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The DENV Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to DEN recombinant antigens (DENRA) in serum for the presumptive clinical laboratory diagnosis of Dengue virus infection. The assay is intended for use only in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease.

The DENV Detect™ IgM Capture ELISA is a sandwich-type immunoassay. The test kit includes microtiter wells coated with anti-human IgM antibodies, DEN IgM Negative, and IgM Positive controls, DENV Sample Dilution Buffer, Dengue-derived recombinant antigens (DENRA) and normal cell antigens (NCA). The test kit also contains a HRPlabeled DEN-specific monoclonal antibody and tetramethylbenzidine (TMB) substrate which are used to detect DEN IgM antibodies in the wells.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. However, the performance metrics observed in the clinical studies can be considered as the reported device performance against implicit expectations for a diagnostic test.

2. Sample Size for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in the clinical studies to evaluate the DENV Detect IgM Capture ELISA's performance.

• Study Site 1: 197 subjects (394 total samples collected 1-2 weeks apart). Retrospective. Southeast Asia (reference laboratory).
• Study Site 2: 212 serially collected archived samples. Retrospective. Western United States (reference lab). Majority from Caribbean, southern/southeastern US; minority from Africa/Asia.
• Study Site 3: 289 lab archived samples. Retrospective. Public health lab (country not explicitly stated, but implies US due to specific mention of a US state without dengue outbreaks).
• Study Site 4: 199 archived samples. Retrospective. State Dept. of Health in Southern US.
• Study Site 5: 55 symptomatic subjects (samples collected at presentation and 4-14 days later, so 110 total samples). Prospective. Dengue endemic region in South America.

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

The document does not specify the explicit number or qualifications of experts involved in establishing the ground truth for most studies. It refers to "reference laboratory," "public health laboratory," and "CDC" for confirmatory testing.

• Study 1: Ground truth determined by a "reference laboratory using a diagnostic algorithm (validated in-house IgM test result and/or PCR result, and/or a rising IgG titer, and/or a four-fold rise of HAI titer between acute and convalescent blood draw)." No specific expert qualifications are given beyond the lab's general diagnostic capabilities.
• Study 2: Ground truth mainly established by "confirmatory PRNT" and "CDC Dengue MAC ELISA at the CDC." Again, specific expert numbers/qualifications are not detailed beyond the implication of CDC diagnostic expertise.
• Study 3: Ground truth based on "All testing and diagnosis was performed at the public health laboratory." and "history of dengue incidences in this general area" for assumed dengue negative status. Also PRNT testing was used. No specific expert numbers/qualifications are detailed.
• Study 4: Ground truth established by "CDC Dengue IgM (MAC) ELISA" and "PRNT testing." No specific expert numbers/qualifications are detailed beyond CDC.
• Study 5: Ground truth established by "Confirmatory PRNT testing." "PRNT changes of 4-fold or greater between visits 1 and 2, indicative of current Dengue infection." No specific expert numbers/qualifications are detailed.

It's implied that these reference laboratories and the CDC possess the necessary expertise for performing these confirmatory tests and making diagnoses.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication committee or method (like 2+1, 3+1). Instead, the "ground truth" (or "final diagnosis") was established by recognized reference methods:

• Study 1: Diagnostic algorithm by the reference lab (validated in-house IgM, PCR, rising IgG titer, four-fold HAI rise).
• Study 2: Confirmatory PRNT and CDC Dengue MAC ELISA. For indeterminate/equivocal CDC MAC ELISA results, PRNT was used for final classification.
• Study 3: Public health laboratory diagnosis, PRNT testing, and epidemiology (dengue-free area).
• Study 4: CDC Dengue IgM (MAC) ELISA and PRNT.
• Study 5: Confirmatory PRNT testing, specifically a 4-fold or greater rise in PRNT titer between two visits.

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 is an ELISA diagnostic device, not an AI-powered image analysis or diagnostic support system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The device provides a quantitative or qualitative result directly, which is then interpreted by a lab professional.

