Search Results

The ZEUS IFA™ nDNA Test System is an indirect immunofluorescence assay utilizing Crithidia luciliae for the qualitative and semi-quantitative determination of anti-native DNA (nDNA) IgG antibodies to DNA in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of nDNA antibodies in conjunction with other serological and clinical findings can be used to aid in the diagnosis of systemic lupus erythematosus (SLE).

Not Found

This document is an FDA clearance letter for the ZEUS IFA nDNA Test System. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a standard FDA 510(k) clearance letter, confirming the device's substantial equivalence to a predicate device and outlining regulatory obligations.

Therefore, I cannot provide the requested information based on the provided input. The details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory document.

Ask a specific question about this device

The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-IDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

Not Found

The provided text is a 510(k) premarket notification clearance letter from the FDA for the "Immuno Concepts IgG Anti-nDNA Fluorescent Test System" and the "Image Navigator® Fluorescence Semiautomated Microscope." It details the device's indications for use and general regulatory information but does not contain the specific acceptance criteria, study details, or performance data that would allow for a complete answer to your request.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. To find the detailed study information, one would typically need to review the full 510(k) summary or the pivotal study report submitted by the manufacturer to the FDA, which is not included in this clearance letter.

Ask a specific question about this device

NOVA Lite® DAPI dsDNA Crithidia luciliae is an indirect immunofluorescent assay for the qualitative and/or semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies in human serum by NOVA View Automated Fluorescence Microscope or manual fluorescence microscopy. The presence of anti-dsDNA can be used in conjunction with other serological and clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE). All results generated with NOVA View device must be confirmed by a trained operator.

The NOVA Lite DAPI dsDNA Crithidia luciliae Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of Anti-dsDNA Antibodies (IgG) in human serum. Samples are diluted 1:10 in PBS and incubated with the antigen substrate (dsDNA on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with antihuman IgG-FITC conjugate. The conjugate contains a DNA-binding blue fluorescent dye, 4',6-diamidino-2phenylindole (DAPI) that is required for NOVA View use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off. Stained slides are read by manual fluorescence microscope or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. dsDNA positive samples exhibit an apple green fluorescence corresponding to areas of the substrate where autoantibody has bound.

Here's a breakdown of the acceptance criteria and study details for the NOVA Lite DAPI dsDNA Crithidia luciliae Kit, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: 6 samples (2 negative, 2 borderline, 2 positive), each processed in triplicate across 14 runs (2 runs/day for 7 days), resulting in 42 data points per sample.
   • Reproducibility Studies (Between sites/instruments): 10 samples (3 negative, 7 positive), each tested in triplicate, twice a day for 5 days at each of 3 sites. This results in 30 data points per sample per site, or 90 data points per sample across all sites. Total data points for this study: 10 samples * 30 data points/sample * 3 sites = 900 data points.
   • Reproducibility (Between lots): 20 clinically and/or analytically characterized samples, tested in duplicate.
   • Linearity Study: 3 positive samples (high, medium, low), serially diluted from 1:10 up to 1:5120. (Number of replicates not specified for this part, but results are given for each dilution).
   • Interference Study: 3 specimens (one negative, one positive, one strong positive) for each interferent, with interfering substances spiked at three different concentrations in 10% of total specimen volume. Samples assessed in triplicates.
   • Sample Stability and Handling: 3 samples (negative, cut-off, positive), tested in duplicates for various conditions (up to 21 days at 2-8°C, up to 48 hours at room temperature, up to 3 freeze/thaw cycles).
   • Reagent Stability (Shelf-life): 3 lots of the kit, tested over 4 weeks accelerated stability (each week = 6 months real time). Real-time stability data was available up to 24, 15, and 19 months for the respective lots at the time of submission.
   • Reagent Stability (In-use/Open Vial): Not detailed how many units/tests were performed each week for 8 weeks.
   • Clinical Performance (Initial Study): 766 clinically characterized serum samples (391 SLE, 375 other diseases). No explicit country of origin is stated, but given this is an FDA submission for Inova Diagnostics, Inc. in San Diego, California, it is reasonable to infer a US-centric data provenance. The study appears to be retrospective based on "clinically characterized serum samples."
   • Clinical Performance (3 Sites Study): 269 clinically characterized samples tested at three sites. Total for reporting: 100 positive (SLE) and 169 negative (non-SLE) per site. The samples comprise 300 SLE and 507 non-SLE clinical diagnoses in total across the three sites. The data provenance is likely multi-center, potentially within the US. The description "clinically characterized samples" suggests these were collected and diagnosed prior to the study, implying a retrospective nature.
   • Expected Values: 120 samples from apparently healthy subjects (60 females, mean age 41, range 18-73).
   • Comparison with Predicate Device: The same 744 serum samples used in the initial clinical study (391 SLE, 353 other diseases).
   • SWT Validation: 31 positive samples for initial validation. 7 positive samples in the between-sites reproducibility study.

