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The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine:

The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use.

The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liguid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format beyond the overarching statement regarding performance. However, based on the accuracy study, the implied acceptance criterion for accuracy against both a legally marketed device and GC/MS or LC/MS is essentially that the device performs at a high level.

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

• Sample Size for Test Set: 80 clinical urine specimens per drug (Buprenorphine, Amphetamine, Methamphetamine, Cocaine), totaling 320 specimens (80 specimens * 4 drugs).
  • Approximately 10% (8 specimens per drug) were at concentrations between -50% cutoff and cutoff ranges.
  • Approximately 10% (8 specimens per drug) were at concentrations between cutoff and +50% cutoff ranges.
• Data Provenance: Clinical urine specimens. The country of origin is not specified, but the study was conducted at "point of care sites." The data is retrospective in the sense that these were "clinical urine specimens," implying they were collected prior to this specific study for testing. However, the study itself is designed to prospectively test the new device against established methods.

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

The document does not specify the "number of experts" or their qualifications for establishing ground truth. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which are analytical laboratory methods considered the gold standard for confirmatory drug testing. These methods are performed by trained laboratory personnel, rather than medical "experts" in the clinical sense (e.g., radiologists).

4. Adjudication Method for the Test Set

The document describes a comparison study where the UCP device's results were compared to both GC/MS or LC/MS results and the predicate devices. It doesn't detail a specific "adjudication method" involving human consensus for discrepancies. The GC/MS or LC/MS results are considered the definitive ground truth, and device performance is measured against them.

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 explicitly described. The study focuses on the device's accuracy against laboratory gold standards and predicate devices, not on human reader performance with or without AI assistance.

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

Yes, the study described is a standalone performance study of the device (UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests). These are rapid, qualitative, competitive binding immunoassays that can be performed "without the use of an instrument," implying visual interpretation of results. While human observation is part of reading the test, the performance being evaluated is that of the assay itself in detecting the target analytes in urine, not for an algorithm in an AI system.

7. The Type of Ground Truth Used

The type of ground truth used was confirmatory analytical methods: Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS).

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of device (rapid, qualitative immunoassay) typically does not involve machine learning or AI models that require specific training sets in the same way. The "training" for such devices is usually in the manufacturing process and quality control to ensure consistent chemical reactivity.

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

Since no training set is mentioned for this type of immunoassay device, the information on how its ground truth was established is not applicable or provided in the document.

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The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:

The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with either single drug test or in combination with multiple other drug tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Acceptance Criteria and Study for UCP Rapid™ Drug Screening TCA, PPX Tests

This response describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria, based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each drug screening test were set against established predicate devices and confirmed by gold standard methods. The reported performance refers to the accuracy demonstrated in the clinical comparison study.

Note: The document explicitly states the "performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS."

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

• Sample Size for Test Set: 128 clinical urine specimens per drug.
  • This included approximately 10% of specimens with the target drug at concentrations between -50% of the cut-off and the cut-off.
  • Another 10% of specimens contained the target drug at concentrations between the cut-off and +50% of the cut-off.
  • Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug.
• Data Provenance: The document does not explicitly state the country of origin. It describes them as "clinical urine specimens." The study is described as a "clinical comparison study," implying prospective collection for the study purpose or retrospective use of clinically collected samples. Without more detail, it's hard to definitively state prospective or retrospective, but the phrasing suggests a dedicated collection or selection process for the study.

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

The establishment of ground truth for the test set did not involve human experts in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth was established by laboratory analytical methods.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by objective laboratory analytical methods (HPLC or GC/MS), not by expert consensus requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test for qualitative detection of drugs in urine, not an imaging device requiring human reader interpretation or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "UCP Rapid™ Drug Screening Tricyclic Antidepressant Test" and "UCP Rapid™ Drug Screening Propoxyphene Test" are described as competitive binding, lateral flow immunochromatographic assays that "can be performed without the use of an instrument" and provide "visual, qualitative end results." The accuracy study directly assesses the performance of these devices in isolation against predicate devices and analytical gold standards.

7. Type of Ground Truth Used

The type of ground truth used was objective laboratory analytical methods:

• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography/Mass Spectrometry (GC/MS)

All test results from the UCP Rapid™ devices and the predicate devices were "confirmed with HPLC or GC/MS analysis."

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. This type of device (lateral flow immunoassay) typically does not involve machine learning algorithms that require a distinct training phase with a labeled dataset in the same way modern AI algorithms do. The development and optimization of such assays rely on biochemical principles, antibody-antigen binding characteristics, and extensive experimental validation, rather than algorithmic training on a dataset. The performance data presented is for validation, not for training.

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

As there is no explicitly defined "training set" in the context of an AI/machine learning algorithm for this device, the concept of establishing ground truth for a training set does not apply directly. The development of the assay would have involved extensive R&D and optimization using various known concentrations of analytes, where the "ground truth" (i.e., the known concentration and presence/absence of the drug) would be intrinsically understood and controlled during the development process.

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The UCP Rapid™ Drug Screening Test Strips and UCP Rapid™ Drug Screening Test Devices are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana and their metabolites in human urine at the following cutoff levels:

The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

UCP Rapid TM Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of drugs and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Here's a breakdown of the acceptance criteria and study information for the UCP Rapid™ Drug Screening Tests, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to a legally marketed predicate device and confirmation by GC/MS, aiming for high accuracy. The reported performance is a single accuracy metric for all drugs rather than individual criteria per drug.

