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The Maverick RNP Assay is an immunoassay for the semi-quantitative determination of anti-RNP IgG antibodies in human serum on the Maverick Diagnostic System. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Mixed Connective Tissue Disease (MCTD).

The Maverick Diagnostic System (MDS) is an automated immunoasay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

The Maverick Diagnostic System (MDS) is an automated immunoasay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Genalyte Maverick RNP Assay and Maverick Diagnostic System does not contain any information regarding the acceptance criteria, the study design, or the results of performance studies that prove the device meets these criteria.

The document primarily focuses on:

• The FDA's notification of clearance (substantial equivalence determination).
• Regulatory requirements related to the device.
• The intended use of the device (Indications for Use).
• Paperwork Reduction Act information.

Therefore, I cannot extract the specific details requested in your prompt, such as:

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 and their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC study details and effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

To obtain this information, you would typically need to refer to the Premarket Notification (510(k)) Summary or the FDA Review Memo for K191085, which are often available on the FDA's website alongside the clearance letter. These documents provide the detailed technical information, study designs, and performance data that support the substantial equivalence determination.

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The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal Pproteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-idermatomyositis, mixed connective tissue disease and Sjögren's syndrome, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) test kit is intended to be used in a clinical, reference or hospital laboratory. This kit is not designed for point-of-care testing.

The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) consists of antigen coated test strips, a positive control, alkaline phosphatase-labelled anti-human IgG conjugate, sample buffer concentrate, NBT/BCIP substrate solution, incubation tray and test instruction. Evaluation protocol, reaction control card as well as further accessories for use with EUROLineScan are available separately.

The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal P-proteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-/dermatomyositis, mixed connective tissue disease and Sjögren's syndrome, in conjunction with other laboratory and clinical findings.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on method comparison studies against predicate devices rather than explicit acceptance criteria with pre-defined thresholds for agreement. However, the tables provided demonstrate the agreement rates between the EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) and predicate ELISA kits (K123261 or K063565). The reported percentages of negative, positive, and overall agreement, along with 95% Confidence Intervals (C.I.), serve as the performance indicators.

Below is a summary of the reported agreement rates for each analyte from the "Method Comparison" section (refer to the document for full tables and 95% C.I.):

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

• Sample Sizes for Method Comparison (Test Set):

  • nRNP/Sm: 936 samples
  • Sm: 917 samples
  • SS-A: 1036 samples
  • Ro-52: 276 samples
  • SS-B: 1036 samples
  • Scl-70: 663 samples
  • Jo-1: 626 samples
  • CENP B: 670 samples
  • Ribosomal P-proteins: 615 samples

• Data Provenance: The samples were "clinically characterized samples obtained from different sources." Specific countries of origin are not detailed in the provided text. The nature of "clinically characterized samples" implies a retrospective collection from patient cohorts.

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 the "clinical characterization" of the samples used in the method comparison and clinical studies. It mentions "clinically characterized samples," which typically implies diagnosis by medical professionals.

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

The document does not specify an adjudication method like 2+1 or 3+1 for the test set. The clinical characterization of samples is assumed to be the established reference.

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 not applicable. The device is an in-vitro diagnostic (IVD) kit for antibody detection, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Its evaluation is based on agreement with predicate devices and clinical performance in detecting antibodies.

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

A "standalone" performance study in the context of an algorithm without human-in-the-loop is not directly applicable here. The device itself is an assay (lineblot strip test). While it can be evaluated visually or by the EUROLineScan software, the performance results presented are for the kit's ability to detect antibodies and its agreement with predicate ELISA kits. The "analytical performance" section covers intra-assay, inter-assay, inter-lot, and inter-observer reproducibility, indicating that visual evaluation by humans plays a role, alongside potential software evaluation (EUROLineScan). However, the primary performance data refers to the assay's output itself, which is a qualitative positive/negative result for each antibody.

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

The ground truth for the method comparison studies was based on the results obtained from legally marketed predicate ELISA kits (EUROIMMUN Anti-nRNP/Sm ELISA (IgG), EUROIMMUN Anti-Sm ELISA (IgG), Inova Quanta Lite™ SS-A 52 ELISA, etc.). For the clinical studies section, the ground truth was "clinically characterized samples," meaning the diagnosis of autoimmune diseases (SLE, SSc, PM/DM, MCTD, Sjögren's, RA) and various control groups. This implies a clinical diagnosis, likely established by expert consensus based on symptoms, other laboratory findings, and possibly pathology where relevant to the disease.