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

The DENV Detect IgM Capture ELISA is a standalone diagnostic assay. Its performance, as described in the clinical studies, represents the algorithm-only performance. The ELISA itself is the "algorithm," producing results based on biochemical reactions and optical density measurements. Human involvement is primarily in performing the assay, interpreting the quantitative output (ISR ratios against cut-offs), and making a final clinical diagnosis based on the test result in conjunction with patient symptoms and other clinical information.

7. The Type of Ground Truth Used

The ground truth used varied slightly across studies but generally involved:

• Plaque Reduction Neutralization Test (PRNT): Widely considered the gold standard for serological confirmation of dengue infection.
• CDC Dengue MAC ELISA: A well-established IgM capture ELISA used by the CDC as a reference method.
• PCR (Polymerase Chain Reaction): For direct detection of viral genetic material, indicating active infection.
• Rising IgG Titer / Four-fold rise of HAI titer: Indicative of a seroconversion or a recent infection.
• Expert Consensus / Diagnostic Algorithm: In Study 1, a reference laboratory's diagnostic algorithm combined multiple methods.
• Outcomes Data / Epidemiological Context: In Study 3, the "dengue non-endemic area" was used as a strong indicator of negative status for many samples.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" in the context of machine learning. For traditional in vitro diagnostic (IVD) devices like this ELISA, the "training" or optimization phase typically involves:

• Assay Cut-off Determination: This involved 109 true Positive and 97 True Negative serum samples. This set serves a similar function to a validation set for determining optimal operating points.

The core assay development and optimization (which would be analogous to "training" for a machine learning model) are inherent to the ELISA kit's design and formulation, not a separate data-driven training process in the modern AI sense.

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

For the cut-off determination:

• 109 true Positive and 97 True Negative serum samples were used. How their "true" status was established is not explicitly detailed in this section, but it is implied they were confirmed positive or negative for dengue infection through reliable reference methods, similar to those used in the clinical studies (PRNT, PCR, other validated assays). The statement "true Positive and true Negative" suggests an established and verified diagnosis for these samples.

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The West Nile Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to WNV recombinant antigens (WNRA) in serum for the presumptive clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningoencephalitis. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms, or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors.

West Nile Detect IgM Capture ELISA

I am sorry, but the provided text from the FDA 510(k) letter for the "West Nile Detect IgM Capture ELISA" device does not contain the specific information requested to describe the acceptance criteria and the study that proves the device meets those criteria, and therefore, I cannot fulfill your request to create the tables and sections you've outlined.

The document is a clearance letter indicating that the FDA found the device substantially equivalent to a predicate device. It defines the "Indications For Use" and general regulatory requirements but does not detail the performance study, acceptance criteria, or the specific results of such a study.

Specifically, the following information is missing from the provided text:

• Table of acceptance criteria and reported device performance: This information would typically be in the 510(k) submission's performance data section, not the clearance letter.
• Sample sizes used for the test set and data provenance: No details on the test set or its origin.
• Number of experts and their qualifications for ground truth: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No mention of such a study or any effect size.
• Standalone (algorithm-only) performance: This is an ELISA kit, not an algorithm in the typical sense for standalone performance.
• Type of ground truth used: While "presumptive clinical diagnosis" and "Plaque Reduction Neutralization Test (PRNT)" are mentioned as confirmation for positive results, the specifics of how the ground truth for the study was established are not provided.
• Sample size for the training set: Not applicable for an ELISA kit in the same way it would be for an AI algorithm, and in any case, not provided.
• How ground truth for the training set was established: Not applicable/not provided.

To obtain this information, one would typically need to consult the full 510(k) submission document, which often contains detailed study protocols and results, or scientific publications related to the validation of this specific assay. The provided FDA clearance letter is a summary of the regulatory outcome, not the detailed technical data.

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The Kalazar Detect™ Test is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.

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This document is an FDA 510(k) clearance letter for the "Kalazar Detect™ Rapid Test for the Detection of Visceral Leishmaniasis." As such, it primarily focuses on the regulatory approval and substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive study proving the device meets specific acceptance criteria in the manner one might find for a more complex diagnostic or AI-based device.

Therefore, many of the requested fields cannot be directly extracted from this document because the letter does not include the detailed study design and results for performance evaluation.

