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The iDart™ Lyme IgM ImmunoBlot Kit is an immunoblot assay intended for the in vitro qualitative detection of IgM antibodies to Borrelia burgdorferi in human serum. The iDart™ Lyme IgM ImmunoBlot Kit is intended to detect antibodies to Lyme Screen Antigen (LSA) and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the iDart™ Lyme IgM ImmunoBlot Kit are supportive evidence for the presence of antibodies and exposure to B. burgdorferi. Negative results do not preclude infection with B. burgdorferi. iDart™ Lyme IgM ImmunoBlot Kit is intended to aid in the diagnosis of Lyme disease and the test kit should only be used on samples from patients with clinical history, signs and symptoms consistent with Lyme disease. The iDart™ Lyme IgM Immunoblot Kit is not intended as a screen for asymptomatic patients.

Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

The iDart™ Lyme IgM ImmunoBlot tests are line immunoblot assays. Antigenic proteins specific for Borrelia species that cause Lyme Disease are produced by recombinant DNA technology in Escherichia coli. The purified proteins are then applied as discrete lines on a nitrocellulose membrane along with two control proteins. The iDart™ Lyme IgM ImmunoBlot Kit contains IgM ImmunoBlot strips and the proteins are applied in the following order: C1 (IgG/IgM – conjugate control), C2 (Protein L – calibrator/serum control), P93, P41 (2 antigen bands), P39 (2 antigen bands), P23 (9 antigen bands), P31 (9 antigen bands), P34, C10 and LSA (a chimeric VlsE peptide termed the Lyme Screen Antigen).

Here's an analysis of the acceptance criteria and study detailed in the provided FDA 510(k) clearance letter for the iDart™ Lyme IgM ImmunoBlot Kit.

Note: The provided text details the performance characteristics but does not explicitly state "acceptance criteria" in a separate section with numerical thresholds. Therefore, the "Acceptance Criteria" column in the table below is inferred from the achieved "Reported Device Performance" and common expectations for such devices (e.g., high agreement, specificity, and sensitivity). The "study that proves the device meets the acceptance criteria" refers to the clinical and analytical performance studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The studies detailed in the "PERFORMANCE CHARACTERISTICS" section of the 510(k) summary are designed to prove that the iDart™ Lyme IgM ImmunoBlot Kit meets the necessary performance standards for its intended use. These include:

• Reproducibility Study: Tested consistency across multiple sites, operators, and runs.
• Analytical Specificity Studies: Evaluated performance in healthy endemic and non-endemic populations, and cross-reactivity with various non-Borrelia pathogens and autoantibodies.
• Interference Study: Assessed impact of common endogenous substances.
• Method Comparison with STTT: Compared the device's accuracy (PPA and NPA) against the Standard Two-Tier Test methodology, which is a recognized approach for Lyme disease diagnosis.
• CDC Serum Panel Study: Evaluated sensitivity and specificity across different disease stages and in various control groups using a well-characterized reference panel.
• Fresh and Frozen Samples Comparison Study: Demonstrated stability of samples under different storage conditions.
• Antibody Class Specificity Study: Confirmed the specific detection of IgM antibodies.

Additional Information:

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

• Reproducibility: A panel of coded samples with different levels of anti-B. burgdorferi IgM (negative, high negative, low positive, moderate positives, and high positive samples). 90 replicates per sample were generated. The specific number of distinct samples in this panel is not explicitly stated beyond "a panel of coded samples".
• Analytical Specificity (Endemic): 177 samples from apparently healthy individuals in the US from endemic areas (CDC and Bay Area Foundation NY, MA, WI).
• Analytical Specificity (Non-Endemic): 127 samples from apparently healthy individuals in the US from non-endemic areas (CDC and IGeneX, Inc.).
• Cross-Reactivity Study: 243 serum samples from patients with bacterial or viral infections, as well as sera from patients with diagnoses that could be confused with Lyme disease (CDC, IGeneX, Inc., New York Biologics (NY), Kamineni Life Sciences Pvt. Ltd, Hydrabad (India), Warde Medical Laboratory (MI)).
• Interference Study: One positive, one low positive, and one negative Borrelia IgM samples (tested in singlicate with various spiked interfering agents).
• Method Comparison with STTT: 997 prospectively collected serum samples procured from IGeneX, Inc.
• CDC Serum Panel: 258 serum samples from the CDC panel. These included patients with Lyme disease at different stages and Lyme disease look-alike infections, and healthy controls.
• Fresh and Frozen Samples Comparison Study: 63 fresh samples and 63 frozen samples.
• Antibody Class Specificity: 8 previously tested patient samples (4 negatives, 4 positives).