8. The sample size for the training set:

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development for this diagnostic kit. The performance data presented is for validation studies. For the clinical studies, a total of 1279 clinically characterized samples were investigated. For establishing the reference range, 173 samples from US asymptomatic blood donors were tested.

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

As no explicit "training set" for an algorithm is mentioned, this question is not directly applicable in the conventional sense for this device. If the EUROLineScan software has its own "training," that information is not detailed in this submission summary. For the assay itself, the "ground truth" during its development would align with the established scientific understanding of antibody presence in specific autoimmune diseases and the performance of existing, validated diagnostic methods.

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The EUROIMMUN Anti-nRNP/Sm ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against nRNP/Sm in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Sm ELISA (IgG) test kit is intended for the qualitative of IgG class autoantibodies against Sm in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-SS-A ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against SS-A in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of Sjögren's syndrome and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-SS-B ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against SS-B in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of Sjögren's syndrome and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Scl-70 ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Scl-70 in human serum and plasma (EDTA, Li-heparin, Citrate), It is used as an aid in the diagnosis of progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Centromeres ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Centromeres in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of limited form of progressive systemic sclerosis (CREST syndrome), in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Jo-1 ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Jo-1 in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of polymyositis and dermatomyositis, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against ribosomal P-proteins in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-nRNP/Sm ELISA (IgG) consists of a microwell ELISA plate coated with nRNP/Sm antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-Sm ELISA (IgG) consists of a microwell ELISA plate coated with Sm antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-SS-A ELISA (IgG) consists of a microwell ELISA plate coated with SS-A antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate. TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-SS-B ELISA (IgG) consists of a microwell ELISA plate coated with SS-B antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-Scl-70 ELISA (IgG) consists of a microwell ELISA plate coated with Scl-70 antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-Centromeres ELISA (IgG) consists of a microwell ELISA plate coated with Centromeres antigen, calibrator, positive control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-Jo-1 ELISA (IgG) consists of a microwell ELISA plate coated with Jo-1 antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG) consists of a microwell ELISA plate coated with ribosomal P-proteins antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution.

Here's a breakdown of the acceptance criteria and study information for each of the EUROIMMUN ELISA kits for autoantibodies, as presented in the provided document.

It's important to note that the document outlines several ELISA kits (Anti-nRNP/Sm, Anti-Sm, Anti-SS-A, Anti-SS-B, Anti-Scl-70, Anti-Centromeres, and Anti-Jo-1, Anti-ribosomal P-proteins). Each kit has its own performance characteristics, and the requested information will be presented for each.

General Acceptance Criteria & Study Information (Applicable to all kits)

• Type of Test: Qualitative enzyme immunoassay (ELISA) for IgG class autoantibodies.
• Assay Cut-off: Ratio 1.0 (for all EUROIMMUN ELISA kits).
• Sample Types: Human serum and plasma (EDTA, Li-heparin, Citrate).
• Calibration: Relative evaluation/units.
• Ground Truth for Training/Testing: Clinically characterized samples. The document does not explicitly separate training and test sets with distinct ground truth methods for each. Instead, "comparison studies" utilize a test set of clinically characterized samples against a predicate device, and "clinical studies" evaluate performance against clinical diagnosis.
• Number of Experts to Establish Ground Truth: Not specifically mentioned for clinical characterization, but it's implied that clinical findings and diagnoses are established by medical professionals.
• Qualifications of Experts: Not explicitly stated, but assumed to be relevant medical specialists for the diagnoses of the conditions studied (e.g., rheumatologists, immunologists).
• Adjudication Method: Not explicitly mentioned. Clinical diagnoses are typically consensus-based among healthcare professionals or based on established diagnostic criteria.
• MRMC Comparative Effectiveness Study: No MRMC studies were performed in this context. The comparisons are between the new ELISA device and a predicate ELISA device (algorithm only, as they are immunoassay kits) and against clinical diagnoses (standalone performance).
• Standalone Performance: Yes, the clinical studies evaluate the standalone performance of the algorithm (the ELISA kit) in terms of clinical sensitivity and specificity against clinical diagnoses.
• Data Provenance: Samples were obtained from different sources from Europe and North America (retrospective, as they are "clinically characterized samples").
• Sample Size for Training Set: Not explicitly stated. The document focuses on performance characteristics and comparison/clinical studies with given sample sizes. It is common for ELISA development to use a subset of samples for initial optimization and cut-off determination, but specific "training set" sizes are not detailed in this regulatory summary.