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

   • For clinical studies: The ground truth for the clinical studies is stated as "clinically characterized serum samples" and "clinical diagnosis." This implies that the samples were obtained from patients with established diagnoses, likely made by medical professionals (e.g., rheumatologists for SLE patients). The text does not specify the number of experts or their exact qualifications (e.g., "Radiologist with 10 years of experience" is not mentioned, as this is an immunoassay, but rather "clinicians" or "diagnosticians").
   • For analytical studies (Precision, Reproducibility, Linearity, Interference, Stability): The ground truth (Expected Result/Expected Grade) for the control samples or known samples was established by the manufacturer, often based on previous characterization or established laboratory practices. The interpretation of "Manual Reading" and "Digital Reading" results are performed by "trained operators."

3. Adjudication method for the test set:

   • For analytical results (Precision, Reproducibility, Linearity, Interference, Stability): The text mentions that "Digital images were interpreted and confirmed" in multiple sections (e.g., Linearity, Interference, Sample Stability). For the "Reproducibility Studies (Between sites/instruments)", manual and digital reading was performed by "two operators at each site, to assess between operator reproducibility." The acceptance criteria then focus on agreement percentages between operators. This implies that if disagreements occurred, they were likely adjudicated to reach the "Summary" percentages. However, a specific formal adjudication method like "2+1" or "3+1" is not explicitly stated.
   • For clinical results: The clinical samples were "clinically characterized," meaning their diagnosis served as the ground truth. There's no indication of an adjudication process for these clinical diagnoses within the context of this device study.

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:

   • This is not a traditional MRMC comparative effectiveness study involving AI assistance improving human readers. The study compares three modes of interpretation:
     • Manual Reading: Human interpretation using a traditional fluorescence microscope.
     • Digital Reading: Human interpretation of NOVA View generated images on a computer monitor.
     • NOVA View (Software): Automated interpretation by the device's software (algorithm only), which is then confirmed by a trained operator.
   • Therefore, the setup is more of a comparison between manual microscopy, human interpretation of digital images, and the device's automated output. The device itself (NOVA View) is not presented as an AI-assistance tool for human readers but as an alternative interpretation method that still requires human confirmation.
   • The "effect size of how much human readers improve with AI vs without AI assistance" is not directly measured in this context because the "NOVA View" results are the algorithm's output, not a human reader assisted by the algorithm. The "Digital Reading" is human interpretation of the images produced by the NOVA View device, which might be considered an "assisted" or "different modality" reading but not in the typical AI-driven improvement sense.

   Let's look at sensitivity/specificity to show the comparison between manual, digital (human on digital images), and NOVA View (algorithm):

   Initial Clinical Study (N=766)

   • Sensitivity (on SLE):
     • Manual: 48.1% (43.2-53.0)
     • Digital: 48.1% (43.2-53.0)
     • NOVA View: 57.0% (52.1-61.8)
   • Specificity:
     • Manual: 91.2% (87.9-93.7)
     • Digital: 92.3% (89.1-94.6)
     • NOVA View: 88.8% (85.2-91.6)

   Clinical Studies 3 Sites (N=807)

   • Sensitivity (on SLE):
     • Manual Reading: 32.7% (27.6-38.2)
     • Digital Reading: 34.0% (28.9-39.5)
     • NOVA View: 40.0% (34.6-45.6)
   • Specificity:
     • Manual Reading: 95.5% (93.3-97.0)
     • Digital Reading: 95.5% (93.3-97.0)
     • NOVA View: 85.4% (82.1-88.2)

   In both clinical studies, the NOVA View algorithm demonstrates higher sensitivity for SLE detection compared to manual or digital human readings, but lower specificity. This highlights a performance difference, not an improvement of human readers with AI assistance.