Data Provenance: The data appears to be a mix of retrospective and prospective. Samples from "apparently healthy individuals" and "patients with bacterial or viral infections" can be either. The "Method Comparison with STTT" explicitly states "Prospectively collected serum samples" from IGeneX, Inc. The CDC Serum Panel is a reference panel, usually well-characterized retrospectively. Locations include the US (CDC, Bay Area Foundation NY, MA, WI, IGeneX, Inc., New York Biologics (NY), Warde Medical Laboratory (MI)) and India (Kamineni Life Sciences Pvt. Ltd, Hydrabad).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the clinical study samples. For the "Method Comparison with comparators (STTT)", the comparison is against "FDA-cleared EIA and immunoblot as part of the standard two-tier test methodology (STTT)". This implies the ground truth for these samples was established by the results of the STTT, which is a standardized and accepted diagnostic algorithm, rather than by individual expert interpretation. For the CDC Panel, the samples are "from patients diagnosed with Lyme Disease at different stages" or "Lyme disease look-like infections", suggesting that the CDC provided established diagnoses based on their protocols, which would implicitly involve expert clinical and laboratory evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe an explicit adjudication method (like 2+1 or 3+1) for establishing ground truth for the clinical test sets. The ground truth for the method comparison study was the result of the "FDA-cleared EIA and immunoblot as part of the standard two-tier test methodology (STTT)". For the CDC panel, it was based on the provided "diagnosis".

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:
No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) kit for laboratory use (an ImmunoBlot assay, specifically evaluating IgM antibodies) rather than an AI-powered image analysis system or a device requiring human-in-the-loop interpretation that would typically necessitate such a study. The "reading" of the immunoblot strips is performed visually but the interpretation criteria are clearly defined, not requiring subjective interpretive discretion usually addressed by MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not directly applicable in the terms typically used for AI/software devices. The iDart™ Lyme IgM ImmunoBlot Kit is a lab-based immunoassay. Its performance characteristics (sensitivity, specificity, reproducibility) were evaluated as a standalone device (without external assistance like AI or human readers for interpretation, other than the standard visual reading of the bands per the kit's instructions), as demonstrated by the analytical and clinical studies. The results are generated by the chemical reaction on the strip and interpreted based on predefined criteria. It's an "algorithm only" in the sense of the assay's biochemical process and visual interpretation rules, operating without additional "human-in-the-loop" modifications to its fundamental mechanism or output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used primarily appears to be:

• Standard Two-Tier Test (STTT) results: For the majority of the clinical method comparison study (N=997), the device was compared against the results from "FDA-cleared EIA and immunoblot as part of the standard two-tier test methodology".
• Clinical Diagnosis from CDC: For the CDC reference panel, samples were from patients "diagnosed with Lyme Disease at different stages" or "Lyme disease look-like infections". This implies a ground truth established through a combination of clinical evaluation, laboratory tests, and expert judgment according to CDC protocols.

8. The sample size for the training set:
Not applicable/Not specified. This is an in vitro diagnostic kit (ImmunoBlot assay), not a machine learning or AI-based device that typically requires a distinct "training set" for model development. The antigens used are recombinant proteins, and the assay's interpretation criteria are rule-based, not learned from a dataset.

9. How the ground truth for the training set was established:
Not applicable. As stated above, this device does not utilize a training set in the context of machine learning. The design and validation of immunoblots are based on known antigen-antibody interactions and assay development methodologies.