1. EUROIMMUN Anti-nRNP/Sm ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against nRNP/Sm in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing mixed connective tissue diseases and systemic lupus erythematosus.

Table of Acceptance Criteria and Reported Device Performance:

2. EUROIMMUN Anti-Sm ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against Sm in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing systemic lupus erythematosus.

Table of Acceptance Criteria and Reported Device Performance:

3. EUROIMMUN Anti-SS-A ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against SS-A in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing Sjögren's syndrome and systemic lupus erythematosus.

Table of Acceptance Criteria and Reported Device Performance:

4. EUROIMMUN Anti-SS-B ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against SS-B in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing Sjögren's syndrome and systemic lupus erythematosus.

Table of Acceptance Criteria and Reported Device Performance:

5. EUROIMMUN Anti-Scl-70 ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against Scl-70 in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing progressive systemic sclerosis.

Table of Acceptance Criteria and Reported Device Performance:

6. EUROIMMUN Anti-Centromeres ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against Centromeres in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing limited form of progressive systemic sclerosis (CREST syndrome).

Table of Acceptance Criteria and Reported Device Performance:

7. EUROIMMUN Anti-Jo-1 ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against Jo-1 in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing polymyositis and dermatomyositis.

Table of Acceptance Criteria and Reported Device Performance:

8. EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG)

Intended Use: Qualitative determination of IgG class autoantibodies against ribosomal P-proteins in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing systemic lupus erythematosus.

Table of Acceptance Criteria and Reported Device Performance:

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EliA™ RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ RNP70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

EliA™ Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA™ Sci-70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

EliATM Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-1 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratory and clinical findings. EliATM Jo-1 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery|-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

This document describes the EliA™ RNP70, EliA™ Scl-70, and EliA™ Jo-1 immunoassays, which are intended for the semi-quantitative measurement of IgG antibodies to RNP70, Scl-70, and Jo-1 respectively, as an aid in diagnosing specific autoimmune diseases. The information provided is for their 510(k) premarket notification and focuses on establishing substantial equivalence to previously marketed predicate devices.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) or the reported device performance against such criteria in a table format.

Instead, the submission states that "the comparability of predicate device and new device is supported by a data set including: results obtained within a comparison study between new and predicate device, results obtained for clinically defined sera, results obtained for samples from apparently healthy subjects (normal population)." It concludes: "In summary, all available data support that the new devices are substantially equivalent to the predicate devices."

This implies a qualitative acceptance criterion of substantial equivalence to the predicate devices (Varelisa U1RNP Antibodies K993589, Varelisa Scl-70 Antibodies K944172, Varelisa Jo-1 Antibodies K944173). The "study that proves the device meets the acceptance criteria" is broadly described as a "comparison study between new and predicate device," along with testing on "clinically defined sera" and "samples from apparently healthy subjects." However, specific quantitative results from these studies were not detailed in the provided summary.

Detailed Information as Requested:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
   Substantial equivalence to predicate devices (Varelisa U1RNP Antibodies K993589, Varelisa Scl-70 Antibodies K944172, Varelisa Jo-1 Antibodies K944173)	"All available data support that the new devices are substantially equivalent to the predicate devices." (Quantitative results are not provided in this summary)

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

   • Sample Size: Not specified in the provided summary. The text mentions "a data set including results obtained within a comparison study," "clinically defined sera," and "samples from apparently healthy subjects."
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be for regulatory submission, but it's not indicated if they were prospective or retrospective. Given they involve "clinically defined sera" and "normal population" samples, these would likely be retrospective selections or collections for a specific validation study.

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

   • Not specified. The ground truth for "clinically defined sera" would presumably be based on established clinical diagnoses, likely determined by medical specialists, but the number and qualifications of experts involved in this determination are not mentioned.

4. Adjudication Method for the Test Set:

   • Not specified. This information is typically relevant for studies where multiple readers or assessors establish ground truth.

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 device is an in vitro diagnostic (IVD) immunoassay, not an AI software intended for human reader assistance with image interpretation or complex decision-making. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.

