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The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 8 and results are negative, testing must be repeated one week later. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.

Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of infection and may be detectable near day 4 post-onset of symptoms and persist up to approximately 12 weeks following initial infection.

Negative results may be seen in specimens collected before day four post-onset of symptoms or after the window of detectable IgM closes and therefore do not preclude the possibility of Zika virus infection, past or present.

The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors.

The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader.

DPP Zika IgM System Control Pack

The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader.

DPP Micro Reader

The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Zika IgM System. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation; the results of DPP Zika IgM System cartridges must be read exclusively with the DPP Micro Reader.

Chembio' s DPP Zika IgM System is a qualitative immunochromatographic assay for the presumptive detection of IgM antibodies to Zika virus. The DPP Zika IgM System is composed of:

• A single-use immunochromatographic test for the presumptive detection of ZIK V 1. IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.

• 2. The DPP Micro Reader to minimize errors from direct visual interpretation.

The document describes the Chembio DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. The system is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum, plasma, and whole blood specimens.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DPP Zika IgM System are primarily demonstrated through its Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a predicate EUA or FDA-cleared comparator assay, across various sample types. Analytical performance (precision, cross-reactivity, interference, analytical sensitivity, and stability) also forms part of the acceptance.

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

• Serum:
  • Positive Predictive Agreement:
    • 99 samples from symptomatic individuals in Peru (retrospective).
    • 11 samples from individuals in the Dominican Republic (retrospective).
    • 32 samples from 26 individuals in Brazil during arbovirus outbreaks (retrospective).
    • FDA Plasma Zika Panel: 24 Zika IgM positive, 12 negative.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Potassium-EDTA Plasma:
  • Positive Predictive Agreement (Manufacturer Study): 299 IgM antibody samples from 48 individuals (from 50 symptomatic subjects) in the Dominican Republic (archived, confirmed by NAT). Includes 12 pregnant women.
  • Positive Predictive Agreement (External Sites): 171 comparator positive IgM antibody samples from 39 individuals in the Dominican Republic (archived). Also, 49 prospectively collected asymptomatic pregnant women from the continental United States (negative by comparator assay) were interspersed.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Potassium-EDTA Venous Whole Blood:
  • Positive Predictive Agreement (Internal/External Sites): 41 plasma samples (from a plasma replacement study) from 6 individuals in the Dominican Republic; 10 frozen natural whole blood samples from individuals in the Dominican Republic; 171 antibody positive plasma specimens (from plasma replacement study) plus 49 antibody negative specimens from asymptomatic pregnant women from the US.
  • Positive Predictive Agreement (Contrived): 299 subjects for analysis (from 300 "all comers" at 3 US clinics); samples were contrived by potassium-EDTA plasma replacement.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Fingerstick Whole Blood:
  • Positive Predictive Agreement (Contrived): 372 subjects for analysis (from 375 adult subjects across 4 US near-patient sites, "all comers" basis); samples were pre-spiked to create contrived samples.
  • Negative Predictive Agreement (Endemic Area): 250 subjects from a Zika endemic area (prospectively collected).
  • Negative Predictive Agreement (Non-Endemic Area): 250 subjects from a Zika non-endemic area (prospectively collected).
• Cross-Reactivity: 329 specimens for various organisms/conditions.
• Interference: Low reactive (n=3) and normal human plasma samples (n=3) for each interfering substance.
• Analytical Sensitivity: Dilution series of WHO 1st International standard.
• Assay Cut-off: 569 natural serum samples (US, Mexico); 184 natural plasma samples (US, Peru); 215 natural venous whole blood samples (US); 102 natural capillary whole blood samples (US).
• Precision/Reproducibility: A blinded panel of four plasma samples (negative, high negative, low positive, moderate positive) tested with 3 lots of the system.
• DPP Zika IgM Control Kit Precision: Moderate positive, low positive, and negative control samples.

Data Provenance: Studies include samples from Peru, Dominican Republic, Brazil, and the United States. Many samples are retrospective (archived, historical data), while some are prospectively collected (e.g., negative predictive agreement studies).

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

The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish ground truth in the traditional sense of multiple human readers independently adjudicating images/cases.

