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The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA). FOR IN VITRO DIAGNOSTIC USE.

The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.

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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2)". This device is an in-vitro diagnostic test for quantitative determination of human IgG rheumatoid factor antibodies.

The letter explicitly states that the device is a "Rheumatoid Factor Immunological Test System" (Regulation Name: 21 CFR 866.5775) and is a "Class II" device.

Crucially, this document is an FDA clearance letter for a laboratory test (an in-vitro diagnostic device), not an AI/ML-based medical device that would have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC, or involve human readers and their improvement with AI assistance.

Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML, human readers, ground truth establishment, etc., is not applicable to this type of device and will not be found in this document.

The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device, and performance measures like precision, accuracy, linearity, measuring range, interference, and agreement studies for clinical performance. These are standard validation tests for IVD products, not AI performance metrics.

In summary, based on the provided text, I cannot provide the requested information because it pertains to an AI/ML medical device, which the K-ASSAY® RF (Ver.2) is not.

I can, however, extract the following relevant information from the document as it pertains to a medical device:

1. Device Name: K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2)
2. Regulation Number: 21 CFR 866.5775
3. Regulation Name: Rheumatoid Factor Immunological Test System
4. Regulatory Class: Class II
5. Indications for Use: The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis (RA). FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.
6. Type of Use: Prescription Use
7. Predicate Device: The letter states the device is "substantially equivalent" to legally marketed predicate devices, but the specific predicate device is not named in this letter.

To reiterate, the questions about acceptance criteria, study design, sample sizes, experts, ground truth, MRMC studies, standalone performance, and training sets are not applicable to this medical device submission as described in the provided FDA 510(k) clearance letter.

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QUANTA Flash RF IgM is a chemiluminescent immunoassay for the quantitative determination of IgM rheumatoid factor (RF) antibodies in human serum. The presence of IgM RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis (RA).

QUANTA Flash RF IgA is a chemiluminescent immunoassay for the semi-quantitative determination of lgA rheumatoid factor (RF) antibodies in human serum. The presence of IgA RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis (RA).

The principle of the assays is chemiluminescent microparticle immunoassay, a variation of solid phase immunoassay. The QUANTA Flash® RF IgM and QUANTA Flash® RF IgA assays are designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash® RF IgM and QUANTA Flash® RF IgA assays utilize a reagent cartridge format, which is compatible with the BIO-FLASH® instrument.

Rabbit polyclonal antibodies are coated onto paramagnetic beads, which are stored in the reagent cartridge under conditions that preserve the antibody in its reactive state. When the assay cartridge is ready to be used for the first time, the entire cartridge is inverted several times to thoroughly mix the reagents. The reagent cartridge is then loaded onto the BIO-FLASH instrument.

A patient serum sample is diluted 1:22.7 by the instrument using system rinse in a disposable plastic cuvette. An aliquot of the diluted patient serum, coupled beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is incubated at 37°C. The beads are then magnetized and washed several times. Isoluminol conjugated anti-human IgM (QUANTA Flash® RF IgM) or anti-human lgA (QUANTA Flash® RF IgA) antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when "Trigger" reagents are added to the light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. RLU values are proportional to the amount of bound isoluminol conjugate, which in turn is proportional to the amount of RF antibodies bound to the antibodies on the beads.

The QUANTA Flash RF IgM and QUANTA Flash RF IgA assays utilize a predefined lot specific Master Curve that is uploaded into the instrument through the reagent cartridge barcode. Based on the results obtained by running the Calibrators, an instrument specific Working Curve is created, which is used by the software to calculate international units per milliliter (IU/mL) (QUANTA Flash® RF IgM) or chemiluminescent units (CU) (QUANTA Flash® RF IgA) from the RLU value obtained for each sample.

QUANTA Flash RF IgM Calibrators, QUANTA Flash RF IgM Controls, QUANTA Flash RF IgA Calibrators and QUANTA Flash RF IgA Controls are sold separately.