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

   • Yes, implicitly. The device is an automated immunoassay system (EliA IgG method on ImmunoCAP® 100/250 instruments) that performs measurements and provides semi-quantitative results. This is inherently a "standalone" or "algorithm only" performance, as it measures antibody levels in patient samples without direct human interpretation of the assay's output during the measurement process. The results are then used by clinicians as an "aid in clinical diagnosis."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • Likely clinical diagnosis based on a combination of clinical findings and possibly other laboratory tests, given the mention of "clinically defined sera" for conditions like mixed connective tissue disease (MCTD), systemic lupus erythematosus (SLE), scleroderma, and polymyositis/dermatomyositis. For the "normal population" samples, the ground truth would be the absence of these diseases.

8. The Sample Size for the Training Set:

   • Not specified. The document does not provide details about a training set, which is more common for machine learning or AI-based devices. For an immunoassay, method development and optimization would occur, but it's not typically categorized as a "training set" in the same way as AI.

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

   • Not applicable, as a distinct "training set" with ground truth establishment for an AI/ML algorithm is not described for this immunoassay device. Quality control and assay calibration are established using standardized materials and calibrators, as mentioned (e.g., "WHO-standardized IgG Calibrators derived from human serum").

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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. (*Antibodies to dsDNA, Sm, Sm/RNP, SSA, SSB, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

Clinical utility: The results of the FIDIS™ CONNECTIVE 10* are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).

FIDIS™ CONNECTIVE 10* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software.

FIDIS™ CONNECTIVE 10* kit may be used with the CARIS™ system (diluting and dispensing device).

This test is for in vitro diagnostic use.

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. The kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with antigens and internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, reconstitution buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER™ Software, and may be used with the CARIS™ system (diluting and dispensing device).

The Biomedical Diagnostics S.A. (bmd) FIDIS™ CONNECTIVE 10* assay is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay that uses flow cytometry to detect 10 autoantibody specificities. The device's performance was established through analytical performance studies and comparison studies against a predicate device (K053653 FIDIS™ CONNECTIVE 10* system) and manual assay preparation steps.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria mainly for precision and outlines performance through agreement studies.

Precision Acceptance Criteria and Reported Performance

Comparison Study with Predicate Device (K053653 FIDIS™ CONNECTIVE 10)*

The acceptance criteria for the comparison study are implicitly that the agreement (Positive Percent Agreement, Negative Percent Agreement, and Overall Agreement) should demonstrate substantial equivalence to the predicate device. While specific percentage targets are not explicitly stated as "acceptance criteria" in the table format, the observed agreement percentages with 95% LCLs are reported and deemed sufficient for substantial equivalence.

Comparison Study: Manual vs. Automated (CARIS™) Assay Preparation

Similar to the predicate comparison, the acceptance criteria here are also implicit that agreement between manual and automated methods shows substantial equivalence.

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

• Precision Study Test Set:

  • Within-run: 6 samples (5 for Jo1) tested 10 times in the same run.
  • Between-run: 6 samples (5 for Jo1) tested 3 times per run, across 6 runs.
  • The document does not specify the country of origin or whether the data was retrospective or prospective for the precision study samples.

• Comparison Study with Predicate Device Test Set:

  • Sample Size: 264 samples.
  • Composition: 194 samples positive for one or more parameters, and 70 negative samples (including some with potential biological interferences).
  • Data Provenance: The document states "obtained from routine laboratory" for interfering substances study (part of analytical performance) and implies a similar source for the comparison study, but the specific country of origin or retrospective/prospective nature isn't explicitly stated. However, given the manufacturer is based in France, it's plausible the samples originated from Europe.

• Comparison Study with Automated (CARIS™) system Test Set:

  • Sample Size: 264 samples.
  • Composition: 194 samples positive for one or more parameters, and 70 negative samples (including some with potential biological interferences).
  • Data Provenance: Same as above.

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

The document does not mention the use of human experts to establish ground truth for the test sets. Instead, the "ground truth" for the comparison studies is defined by the results obtained from the predicate device (K053653 FIDIS™ CONNECTIVE 10 system)* or the manual assay preparation steps of the modified device. For the analytical performance (e.g., precision, interfering substances), the "truth" is based on the inherent characteristics of the spiked or characterized samples.

