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The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the SCoV-2 Ag Detect Rapid Test and followed up with a molecular test.

A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as tor diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024. The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens.

The provided text is a 510(k) clearance letter from the FDA for the "SCoV-2 Ag Detect Rapid Test." It primarily focuses on the regulatory aspects of the device's clearance and does not contain detailed information about the acceptance criteria, specific study design, or performance metrics from the validation study.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, expert qualifications, etc.) from this document. The letter itself confirms the device's substantial equivalence to legally marketed predicates but does not include the performance data that supported this determination.

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The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent 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). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). 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 evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day four 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.

This assay is not indicated for testing blood or plasma donors.

The ZIKV Detect IgM Capture ELISA is a sandwich-type immunoassay. The test kit includes microtiter wells coated with anti-human IgM antibodies, ZIKV IgM Negative, and IgM Positive controls, ZIKV Sample Dilution Buffer, ZIKV Recombinant Antigen (Zika Ag) for IgM, Cross-reactive Control Antigen (CCA) for ZIKV IgM and normal cell antigens (NCA), secondary antibodies targeting the flavivirus antigens. The test kit also contains a HRPlabeled ZIK V-specific monoclonal antibody and tetramethylbenzidine (TMB) substrate which are used to detect ZIKV IgM antibodies in the wells.

The ZIKV Detect 2.0 IgM Capture ELISA contains sufficient reagents for one plate of 96 wells (12 x 8 strips) for human IgM targeting Zika virus. This is sufficient for testing a maximum of 28 unknown samples for human IgM, with controls included in duplicate.

Here's a breakdown of the acceptance criteria and the study details for the ZIKV Detect 2.0 IgM Capture ELISA, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text doesn't explicitly state "acceptance criteria" in a separate section with specific numerical targets like "Sensitivity > X%" or "Specificity > Y%." However, from the "Performance Characteristics" and "Clinical Studies" sections, we can infer the expected performance and compare it with the reported results. The FDA's conclusion that the device's information is "sufficient" to classify it implies that the presented performance met their internal, unstated acceptance criteria for a class II device with special controls.

Here's an inferred table based on the provided results:

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

• Analytical Reproducibility Study:

  • Test Set Sample Size: 5 panel members (negative, high negative, low positive, moderate positive, re-test specimen). Each panel member had 270 replicates (3 replicates x 3 sites x 2 operators x 5 days x 3 kit lots / 3 kit lots). So, essentially 5 samples were tested extensively.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-generated samples or well-characterized clinical samples for analytical studies.

• Cross-Reactivity Studies (Table 2):

  • Test Set Sample Size: 346 IgM positive serum specimens (across various microorganisms like Dengue, WNV, JE, Chikungunya, Malaria, Syphilis, etc.).
  • Data Provenance: Sourced from patients with confirmed IgM antibodies to potentially cross-reactive microorganisms. Some specific details: Yellow Fever Vaccine recipients from Colombia during a 2016 Zika outbreak; convalescent phase samples for Dengue. Seems retrospective collection.

• Interfering Substances Study:

  • Test Set Sample Size: 3 low reactive human serum samples and 3 normal human serum samples per interfering substance.
  • Data Provenance: Laboratory spiked samples.

• Analytical Sensitivity (LOD) Study:

  • Test Set Sample Size: Multiple dilutions of the WHO 1st International Standard for anti-Asian lineage Zika virus antibody (human) were tested in 20 replicates each.
  • Data Provenance: WHO International Standard, a reference material.

• Clinical Studies (Endemic and Non-Endemic Subjects):

  • Test Set Sample Size: 807 unique samples were collected from 609 subjects.
    • Endemic subjects: 353 samples.
    • Non-endemic subjects: 256 samples.
    • 744 samples had known Days Post Symptom Onset (PSO).
  • Data Provenance: Collected from endemic sites (presumed positive and presumed negative) and non-endemic sites (presumed negative). Some subjects provided serial draws up to 84 days PSO. Some from Zika endemic areas provided paired acute/convalescent draws. This is a prospective collection for the vast majority, as samples were "collected from these subjects." Geographical origin of "endemic" and "non-endemic" sites is not explicitly mentioned by country, but they are clearly differentiated.

• FDA Performance Panel:

  • Test Set Sample Size: Not explicitly stated for the entire panel, but reported for the subsets analyzed: 24 Zika IgM Consensus Positive, 12 Negative, 10 West Nile positive, 10 Dengue positive.
  • Data Provenance: Provided by the FDA from individuals infected with Zika, West Nile, or Dengue viruses at various stages of infection. This appears to be a retrospective collection of well-characterized samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The text does not specify the number or qualifications of experts used to establish the ground truth for any of the studies.

• Clinical Studies (Endemic and Non-Endemic): The ground truth was established by a "composite reference method that included a validated Zika RT-PCR and CDC Zika MAC-ELISA." While these are laboratory tests, they would have been interpreted by trained laboratory professionals, but no specific expert count or qualification is given.
• FDA Performance Panel: Ground truth ("established consensus of sero-status") was established by the FDA. Again, specific expert details are omitted.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method (like 2+1, 3+1) for resolving discrepancies in ground truth determination for any of the studies.

