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The First Check® Home Drug Test for MDMA (Ecstasy) is a screening test for the rapid detection of MDMA and its metabolites in human urine at a cut-off level of 500 ng/ml. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of MDMA or its metabolites in a urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

The First Check® Home Drug Test for MDMA (Ecstasy), like other commercially available drug screening tests, qualitatively measures the presence or absence of MDMA and its metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes.

The document describes the First Check® Home Drug Test for MDMA (Ecstasy), an immunoassay for the qualitative detection of drugs of abuse in urine.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the consumer study, but it implies that the test should perform "excellently" in the hands of lay users and that consumers should be able to interpret the results effectively. The performance is compared to a predicate device.

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

• Sample Size: Not explicitly stated for the consumer study.
• Data Provenance: The consumer study was conducted using the First Check® Home Drug Test for MDMA (Ecstasy). It is implied to be prospective, as it's a "consumer study." The country of origin is not specified but is implicitly the country where Worldwide Medical Corporation operates or markets its products, likely the USA given the FDA 510(k) submission.

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

Not applicable. The document describes a home drug test for lay users; the ground truth for consumer performance would not typically be established by experts interpreting the test results but rather by the ability of consumers to correctly use and interpret results (which may be verified against a reference method or expert interpretation of the reference method's results). The specificity testing against related compounds (d-amphetamine, l-amphetamine, etc.) would likely involve laboratory analysis overseen by qualified personnel, but the number and qualifications of those individuals are not mentioned.

4. Adjudication Method for the Test Set:

Not applicable for the consumer study as described. The focus is on consumer use and interpretation, not expert adjudication of multiple readings.

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

No, an MRMC comparative effectiveness study is not mentioned. The study described focuses on standalone performance by consumers. The effectiveness is implied by the "excellent overall performance in the hands of lay users" and their ability to obtain preliminary information.

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

Yes, a standalone performance is described. The "consumer study" focuses on the device's performance when used by lay users without expert assistance or further intervention at the point of initial use and interpretation. The analytical studies of the identical Applied Biotech SureStep™ MDMA (Ecstasy) Drug Screen Test (K011133) on specificity also represent standalone performance in a laboratory setting.

7. Type of Ground Truth Used:

• For Specificity: Laboratory reference methods testing for MDMA and its metabolites versus structurally related compounds at specified concentrations.
• For Consumer Study: The ground truth for the "excellent overall performance in the hands of lay users" and effective use/interpretation would likely be established by comparing consumer results to a definitive reference method (e.g., GC/MS) performed on the actual urine samples. The document states the test provides "preliminary information," implying further confirmatory testing is the ultimate ground truth.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI-based device that would require a "training set" in the traditional sense. It's an immunoassay. The development and validation of such immunoassay devices involve extensive laboratory testing and optimization, but not typically a training set in the context of AI.

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

Not applicable, as there is no training set mentioned for this immunoassay device.

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The First Check® Home Drug Fest Panel 4 is an educational sereening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/mL respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the four drugs concorned parchib, was not information is beneficial to consumer offorts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

The First Check® Home Drug Test Panel 4, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine and/or their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes.

The provided text is a 510(k) summary for a home drug test panel and a subsequent FDA clearance letter. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous scientific study with ground truth established by experts.

The document states:

• "Because the First Check® Home Drug Test Panel 4 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425, and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function" (Page 1, Section IX).
• "Because the labeling of the First Check® Home Drug Test Panel 4 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution... and there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months in which the product line has been purchased by the general public and used in quantities exceeding 200,000 tests, it is concluded that the product can be used effectively by the lay user." (Page 1, Section IX).

This indicates that the clearance was based on substantial equivalence to a predicate device and anecdotal evidence of effective consumer use, rather than a specific performance study with acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

To directly answer your numbered points based on the absence of this information:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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, as this is a qualitative drug screening test, not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a qualitative drug screening test, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. The basis for effectiveness claims is substantial equivalence to a predicate device and widespread consumer use without reported issues.
8. The sample size for the training set: Not applicable, as this device functions via immunoassay, not machine learning.
9. How the ground truth for the training set was established: Not applicable.