4. Adjudication Method for the Test Set

This type of in-vitro diagnostic device study typically doesn't involve human adjudication in the traditional sense (e.g., for imaging studies). For the comparison studies, discrepancies were handled as follows:

• "All equivocal samples with predicate and modified CONNECTIVE 10* assays are considered negative for the comparison and the evaluation studies."
• For individual specificities, the number of equivocal results is noted (e.g., "There were 3 equivocal results with the assay. For purposes of calculation, these results were considered as negative."). This method effectively converts equivocal results into negative results for agreement calculations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test system, not an AI-assisted diagnostic tool that human readers would interact with in the context of interpretation. The comparison is between different versions or methods of the assay itself, or against a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone in-vitro diagnostic test system. The performance studies evaluate the device's analytical characteristics and its agreement with a predicate device or different operational modes (manual vs. automated sample preparation). There isn't an "algorithm" in the sense of a standalone AI intended to perform diagnostic interpretation; rather, it's a test system that provides semi-quantitative results. The system operates without human interpretive intervention beyond running the assay and reading the numerical output.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was:

• The results generated by the predicate device (K053653 FIDIS™ CONNECTIVE 10 system)* when comparing the modified device to the predicate.
• The results generated by the manual assay preparation steps when comparing the automated (CARIS™) assay preparation to manual preparation.

For the analytical precision and interfering substances studies, the ground truth was based on the known characteristics of the samples (e.g., characterized positive/negative samples, spiked samples, or samples with known interferences). There is no mention of pathology, expert consensus, or outcomes data being directly used as ground truth for these performance evaluations.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning or algorithm development. The studies performed are for performance evaluation and comparison studies for a medical device. Therefore, no training set size is reported in the provided text.

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

As no training set is indicated, this question is not applicable. The device's operational characteristics and comparisons are the focus of performance evaluation, not machine learning model training.

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The RhiGene MESACUP-2 TEST RNP is a semi-quantitative enzyme-linked immunosorbent assay for the detection of antibodies to RNP in human serum. The RhiGene MESACUP-2 TEST RNP is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

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I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request. The document discusses regulatory approval for a medical device (RhiGene MESACUP-2 Test RNP) and its intended use, but it does not include specifics about the acceptance criteria, the study design, sample sizes, or expert qualifications for performance evaluation.

Therefore, many of the requested fields cannot be filled based on the given text.

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The Varelisa® RNP Antibodies EIA kit is designed for the semiquantitative and qualitative determination of RNP antibodies in serum or plasma to aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD).

The Varelisa RNP Antibodies is an enzyme immunoassay for the semiquantitative and qualitative determination of RNP antibodies in serum or plasma. The determination of RNP antibodies is of central importance for the clinical diagnosis rheumatic autoimmune diseases. The presence of RNP antibodies suggests the possibility of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Diseases (MCTD). The Varelisa RNP Antibodies is an indirect noncompetitive enzyme immunoassay. The wells of a microplate are coated with human recombinant RNP (68 kDa, A, C) antigens. Antibodies specific for RNP present in a patient sample bind to this antigen. In a second step an enzyme labeled second antibody (Conjugate) binds to the antigenantibody complex which leads to the formation of an enzyme labeled antigen-antibody sandwich complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution. The rate of color formation from the chromogen is a function of the amount of Conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.

Here's an analysis of the provided text regarding the Varelisa® RNP Antibodies device, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a "Laboratory Equivalence" study rather than a traditional acceptance criteria study with predefined thresholds. The goal was to demonstrate substantial equivalence to a predicate device.

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

• Sample Size for Test Set: 70 samples (including 20 apparently healthy blood donors).
• Data Provenance: Not explicitly stated, but it's a "Laboratory Equivalence" study comparing two in-vitro diagnostic assays. The context implies the samples were human serum or plasma. It is not specified if the samples were retrospective or prospective, or the country of origin.

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

Not applicable. The "ground truth" for this comparative study was the result obtained from the predicate device (Synelisa™ U1-snRNP Antibodies), not an independent expert assessment. The study aimed to demonstrate agreement between the new device and an existing, legally marketed device.

4. Adjudication Method for the Test Set

Not applicable. There was no explicit adjudication method described. The comparison was directly between the results of the new device and the predicate device. For some omitted samples, the discrepancies were explained by the compositional differences of the assays (e.g., presence of RNP A and C in the new device, but not in the predicate).

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 device (an immunoassay) and the submission refers to the device itself, not AI assistance for human readers.

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

Yes, this study represents a standalone performance evaluation of the Varelisa® RNP Antibodies immunoassay. Its performance was compared directly to the predicate device without human interpretation or intervention as part of the primary measurement.