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

• Sample Size: 128 clinical specimens per drug type. This included approximately:
  • 10% of specimens with drug concentrations between -50% of the cutoff and the cutoff.
  • 10% of specimens with drug concentrations between the cutoff and +50% of the cutoff.
  • Total: 64 positive clinical urine specimens and 64 negative clinical urine specimens tested against each drug.
• Data Provenance: "Clinical specimens" is mentioned, implying human urine samples. The country of origin is not specified but is likely the U.S. given the FDA submission. The study is retrospective, as it gathered existing clinical specimens for testing.

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

This information is not provided in the document. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is a laboratory method, not reliant on human experts in this context.

4. Adjudication Method for the Test Set

This information is not provided as the ground truth was established by GC/MS, an objective analytical method. Adjudication by human experts is typically relevant when ground truth itself is subject to interpretation (e.g., image-based diagnosis).

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

There was no MRMC comparative effectiveness study and no "human readers" involved in the product's intended use as a rapid, qualitative immunoassay. The device provides visual, qualitative results without requiring specialized interpretation expertise in the same manner as, for instance, a radiologist reading an image. The comparison was between the UCP Rapid™ device, a predicate device, and GC/MS.

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

Yes, this was a standalone performance study. The UCP Rapid™ Drug Screening Tests are described as providing visual, qualitative end results without the use of an instrument, indicating a standalone test that is interpreted by the user without real-time "human-in-the-loop" assistance from the device itself.

7. The Type of Ground Truth Used

The primary ground truth for the test set was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an objective and highly accurate laboratory method for confirming the presence and concentration of drugs and their metabolites.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is common for this type of immunoassay device submission, as such devices are typically developed and validated using biochemical principles, and performance characteristics are then confirmed with clinical samples. They are not "trained" in the same way an AI/ML algorithm would be.

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

Since there is no explicitly mentioned "training set" in the context of an AI/ML model, the ground truth for any internal development or validation (implied as part of "performance characteristics" and "precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study") would have been established through well-defined laboratory methods, likely including spiked samples with known concentrations and confirmed clinical samples, analogous to how the test set's ground truth was established with GC/MS. The document does not detail these specific methods for internal development.

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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.

Not Found

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' 9-Panel is a one-step, lateral flow immunoassay for the simultaneous detection of 8 abused substances and tricyclic antidepressants in urine. The "Rapid Drug Screen" 9-Panel test is intended for use in the qualitative detection of the following 9 drugs 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
Tricyclic Antidepressants 1000 ng/ml

'Rapid Drug Screen' 9-Panel is intended for use by professional laboratories. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).

'Rapid Drug Screen' 9-Panel 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.

All of the assays employed in the Rapid Drug Screen 9-Panel are based on the same principle of the 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 an 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 negative.

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 of 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' 9-Panel, structured according to your requested information.

Acceptance Criteria and Device Performance Study for K992033: 'Rapid Drug Screen' 9-Panel

1. Table of Acceptance Criteria and Reported Device Performance

The device is a qualitative screening method; therefore, the primary performance criteria are sensitivity (correctly identifying positive samples) and specificity (correctly identifying negative samples) relative to a reference method at specific cut-off concentrations. The document defines the target cut-off levels for each drug as its acceptance criteria.

Summary of Performance Study:
The study compared the 'Rapid Drug Screen' 9-Panel to two predicate devices: American BioMedica 'Rapid Drug Screen' 9-Panel test kit (K983770) and Biosite Diagnostics' Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (K955935), and to Syva EMIT-II for initial positive identification.

• Positive Agreement: The device "correctly identified all of the… 40 drug-containing specimens to be positive" when compared to Syva EMIT-II.
• Negative Agreement: The device "correctly identified all of the… fifty (50) of which were found to be drug-free" when compared to predicate devices/Syva EMIT-II.
• Reproducibility: Evaluated using control urines containing concentrations above and below the stated cut-off, as well as negative controls. The results "confirmed the reproducibility of the Rapid Drug Screen 9-Panel performance."

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

• Test Set Size: 90 samples.
  • 50 drug-free samples.
  • 40 drug-containing samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, demographics). The samples were "selected for evaluation," implying they were pre-collected. The study is retrospective in the sense that existing samples (either drug-free or pre-identified as positive by EMIT-II) were used. It does not mention prospective collection or controlled spiking of samples to reach specific concentrations for evaluation against the cut-offs, though reproducibility was checked with control urines "above and below the stated cut-off."

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

Not applicable in the typical sense for this type of IVD device. The ground truth for the drug-containing samples relied on a laboratory method for detection, not expert human interpretation of images or other data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory methods (Syva EMIT-II for initial screening of positives, HPLC for confirmation of identification but not quantification).

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

No. This is a point-of-care or laboratory screening immunoassay; human "readers" are not involved in interpreting complex data, but rather a simple visual presence or absence of a line. The comparison was device-to-device and device-to-laboratory method, not reader-to-reader.

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

Yes, this is a standalone device study. The device itself (the immunoassay) provides the result based on chemical reactions. A human merely reads the visual output (presence or absence of a line). The study evaluates the performance of the device itself.

7. The Type of Ground Truth Used

The ground truth was established using established laboratory methods:

• Initial screening for positive samples: Syva EMIT-II.
• Confirmation for positive samples: HPLC (identified but not quantified).
• For reproducibility: "Control urines containing concentrations above and below the stated cut-off" and "Negative controls."

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning algorithm that requires a training set. Its performance is based on the chemical specificity and sensitivity of the antigen-antibody reactions embedded in its design.

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

Not applicable, as there is no training set for an immunoassay.

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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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