The QUANTA Flash® RF IgM Reagents / QUANTA Flash® RF IgA Reagents kit contains the following materials:

One (1) QUANTA Flash RF IgM / RF IgA Reagent Cartridge

QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations:

• a. Rabbit pAb coated paramagnetic beads.
• b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
• Tracer IgM Isoluminol labeled anti-human IgM antibody, containing buffer, protein C. stabilizers and preservative.

QUANTA Flash RF IgA Reagent Cartridge contains the following reagents for 100 determinations:

• a. Rabbit pAb coated paramagnetic beads.
• b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
• Tracer IgA Isoluminol labeled anti-human IgA antibody, containing buffer, protein C. stabilizers and preservative.

The document describes the analytical and clinical performance characteristics of the QUANTA Flash® RF IgM and QUANTA Flash® RF IgA Reagents, which are chemiluminescent immunoassays for the quantitative or semi-quantitative determination of rheumatoid factor (RF) antibodies in human serum. These assays are intended to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with clinical findings and other laboratory tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this document describes two assays (RF IgM and RF IgA), the acceptance criteria and performance are presented for each. The acceptance criteria for analytical performance studies are generally stated in the document (e.g., %CV < 12% for precision), while clinical performance acceptance is implied by the reported sensitivity and specificity, demonstrating substantial equivalence to the predicate device.

QUANTA Flash® RF IgM Reagents

QUANTA Flash® RF IgA Reagents

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

• Test Set (Clinical Validation Study): A total of 706 characterized samples were used.
  • Data Provenance: The document does not explicitly state the country of origin. However, given it's an FDA 510(k) submission, it's generally understood that the studies conform to regulatory requirements for market clearance in the US.
  • Retrospective/Prospective: The document does not explicitly state whether the samples were collected retrospectively or prospectively. It mentions a "cohort of characterized samples, none of which were used for establishing the reference range," suggesting they were pre-existing and evaluated in a retrospective manner.

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

• This information is not provided in the document. The document describes a "cohort of characterized samples" but does not detail how the characterization (diagnosis of RA vs. control conditions) was established, nor does it mention the number or qualifications of experts involved in this process. This study is not an MRMC study or an AI-based diagnostic study requiring expert ground truth for image interpretation. Instead, it's about the performance of an in-vitro diagnostic (IVD) assay where the "ground truth" for clinical performance is the clinical diagnosis of the patient.

4. Adjudication Method for the Test Set

• This concept is not applicable to this type of study. Since the device is an IVD assay measuring biomarkers, there is no "adjudication" in the sense of comparing human reads with an AI output or resolving discrepancies among readers. The assay itself provides a quantitative or semi-quantitative result. The "ground truth" for clinical sensitivity and specificity is the medical diagnosis of rheumatoid arthritis based on various clinical findings and laboratory tests.

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, an MRMC comparative effectiveness study was not done. This document describes an in-vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool that would involve human "readers" or image interpretation. Therefore, this type of study is not relevant to the described device.

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

• Yes, the primary study described is a standalone performance study of the assay. The QUANTA Flash® RF IgM and IgA assays provide a quantitative or semi-quantitative result directly from the sample. Their performance in terms of precision, linearity, interference, stability, and clinical sensitivity/specificity is evaluated as the standalone performance of the assay itself, without a human "interpretation" component that would be integrated into the device's output.

7. The Type of Ground Truth Used

• Clinical Diagnosis: For the clinical performance characteristics (sensitivity and specificity), the ground truth was the diagnosis of rheumatoid arthritis (RA) for patient samples and the characterization of control patient groups with other conditions or as apparently healthy donors. This "characterization" implies a pre-existing medical diagnosis, likely based on a combination of clinical findings, medical history, and other standard laboratory tests.
• Reference Values/Spiked Samples: For analytical performance characteristics (e.g., linearity, LoQ, interference), the ground truth involved reference standards, known concentrations, or spiked samples where the target analyte amount was precisely known.

