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Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL.

The provided text contains information about the Acro Biotech Rapid MDMA Urine Test and its FDA 510(k) clearance. However, it does not include the detailed study information required to fully answer your request regarding acceptance criteria and performance data. The document is an FDA clearance letter and an Indications For Use form, focusing on regulatory approval rather than a comprehensive study report.

Therefore, I cannot provide a complete answer with all the requested details. However, I can extract what is present and then indicate what information is missing.

Information Extracted from the Provided Text:

• Device Name: Acro Biotech Rapid MDMA Urine Test
• Intended Use: Qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. It is a lateral flow, rapid immunoassay for laboratory use only.
• Result Type: Visual qualitative result.
• Preliminary Nature: Provides only a preliminary result; clinical consideration and professional judgment are needed. Confirmation with a more specific alternate chemical method (preferably GC/MS) is required for positive results.

Attempt to Answer Based on Limited Information (with significant gaps):

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

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided (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 provided. For a drug test, the ground truth is typically established by a reference method like GC/MS, not expert consensus on interpretation. However, the document does not detail this.

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

• Not applicable/Not provided. For a laboratory immunoassay, adjudication by human experts in the typical sense for imaging or clinical diagnosis is not usually conducted. The comparison is against a reference method.

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, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

• Yes, implicitly. As an immunoassay, its performance is evaluated in a "standalone" manner against a reference method (GC/MS). The document, however, does not provide performance results.

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

• The document implies that Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred method for confirmation, strongly suggesting this would be the ground truth used in performance studies.

8. The sample size for the training set

• Not applicable/Not provided. This is an immunoassay, not a machine-learning algorithm that requires a training set in the typical sense.

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

• Not applicable (see point 8).

Summary of Missing Information:

The provided document is a regulatory approval letter and indications for use. It does not contain:

• Specific performance metrics (sensitivity, specificity, accuracy, precision, cross-reactivity, interference studies) for the device.
• The sample sizes used in any validation studies.
• Details on how ground truth was established by the manufacturer's internal studies (though it implies GC/MS would be used for confirmation outside the scope of the rapid test).
• Any information regarding the design (prospective/retrospective), data provenance, or geographical origin of samples for performance studies.
• Any information related to multi-reader studies or AI assistance, as this is a qualitative immunoassay.

To obtain the detailed study information, one would typically need to consult the full 510(k) summary or submission dossier, which is publicly available on the FDA website for cleared devices but not included in this excerpt.

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Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual, qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Not Found

The provided text is related to a 510(k) premarket notification for a medical device called "Acro Rapid Benzodiazepine Urine Test." This seems to be an in-vitro diagnostic device.

Unfortunately, the provided text does not contain any information about acceptance criteria, detailed study designs, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed. It also includes the "Indications for Use" for the device, which states:

Device Name: Acro Rapid Benzodiazepine Urine Test
Indications for Use: Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual, qualitative result and is intended for laboratory use only.

The letter explicitly states that this assay provides only a preliminary result and that a more specific alternate chemical method (like Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis) is needed to confirm a preliminary positive result. This implies that the device itself is not providing a definitive diagnostic outcome, but rather a screening result.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided text. This information would typically be found in the 510(k) submission summary or detailed study reports, which are not included in this extract.

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Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

A lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine.

This is a FDA 510(k) premarket notification for the Acro Rapid Opiate Urine Test, a device used for the qualitative detection of Opiate in human urine. The document is a letter from the FDA to Acro Biotech LLC, indicating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

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

The provided document, being an FDA 510(k) clearance letter, primarily establishes substantial equivalence without detailing specific acceptance criteria or performance metrics in a tabular format within the available text.

However, the "Indications for Use" section mentions:

• Qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL.
• The test is used to obtain a visual qualitative result and is intended for laboratory use only.

To infer performance, we can deduce that the device must demonstrate sufficient accuracy (sensitivity and specificity) around this cutoff for qualitative detection. Since this document declares substantial equivalence, it implies that the device's performance is comparable to or better than existing legally marketed predicate devices for the same intended use.

Without the actual study report or further sections of the 510(k) submission, specific reported device performance metrics like sensitivity, specificity, accuracy, or repeatability at the 2000 ng/mL cutoff are not quantifiable from the given text.

