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The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

The Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana or cocaine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine antibodies and therefore the colored line will not form in the test region. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The provided text describes two devices, the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC). It outlines their intended use and claims substantial equivalence to predicate devices, but does not include a detailed study with acceptance criteria and specific performance metrics for the Accu-Stat™ devices themselves.

Instead, the submission states that "The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC and COC."

It further argues for safety and effectiveness by claiming the devices are "identical to the ACON Laboratories One Step Marijuana Test Device and the Multi-Drug Multi-Line Device that is legally marketed under K003557 and K020313 respectively for professional use." This suggests reliance on the predicate devices' performance rather than a new, independent study with specific acceptance criteria reported in this document for the Accu-Stat™ devices.

Therefore, I cannot populate all the requested fields with specific, quantifiable data directly from this document regarding the Accu-Stat™ devices' performance against explicit acceptance criteria. The document claims substantial equivalence and mentions "consumer studies" but does not detail their methodology, results, or the acceptance criteria used.

Based on the provided text, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated for the Accu-Stat™ devices in this document. The document refers to cut-off levels as part of the device's mechanism: "Marijuana, if present in the urine specimen below 50 ng/ml... and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites..." This describes the functional threshold rather than an acceptance criterion for accuracy or precision.
• Reported Device Performance: The document offers a qualitative statement: "demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC and COC." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are provided in this text for the Accu-Stat™ devices themselves.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document mentions "consumer studies" but does not quantify the sample size.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document does not describe the establishment of a ground truth for a test set for these specific devices, only mentions that they are "screening tests" and preliminary, requiring confirmation testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as the details of a specific test set study for these devices (beyond "consumer studies") are not provided.

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

• Not applicable. This device is a rapid immunoassay for drug detection, not an AI-assisted diagnostic device, nor does the document describe a study of human readers.

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

• The device is a standalone immunoassay kit intended for "lay users" (consumers) at home without professional human-in-the-loop involvement for initial screening. However, the performance data for such standalone use (e.g., accuracy against a gold standard) is not detailed in this document. The instructions advise a second step of confirmation testing by a lab for positive results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not specified for the "consumer studies." Given the nature of a drug test, a typical ground truth would be laboratory confirmation using a highly accurate method like GC/MS (Gas Chromatography/Mass Spectrometry). The document only states that the device is the "first step in a two-step process to provide over-the-counter (OTC) consumers... with information regarding the presence of THC or COC and their metabolites in a urine sample. Information regarding the second step, confirmation testing, is provided." This implies that the device offers a preliminary result rather than a definitive ground truth.

8. The sample size for the training set

• Not applicable. This device is an immunoassay, not a machine learning or AI-based system that would typically have a "training set."

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

• Not applicable for the same reason as above.

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A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.

The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Cup, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / complexes.

The At Home Drug Cup (Model 9150X) is an immunoassay for the qualitative detection of amphetamine, MDA, methamphetamine, MDMA, THC, cocaine, and opiates in urine. The device's performance was evaluated through a clinical sample correlation study and a blind labeled spiked study.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "excellent overall accuracy" claims and correlation percentage. Specific, explicit acceptance criteria (e.g., "must achieve >95% accuracy") are not provided in the document.

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

• Test Set Sample Size:
  • For the "Correlations studies, using clinical specimens," the specific sample size is not provided, only the resulting correlation percentage.
  • For the "Clinical studies, performed at two independent laboratories" (professional user study), the specific sample size is not provided.
  • For the "consumer study," the sample size was 400 cases (resulting in 388 correct interpretations).
• Data Provenance: The document does not explicitly state the country of origin for the clinical specimens or the location of the independent laboratories. The studies appear to be prospective as they are described as performance evaluation studies for the device.

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

• Correlation Study: The ground truth was established by two methods:
  • Behring EMIT II: This is another commercially available drug screening test. While it's a device, its results are considered a form of established truth in this context.
  • GC/MS methodology: Gas Chromatography-Mass Spectrometry (GC/MS) is a highly accurate analytical method often used as a gold standard for drug detection and quantification.
• Clinical Studies (Professional Users): The document doesn't explicitly state the number or qualifications of "professional users," but implies they are trained personnel in laboratory settings.
• Consumer Study (Lay Users): The ground truth against which lay users' interpretations were compared is not explicitly detailed but would presumably have been established by laboratory methods (like GC/MS or EMIT II) on the same samples.