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

   • Yes, the "NOVA View" performance reported in the tables (e.g., sensitivity, specificity, qualitative agreements in reproducibility studies) represents the standalone algorithm's performance.
   • The text explicitly states: "All results generated with NOVA View device must be confirmed by a trained operator." This indicates that while the software generates automated classifications, the final clinical interpretation includes a human-in-the-loop for confirmation. The reported performance metrics for "NOVA View" specifically reflect the device's automated output.

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

   • Clinical Ground Truth: "Clinical diagnosis" for patient-derived samples (e.g., Systemic Lupus Erythematosus (SLE), Drug Induced Lupus, Infectious Disease, etc.). This is likely based on a combination of clinical findings and serological tests by clinicians. It is stated as "clinically characterized serum samples."
   • Analytical Ground Truth: For the precision, reproducibility, linearity, interference, and stability studies, the "Expected Result" or "Expected Grade" for the tested samples serves as the ground truth. These are typically reference materials or well-characterized samples with known positive/negative status or reactivity grades established by the manufacturer.

7. The sample size for the training set:

   • The document does not explicitly state the sample size of a training set for the NOVA View algorithm. It describes validation studies (test sets) for the kit and the performance of the NOVA View device, but not how the algorithm itself was developed or trained.
   • What is mentioned is that for the SWT (Single Well Titer) feature, "The SWT function was established using 22 dsDNA positive samples that represent various levels of antibodies." However, this refers to establishing the intensity curves for titer determination, not necessarily a broad 'training set' for the overall positive/negative classification logic or image analysis.

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

   • As the training set size is not stated, neither is the method for establishing its ground truth.
   • For the 22 dsDNA positive samples used to establish SWT intensity curves, it is implied that manual and digital readings (human interpretations) served as comparison points for establishing the LIU (Light Intensity Units) to titer relationship. The validation of SWT compares its output to manual and digital end-point titers.

Ask a specific question about this device

The EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern test kit is intended for the qualitative and semiquantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is a sensitive method, used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

Not Found

This is an FDA 510(k) clearance letter for a medical device. It does not contain the detailed study information needed to answer the questions about acceptance criteria, device performance, and study design. The letter confirms that the device, "EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern," has been found substantially equivalent to a predicate device for aiding in the diagnosis of systemic lupus erythematosus (SLE).

To answer your questions, I would need access to the full 510(k) submission, which would include the performance studies and acceptance criteria agreed upon with the FDA. This information is typically not publicly available in the clearance letter itself.

Ask a specific question about this device

The EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit is intended for the quantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

Not Found

The provided text is a U.S. FDA 510(k) clearance letter for the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit. This document primarily focuses on regulatory approval and indications for use, stating that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does NOT contain the detailed information about acceptance criteria or the specific study that proves the device meets those criteria, as typically found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot provide the requested information from the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Information about experts, ground truth establishment, or adjudication methods.
4. Details about MRMC studies, effect sizes, or standalone algorithm performance.

To provide the requested information, you would typically need to refer to the device's 510(k) summary, the full 510(k) submission, or relevant clinical study publications, which are not included in this document.

Ask a specific question about this device

Ask a specific question about this device

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum.

Immuno Concepts IgG Anti-nDNA Fluorescent Test System - Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The study compares the Immuno Concepts IgG Anti-nDNA Fluorescent Test System to a legally marketed predicate device, "Crithidia lucilliae DS DNA Kit (Diagnostic Use)" (K930987). The acceptance criteria are implicitly derived from the reported statistics based on this comparison.