• Clinical Studies: The "composite reference method" combining RT-PCR and CDC Zika MAC-ELISA implies a sequential or parallel testing strategy where results from both contribute to the final ground truth. It does not mention an expert adjudication process if these reference methods yielded conflicting results.
• FDA Performance Panel: The "established consensus of sero-status" suggests that a consensus process was used by the FDA, but the details of this process (e.g., how many readers/experts, how discrepancies were resolved) are not provided.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an ELISA assay, which is a laboratory diagnostic tool, not an AI-assisted diagnostic imaging or interpretation system. Therefore, the concept of human readers improving with AI assistance does not apply here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the performance presented in the "Analytical performance" and "Clinical studies" sections primarily reflects the standalone performance of the ZIKV Detect 2.0 IgM Capture ELISA device. The results (e.g., PPA, NPA, cross-reactivity tables) are direct outputs of the assay based on its internal algorithms and interpretation rules described (Zika ISR, CCA/NCA ratio). While human operators perform the test and interpret the final result based on the device's guidelines, the performance metrics reported are for the device itself against the established ground truth, not for human interpretation aided by the device.

7. Type of Ground Truth Used

• Analytical Sensitivity (LOD): World Health Organization (WHO) 1st International Standard for anti-Asian lineage Zika virus antibody (human) – a standardized reference material.
• Clinical Studies (Endemic and Non-Endemic): A composite reference method consisting of a validated Zika RT-PCR and CDC Zika MAC-ELISA. This is a combination of molecular (RT-PCR) and serological (MAC-ELISA) laboratory tests.
• FDA Performance Panel: "Established consensus of sero-status" – this implies a consensus derived from laboratory tests (Zika IgM, West Nile, Dengue).

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device's development in the context of machine learning or AI models. Given that this is an ELISA assay, the concept of a training set as understood in AI/ML is not directly applicable.

However, the "Assay cut-off" section mentions:

• "The study included a testing of eight hundred thirty five (835) specimens that included 72 Zika positive, 198 other flavivirus positive, and 565 other disease positive and negative serum specimens. Receiver Operating Characteristic (ROC) curve analyses were performed to optimize for those cut-off values that maximize both sensitivity and specificity. A rudimentary bootstrap method was applied to minimize bias by any potential outliers in the sample set."
  This process of optimizing cut-off values using 835 specimens could be considered analogous to a "training" or "calibration" phase for the device's interpretation algorithm, where the rules for classifying samples (e.g., Zika Ag OD450 > Threshold, Zika ISR > 1.90) were established.

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

For the 835 specimens used to establish the assay cut-off:

• Ground Truth Establishment: The specimens were categorized as "Zika positive," "other flavivirus positive," and "other disease positive and negative." The method by which these 835 specimens were initially classified (i.e., their ground truth) is not explicitly detailed in the document. It is implied these were diagnostically confirmed samples (e.g., using reference assays like those used in the clinical studies), but the specific process is not described.

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The DENV Detect™ NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 - day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision.

This assay is not FDA cleared or approved for testing blood or plasma donors.

Not Found

The provided document is a 510(k) premarket notification for a medical device called "DENV Detect™ NS1 ELISA", which is for the early detection of Dengue virus NS1 antigen. The document does not include information about acceptance criteria or specific study results to prove the device meets said criteria. It primarily covers the FDA's decision regarding substantial equivalence.

Therefore, I cannot fulfill your request for:

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

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The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi. The CDP when used in conjunction with other serological and clinical information is useful for the diagnosis of individuals with Chagas disease. Definitive diagnosis of an acute phase infection (including acute congenital infection) must be made by alternative methods, e.g., hemoculture, blood smear. This test is not intended for use on cord blood or for screening blood or plasma donors.

The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood).

The provided text is a 510(k) premarket notification letter from the FDA regarding the Chagas Detect™ Plus Rapid Test. It confirms the device's substantial equivalence to legally marketed predicate devices.

However, the document does not contain any information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. It is for a rapid immunochromatographic strip assay, which is a laboratory diagnostic test, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML model's performance evaluation cannot be extracted from this document.

The document discusses:

• The device name: Chagas Detect™ Plus Rapid Test
• Its intended use: Qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood.
• Regulatory information: Regulation Number, Name, Class, and Product Code.
• The FDA's determination of substantial equivalence.
• General controls provisions and other regulatory requirements for the device.

To fulfill the request, a document describing an AI/ML medical device's performance study would be necessary.

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The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.

Not Found

The provided document is an FDA 510(k) clearance letter for the "CL Detect™ Rapid Test" and its Indications for Use statement. It declares the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only states the intended use of the device:

Device Name: CL Detect™ Rapid Test

Indications for Use: The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four-month-old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL Detect™ Rapid Test is to aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.

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