4. Adjudication Method for the Test Set

The document does not describe a particular adjudication method (like 2+1, 3+1) for resolving discrepancies in the ground truth establishment. For the correlation study, the comparison was made against established laboratory methods (EMIT II and GC/MS), which inherently provide a single result. For the consumer study, the "correct" result was presumably pre-determined.

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

• No evidence of MRMC study: The document does not describe a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. The device is a standalone immunoassay kit, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

• Yes, standalone performance was done: The entire evaluation focuses on the standalone performance of the "At Home Drug Cup." Both the clinical sample correlation study and the consumer study assess the device's ability to detect target drugs independently. The clinical studies with professional users also represent standalone performance.

7. Type of Ground Truth Used

• Expert Consensus/Reference Method:
  • For the correlation studies, the ground truth was established using reference laboratory methods, specifically the Behring EMIT II and Gas Chromatography-Mass Spectrometry (GC/MS). GC/MS is widely considered a gold standard in toxicology.
  • For the clinical and consumer studies, the "correct" result against which the device's accuracy was measured would have been derived from these or similar established laboratory methods.

8. Sample Size for the Training Set

• The document does not mention a "training set" or "training data." As an immunoassay device, it is not an AI/ML algorithm that undergoes a training phase with a distinct dataset. Its performance is inherent to its biochemical design.

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

• Not applicable, as there is no "training set" for this type of device.

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Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use

Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use

Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.

Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided documents describe two variations of the device:

1. Life Sign® Home Drug Test (MET): Intended for home or workplace use (Over-The-Counter).
2. Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, AccuStrip™ MET (collectively referred to as "Professional Use Devices"): Intended for professional/prescription use.

Both devices are for the qualitative detection of methamphetamine in urine at a cutoff of 1000 ng/mL.

Study Information

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

   • Test Set Size: 94 specimens (50 negative and 44 positive) were used for comparison between the new device and the predicate device.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective comparison as it evaluates the new device against already available specimens.

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

   • This information is not provided in the given text. The "ground truth" seems to be established by comparison to a legally marketed predicate device (Status DS™ DOA 10) rather than by independent expert assessment of each sample.

3. Adjudication Method for the Test Set:

   • This information is not provided. The method mentioned is a direct comparison to the predicate device's results.

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

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study focused on a 100% correlation between the new device and a predicate device.
   • The "consumer study" for the LifeSign® Home Drug Test (MET) that showed "over 96% overall accuracy" might involve multiple lay users, but it's not described as a formal MRMC comparative effectiveness study demonstrating improvement with AI vs. without AI. The device described is a rapid immunoassay, not an AI-powered diagnostic system.

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

   • Yes, a standalone performance was done. The 100% correlation study between the new device and the predicate device is a standalone performance evaluation of the device itself.
   • For the professional use versions, the device is intended for clinical laboratory or professional settings, implying human interpretation of the result, but the 100% correlation study is about the device's inherent detection capability.
   • For the home use version, the "consumer study" also evaluates the standalone performance, likely including the human-in-the-loop (the consumer performing and interpreting the test). However, it's not an AI algorithm.

6. Type of Ground Truth Used:

   • The primary ground truth for the comparison study was the results obtained from a legally marketed predicate device (K990786; Status DS™ DOA 10).
   • For the 94 specimens, the predicate device results likely served as the reference standard to determine if the 50 negative and 44 positive classifications were truly negative and positive, respectively. This implies the predicate device's performance was accepted as truth.

7. Sample Size for the Training Set:

   • This information is not provided. The description focuses on a comparison study/test set, not the development or training of the immunoassay itself. As this is a rapid immunoassay (not an AI/machine learning model), the concept of a "training set" in the context of machine learning does not apply directly. The development would involve analytical validation rather than machine learning training.

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

   • Not applicable as no training set (in the machine learning sense) is described. The "ground truth" reference during the immunoassay development would typically involve analytical methods (e.g., GC/MS, HPLC) to confirm the presence and concentration of the target analyte in spiked or characterized samples.

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The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:

The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.

The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:

The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.

The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.

The provided text does not contain detailed information about a study proving the device meets acceptance criteria. It primarily focuses on the regulatory submission, device description, intended use, and substantial equivalence to other devices.