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

• Sample Size: 223 samples
  • 121 samples submitted to clinical laboratories for anti-nDNA testing.
  • 100 blood donors.
  • 2 WHO standards known to contain anti-nDNA antibodies.
• Data Provenance: Not explicitly stated, but based on the context of samples submitted to clinical laboratories and blood donors, it is likely retrospective clinical samples. The country of origin is not specified.

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

• Number of Experts: Not applicable. The ground truth for comparative effectiveness was established by the predicate device's results, not by independent experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study is a direct comparison to a predicate device, where the predicate device's results serve as the reference. There is no mention of an adjudication process by human readers for the primary comparison.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This study directly compared the performance of the new device to a predicate device, rather than assessing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance: Yes, a standalone performance study was done in the sense that the device's diagnostic performance metrics (sensitivity, specificity, etc.) were calculated based on its output compared to a reference standard (the predicate device). The algorithm's output was directly compared to the predicate's output for all 223 samples.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for the primary comparative effectiveness study was the results obtained from the legally marketed predicate device ("Crithidia lucilliae DS DNA Kit (Diagnostic Use)"). Additionally, two WHO standards known to contain anti-nDNA antibodies were used as positive controls, and samples submitted to clinical laboratories and blood donors provided a range of reactivity.

8. Sample Size for the Training Set

• Sample Size for Training: Not applicable. This device is an indirect fluorescent antibody test kit, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's performance is inherently based on its physical and chemical components and their interaction, which are generally developed through R&D and quality control, rather than machine learning training.

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

• Ground Truth for Training Set: Not applicable, as explained in point 8. The "training" for this type of test involves developing and optimizing the reagents and assay procedure, ensuring consistency and reliability through standard laboratory practices and quality control, not by processing a "training set" with established ground truth labels for an algorithm.

Ask a specific question about this device

The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Anti-native DNA (nDNA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to nDNA in human serum. Detection of nDNA IgG antibody in humans can be used as an aid in the diagnosis of systemic lupus erythematosus (SLE).

The nDNA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to nDNA antigen in human serum.

The provided document describes the performance characteristics of the "Indirect Fluorescence Assay for Anti-native DNA (nDNA) IgG Antibody" device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a separate section. However, the "Performance Characteristics" section provides data comparing the new device against an "Alternate IFA" (a commercially available nDNA IFA), implying these comparative metrics serve as the basis for acceptance. The performance is reported in terms of relative sensitivity, relative specificity, and relative agreement.

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

• Sample Size for Test Set: 149 sera for relative sensitivity/specificity/agreement. 20 positive sera for titer agreement. 4 sera (3 positive, 1 negative) evaluated for reproducibility, with serial dilutions and multiple assays resulting in 36 data points.
• Data Provenance: "The samples were frozen retrospective relative to a commonly treated population of patients diagnosed with SLE." The sera were "gender, and geographical areas," implying a diverse, though unspecified, geographical origin. It's explicitly stated that there was not an attempt to correlate the assay's results with disease presence or absence, and "No judgment can be made on the comparison assay's accuracy to predict disease." This means the study is a comparison to a predicate, not a clinical diagnostic performance study against a true disease gold standard.

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

• Number of experts: Not applicable. The "ground truth" for the test set was established by the "Alternate IFA" (a commercially available nDNA IFA), not by human experts. The study directly compares the new device's results to the predicate device's results.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable, as the "ground truth" was derived from a predicate device's results, not human interpretation requiring adjudication.

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 is an in vitro diagnostic (IVD) device for laboratory testing, not an AI-assisted diagnostic imaging or interpretation tool for human readers. There are no human readers or AI involved in the interpretation of results as per the described device operation.

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

• Yes, this study is inherently a standalone performance evaluation of the device itself. The device (IFA for nDNA IgG antibody) is an in vitro diagnostic test. Its performance is measured based on its direct output (positive/negative, titer) in comparison to a predicate device. There is no human-in-the-loop component described for its operation or interpretation.

7. The type of ground truth used:

• Reference standard/Predicate device result: The "ground truth" for this study was the results obtained from a "commercially available nDNA IFA" (the Alternate IFA). The study explicitly states, "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease."

8. The sample size for the training set:

• Not applicable. This is a traditional IVD device, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device