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The First Check Home Drug Test (THC) is an educational screening test for the rapid detection of THC (and its metabolites) in human urine at a cut off for the rapid dececeion of the (antended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned a two seep process to provious concerning the presence of THC (and its parents, with information obliozing is beneficial to consumer metabolices) in a arine baspeable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

The First Check® Home Drug Test (THC), like many commercially available drug screening tests, qualitatively measures the presence or absence of THC and its metabolites in urine using a one step rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes. The cut-off concentration for THC is 50ng/mL.

This 510(k) summary does not contain the detailed criteria or study information typically found in a standalone performance study report. Instead, it relies on substantial equivalence to legally marketed predicate devices.

As such, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor detailed information on sample sizes, ground truth establishment methods, or multi-reader multi-case studies.

However, I can extract the following relevant information:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "First Check® Home Drug Test (THC) is identical to the Applied Biotech SureStep™ Drug Screen THC Test in terms of intended use, product design, performance characteristics, materials of construction, and manufacturing process." It also claims substantial equivalence to "other commercially available drug screening tests which qualitatively measure the presence of target drugs or metabolites by visual color one step immunoassay technology."

The core performance characteristic mentioned is the cut-off concentration for THC, which is 50ng/mL. The device is intended for the qualitative detection of THC and its metabolites.

Since the submission relies on substantial equivalence rather than a new performance study demonstrating specific sensitivity/specificity metrics, a table of novel acceptance criteria and reported device performance for this specific device would not be present in this type of submission. The performance is assumed to be equivalent to the predicate devices.

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

This information is not provided in the given 510(k) summary for the "First Check® Home Drug Test (THC)". The submission instead refers to the predicate device K960744 (Applied Biotech SureStep™ Drug Screen THC test) as being "legally marketed". It likely means that the performance data for K960744 was previously established. The current submission focuses on demonstrating equivalence.

The text does mention: "there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months the product has been purchased by the general public and used in quantities exceeding 87,000 tests". This refers to real-world usage of a similar product (the Phamatech QuickScreen™ At Home Drug Test), not a formal test set for the device in question.

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):

This information is not provided in the given 510(k) summary. The nature of the device (a home drug test) and its reliance on substantial equivalence to a predicate device suggests that a complex expert-adjudicated ground truth for a new test set was likely not established for this specific 510(k) submission. For drug tests, ground truth is typically established by confirmatory laboratory methods (e.g., GC/MS).

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

This information is not provided in the given 510(k) summary.

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:

This device is a rapid screening immunoassay for drug detection, not an AI-assisted diagnostic device for human readers. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance would be not applicable and was not performed.

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

This device is a standalone rapid screening test that provides a visual result. It is not an algorithm, but a physical immunoassay device. Its performance is inherent to the device itself. The product is intended for lay users "to follow instructions or interpret results," implying a human-in-the-loop, but the "standalone performance" of the device itself (its ability to detect the analyte at the specified cut-off) is fundamental to its design. However, a formal "standalone (algorithm only)" study as typically understood in AI/software medical devices is not applicable.

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

While not explicitly stated for a new study in this document, for drug screening tests like this, the ground truth is typically established by confirmatory laboratory methods, such as Gas Chromatography/Mass Spectrometry (GC/MS). This is implied by the mention of "confirmatory testing" as the "second step" to follow the home test.

8. The sample size for the training set:

This information is not provided in the 510(k) summary. As this is an immunoassay device, not a machine learning algorithm, the concept of a "training set" as used in AI development is not applicable in the same way. The device is manufactured based on established chemical and biological principles.

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

As mentioned above, the concept of a "training set" for this type of immunoassay device is not applicable. The performance characteristics are based on the chemical and biological design of the test, and validation would involve testing against known positive and negative samples, with ground truth established by confirmatory lab methods.