Instead, the ground truth for clinical performance studies (PPA and NPA) was established by:

• Comparison with an EUA (Emergency Use Authorization) or FDA-cleared comparator assay.
• In some cases, samples were confirmed positive by RT-PCR assay for Zika virus (e.g., Peruvian and Brazilian serum samples).
• Consensus results were provided for the FDA Plasma Zika Panel, and these are stated to be the responsibility of the FDA.
• For contrived samples (venous whole blood, fingerstick whole blood), the "ground truth" was based on expected results from spiking with known positive or negative material, corroborated by comparator testing.

4. Adjudication Method for the Test Set

The primary method for "adjudication" (or reference standard determination) appears to be comparison with another laboratory assay (EUA or FDA-cleared comparator assay). For Negative Percent Agreement, results were compared against an FDA Cleared Comparator and an Additional EUA Test, and "Both FDA Cleared and EUA tests" where results from both were in agreement. There is no mention of a traditional expert consensus or adjudication panel (e.g., 2+1, 3+1) for clinical performance in this document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the DPP Zika IgM System against reference methods/comparator assays, not on how human readers improve with or without AI assistance. The DPP Micro Reader is an integral part of the device, reading results from the immunochromatographic assay, and is not an AI tool assisting human interpretation. The document explicitly states the test "cannot be visually interpreted by the operator and must be read on the DPP Micro Reader," meaning it's not a human-in-the-loop scenario.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The document provides extensive data on the performance of the DPP Zika IgM System (algorithm only, as it's an automated reader) in detecting Zika virus IgM antibodies across various sample types and clinical scenarios, independently compared to established reference standards (comparator assays, RT-PCR, or expected reactivity from spiked samples).

7. The Type of Ground Truth Used

The ground truth used various forms:

• Comparator Assay Results: Results from an EUA or FDA-cleared Zika IgM comparator assay.
• RT-PCR Confirmation: For some positive samples, PCR confirmation for Zika virus was used.
• Consensus Data: For the FDA Plasma Zika Panel, consensus results were utilized.
• Expected Reactivity from Spiked Samples: For contrived samples (venous whole blood, fingerstick whole blood), the ground truth was based on the known positive or negative status of the spiked material.

8. The Sample Size for the Training Set

The document does not explicitly specify a "training set" in the context of machine learning. The DPP Micro Reader and assay are likely developed based on extensive R&D and optimization, but the provided performance data relates to validation studies, not an explicit training set for a distinct AI model. The product is an in-vitro diagnostic device that produces quantitative results read by a device, not a machine learning algorithm requiring a separate training dataset in the typical sense.

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

Since an explicit "training set" for a machine learning model is not described, the method for establishing its ground truth is not applicable or detailed in this document. The development of the assay and the Micro Reader's algorithm would have involved internal validation and optimization using various samples, but these are part of product development rather than a defined, separate "training set" for regulatory evaluation in the context of this 510(k) summary.

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The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians' office laboratories.

The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a Class II in vitro diagnostic device that utilizes standard immunochromatographic chromophore technology to qualitatively detect, in serum or whole blood, the presence of IgG and IgM antibodies to recombinant Borrelia burgdorferi antigens, as an aid in the diagnosis of Lyme Disease. It consists of a plastic housing, containing an absorbent material that collects the specimen and, with the addition of buffer, delivers it and adjacent adsorbed reagents, onto a chromatographic strip, onto which recombinant test antigen and control antibodies have been adsorbed within their respective test and control detection zones. As the mixture migrates along the strip, gold-conjugated antibodies specific for human IgG and IgM bind to the antibodies in the specimen. Antibodies specific for Borrelia burgdorferi antigens, if present, will bind to the adsorbed recombinant antigens in the test zone, resulting in a visually detectable colored line due to the presence of goldconjugated antibodies, which are bound to the specimen antibodies. If no antibodies to Borrelia burgdorferi are present, no line will appear in the test zone. A line will always appear in the control zone, indicating a valid result, as goat anti-human IgG antibodies adsorbed in the control zone bind excess IgG in the specimen, which have been bound to the gold-conjugate.

The provided text describes a medical device, the Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay, but does not contain the detailed acceptance criteria or the study data that proves the device meets specific performance criteria. The document is a 510(k) summary for regulatory submission, focusing on device description, intended use, and substantial equivalence to a predicate device, rather than a full study report with detailed results.

Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set.

The document mainly focuses on establishing the device's functionality and its substantial equivalence to another device (Wampole Borrelia burgdorferi IgG/IgM ELISA) for regulatory approval.