8. The Sample Size for the Training Set

• This document describes the regulatory submission for an IVD reagent kit. The concept of a "training set" is more relevant to machine learning algorithms. For IVD development, the samples used to establish initial parameters like the Master Curve for calibration are distinct from a "training set" in an AI context.
  • Reference Range/Cutoff Establishment:
    • Reference population: 191 subjects (117 apparently healthy donors, plus various infectious disease and autoimmune cohorts).
    • RA patient specimens: 42 diagnosed RA patient specimens.
  • Standards for Master Curve: The Master Curve for each assay (IgM and IgA) consists of 6 different Standards. The document implies these standards are pre-defined and used during manufacturing to create the lot-specific Master Curve. The specific number of runs or samples used to define these initial standards is not detailed, but they are manufactured as high-quality reference materials.

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

• As noted above, "training set" doesn't directly apply in the AI sense. However, for the samples used to establish the reference range and cutoff values:
  • The reference population (191 subjects) was classified based on their underlying health status (e.g., "apparently healthy donors," "Infectious Disease Controls," "Rheumatoid Arthritis"). This classification represents the ground truth for establishing the assay's normal range and discriminating cutoff.
  • The cutoff values were established in accordance with CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition.
  • The non-parametric percentile method was used due to the non-normal distribution of results.
  • For QUANTA Flash RF IgM, the cutoff of 5 IU/mL was set based on the distribution of results in the reference population and the (known) positive RA samples to ensure optimal differentiation.
  • For QUANTA Flash RF IgA, the cutoff was established at 6,000 RLU (assigned 20 CU), which was greater than the 95th percentile of control results (3,767 RLU).

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EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K102673, but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells: EliA RF IqM Wells are coated with aggregated rabbit IgG 4 carriers (12 wells each), ready to use; EliA Sample Diluent: EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use; EliA IgM Method Reagents: EliA IgM Conjugate 50 or 200: ß-Galactosidase labeled anti-IgM (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide - 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use - -EliA IgM Calibrator Strips: Human IgM (0, 10, 35, 80, 500, 1000 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use; - EliA IgM Curve Control Strips: Human IgM (80 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide – 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use; - EliA IgM Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use. The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out an EliA RF IgM test.

Here's a breakdown of the acceptance criteria and study information for the EliA RF IgM Immunoassay on the Phadia 2500/5000 instruments, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the EliA RF IgM Immunoassay, previously cleared on the Phadia 250 instrument (K102673), performs substantially equivalently when used on the new Phadia 2500/5000 instrument platform. Therefore, the acceptance criteria are primarily focused on method comparison and analytical performance to show this equivalence. No explicit "acceptance criteria" are provided as a single table within this document for each performance characteristic, but they are implied by the statistical analyses and cut-offs used.

Here's an organized table presenting the relevant acceptance criteria (implied or stated) and the reported device performance:

2. Sample Sizes and Data Provenance

• Precision Test Set Sample Size: Five samples (at various concentrations: 1.6, 3.9, 7.0, 73.7, 169.6 IU/mL). Each sample tested in four replicates/run, over 21 runs (3 instruments x 7 runs), totaling 84 replicates per sample.
• Linearity Test Set Sample Size: Four patient serum samples.
• Detection Limit (LoD/LoB) Test Set Sample Size: One blank sample (measured in 33 replicates in each of two runs) and three low-level samples (measured in 11 replicates in each of two runs). Total 66 blank determinations and 66 low-level determinations for LoD. 66 determinations for LoQ.
• Method Comparison Test Set Sample Size: More than 100 samples (with ≥20% of the samples within ±25% of the medical decision point).
• Expected Values/Reference Range Test Set Sample Size: n = 400 apparently healthy subjects.
• Data Provenance: Not explicitly stated for specific sample origins (e.g., country of origin, retrospective/prospective). The reference range study mentions "sera from a Caucasian population obtained from a blood bank," which implies a prospective collection for that specific study, but the overall patient samples used in other analytical studies are not detailed.

3. Number of Experts and Qualifications (Ground Truth Establishment for Test Set)

• Not Applicable: This submission is for an immunoassay, which detects specific antibodies in patient samples. The "ground truth" for such devices is established by the assay's ability to accurately measure the analyte (IgM class rheumatoid factor antibodies) and correlate with clinical diagnosis of rheumatoid arthritis, as per established medical criteria for the disease itself, not by expert consensus on image interpretation or similar qualitative assessments. For method comparison studies, the "ground truth" is essentially the result obtained by the predicate device (EliA RF IgM on Phadia 250).