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The iDart™ Lyme IgG ImmunoBlot Kit is an immunoblot assay intended for the in vitro qualitative detection of IgG antibodies to Borrelia burgdorferi in human serum. The iDart Lyme IgG ImmunoBlot Kit is intended to detect antibodies to LSA and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the iDart Lyme IgG ImmunoBlot Kit are supportive evidence for the presence of antibodies and exposure to B. burgdorferi. Negative results do not preclude infection with B. burgdorferi. iDart™ Lyme IgG ImmunoBlot Kit is intended to aid in the diagnosis of Lyme disease and the test kit should only be used on samples from patients with clinical history, signs and symptoms consistent with Lyme disease. The iDart Lyme IgG Immunoblot Kit is not intended as a screen for asymptomatic patients.

Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

For in vitro diagnostic use only
For professional use only
For prescription use only

The iDart™ Lyme IgG ImmunoBlot tests are line immunoblot assays. Antigenic proteins specific for Borrelia species that cause Lyme Disease are produced by recombinant DNA technology in Escherichia coli. The purified proteins are then applied as discrete lines on a nitrocellulose membrane along with two control proteins.

The iDart™ Lyme IgG ImmunoBlot Kit contains IgG ImmunoBlot strips and the proteins are applied in the following order: C1 (lgG/lgM - conjugate control), C2 (Protein L - calibrator/serum control), P93, P41, P39, P23, P31, P66, P58, P45, P34, P30, P28, P18 and LSA (a chimeric VISE peptide termed the Lyme Screen Antigen).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iDart™ Lyme IgG ImmunoBlot Kit are primarily demonstrated through its analytical performance (reproducibility, analytical specificity, cross-reactivity, interference) and clinical performance (method comparison with STTT, clinical sensitivity/specificity using a CDC panel).

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

• Reproducibility: 90 samples for each of the 6 sample types (High Positive, Moderate Positive, Negative-1, Negative-2, Negative-3, Low Positive). Total of 540 tests performed across 3 sites, 2 operators, 5 days, 2 runs/day. Data provenance is not explicitly stated beyond "blinded and coded samples."
• Analytical Specificity (Healthy Individuals):
  • 313 samples from endemic areas (CDC, Bay Area Lyme Foundation - NY, MA, WI).
  • 112 samples from non-endemic areas (CDC, CA).
• Cross-Reactivity Study: 376 samples from various disease states/infections (CDC, IGeneX (CA), New York Biological (NY), BEI, Kamineni Life Sciences Pvt. Ltd, Hydrabad (India), Warde Medical Laboratory (MI)).
• Interference Study: One positive, one low positive, and one negative Borrelia IgG sample were used for each interference agent and concentration, tested in singlicate.
• Clinical Studies (Method Comparison with STTT): A total of 768 serum samples.
  • Site 1: 290 clinical serum samples from Bay Area Lyme Foundation.
  • Site 2: 37 clinical serum samples (Cohort 2) + 230 clinical serum samples (Cohort 3) from IGeneX Inc.
  • Site 3: 211 clinical serum samples (Cohort 2) from IGeneX Inc.
  • Data provenance: "procured from two vendors" (Bay Area Lyme Foundation and IGeneX Inc.). Samples were "prospective banked samples" or "clinical serum samples."
• Clinical Sensitivity/Specificity (CDC Serum Panel): 280 serum samples from CDC (patients with Lyme disease at different stages, look-alike conditions, healthy controls from endemic and non-endemic regions).
• Fresh and Frozen Samples Comparison Study: 72 decoded left-over patient serum samples.
• Antibody Class Specificity: 10 previously tested patient samples (6 negatives, 4 positives).

All clinical samples were "blinded, re-coded."