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The First Check® Home Drug Test Panel 3 is an educational screening test for the rapid detection of marijuana, cocaine, methamphetamine and/or their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL and 1,000 ng/mL, respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the three drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

The First Check® Home Drug Test Panel 3, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, methamphetamine and/or their metabolites in urine, using a one stee, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drog/anibody complexes. The cut-off concentration for THC is 50ng/mL. The out-off concentration for COC is 300ng/mL. The cut-off concentration four MET is 1,000ng/mL.

This document is a 510(k) summary for a home drug test panel. It claims substantial equivalence to previously marketed devices and focuses on the intended use, technological characteristics, safety, and effectiveness in comparison to those predicates. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way requested for a medical AI/software device.

The provided text describes a qualitative immunoassay device, not an AI/software device. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device.

For completeness, I can extract the relevant information that is present:

Device: First Check® Home Drug Test Panel 3

Intended Use: An educational screening test for the rapid, qualitative detection of marijuana, cocaine, and methamphetamine and/or their metabolites in human urine at specified cut-off levels (50ng/mL for THC, 300ng/mL for COC, and 1,000ng/mL for MET). It's intended for consumer use as the first step in a two-step process, with information provided for confirmatory testing.

Acceptance Criteria and Device Performance:
The document implies acceptance criteria by claiming substantial equivalence to predicate devices and stating that its performance characteristics are identical to one predicate (Applied Biotech SureStep™ Drug Screen Multi Test). However, it does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity or specificity values) with corresponding reported device performance metrics.

Instead, the argument for safety and effectiveness is based on:

1. Identicality to a legally marketed predicate: "Because the First Check® Home Drug Test Panel 3 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425..."
2. Lack of special skills for use: "...and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function..."
3. Substantial equivalence of labeling and consumer use history: "Because the labeling of the First Check® Home Drug Test Panel 3 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the Phamatecchi QuickScreen™ At Home Drug Test, and there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months in which the product line has been purchased by the general public and used in quantities exceeding 200,000 tests, it is concluded that the product can be used effectively by the lay user."

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The document relies on proving substantial equivalence to existing devices rather than presenting new performance data against pre-defined acceptance metrics for this specific device.

Regarding the other requested points (which are generally for AI/Software devices):

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study reporting on a test set for an AI/software device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay. Its performance is inherent to its design, not a separate algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of test would be confirmed analytical methods, often Gas Chromatography coupled with Mass Spectrometry (GC/MS) or Liquid Chromatography coupled with Mass Spectrometry (LC/MS), which are the gold standards for drug confirmation in urine. However, this document does not detail any such validation study for this specific device, instead relying on equivalence to a predicate.
7. The sample size for the training set: Not applicable. This is not a machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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The First Check® Home Drug Test Panel 2 is an educational screening test for the rapid detection of marijuana and cocaine and/or their metabolites in human urine at cut-off levels of 50ng/mL and 300ng/mL, respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the two drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

The First Check® Home Drug Test Panel 2, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, and cocaine, and/or their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes. The cutoff concentration for THC is 50ng/mL. The cut-off concentration for COC is 300ng/mL.

The provided document is a 510(k) summary for the First Check® Home Drug Test Panel 2. It describes the device's intended use, technological characteristics, and claims substantial equivalence to a legally marketed predicate device. However, it does not contain specific acceptance criteria, performance data from a study, or details about the study design, sample sizes, ground truth establishment, or expert involvement that you've requested.

The document states:

• Intended Use: "a preliminary, rapid screening test for the detection of marijuana and cocaine and/or their metabolites in urine." at cut-off levels of 50ng/mL for THC and 300ng/mL for COC.
• Safety and Effectiveness: "Because the First Check® Home Drug Test Panel 2 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425, and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of the listed drugs and their metabolites."

Therefore, I cannot provide the requested information as it is not present in the given text.

To fully answer your questions, details from a specific performance study (clinical or in-vitro) would be required, which are typically found in the full 510(k) submission, not just the summary.

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