for this validation purpose.

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

• Experts: Not applicable for establishing the ground truth of the test set itself.
• Qualifications: The ground truth for the test set (control urines) was established through GC/MS (gas chromatography/mass spectrometry), which is a highly accurate analytical method, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "ground truth" for the control urines was established by GC/MS, an objective chemical analysis. The device's results were then compared against these GC/MS verified concentrations to assess reproducibility. There was no human expert adjudication of the test results themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an imaging or diagnostic AI system requiring human interpretation or MRMC studies comparing human readers with and without AI assistance. The performance described relates to the accuracy of the assay itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Yes, this is a standalone performance study. The device itself (the immunoassay strip) provides a visual result (presence or absence of a line). The reproducibility study evaluates the device's ability to consistently produce this visual result based on known drug concentrations, without direct human intervention affecting the reading mechanism itself. The output is a clear visual signal (line or no line) that a human then interprets as positive or negative.

7. Type of Ground Truth Used:

• Analytic Ground Truth: The ground truth for the control urine samples was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All concentrations were verified by GC/MS." GC/MS is considered the gold standard for confirming drug presence and concentration in urine.

8. Sample Size for the Training Set:

• Not applicable. This document describes the validation of a lateral flow immunoassay, which is a pre-designed chemical reaction on a strip. It does not involve machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device is inherent in its chemical design and manufacturing process, optimized to react at specific cut-off levels.

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

• Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this type of device. The development of the device (e.g., antibody selection, conjugate immobilization) would have involved extensive R&D and optimization based on known drug concentrations and chemical principles to achieve the desired cut-offs. The "ground truth" during this development phase would have been lab-prepared samples with known concentrations, verified by analytical methods like GC/MS.

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"Rapid Drug Screen" 5-panel with cocaine, marijuana, opiates, amphetamine and methamphetamine is a 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 (1000 ne/ml). Benzoyl ecgonine (300 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (300 ng/ml).

"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualatative screening methods 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.

"Rapid Drug Screen" is not intended as a point of care test.

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 positive sample will produce only one band.

Here's an analysis of the provided 510(k) summary for the American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine, structured to answer your questions:

Acceptance Criteria and Device Performance Study for American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine (K993796)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by its ability to qualitatively detect specific drugs of abuse in human urine at or above established cut-off concentrations. The reported device performance is described as successful reproducibility around these cut-off levels.

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

• Sample Size for Test Set: Each sample (control urine above, below, and at cut-off, and negative controls) was tested four times, twice daily, for five days. The total number of individual samples tested is not explicitly stated. However, this indicates a significant number of repetitions per sample to establish reproducibility.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective as it involves the repeated testing of control urines under specified conditions to evaluate reproducibility.

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

The document does not mention the use of human experts to establish the ground truth for the test set in the traditional sense of consensus reading or interpretation.

4. Adjudication Method for the Test Set

No adjudication method involving multiple human readers is described. The ground truth (drug concentration) was established through an objective analytical method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a standalone in-vitro diagnostic test, not an AI assistance tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Performance Characteristics" section describes the evaluation of the device's ability to detect drugs at specified cut-off levels and its reproducibility. This is a study of the algorithm/device only, without human-in-the-loop performance evaluation.

7. Type of Ground Truth Used

The ground truth used for the test set was GC/MS (Gas Chromatography/Mass Spectrometry) verification of drug concentrations. This is a highly accurate and commonly accepted confirmatory analytical method for drug testing, providing an objective, chemical confirmation of the presence and concentration of the target analytes.

8. Sample Size for the Training Set

The document does not explicitly state a training set or its sample size. This type of immunoassay device likely relies on established biochemical principles and manufacturing controls rather than a machine learning model that requires a discrete training dataset in the modern sense. The "training" in this context would be inherent in the device's development and optimization, rather than a separate data-driven training phase as seen in AI/ML applications.

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

Since a distinct training set (in the AI/ML sense) is not mentioned, the method for establishing its ground truth is also not provided. The development and calibration of such assays typically involve laboratory testing with known concentrations of analytes, verified by methods like GC/MS.

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"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.

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.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

Device: Rapid Drug Screen 5-Panel with Methamphetamine

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined by the cut-off levels at which the device is intended to detect the drugs. The reported performance refers to the agreement with established comparator methods.

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

• d-Amphetamine:
  • 75 negative specimens
  • 40 positive specimens
  • Total: 115
• Benzoyl ecgonine (cocaine):
  • 75 negative specimens
  • 40 positive specimens
  • Total: 115
• Cannabinoids (THC):
  • 75 negative specimens
  • 40 positive specimens
  • Total: 115
• Opiates:
  • 75 negative specimens
  • 40 positive specimens
  • Total: 115
• Methamphetamines:
  • Total: 454 specimens
    • 256 below cut-off (negative)
    • 198 positive (by EMIT II)
• Data Provenance: The data used clinical specimens. The country of origin is not specified but implicitly assumed to be the US given the submission to the FDA. The study appears to be retrospective, as it uses "clinical specimens" that were subsequently analyzed.

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

The summary does not specify the number or qualifications of experts. However, the ground truth was established by laboratory methods, not expert consensus.