However, based on the context of a drug test, we can infer some general acceptance criteria and what a typical study for such a device would entail. I will use the available information to construct the response, and clearly indicate where assumptions or general knowledge about drug testing device studies are used.

Acceptance Criteria and Device Performance (Inferred/General)

Since this is an immunoassay for drug detection, key performance metrics usually involve sensitivity, specificity, and accuracy against a gold standard method. The document specifies "cut-off concentrations," which are crucial for defining performance.

Study Details (Largely Inferred based on typical drug test validation studies, as specific study details are not provided in the input)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. For a multi-analyte home drug test, test sets typically involve hundreds to thousands of urine samples, covering a range of concentrations around the cut-off (negative, near cut-off, positive). This would include samples spiked with known drug concentrations and potentially clinical samples.
   • Data Provenance: Not specified. Typically, studies for such devices involve a mix of spiked samples (known concentrations prepared in a lab) and clinical urine samples collected retrospectively or prospectively from individuals who may or may not have used the drugs. The country of origin for the data is not mentioned but would likely be the USA if the submission is for FDA approval.

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

   • Number of Experts: Not applicable in the traditional sense for drug tests. The "ground truth" is established by a highly sensitive and specific analytical method, not by expert consensus for interpretation of results.
   • Qualifications of Experts: Not applicable. The "experts" would be laboratory technicians or chemists operating the confirmatory method (GC/MS).

3. Adjudication method for the test set:

   • Method: Not applicable. The "ground truth" for drug presence and concentration in urine is determined by a definitive analytical method, most commonly Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the document ("Confirmation, using GC/MS, of any possible drug result is recommended as the second step"). There is no subjective interpretation requiring adjudication of results from the reference method.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • MRMC Study: Not mentioned and highly unlikely for this type of device. MRMC studies are typically for image-based diagnostics where human interpretation is a primary variable. For a qualitative, visually read immunoassay, the "reader" is usually the end-user (a layperson for a home test) following instructions. The performance is assessed on how accurately the device itself reflects the presence of the drug, not on improved human reading with AI assistance.

   • Effect Size of AI vs. without AI assistance: Not applicable, as AI assistance is not described or implied for this device.

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

   • Standalone Performance: Yes, the core "performance" of the Peace of Mind Home Drug Test itself is a standalone assessment. The device is a qualitative immunoassay. The study would assess how well the device, when read according to its instructions (presumably by a human), matches the GC/MS results. While a human reads the test, the performance is inherently of the device's chemical reaction and visual output. The device itself produces the "result" (line or no line), and the human merely observes it.

6. The type of ground truth used:

   • Type: Analytical Gold Standard (GC/MS - Gas Chromatography/Mass Spectrometry). The document explicitly states: "Confirmation, using GC/MS, of any possible drug result is recommended as the second step." This indicates that GC/MS is the definitive method for validating the presence and concentration of drugs.

7. The sample size for the training set:

   • Sample Size: Not applicable. Immunoassays are not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical design. While development and optimization use various samples, there isn't a "training set" in the sense of AI or statistical modeling.

8. How the ground truth for the training set was established:

   • Ground Truth Establishment: Not applicable for a training set, as there isn't one in the AI sense. During the development and validation phase, ground truth for sample characterization (e.g., preparation of spiked samples to known concentrations, or confirmation of clinical samples) would be established using GC/MS.

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A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of the following drugs of abuse in urine: Cocaine.

Immunoassay for the qualitative detection of benzoylecgonine in urine. The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: cocaine; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.

This document describes the regulatory submission for the At Home Drug Test (Model 9074) by Phamatech, an immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in urine.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "correlation" and "accuracy" thresholds achieved in the studies. Given the context of a 510(k) submission, the implicit acceptance criterion is "substantial equivalence" to a predicate device.

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

• Clinical Sample Correlation Study: The text does not explicitly state the sample size for this study. It mentions using "clinical specimens."

  • Data Provenance: Not explicitly stated, but "clinical specimens" suggest a real-world origin, likely retrospective from patients. The study was performed at "two independent laboratories."

• Blind Labeled Spiked Study: The text does not explicitly state the sample size for this study.

  • Data Provenance: This is a prospective study where samples are "spiked" with known concentrations of the analyte.