However, I can provide the information that is present or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) or a direct performance table for the Kalazar Detect™ Rapid Test. The clearance is based on substantial equivalence to legally marketed predicate devices.

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

This information is not provided in the FDA clearance letter. It would typically be found in the manufacturer's 510(k) submission, which is not included here.

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

This information is not provided in the FDA clearance letter. Ground truth for diagnostic tests typically relies on established clinical diagnoses or reference methods, but the specifics of how this was established for the performance evaluation are not detailed here.

4. Adjudication Method for the Test Set:

This information is not provided in the FDA clearance letter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This is a rapid immunoassay kit. An MRMC study is generally relevant for imaging or interpretation-heavy diagnostics where human reader performance is a key variable. Given the nature of a rapid immunochromatographic strip assay, an MRMC study is highly unlikely to have been performed or relevant in the context of improving human reader performance with AI assistance. The device itself is not an AI algorithm.

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

The Kalazar Detect™ Test is a rapid immunoassay kit, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. The device is designed for professional in vitro diagnostic use, meaning a human interprets the visual result on the strip.

7. The Type of Ground Truth Used:

While not explicitly stated in the letter, for an in vitro diagnostic test for Leishmaniasis antibodies, the ground truth would typically be established by a combination of clinical diagnosis (e.g., symptoms, geographic exposure) and confirmation by a validated reference method, such as microscopy, PCR, or culture for L. donovani in patient samples.

8. The Sample Size for the Training Set:

This information is not provided in the FDA clearance letter. For an immunoassay, the concept of a "training set" as understood in machine learning is not directly applicable. Instead, the device development would involve various stages of prototype testing and optimization using relevant biological samples.

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

This information is not provided in the FDA clearance letter. Similar to the test set, the "ground truth" for samples used during development would be established through robust reference methods for diagnosing Visceral Leishmaniasis.

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The Insure Pro Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request. The document is an FDA 510(k) clearance letter for the "InSure Pro Test," confirming its substantial equivalence to a predicate device for the detection of early pregnancy.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Details about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report or clinical trial summary. To answer your questions, you would need to refer to the actual 510(k) submission document (K992695) itself, which would contain the performance data and study details.

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The InSure Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the InSure Pregnancy Test. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's acceptance criteria and the study proving it meets them.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the FDA found the device to be comparable to an existing device, but the letter itself does not provide the underlying study data.

To get the information you're asking for, one would typically need to review the original 510(k) submission document (K991515) itself, which includes the detailed performance data and study protocols provided by InBios International, Inc. to the FDA. Unfortunately, this specific letter does not contain that level of detail.

Therefore, for each of your questions, the answer based solely on the provided text would be:

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

• Response: Not available in this document. The document is a clearance letter, not the performance study report itself.

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

• Response: Not available in this 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)

• Response: Not applicable. This is an in vitro diagnostic device (pregnancy test), not an imaging or diagnostic device that typically involves human expert interpretation for ground truth establishment. Clinical studies for such devices usually involve comparing the test's results to a gold-standard chemical assay or confirmed clinical outcome. The document does not provide details on such a study.

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

• Response: Not applicable. See response to #3.

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

• Response: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting images or data with or without AI assistance.

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

• Response: Not applicable. This is a manual in vitro diagnostic test. Its standalone performance would be its accuracy, sensitivity, and specificity in detecting hCG, but the document does not provide these metrics.

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

• Response: Not available in this document. For a pregnancy test, ground truth would typically be established through a confirmatory chemical method (e.g., quantitative hCG assay) or clinical follow-up, but the document does not specify.

8. The sample size for the training set

• Response: Not available in this document. (For an IVD like this, the concept of a "training set" in the context of machine learning isn't directly applicable unless an AI component was involved, which is not indicated for this 1999 device. There would be a clinical study or verification/validation sample size, but it's not specified here.)

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

• Response: Not available in this document. (See response to #8.)

In summary, the provided FDA clearance letter ("K991515") confirms that the InSure Pregnancy Test was found substantially equivalent, but it does not contain the detailed technical, performance, or study data necessary to answer your specific questions. These details would be in the original 510(k) submission itself.

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