What information is available in the provided text:

• Device Name: Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay
• Intended Use: Qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood using recombinant B. burgdorferi antigens. It's intended for patients with a history, signs, and symptoms consistent with Lyme disease, and for use in clinical and physicians' office laboratories.
• Predicate Device: Wampole Borrelia burgdorferi IgG/IgM ELISA (510(k) Document Control Number: K965131)
• Technology: Immunochromatographic in vitro diagnostic device, utilizing recombinant Borrelia burgdorferi antigens.
• Claimed Advantages of Recombinant Antigens: Improved specificity and a continued supply of high-quality, uniform antigen.

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An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.

The Sure Check™ Pregnancy Test is a self contained immunochromatographic test designed for use in detecting hCG in urine samples. After the person wets the wick in the device the urine is absorbed and transferred to a pad where a labelled colloidal gold containing a monoclonal antibody directed against beta hCG is present. If the antigen (hCG) is present, an antigen/antibody reaction takes place forming a complex. This migrates along the nitrocellulose support to the Test Line which is printed on the membrane. This is another antibody, in this case a monoclonal anti-hCG antibody, which captures the colored complex when it passes over the immobilized test line antibody. As the complex adheres to the capture antibody a visible light to dark purple band appears indicating a positive test result. The remaining complex travels further along the membrane to another immobilized control antibody. This captures the remaining complex forming another purple band indicating that the test has been performed properly.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Sure Check™ Pregnancy Test Performance vs. Predicate Device (Chembio HCG STAT-PAK)",
    "headers": ["Metric", "Acceptance Criteria", "Reported Sure Check™ Performance"],
    "rows": [
      ["Early Detection of Pregnancy", "Not explicitly stated, but implied to be comparable to predicate", "Effective in diagnosing pregnancy"],
      ["Accuracy (vs. Predicate Device)", "Comparable to predicate device", "Demonstrated substantial equivalence"],
      ["Sensitivity/Detection Limit", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #6a)"],
      ["Specificity", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #7b)"],
      ["Interfering Substances", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #8c)"],
      ["Time Study for Holding Device in Urine Stream", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #9d)"],
      ["Optimal Reaction Time", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #10e)"],
      ["Reproducibility", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #11f)"],
      ["Linearity", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #12g)"]
    ]
  },
  "sample_size_test_set": "Not specified in the provided text. The document refers to \"clinical trials\" and \"Comparative Study Data\" (Exhibit #3) but does not provide the exact sample size.",
  "data_provenance": "The clinical trials were conducted by Target Health Inc. in New York, NY. The data appears to be prospective, collected for the purpose of the study (an \"Open Study to Evaluate the Ability of Sure Check™ to Determine Pregnancy\"). The country of origin for the data is the USA.",
  "number_of_experts_ground_truth_test_set": "Not specified. The ground truth for the clinical trials was established by comparison to a \"currently marketed device (Professional Use)\", the Chembio HCG STAT-PAK, K#923925/A. It's not explicitly stated that experts established the ground truth for individual cases, but rather a professional-use device served as the reference standard.",
  "qualifications_experts_ground_truth_test_set": "Not applicable, as expert involvement in establishing ground truth for individual cases is not specified. The reference standard was a professional-use device.",
  "adjudication_method_test_set": "Not applicable/Not specified. The study compared the Sure Check™ to a predicate device; it doesn't mention a specific adjudication method for discrepancies between test results and a true ground truth if that ground truth itself was established by human readers.",
  "mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the new device (Sure Check™) to a predicate device (Chembio HCG STAT-PAK) in clinical trials for accuracy. It's a device-to-device comparison, not an evaluation of human readers' improvement with or without AI assistance.",
  "standalone_performance_done": "Yes, a standalone performance study was done for the device. The clinical trials evaluate the device's accuracy in diagnosing pregnancy. The non-clinical tests (Sensitivity/Detection Limit, Specificity, etc.) also assess the device's inherent performance characteristics.",
  "type_of_ground_truth_used": "The ground truth for the clinical trials was established by correlation with a currently marketed professional-use device, the Chembio HCG STAT-PAK. This implies that the results of the predicate device were considered the reference standard for truth in diagnosing pregnancy.",
  "sample_size_training_set": "Not applicable. This device is an immunochromatographic test, not an AI/ML algorithm that requires a training set in the conventional sense.",
  "how_ground_truth_training_set_established": "Not applicable, as this device does not use an AI/ML algorithm that requires a training set with established ground truth."
}

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