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dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.

dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine.

The provided document is a 510(k) clearance letter for the "dBest Urinary Track Infection Test Kit for Home-Use." It states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. However, the document does not contain detailed information about acceptance criteria, specific device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and information based on the given text. The letter primarily focuses on regulatory approval and points to general controls provisions of the Act and other relevant FDA regulations.

To answer your request, I would need access to the actual 510(k) submission document or a summary of its contents, which would typically include the performance study details.

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dBest MultiDrug Screen Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml, cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml, methamphetamines and its metabolites such as oxidized, deaminated derivatives in urine with cutoff of 1000 ng/ml, opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml and tetrahydrocannabinol and its metabolites 11-nor- 9tetrahydrocannabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest MultiDrug Screen Test Kits are for professional and laboratory use only.

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The provided document is a 510(k) clearance letter for the "dBest MultiDrug Screen Test Kit." This type of document declares substantial equivalence to a predicate device and does not typically include detailed acceptance criteria or a comprehensive study plan with the specific performance metrics you're requesting for a device like a diagnostic AI or imaging system.

The acceptance criteria and performance reported in this document are framed within the context of a drug screen test kit, which focuses on cut-off levels and qualitative detection.

Here's an attempt to answer your questions based on the limited information available in this 510(k) letter, interpreting the information in a way that aligns with your request where possible, and noting when the information is not present.

The dBest MultiDrug Screen Test Kit is a qualitative immunochromatographic assay for the rapid detection of specific drugs in urine.

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document lists the cutoff levels which serve as a form of acceptance criteria for a qualitative drug test. It doesn't report specific sensitivity, specificity, or accuracy percentages, as these would typically be detailed in the study report submitted to the FDA, not necessarily in the clearance letter itself.

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

• Sample Size for Test Set: Not specified in this document.
• Data Provenance: Not specified in this document. Typically, drug screen test kits would involve clinical samples from human subjects. The document does not indicate retrospective or prospective studies.

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

• Not applicable/Not specified. For a qualitative drug test, ground truth is typically established by definitive analytical methods (e.g., GC/MS) rather than expert consensus on interpretation of the device's results.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods are more commonly used in interpreting subjective findings (e.g., medical images) rather than the binary (positive/negative) output of a qualitative drug screen.

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 diagnostic test kit, not an AI-powered diagnostic imaging or interpretation system. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• The device itself is a standalone test kit; it performs the detection without human interpretation beyond reading the visual result (e.g., line appearance). However, this question typically refers to AI algorithms. In that context, it's not applicable.

7. The type of ground truth used:

• While not explicitly stated in this document, for drug screen tests, the ground truth for establishing performance is typically definitive analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS)) to confirm the presence and concentration of the drug metabolites in the urine samples.

8. The sample size for the training set:

• Not applicable or not specified. Immunochromatographic assays do not typically involve a "training set" in the machine learning sense. The device's performance is based on its chemical and biological design.

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

• Not applicable. (See #8).

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dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory use only.

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I am sorry, but after reviewing the provided document, I was unable to locate the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria. The document appears to be a 510(k) clearance letter from the FDA for a device called "AmeriTek dBest Sensitive Occult Blood Test Kit". It outlines the regulatory classification, general controls, and permits marketing of the device, but it does not contain details about specific performance acceptance criteria or a study proving its performance.

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dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only.

dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml.

The provided text is a 510(k) clearance letter from the FDA for a device called "dBest Tetrahydrocannabinol Test Kits." It determines the device's substantial equivalence to a predicate device. However, this document does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a device's submission or clinical study report.

Therefore, I cannot fully complete the requested table and information based solely on the provided text. The document is an FDA clearance letter, not a detailed technical report of a study.

Here's what I can extract and what I cannot:

What can be extracted:

• Device Name: dBest Tetrahydrocannabinol Test Kits
• Intended Use Statement: "dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only."
• Regulatory information: This is a Class II device, Cleared via 510(k) K983188.

What cannot be extracted (as it's not present in the provided document):

• Specific acceptance criteria (e.g., sensitivity, specificity thresholds).
• Reported device performance values against acceptance criteria.
• Details of the study that proves the device met acceptance criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

Table of Acceptance Criteria and Reported Device Performance (Based on what should be there, but is not in the provided text):

Detailed Study Information (Not available in the provided document):

1. Sample size used for the test set and the data provenance: Not mentioned in the provided text.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned in the provided text.
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. This is an immunochromatographic assay for THC, not an AI-assisted diagnostic imaging task that would typically involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a "one step immunochromatographic assay," implying it is a standalone test kit, not an algorithm. Performance would be assessed directly from the test result.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned in the provided text. For a drug test, the ground truth would typically be established by a more definitive laboratory method (e.g., GC/MS or LC/MS) on the same urine samples.
7. The sample size for the training set: Not applicable based on the nature of this device as a traditional immunochromatographic assay. There isn't an "algorithm" being trained in the typical AI sense.
8. How the ground truth for the training set was established: Not applicable for the same reason as point 7.

In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical or clinical study data requested. To answer these questions, one would need access to the full 510(k) submission document or a summary of the performance data that supported this clearance.