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

The document does not provide any information regarding the sample size used for the test set, the country of origin of the data, or whether the study was 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)

The document does not provide any information regarding the number of experts used to establish the ground truth or their qualifications.

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

The document does not provide any information regarding an adjudication method for the test set.

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 an "Acro Rapid Opiate Urine Test," described as a "lateral flow, one-step immunoassay." This type of device is a diagnostic test kit that provides a direct visual qualitative result, not an AI-powered image analysis or diagnostic tool that would involve "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

This device is a standalone test kit. Its performance is inherently "algorithm only" in the sense that it produces a direct visual qualitative result based on its chemical/immunological reactivity. There isn't an "algorithm" in the computational sense applied to interpret a human observation; rather, the device itself provides the result for interpretation. So, yes, its performance would be assessed as a standalone device, but not in the context of a computational algorithm.

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

The "Indications for Use" states: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This strongly indicates that Gas Chromatography/ Mass Spectroscopy (GC/MS) is the preferred method for establishing the ground truth (the reference standard or true positive/negative for Opiate presence in urine).

8. The sample size for the training set

The document does not provide any information regarding the sample size for the training set. This context is less relevant for a lateral flow immunoassay compared to machine learning models, as these devices are designed and optimized based on chemical principles and reagent characteristics rather than being "trained" on data in the same way an AI model is.

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

The document does not provide any information on how ground truth for a "training set" (if such a concept is applied in this context of immunoassay development) was established. As mentioned above, for this type of device, development involves chemical formulation and optimization, not data-driven "training" as in AI. However, if any reference samples were used during development, it is highly probable that GC/MS would have been used to confirm the presence and concentration of opiates in those samples.

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Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL.

The provided text is an FDA 510(k) clearance letter for the Acro Rapid Methamphetamine Urine Test. It includes the device name, regulation information, significant equivalence determination, and indications for use. However, it does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or other specifics of performance testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a clearance letter, not a performance study report.

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Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL

This document is a 510(k) clearance letter from the FDA for the Acro Rapid (THC) Marijuana Urine Test, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details on ground truth establishment and expert qualifications for those sets.
• Information on MRMC studies or standalone algorithm performance.
• Details regarding the training set.

The document only states the intended use of the device and its regulatory classification. It confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing Acro Biotech LLC to market it.

Below is information that can be extracted from the provided text, and an explanation of why other requested details are not present.

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

• Acceptance Criteria (Implied from Indications for Use): Qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL. The device must produce a "preliminary positive result" when THC is present at or above this cutoff, and a "negative result" when below.
• Reported Device Performance: Not provided in this document. The FDA letter states that the device has been found "substantially equivalent" to predicate devices, implying its performance meets acceptable standards, but specific performance metrics (e.g., sensitivity, specificity, accuracy) are not listed here.

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

• Not provided. This document is a regulatory clearance letter, not a study report.

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 provided. The "ground truth" for drug tests like this typically involves a more specific analytical method, such as GC/MS. The document mentions: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This implies GC/MS is the reference method, but details on how this was applied in a test set, including expert involvement, are absent.

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

• Not applicable/Not provided. Adjudication methods are typically relevant for subjective interpretations (like medical imaging), not for qualitative chemical tests where a reference method (GC/MS in this case) provides the definitive answer.

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/Not provided. This device is a rapid urine test for THC, not an AI-based system or an imaging device requiring human reader interpretation in the context of an MRMC study.

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

• Not applicable/Not provided. This is a rapid immunoassay device, not an algorithm. The "standalone" performance would refer to the device's accuracy in detecting THC against a reference method (GC/MS), but specific study details are not in this document.

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

• Chemical Analysis: The document states, "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This indicates that GC/MS is the 'gold standard' or ground truth method for confirmation.

8. The sample size for the training set

• Not applicable/Not provided. This is a chemical immunoassay, not a machine learning model, so there is no "training set" in the context of AI.

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

• Not applicable/Not provided. As above, there is no "training set" in the context of this device.

In summary: The provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence but does not detail the specific performance study results, methodologies, or data characteristics (like sample size, provenance, expert details) that would typically be found in a study report. For that level of detail, one would need to refer to the actual 510(k) submission itself or related performance studies if they were made public.

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Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) anchiate is preferred.

Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL

The provided text is related to the FDA 510(k) premarket notification for the "Acro Rapid Benzoylecgonine (Cocaine) Urine Test." It describes the regulatory approval of the device and its intended use. However, it does not contain any information about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions regarding the study design and results based on the provided text. The document is a regulatory approval letter and a statement of indications for use, not a detailed study report.

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Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL.

This document describes the Acro Rapid Phencyclidine Urine Test, a lateral flow immunoassay for detecting Phencyclidine (PCP) in human urine.

Here's an analysis of the provided text in relation to your questions:

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

The document explicitly states the "cutoff of 25 ng/mL" for Phencyclidine detection. However, it does not contain a table of acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or positive/negative predictive values. These are typically found in the clinical study section of a 510(k) submission, which is not included here. The document is primarily the FDA's clearance letter and the Indications for Use statement.

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

The document does not provide any information about a test set sample size, data provenance, or whether the study was 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):

This information is not provided in the document.

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

This information is not provided in the document.

5. If a multi-reader multicase (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 an immunoassay for drug detection, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not applicable to its function, and no such study details are present.

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

The device is a lateral flow immunoassay that provides a visual qualitative result. It is not an algorithm, and its performance is inherently "standalone" in giving a preliminary result. However, the document emphasizes that "Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result" and that confirmation with GC/MS is needed. This implies a human interpretation step and subsequent confirmation. Therefore, while the initial test is standalone, it's not a fully automated diagnostic without human involvement in the overall clinical pathway. The document does not detail a study specifically on 'standalone' performance in the context of an algorithm.

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

The document states, "In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This indicates that GC/MS analysis is the accepted "gold standard" or ground truth for confirming Phencyclidine presence.

8. The sample size for the training set:

The document does not provide any information about a training set sample size.

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

The document does not provide any information about a training set or how its ground truth was established. For an immunoassay, the "training" typically involves optimizing antibody-antigen reactions and cutoff concentrations, which would be validated against known concentrations (spiked samples) and confirmed clinical samples (with GC/MS as ground truth). However, these details are not in the provided text.

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Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.. The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.

The provided text is a 510(k) clearance letter from the FDA for the Acro Biotech LLC Rapid Amphetamine Urine Test. It does not contain the acceptance criteria or a detailed study description with specific performance metrics (like sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for ground truth, as would be expected for a comprehensive study report.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided in the 510(k) submission, which would have included performance data, but that specific data is not detailed in this document.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail. The FDA letter is a regulatory clearance document, not a scientific study report.

Here's what I can extract and what is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. In the context of a 510(k), acceptance criteria for performance would typically be defined relative to the predicate device's performance, but the specific metrics are not present here.
• Reported Device Performance: Not reported in the provided text. The letter only states that the device was found "substantially equivalent."

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

• Sample Size (Test Set): Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text.

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)

• Number of Experts/Qualifications: Not mentioned in the provided text.

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

• Adjudication Method: Not mentioned in the provided text.

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 an "Acro Rapid Amphetamine Urine Test," which is a rapid immunoassay for detecting amphetamine in urine. It is a diagnostic test kit, not an AI-based system or an imaging device requiring human reader interpretation in the same way. Therefore, an MRMC study with human readers and AI assistance would not be applicable to this type of device.

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

• The device described is a "lateral flow, rapid immunoassay" for qualitative detection. This is essentially a "standalone" test in that it produces a visual result without direct human interpretation of complex images or algorithms. However, the "Indications for Use" states: "This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This implies that while the initial test is standalone, human judgment and further confirmatory testing are critical for clinical decision-making.

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

• The Indications for Use section mentions that "Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred" for confirming results. It is highly probable that GC/MS would have been used as the ground truth for validating the rapid immunoassay's performance in the 510(k) study. GC/MS is a highly accurate and specific analytical method for drug detection.

8. The sample size for the training set

• Sample Size (Training Set): Not mentioned in the provided text. Rapid immunoassays typically don't have "training sets" in the same way machine learning models do. Their development involves optimizing antibodies and test parameters, and performance is then validated on clinical samples.

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

• See point 8. For typical immunoassay development and validation, GC/MS (or a similarly gold-standard analytical method) would be used to establish the true presence or absence of the analyte (amphetamine) in samples used for both development and validation.

To obtain the detailed information requested, one would need to review the specific 510(k) submission (K053032) from Acro Biotech LLC to the FDA, which is a much more extensive document than this clearance letter.

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