4. Adjudication Method for the Test Set

Adjudication by human experts is not applicable here. The ground truth for the test set was established using reference laboratory methods:

• Primary Comparator for d-Amphetamine, Benzoyl ecgonine, Cannabinoids, and Opiates: Syva EMIT II for initial positive/negative determination.
• Primary Comparator for Methamphetamines: Syva EMIT II.
• Confirmatory Method for all drugs: Gas Chromatography/Mass Spectrometry (GC/MS) was used to verify concentrations for both positive and negative samples, as well as discordant samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic test for qualitative detection of substances in urine, not an imaging device or a device requiring human interpretation for its primary output. Therefore, improvement of human readers with or without AI assistance is not relevant to this type of device.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, the studies described are standalone performance evaluations. The device's output (presence or absence of a line) is directly compared against established laboratory reference methods (EMIT II, GC/MS). There is no human interpretation integrated into the device's performance assessment itself. The intended use states it provides a "preliminary result" for use in determining the need for additional or confirmatory testing, implying it's a standalone screening tool.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Reference Immunoassay: Syva EMIT II for initial positive/negative classification.
• Confirmatory Analytical Method: Gas Chromatography/Mass Spectrometry (GC/MS) was used to verify actual drug concentrations in both positive and negative samples, and importantly, to analyze discordant results. This is considered a highly reliable and definitive method for drug quantification.

8. The Sample Size for the Training Set

The summary does not provide information on a training set. For immunoassay devices like this, the development process typically involves optimizing antibody-antigen reactions and conjugation during R&D, rather than "training" an algorithm in the way a machine learning model is trained. The data presented here is for analytical performance validation/testing.

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

As no training set is described, the method for establishing its ground truth is not applicable. The development of such diagnostic devices involves extensive laboratory testing and optimization of reagents and cut-off points, but not in the sense of a data-driven "ground truth establishment" for a training set in machine learning.

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"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:

d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml

"Rapid Drug Screen" 8-Panel test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., gas chromatography/mass spectrometry (GC/MS)).

"Rapid Drug Screen" 8-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel).

The document provided is a 510(k) clearance letter from the FDA for a device called "Rapid Drug Screen" 8-Panel test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information typically found in a clinical study report or a more comprehensive submission, which would detail acceptance criteria, device performance, sample sizes, ground truth establishment, etc.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory clearance and indications for use.

To illustrate what would be provided if the information were available, here's a hypothetical structure for the answer, assuming the device performance and study details were present:

Acceptance Criteria and Device Performance Study

This document describes the FDA's 510(k) clearance for the "Rapid Drug Screen" 8-Panel test, but it does not contain the detailed study that proves the device meets specific acceptance criteria. Such information is typically found in the full 510(k) submission, specifically in the clinical or analytical performance study sections, which are not included in this letter.

However, based on the Indications For Use and the nature of such qualitative drug screening tests, the acceptance criteria would most likely revolve around the accuracy (sensitivity and specificity) of detecting the specified drugs at or above their respective cut-off concentrations.

Below is a hypothetical example of how the requested information would be presented if it were available in the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size (Test Set): [Information not available in the provided document. A hypothetical example would be: "Approximately 500 urine samples (250 positive, 250 negative) for each drug target."]
• Data Provenance: [Information not available. A hypothetical example would be: "Retrospective collection from clinical laboratories in the United States and Canada."]

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: [Information not available. A hypothetical example would be: "Three clinical toxicologists and two laboratory directors."]
• Qualifications of Experts: [Information not available. A hypothetical example would be: "Board-certified clinical toxicologists with 10-15 years of experience in forensic and clinical toxicology, and laboratory directors with extensive experience in drug screening and confirmation methodologies."]

4. Adjudication method for the test set

• Adjudication Method: [Information not available. A hypothetical example would be: "All discrepancies between initial GC/MS results and expert review were resolved by a third independent expert (3+1 adjudication). For qualitative tests, the primary ground truth would be the confirmatory method, not expert adjudication of the test results itself."]

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: [Information not available. Given this is a qualitative immunoassay device from 1998, it is highly unlikely an MRMC study with AI assistance would have been conducted or applicable. This type of study is more common for imaging diagnostics with human interpretation.]

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, for this type of qualitative immunoassay, the reported performance would inherently be a standalone, algorithm-only (or device-only) performance, as it provides a direct qualitative result without human interpretation influencing the device's direct output. The human "in-the-loop" would be reading the test strip. The performance detailed in the table above would represent this standalone performance.

7. The type of ground truth used

• Ground Truth Type: [Information not available in the provided document, but for such a device, it would most certainly be:] "Confirmatory analytical methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the indications for use as the preferred confirmatory method."

8. The sample size for the training set

• Sample Size (Training Set): [Information not available. For a qualitative immunoassay, the "training set" might not be a separate dataset in the same way as machine learning. It would refer to the samples used during assay development and optimization. A hypothetical example: "During assay development and optimization, hundreds to thousands of characterized urine samples (spiked and endogenous) were used."]

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): [Information not available. A hypothetical example: "For spiked samples, the concentration was precisely known. For endogenous clinical samples, the ground truth was established by independent laboratory testing using GC/MS."]

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