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

The document does not explicitly state that experts were used to establish ground truth for the test set derived from clinical samples. Instead, the ground truth for these clinical performance studies appears to be based on:

• STTT (Standard Two-Tier Test Methodology): This is a laboratory-based diagnostic algorithm involving an EIA/IFA screen followed by an immunoblot. Its results serve as the comparator (ground truth) for the method comparison study.
• CDC Reference Panel: For the clinical sensitivity/specificity, the CDC reference panel implicitly has established diagnoses for Lyme disease stages and other conditions. The process by which CDC established these diagnoses (e.g., expert consensus, other gold standards) is not detailed here.

For the reproducibility study, the samples were "blinded and coded" with "expected result" (e.g., High Positive, Negative). It's not specified how these initial categorizations were established.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple experts resolving discrepancies for the test set results. The evaluations are primarily against established comparators like STTT or reference panels (CDC). For the reproducibility study, the agreement was 100%, so no adjudication would have been required for discrepancies.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance studies focus on the device's standalone accuracy against existing diagnostic methods/reference panels, rather than how human readers' performance might improve with or without AI assistance. The device is an ImmunoBlot Kit, not an AI-assisted diagnostic imaging or interpretation system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies reflect the standalone performance of the iDart™ Lyme IgG ImmunoBlot Kit. The "Principle of procedures" describes manual interpretation ("A strip reading guide included in each test kit shows the location of specific antigens in the test strip. ... Any band found having a visual intensity equal to or greater than the C2 control band intensity is considered as a significant (positive) band. Depending on the observed bands pattern, one can interpret the presence or absence of Lyme specific IgG antibodies in the patient serum."). The "Result Generation" for the device is listed as "Manual reading" in the comparison table. This indicates the studies assess the kit's performance as a laboratory test, interpreted by a human, but without a "human-in-the-loop" AI system.

7. The Type of Ground Truth Used

• Clinical Performance (Method Comparison): The "ground truth" was established by Standard Two-Tier Test Methodology (STTT), which involves FDA-cleared EIA and immunoblot tests, performed by laboratory personnel.
• Clinical Sensitivity/Specificity: The "ground truth" was established by the CDC Reference Panel, which represents diagnosed cases of Lyme disease at various stages, look-alike conditions, and healthy controls. The methods for establishing these CDC diagnoses are not detailed but likely involve a combination of clinical assessment and established laboratory criteria.
• Analytical Specificity / Cross-reactivity: Ground truth for these samples was "known to contain potentially cross-reactive antibodies to Lyme infection" or "healthy individuals" or specific disease states, implying prior clinical diagnoses or sample characterization.
• Reproducibility: Samples were initially characterized as "High Positive," "Negative," etc., which served as the expected result for comparison. The method for this initial characterization is not specified.
• Fresh/Frozen & Antibody Class Specificity: Ground truth was based on "previously tested patient samples" with known IgG status.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. The iDart™ Lyme IgG ImmunoBlot Kit is an immunoassay kit, not an AI-based device that requires model training. Therefore, this question is not applicable to the information provided.

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

As the device is not an AI/ML product, there is no "training set" or corresponding ground truth establishment process described in the document.

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ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV) are intended for in vitro diagnostic use in the clinical laboratory for detection of Plasmodium species in human venous whole blood (EDTA) samples from patients suspected of Plasmodium infection. The test kits are intended to aid in the diagnosis of malaria and to aid in the differential diagnosis of P. falciparum and P. vivax infection. The test kits should be used only on samples from patients with a clinical history, signs and symptoms consistent with malaria, and are not intended as a screen for asymptomatic patients.

The ID-FISH Plasmodium Genus Test Kit is a qualitative test for detection of malaria parasites in blood smears. Positive results should be supplemented with the Plasmodium species specific test kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit for identification and differentiation of Plasmodium falciparum and Plasmodium vivax. The results of these test kits should be used in conjunction with other diagnostic test results. Clinical performance has not been established for P. ovale, P. malariae, or P. knowlesi.

The ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV) are fluorescence in situ hybridization (FISH) assays to detect Plasmodium spp. or P. falciparum or P. vivax parasites in thin film blood smears prepared from EDTA venous whole blood samples.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

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