4. Adjudication Method (for Test Set)

• Not Applicable: Adjudication methods (like 2+1 or 3+1) are typically used for qualitative assessments, such as image interpretation, where multiple experts provide independent reads that may then be reconciled. This device is a quantitative immunoassay.

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

• No: An MRMC study is not relevant for this type of in vitro diagnostic device (immunoassay). MRMC studies are used to assess the comparative effectiveness of different diagnostic methods (e.g., AI-assisted vs. unassisted human readers) using multiple readers and multiple cases, typically for image-based diagnostics.

6. Standalone Performance Study (Algorithm Only)

• Yes, implicitly: The entire submission describes the standalone performance of the device (EliA RF IgM Immunoassay on the Phadia 2500/5000 instrument) in terms of its analytical characteristics (precision, linearity, detection limits, method comparison to the predicate). There is no "human-in-the-loop" for this automated immunoassay; the result is generated by the instrument and its associated software based on the specimen's reaction.

7. Type of Ground Truth Used

• For Analytical Performance:
  • Predicate Device Results: For method comparison, the results obtained from the predicate device (EliA RF IgM on Phadia 250) served as the comparative "ground truth" against which the new instrument's results were evaluated for substantial equivalence.
  • Expected Values/Spiked Samples/Known Standards: For studies like linearity and precision, the "ground truth" is based on samples with known or expected concentrations, or samples created through controlled dilutions.
• For Clinical Relevance: While the direct analytical studies here used the predicate as a reference, the original clinical performance values for the EliA RF IgM immunoassay were "reviewed in K102673," which would have established its "aid in diagnosis" claim against clinical findings of rheumatoid arthritis.

8. Sample Size for the Training Set

• Not Applicable in the traditional sense: This device is an immunoassay, not an AI/ML algorithm that undergoes a distinct "training phase" on a dataset in the way an imaging algorithm would. The development of an immunoassay involves optimization of reagents and protocols, which is a different process than "training" an algorithm. The 510(k) process focuses on demonstrating analytical and clinical performance for regulatory clearance.

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

• Not Applicable: As explained above, there is no traditional "training set" or "ground truth for a training set" as it would apply to an AI/ML device. The "ground truth" related to the assay's development (optimization, reagent formulation, etc.) would stem from biochemical principles, manufacturing specifications, and initial performance evaluations to ensure the assay functions as intended before formal validation studies.

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The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite Rheumatoid Factor Kit comprises the following reagents: Reaction Buffer, Latex Reagent, RF Controls (supplied at 2 levels, Low and High), and RF Calibrator.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them, structured according to your requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Precision/Reproducibility: 5 sample preparations, each tested 84 times (2 runs/day, 2 duplicates/run, over 21 days).
• Linearity/Assay Range: A dilution series comprising a high pool and a low pool, tested in 3 replicates.
• Method Comparison with Predicate Device: 103 samples tested.
• Analytical Sensitivity (LoD/LoB/LoQ):
  • LoB: 60 determinations of a blank sample.
  • LoD: 6 determinations of 4 samples near the lower limit of the reportable range.
• Analytical Specificity: Not explicitly stated, but samples were spiked with interfering substances.

Data Provenance: The document does not explicitly state the country of origin of the samples or whether they were retrospective or prospective. Given the manufacturer is based in the UK and it's a medical device submission, it's plausible the data collection occurred within a regulatory-compliant framework, potentially from a clinical laboratory setting.

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

There is no mention of experts being used to establish ground truth in the context of the analytical performance studies (precision, linearity, specificity, method comparison). This device is an in vitro diagnostic (IVD) for quantitative measurement of Rheumatoid Factor, and its performance is assessed through analytical validation against an established reference standard (WHO 64/2) and comparison with a predicate device. Ground truth, in this context, refers to the known concentration or behavior of the analyte, verified through laboratory methods rather than expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. The studies described are analytical performance validations, which do not involve subjective interpretation or adjudication by experts. The results are quantitative measurements against defined criteria and methods.

