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Bionike's AQ™ Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated". Bionike Laboratories' AQ™ Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Bionike Laboratories' AQ™ Phencyclidine (PCP) Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 25 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

1. Acceptance Criteria and Device Performance

Note: The document states the device "yielded relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100%," implying these were the target acceptance criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: 286 samples
• Data Provenance: Not explicitly stated, but based on the "clinical trial" wording, it suggests prospective collection for the purpose of the study. The absence of specific country information usually implies domestic (US) data for FDA submissions unless otherwise mentioned.

3. Number of Experts and Qualifications

• Not applicable. The ground truth was established by laboratory methods (chemical analysis) rather than expert human interpretation of images or clinical cases.

4. Adjudication Method

• Not applicable. The ground truth was established by laboratory methods, not through reconciliation of multiple human readers.

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

• No, a multi-reader multi-case comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The Bionike AQ™ Phencyclidine (PCP) Test's performance (sensitivity, specificity, accuracy) was evaluated directly against a reference method (Syva EMIT® (25) II, confirmed by GC/MS).

7. Type of Ground Truth Used

• The primary ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) at a cutoff of 25 ng/ml. Syva EMIT® (25) II was used as an initial comparator, but GC/MS served as the definitive confirmation method.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" for the device development. The reported performance refers to the in-house testing and a clinical trial. Given the nature of a rapid immunoassay, it's more likely that the device's design and operating parameters were established through iterative development and testing, rather than a distinct machine learning "training set."

9. How Ground Truth for the Training Set Was Established

• Not applicable, as a distinct training set in the context of machine learning is not described. For the device's development/optimization (analogous to training), it's implied that various samples with known PCP concentrations (likely determined by GC/MS or similar precise analytical methods) would have been used during the research and development phases to establish the assay's sensitivity, specificity, and cutoff levels.

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The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

Not Found

This FDA premarket notification (510k) provides marketing authorization for a device and therefore does not contain acceptance criteria or study data.

To clarify, 510(k)s demonstrate substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This typically involves performance data compared to the predicate, but not necessarily a formal study with acceptance criteria in the same way a de novo or PMA submission would require.

Therefore, I am unable to provide the requested information based on the provided document.

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The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

Not Found

This is a 510(k) clearance letter for a device from 1997, and as such, it does not contain the detailed information about acceptance criteria and study design that would be present in a modern regulatory submission for AI/ML devices. The letter primarily confirms substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted from the provided text. However, based on the information available, here's what can be provided and what cannot:

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

The provided document (a 510(k) clearance letter) does not contain a table of acceptance criteria or specific reported device performance metrics. It states that the device is a "rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL." The clearance letter confirms the device's substantial equivalence to a predicate device, implying that its performance is considered acceptable relative to that predicate. For detailed performance, one would typically need to refer to the original 510(k) submission, which is not provided here.

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 available in the provided document.

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 available in the provided document. For drug screening tests like this, the "ground truth" would typically be established by a reference method such as GC/MS rather than expert consensus on images.

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

This information is not available in the provided document. This type of adjudication is more relevant for subjective interpretations (e.g., image reading) rather than a qualitative chemical assay.

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

A Multi-Reader Multi-Case (MRMC) study is not applicable to this device. This device is an in vitro diagnostic test (a chemical assay) and does not involve human readers interpreting AI outputs.

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

This device is a standalone diagnostic test. It's a "rapid immunochromatographic competitive assay." This means it provides a result directly from a sample without an "algorithm" in the modern AI sense or a human-in-the-loop interpretation of AI output. Its performance would inherently be "standalone."

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

The "ground truth" for a cannabinoid screen, as indicated by the statement "The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS," would be GC/MS (Gas Chromatography-Mass Spectrometry). GC/MS is the gold standard for confirming drug presence and concentration in toxicology.

8. The sample size for the training set

This information is not available in the provided document. For a traditional immunochromatographic assay, there isn't a "training set" in the sense of machine learning. The development involves analytical studies to establish performance characteristics, which would use samples, but not for "training" an AI model.

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

Not applicable as there is no "training set" in the AI/ML sense for this type of device. The accuracy of such a device is established through comparison with a reference method, typically GC/MS, for both development and validation.

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The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

Not Found

This is a 510(k) clearance letter for the Bionike AQ™ Opiates (morphine) Test, which is an in vitro diagnostic device. The letter determines substantial equivalence to a predicate device, allowing the sale of the device.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria or report detailed device performance metrics (e.g., sensitivity, specificity, accuracy) in a tabular format as would be found in a study summary.

However, the "Indications for Use" section (page 2) provides a key piece of information that can be inferred as a performance parameter:

Note: This is a very limited interpretation as the document is a clearance letter, not a detailed study report. The 300 ng/mL value is a threshold for detection, not a performance metric like sensitivity or specificity. A full study report would include those details.

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

The provided document does not contain any information regarding:

• The sample size used for the test set.
• The data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The provided document does not contain any information regarding:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The provided document does not contain any information regarding the adjudication method used for the test set.

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

The provided document does not contain any information indicating that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect sizes related to human reader improvement with or without AI assistance. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is an "immunochromatographic competitive assay." This is a laboratory test, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable here. The test itself is a standalone diagnostic tool once run by a healthcare professional, providing a preliminary analytical result without real-time human interpretation within the test mechanism.

The document states: "The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only." This indicates the device acts as a standalone screening tool that requires subsequent confirmatory testing and professional interpretation.

7. The Type of Ground Truth Used

The ground truth for detecting opiates (morphine) in urine, as hinted by the document, would be the results from a confirmatory method. The document explicitly states: "The test... provides only a preliminary analytical result which must be confirmed using GC/MS."

Therefore, the type of ground truth used for validation would likely be Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly accurate and commonly accepted gold standard for drug confirmation in toxicology.

8. The Sample Size for the Training Set

The provided document does not contain any information regarding the sample size for the training set. This is consistent with a medical device 510(k) clearance letter for an in vitro diagnostic test rather than an AI/ML device that requires explicit training data.

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

Since this is not an AI/ML device, the concept of a "training set" in the context of machine learning does not apply. If there were any "training" or development involved for the assay characteristics before the pivotal study, the ground truth would still likely have been established using a highly accurate confirmatory method like GC/MS to ensure the assay's performance characteristics (like the 300 ng/mL cutoff) were correctly set. However, the document does not elaborate on this.

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