• Consumer Study:

  • Sample Size: 943 cases (implied by 917/943 accurate interpretations).
  • Data Provenance: Prospective, as it involved consumer interpretation of the test.

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

• Clinical Sample Correlation Study:

  • Number of Experts: Not explicitly stated. The comparison was against "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." GC/MS is a highly accurate laboratory method, implying a high level of expertise in running and interpreting these sophisticated tests. The reference to "two independent laboratories" performing clinical studies suggests multiple professional users/experts were involved.
  • Qualifications: "Professional users" are mentioned, implying trained laboratory personnel or clinical staff experienced with drug testing, GC/MS, and EMIT II assays. Specific qualifications (e.g., years of experience, specific certifications) are not provided.

• Blind Labeled Spiked Study:

  • Number of Experts: Not explicitly stated, but the performance was evaluated in "professional users," similar to the clinical study.
  • Qualifications: As above, "professional users" would be experienced laboratory personnel.

• Consumer Study: Ground truth for this study was likely established by the manufacturer, comparing consumer results to the expected result of the spiked or clinical samples. No "experts" were used to establish ground truth for the consumer interpretation itself, but rather to establish the "true" status of the samples given to consumers.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The performance is reported based on direct comparison with established methods (Behring EMIT II, GC/MS) for professional use, and consumer interpretation compared to a known result.

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

No, an MRMC comparative effectiveness study for human readers with/without AI assistance was not done. This device is a standalone diagnostic test, not an AI-assisted diagnostic tool for human readers.

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

Yes, the primary performance studies ("Clinical sample correlation study" and "Blind labeled spiked study" for professional users) represent the standalone performance of the device when used by trained professionals. The consumer study evaluates its standalone performance in the hands of lay users.

7. The Type of Ground Truth Used

• Clinical Sample Correlation Study: The ground truth was established by comparison with a predicate device (Behring EMIT II) and a gold standard laboratory method (GC/MS methodology).
• Blind Labeled Spiked Study: The ground truth was established by known concentrations of the target analyte (cocaine) spiked into urine samples.
• Consumer Study: The ground truth was established by the known status of the samples provided to consumers (based on spiking or professional lab results).

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This is an immunoassay (a chemical test), not a machine learning or AI-based device that typically requires a training set. The "studies" described are performance validation studies, not algorithm training.

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

Since there is no mention of a training set or an algorithm that requires training, this question is not applicable to the provided text.

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A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection/presence of the following drugs of abuse in urine: Amphetamines.

Immunoassay for the qualitative detection of Amphetamines in urine. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implicit" because the document states that the device is "substantially equivalent to the reported performance characteristics of other commercially available tests," and then immediately provides the performed results as if they met this standard. The specific numerical targets for "acceptance" are not explicitly called out as such but are implied by the results presented.

2. Sample Sizes and Data Provenance

• Clinical Sample Correlation Study: The exact sample size is not specified, only referred to as "clinical specimens." The provenance is not explicitly stated, but the reference to "two independent laboratories" performing clinical studies suggests multiple sites, likely within the USA given the manufacturer's and FDA's location. The study was retrospective, comparing the device to established methods.
• Blind Labeled Spiked Study: Sample size and provenance are not specified.
• Consumer Study: The sample size for the Amphetamine test interpretation was 943 (917/943 accurate interpretations). Provenance is not stated but suggests a US consumer population.

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

• No specific number of experts is provided for the clinical sample correlation study or the blind labeled spiked study.
• The "professional users" in the clinical studies are implied to be experts, but their specific qualifications (e.g., medical technologists, toxicologists) are not detailed.
• For the consumer study, the "experts" were the analytical methods (Behring EMIT II and GC/MS) that established the true presence or absence of amphetamines, not human interpreters of the device itself.

4. Adjudication Method for the Test Set

• No specific adjudication method is mentioned. The comparison was made against a "gold standard" (Behring EMIT II and GC/MS), implying direct comparison rather than an adjudication process between conflicting device results.

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

• No MRMC comparative effectiveness study was explicitly described. The studies focused on device performance in isolation and consumer interpretation of results, not on how human readers' performance might improve with or without AI assistance. This device is not AI-driven; it's a qualitative immunoassay for home use.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The entire performance section describes the device's (an immunoassay, not an algorithm) standalone performance, both in "clinical sample correlation" and "blind labeled spiked" studies. The "consumer study" also assessed the device's standalone performance in the hands of lay users.