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 a fully automated in vitro diagnostic (IVD) kit for measuring a biomarker; it does not involve human "readers" or Artificial Intelligence (AI) in its measurement process. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device.

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

Yes, the studies detailed in "1. Analytical performance" and "2. Comparison studies" demonstrate the standalone performance of the Optilite® Rheumatoid Factor Kit without human intervention in the measurement process after the sample is introduced to the analyzer. The device performs the quantitative analysis automatically.

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

The primary ground truth for the quantitative measurement performed by this device is:

• International Reference Preparation: The calibration of the assay is traceable to the International Reference Preparation of Rheumatoid Arthritis Serum WHO 64/2. This standard serves as the "ground truth" for the quantitative accuracy of Rheumatoid Factor levels.
• Predicate Device/Established Methods: For method comparison, an alternative commercially available assay (presumably a legally marketed and validated method) served as a comparative ground truth.

For analytical performance studies (precision, linearity, specificity), the ground truth is either:

• Known concentrations: Samples with known or spiked concentrations of analytes or interferents.
• Blank samples: Samples known to contain no analyte (for Limit of Blank).

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay kit, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of developing the device. The reagents and assay parameters are developed based on biochemical principles and optimized through laboratory testing, not machine learning.

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

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

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The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of rheumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

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This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not contain information about acceptance criteria or specific study details that would allow me to populate the requested table and answer the detailed questions about device performance and study design.

The document primarily states that the device, "Rheumatoid Factor (RF) Kit For Use On SPAPLUS®," is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot fulfill the request based on the provided text.

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Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.

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This document is a 510(k) Premarket Notification from the FDA regarding the ImmuLisa Enhanced™ RF IgA Antibody ELISA, ImmuLisa Enhanced™ RF IgG Antibody ELISA, ImmuLisa Enhanced™ RF IgM Antibody ELISA, and ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISA. It doesn't contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information such as:

• Trade/Device Name: ImmuLisa Enhanced™ RF IgA Antibody ELISA, ImmuLisa Enhanced™ RF IgG Antibody ELISA, ImmuLisa Enhanced™ RF IgM Antibody ELISA, ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISA
• Regulation Number: 21 CFR 866.5775
• Regulation Name: Rheumatoid factor immunological test system
• Regulatory Class: Class II
• Product Code: DHR
• Indications for Use: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, and/or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
• Type of Use: Prescription Use

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.

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1. EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA; citrate ) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instruments Phadia 100 and Phadia 250.

2. EliA RF IgA is intended for the in vitro quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

3. EliA RF Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 100 using the EliA IgM or IgA method.

4. EliA RF Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA IgM or lgA method.

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 Phadia 100 and Phadia 250.

The conjugate for the EliA IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbellifery1-BD-Galactoside as substrate.

The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, respectively, 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.

The provided document describes the EliA™ RF IgM Immunoassay and EliA™ RF IgA Immunoassay, along with their respective positive controls, for aiding in the diagnosis of rheumatoid arthritis. The study provided focuses on establishing laboratory equivalence to a predicate device, rather than defining specific acceptance criteria for diagnostic performance metrics like sensitivity or specificity against a clinical ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet against a predefined standard of truth. Instead, the study's goal was to demonstrate laboratory equivalence to existing predicate devices.

The "reported device performance" is summarized conceptually as:

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

• Sample Size: The document mentions "a comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." However, the exact numerical sample sizes for these test sets are not provided.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be retrospective, as it involves comparing results from existing serum and plasma samples with the new devices against predicate devices.

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

The document does not describe the establishment of a "ground truth" for the test set in the traditional sense of expert consensus on patient diagnosis. Instead, the study aims to establish equivalence to predicate devices. The "clinically defined sera" used would have implicit ground truth based on their clinical diagnosis of rheumatoid arthritis, but the process of establishing this clinical diagnosis (e.g., how many experts, their qualifications) is not detailed. It's likely these were pre-diagnosed samples.

4. Adjudication Method for the Test Set

Since the study focuses on laboratory equivalence to predicate devices and not on establishing a new diagnostic ground truth by expert review, an adjudication method (like 2+1 or 3+1) for diagnosing patients within the test set is not applicable and not mentioned.