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dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, deaminated and conjugated derivatives in urine. dBest Methamphetamines Test Kit is intended for professional and laboratory use only.

dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, deaminated and conjugated derivatives in urine.

{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "Not explicitly stated in the provided text.",
"Reported Device Performance": "Not explicitly stated in the provided text."
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not explicitly stated 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)": "Not applicable, as this device is an in vitro diagnostic test for methamphetamine and not a medical imaging device requiring expert interpretation.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable, as this device is an in vitro diagnostic test for methamphetamine and not a medical imaging device requiring expert interpretation.",
"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 device is an in vitro diagnostic test for methamphetamine and not an AI-assisted diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device is described as a 'simple one step immunochromatographic assay', implying it functions as a standalone test without human-in-the-loop performance in its primary operation. However, no specific study details are provided.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not explicitly stated in the provided text. For an immunochromatographic assay, the ground truth would typically be established through confirmatory laboratory methods (e.g., GC/MS) on the same samples.",
"8. The sample size for the training set": "Not explicitly stated in the provided text.",
"9. How the ground truth for the training set was established": "Not explicitly stated in the provided text. For an immunochromatographic assay, the ground truth would typically be established through confirmatory laboratory methods (e.g., GC/MS) on the same samples."
}

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dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml. The dBest Opiates Test Kits are for professional and laboratory use only.

dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml.

This document is a 510(k) clearance letter from the FDA for a diagnostic device, the dBest Opiates Test Kit. It does not contain the detailed acceptance criteria or a study write-up proving the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not elaborate on the performance data or studies that led to this determination.

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dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml. The dBest Cocaine Test Kits are for professional and laboratory use only.

dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml.

This appears to be a 510(k) clearance letter from the FDA for a device called "dBest Cocaine Test Kit." However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on:

• Confirming the substantial equivalence of the "dBest Cocaine Test Kit" to a legally marketed predicate device.
• Outlining the regulatory implications and responsibilities of the manufacturer (AmeriTek, Inc.).
• Providing contact information for various FDA offices.
• Stating the intended use of the device.

To address your request, I would need a different document, likely a 510(k) Summary, 510(k) Premarket Notification submission, or a clinical study report associated with this device. These documents typically contain the detailed performance data, study designs, and acceptance criteria you are asking for.

Since the provided text does not contain the necessary information, I cannot complete the table or answer the specific questions about acceptance criteria and the supporting study.

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dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "dBest AMP Test Kit" and related documents. It does not contain the detailed information necessary to answer all the questions about acceptance criteria or a specific study proving the device meets them. This type of regulatory document typically confirms equivalence to a predicate device based on submitted data, rather than detailing the full study methodology and results.

However, based on the limited information present in the document, here's what can be extracted:

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

The document does not explicitly state acceptance criteria or a detailed performance table. The "Indications For Use" section provides a key performance characteristic:

2. Sample size used for the test set and the data provenance

This information is not available in the provided text. The document is a clearance letter, not the study report itself.

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

This information is not available in the provided text.

4. Adjudication method for the test set

This information is not available 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 "immunochromatographic assay" – a rapid test kit for detecting amphetamines. It is not an AI-powered diagnostic device, nor does it involve "human readers" in the sense of interpreting complex images. Therefore, an MRMC study comparing human readers with and without 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 refers to AI algorithm performance. As established above, this is not an AI device. The device itself is standalone in that it provides a direct result (qualitative detection of amphetamines).

7. The type of ground truth used

While not explicitly stated for the testing proving the device performance, for a diagnostic test like this, the ground truth would typically be established by a reference method, such as:

• Mass Spectrometry (e.g., GC-MS or LC-MS): This is the gold standard for confirming drug presence and concentration in urine samples.

8. The sample size for the training set

This information is not available in the provided text, as it doesn't describe the study details. Furthermore, for a simple immunochromatographic assay, the concept of a "training set" (as typically used in machine learning) might not directly apply in the same way. Development would involve extensive analytical validation, but not necessarily machine learning training.

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

This information is not available in the provided text. (See point 8 regarding "training set.")

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dBest Ovulation Test measures luteinizing hormone (LH), which is always present in women's urine, and increases just before most fertile day of the month. This increase, or "surge" in LH triggers ovulation, which is the release of an egg from ovary. dBest Ovulation Test will help women find the time that when they are most able to become pregnant. Fir accounter USC.

dBest Ovulation luteinizing hormone (LH).

This document is an FDA 510(k) clearance letter for a medical device called the "dBest One-Step Ovulation Test." It indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, or performance data.

The letter is a regulatory approval document and focuses on:

• Confirming substantial equivalence.
• Indicating the regulatory class (Class I) and product code (CEP).
• Stating that the device can be marketed.
• Outlining general controls and other FDA regulations applicable to the device.
• Referencing the "Indications For Use" statement (which is included in a subsequent part of the document) but not the actual study data.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, ground truth details, or information about MRMC studies based solely on the provided text.

The "Indications for Use" section (part 2 of the input) describes what the device does (measures luteinizing hormone to help women find their most fertile time) but does not provide performance metrics or study details.

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