7. The Type of Ground Truth Used

The "ground truth" for the purpose of the substantial equivalence study was the results obtained from the predicate device (Synelisa™ U1-snRNP Antibodies). This is a common approach for demonstrating equivalence for IVD devices aiming for a 510(k) clearance. Clinical diagnosis (SLE and MCTD) is the ultimate clinical outcome, but for this specific regulatory submission, the predicate device's results served as the reference.

8. The Sample Size for the Training Set

Not applicable. This is an immunoassay kit, not a machine learning model, so there is no "training set" in the context of algorithm development.

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

Not applicable. There is no training set for this type of device.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of ten and the country liness of . DAR in byen secure Enzyme intiked minialioscroom and "ANP in human serum.

Uses:

The results of the anti-Sm/RNP assay can be used as an aid in the diagnosis of auto-immune I he results of the anti-Sits Reviews assure Disease (MCTD).
diseases including Mixed Connective Tissue Disease (MCTD).

For in vitro diagnostic use only.

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The provided document is a 510(k) clearance letter from the FDA for the Autostat™ II Anti-Sm/RNP ELISA device.

This document does not contain the detailed study information required to answer your request, such as acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or multi-reader multi-case study results.

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 indicates that the FDA's decision is based on a determination of substantial equivalence to a predicate device, rather than a detailed presentation of novel clinical study results with specific performance statistics against predefined acceptance criteria for this new device. The 510(k) submission itself would contain such data, but this letter is merely the FDA's response to that submission.

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Liquichek Anti-RNP Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies.

Liquichek Anti-RNP Control, EIA is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

This document describes a 510(k) submission for the Bio-Rad Liquichek Anti-RNP Control, EIA. This product is an unassayed quality control for monitoring enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies. As such, it is a quality control product, not a diagnostic device intended to directly measure patient analytes. Therefore, the traditional performance metrics and study designs (e.g., sensitivity, specificity, reader studies, etc.) typically associated with diagnostic devices are not applicable in this context.

Instead, the review focuses on establishing substantial equivalence to a predicate device, specifically the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, in terms of its characteristics as a quality control material.

Given the nature of the device as a quality control, the following information is not provided in the document and is generally not required for this type of submission:

• A table of acceptance criteria and reported device performance (in the diagnostic sense).
• Sample size used for the test set or data provenance (as there isn't a "test set" of patient samples in the traditional sense).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The "study" implicitly revolves around demonstrating that the Liquichek Anti-RNP Control, EIA is suitable for its intended use as a control, and its characteristics are comparable to an existing, legally marketed control or a device against which it can be benchmarked for substantial equivalence.

Acceptance Criteria and Device Performance (as inferred for a quality control device):

The acceptance criteria for a quality control device primarily focus on its composition, stability, and suitability for monitoring the intended assay. Based on the provided 510(k) summary, the device's performance is demonstrated by its substantial equivalence to the predicate device in terms of its intended use, form, matrix, storage conditions, and relevant analytes.

The Study Proving the Device Meets Acceptance Criteria (as inferred from the 510(k) submission):

The "study" for this device is the process of comparing its characteristics and intended use to a legally marketed predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit) to establish substantial equivalence. The FDA's review and subsequent clearance (K984476) confirm that this comparison was satisfactory.

The provided information focuses on the descriptive aspects of the device and its comparison to the predicate rather than a clinical performance study. The key elements of this "study" are:

1. Comparison Table: The document explicitly provides a table comparing the Bio-Rad Liquichek Anti-RNP Control, EIA with the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit across critical parameters such as intended use, form, matrix, levels, storage, and analytes. This table serves as the primary evidence for demonstrating substantial equivalence.
2. Product Description: A detailed description of the device's composition (human serum with preservatives and stabilizers, liquid form) is provided to ensure its suitability as a control.
3. Intended Use Statement: The stated intended use for monitoring RNP autoantibody EIA procedures is clearly defined, demonstrating its specific application.

In summary, for a quality control device like the Liquichek Anti-RNP Control, EIA, "acceptance criteria" are met by demonstrating that its physical and chemical properties, as well as its intended use, are consistent with established good manufacturing practices for control materials and are substantially equivalent to a legally marketed predicate device used for similar purposes in an immunoassay setting. No clinical "performance" study on patient samples is presented or typically required for this type of device.

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