7. Type of Ground Truth Used

• Analytical Gold Standards: For the clinical sample correlation study, the ground truth was established by:
  • Behring EMIT II: A commercially available immunoassay considered a predicate device.
  • GC/MS (Gas Chromatography/Mass Spectrometry): A highly accurate and sensitive laboratory confirmatory method, often considered a "gold standard" for drug testing.
• For the consumer study, the ground truth was also based on these analytical methods, against which consumer interpretations were compared.

8. Sample Size for the Training Set

• Not applicable / Not provided. As a rapid, qualitative immunoassay, this device does not utilize a "training set" in the context of machine learning or AI models. Its performance is based on the chemical and immunological properties of the test components, which are designed and validated through laboratory testing, not trained on data.

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

• Not applicable / Not provided. As mentioned above, there is no "training set" for this type of immunoassay device. The "ground truth" for its development and validation would involve controlled laboratory experiments using known concentrations of analytes and interferents, established through certified reference materials and analytical chemistry techniques.

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A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of any of the following drugs of abuse in urine: Methamphetamine, MDMA.

The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: Methamphetamine, MDMA; 500 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the "At Home Drug Test (Model 9069)":

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets. Instead, the document frames the device's performance in terms of "substantial equivalence" to existing commercially available tests and a high percentage of accuracy. The key performance indicators mentioned are:

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size:
     • Clinical sample correlation study: Not explicitly stated, but "clinical specimens" are mentioned.
     • Blind labeled spiked study: Not explicitly stated.
     • Clinical studies (professional users): Not explicitly stated, but "performed at two independent laboratories."
     • Consumer study (methamphetamine accuracy): 444 samples.
   • Data Provenance: Not explicitly stated as retrospective or prospective. It implies prospective data collection for the "clinical sample correlation study," "blind labeled spiked study," "clinical studies," and "consumer study." The countries of origin for the data are not specified beyond the locations of the manufacturers (San Diego, CA, USA for Phamatech; Cupertino, CA, USA for Behring EMIT II).

2. Number of Experts and Qualifications:

   • The document implies the use of "professional users" in the "clinical studies" and comparison to "SAMHSA certified laboratory" for confirmation. However, the specific number of experts involved in establishing ground truth for the test set and their qualifications are not explicitly stated.

3. Adjudication Method:

   • The document mentions "Correlation studies... when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." This suggests that the EMIT II and GC/MS results served as the reference or adjudicating methods, rather than a human consensus approach among the "professional users." No specific human adjudication method (e.g., 2+1, 3+1) is mentioned.

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

   • No MRMC comparative effectiveness study is explicitly mentioned. The study focuses on comparing the device's performance to predicate devices and laboratory methods, and on consumer interpretation, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic tool for human interpretation.

5. Standalone Performance:

   • Yes, a standalone performance was done. The entire performance section describes the results of the device (an immunoassay) detecting drugs/metabolites, both when compared to laboratory standards and when interpreted by consumers. This represents the algorithm's (immunoassay's) standalone performance.

6. Type of Ground Truth Used:

   • The ground truth for the "clinical sample correlation study" was established using Behring EMIT II and GC/MS methodology, which are highly regarded laboratory analytical methods.
   • For the "blind labeled spiked study" and "clinical studies," the ground truth is implicitly the known spiked concentrations or the results from the EMIT II/GC/MS comparisons.
   • For the "consumer study," the accuracy is reported against an assumed established ground truth, likely the EMIT II/GC/MS results or a confirmed positive/negative status.

7. Training Set Sample Size:

   • The document does not specify a separate "training set" sample size. As this is a rapid immunoassay, it typically doesn't involve a machine learning training phase in the same way an AI algorithm would. The development of such a test relies on chemical and biological design, optimization, and then validation studies (the "performance" section describes these validation studies, effectively the "test set" for regulatory purposes).

8. Ground Truth for Training Set:

   • Since a distinct "training set" for an AI algorithm is not applicable here, the concept of establishing ground truth for a training set in the AI sense is not relevant or described. The development of the immunoassay involves establishing its chemical and biological parameters to accurately detect the target analytes at the specified cut-off, which is a different process than "training" an AI model.

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