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 section is not applicable to this device. The EliA™ RF immunoassays are in vitro diagnostic devices that measure specific antibodies in patient samples. They are not AI-powered devices that assist human readers (e.g., radiologists) in interpreting medical images or other complex data. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are outside the scope of this submission.

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

The EliA™ RF immunoassays are standalone devices in the sense that they provide quantitative measurements of RF IgM and IgA levels directly. The "algorithm" here is the biochemical assay and the instrument's software for calculating results from fluorescence measurements. Their performance is evaluated independently of human interpretation of the raw assay signal (though a clinician then interprets the final quantitative result). The study described focuses on this standalone performance in comparison to predicate devices.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary "ground truth" for the comparison study is the results obtained from the legally marketed predicate devices. For the "clinically defined sera," the ground truth would be the clinical diagnosis of Rheumatoid Arthritis established by treating physicians using a combination of clinical findings and other laboratory tests. For "samples from apparently healthy subjects," the ground truth is the absence of Rheumatoid Arthritis. The method by which these clinical diagnoses were originally established (e.g., based on ACR/EULAR criteria, pathology, long-term outcomes) is not specified in this document.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For immunoassay development, "training" typically refers to the development and optimization of the assay itself, selection of reagents, and establishment of calibration curves. The document mentions that the total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, but this is for calibration, not a "training set" in the context of machine learning.

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

As no specific "training set" in the machine learning sense is described, the question of how its ground truth was established is not applicable. The "ground truth" for the instrument's calibration is based on WHO-standardized IgM and IgA Calibrators, which are reference materials with known concentrations.

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The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCPproprietary third generation equivalent formulation) in human serum specimens.

The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

The device consists of the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay (RL1 kit) and the SQiDworks™ Diagnostics Platform (the Platform); the Platform incorporates the SQiDworks™ Integrated Software (the Software). The Platform is a multiplex immunoassay instrument that fully automates the process of a specific IgX PLEX™ Assay from serum transfer to reporting of all assay markers for each individual patient sample. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for all assay markers. The SQiDworks Diagnostics Platform also includes numerous internal quality checks and user safety features with fail-safe and interlock mechanisms.

The instrument integrates an automated pipetting station, a fluorescent scanner, washing and drying stations, and other ancillary hardware components using dedicated instrument control. In addition, the software provides scheduling, self-verification, data acquisition, data management, analysis algorithms and reporting software.

Results for each patient sample from the IgX PLEXIM Rheumatoid Arthritis Qualitative Assay and the SQiDworks™ Diagnostics Platform are obtained simultaneously for cach of the three assay markers: RF IgM, RF IgA and CCP IgG using the results from one well containing one aliquot of the patient's serum. Results are reported independently.

The IgX PLEXIM Rheumatoid Arthritis Qualitative Assay (RL1) kit consists of two boxes (with different temperature requirements) of components as described below.

The provided document describes the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform. Here's a breakdown of the acceptance criteria and study details based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance characteristics from nonclinical (in-house) studies. It describes ranges for reproducibility, clinical sensitivity, clinical specificity, and overall agreement with predicate devices rather than pre-defined acceptance criteria with specific thresholds. It implies these ranges demonstrate the safety and effectiveness for intended use.

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

The document mentions "A series of nonclinical (in-house) studies were conducted," but it does not specify the sample size for the test set used in these studies. The data provenance is stated as "in-house" studies, implying it was conducted by the manufacturer, SQI Diagnostics Systems, Inc., which is based in Toronto, Ontario, Canada. It does not explicitly state whether the studies were retrospective or prospective.

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

The document states that "clinical diagnosis (RA or non-RA, including normals) was used as the reference result" for clinical sensitivity and specificity. However, it does not specify the number or qualifications of experts who established this clinical diagnosis (ground truth). It also does not mention if experts were used for interpreting the device's results in the study.

4. Adjudication Method for the Test Set:

The document does not provide information on any adjudication method used for the test set, or for establishing the clinical diagnosis that served as 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:

This device is an in vitro diagnostic test system that automates the process from serum transfer to reporting of assay markers. It does not involve human "readers" in the context of interpreting images or complex data that would typically necessitate an MRMC comparative effectiveness study with AI assistance. Therefore, no MRMC comparative effectiveness study involving human readers with and without AI assistance was done.

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

Yes, the studies described are for the "IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform." The platform "fully automates the process... from serum transfer to reporting of all assay markers." The performance characteristics described (reproducibility, clinical sensitivity, specificity, agreement) refer to the performance of this automated system, i.e., the algorithm/device primarily in a standalone capacity. While the intended use requires it in conjunction with other laboratory and clinical findings, the reported performance metrics are for the device's direct output.

7. The Type of Ground Truth Used:

For clinical sensitivity and specificity, the ground truth was clinical diagnosis (RA or non-RA, including normals). For the study assessing overall agreement, the predicate test systems (Quanta LITE™ RF IgA ELISA, Quanta LITE™ RF IgM ELISA, and Quanta LITE™ CCP3 IgG ELISA) served as the reference for comparison.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size used for any training set. Given the nature of a multiplex immunoassay instrument and assay, "training set" might refer to data used for establishing assay parameters, cutoff values, or calibration curves rather than machine learning model training in the typical sense. However, no specifics are provided.

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

The document does not mention a distinct "training set" or how its ground truth would have been established. It only discusses the ground truth for the clinical validation referenced in the performance characteristics section. For calibrators, it mentions they are "eight dilutions of a sample derived from human sera containing an appropriate representation of each of the analytes to be reported" and that "The assay standards (secondary standards) for RF (IgA and IgM) are traceable to the WHO/First British Standard 64/2 (primary standards)." For CCP IgG, it states "results are internally calculated in U/mL and are comparable to other assays on the market." This suggests a process of using established standards and internal calculations to define quantitative values, which are then converted to qualitative results based on assay-specific cutoff values.

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Quantitative determination of rheumatoid factors (RF) in human serum. lithium heparin and EDTA plasma on the BN™ II and BN ProSpec® Systems as an aid in the diagnosis of rheumatoid arthritis.

Polystyrene particles coated with an immunocomplex consisting of human immunoqlobulin and antihuman IgG from sheep are aggregated when mixed with samples containing RF. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined clinical acceptance criteria often seen with novel devices. The primary performance metric presented for equivalence is strong correlation with the predicate device.

Note: The acceptance criteria are "implied" because the document states the goal is to demonstrate substantial equivalence, and the reported performance metrics are key indicators used to support that claim. Specific numerical thresholds for "strong correlation" or "close to" are not explicitly defined as pass/fail criteria within this summary.

Study Information

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

   • Sample Size: 90 serum samples were evaluated, with 43 of these samples specifically evaluated for concentrations ≤ 100 IU/mL.
   • Data Provenance: Not explicitly stated regarding country of origin or specific demographics. The study is retrospective in the sense that it uses existing samples to compare performance with the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study compares the performance of a new device against an existing, legally marketed predicate device (N Latex RF – K942328). The "ground truth" for the test set is established by the measurements from the predicate device itself. No human experts were involved in establishing an independent ground truth for the test set.

3. Adjudication method for the test set: Not applicable. As the study compares against a predicate device's measurements, there is no need for expert adjudication.

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: Not applicable. This is an in vitro diagnostic (IVD) device for quantitative determination of rheumatoid factors, not an imaging device or an AI-assisted diagnostic tool that involves human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes. The performance study evaluates the N Latex RF Kit as a standalone assay (algorithm only) without any human-in-the-loop component influencing the measurement results. The device quantifies RF levels directly.

6. The type of ground truth used: The "ground truth" for this substantial equivalence study is the measurements obtained from the legally marketed predicate device (N Latex RF). The new device's measurements are compared against these predicate measurements.

7. The sample size for the training set: Not applicable. This device is a reagent kit for an immunoassay, not a machine learning or AI model that requires a "training set" in the conventional sense. The device's calibration would be part of its manufacturing and quality control process, but not a "training set" like that for an AI algorithm.

8. How the ground truth for the training set was established: Not applicable. See point 7.

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