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In-vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG. IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BN II and BN ProSpec® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The N Antiserum to Human IgG reagent containing animal serum, produced by immunization of rabbits with highly purified human immunoglobulin (

The provided text describes a special 510(k) premarket notification for a modified device, "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)". The sole modification is the addition of a High Dose Hook (HDH) effect claim for IgG in cerebrospinal fluid (CSF) samples.

Here's a breakdown of the requested information based on the provided document:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The study used a "CSF high sample pool." The exact number of individual patient samples contributing to this pool (if multiple were pooled) is not specified. However, the study involved a dilution scheme with twelve (12) individual dilution levels, including the neat sample.
• Data Provenance: Not explicitly stated. The manufacturer is Siemens Healthcare Diagnostics Products GmbH, located in Marburg, Germany, which suggests the study was likely conducted in Germany or a similar geographic region. It is implicitly a prospective study designed to evaluate the HDH effect for the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the device is an in-vitro diagnostic reagent for quantitative determination, not an imaging or interpretive device that would typically require expert ground truth establishment in the described manner. The "ground truth" for this type of test is the quantitatively measured concentration of IgG in a sample, established through laboratory methods and comparison to known standards.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in interpretive studies (e.g., radiologists reviewing images). For a quantitative in-vitro diagnostic test, the "ground truth" is determined by the analytical method itself against known standards.

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 reagent, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was performed.

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

This refers to the performance of the analytical system (N Antisera reagent on BN II System) without human intervention in the measurement process. The HDH study performed is a standalone performance evaluation of the reagent/instrument system. The acceptance criteria and performance data in the table above demonstrate this standalone performance.

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

For this in-vitro diagnostic device, the "ground truth" for the High Dose Hook study was established by creating known dilutions of a high-concentration CSF sample, which were then measured by the device. The reported concentrations for these dilutions serve as the reference. The ultimate analytical ground truth for the quantitative measurement itself is tied to international standards like ERM-DA470k/IFCC (as stated in the "Traceability/Standardization" section).

8. The sample size for the training set

This document does not describe the development or training of a machine learning model, so there is no training set in the typical sense. The "training" for such a diagnostic test involves method development, optimization, and validation using various samples and controls, but these are not referred to as a "training set" for an algorithm.

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

As there is no training set for an algorithm, this question is not applicable.

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The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures. A front breast restraint immobilizes the patient's breast to permit three-dimensional MR imaging to identify the location of the breast lesion(s) for the purposes of selecting a target for biopsy. The IGAR System guides a breast biopsy tool to the target location of the breast from which a biopsy can be obtained. The IGAR System is intended to be used by qualified professionals.

The IGAR System is a tool-positioning system for enabling accurate MR-quided breast biopsies. The IGAR System is designed to provide biopsy tool guidance and accurate targeting of lesions in the breast while the patient is in the MRI room– this creates the ability to "see and evaluate" within a single session. The system consists of the following components: Workstation, Patient Support, Manipulator, Pendant, Control Cart. The IGAR System integrates with an FDA-cleared MRI system from GE, 3 Tesla (3T) GE Discovery™ MR750 - 60cm (Bore size).

The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text mentions "Predefined acceptance criteria for targeting accuracy were met" and "Verification test results demonstrate acceptance criteria were met, and design outputs met the design input requirements." However, it does not explicitly list the quantitative acceptance criteria for targeting accuracy or other functional aspects.

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

The primary study mentioned for performance evaluation is phantom accuracy testing.

• Sample Size: Not explicitly stated. The text only mentions "a representative clinical setting using a simulated tissue phantom." This suggests a single or limited number of phantoms rather than a large test set of patients.
• Data Provenance: The data is from non-clinical bench testing ("simulated tissue phantom"). No information on country of origin for this specific test, as it's a lab-based test. It is not prospective or retrospective patient data.

No information is provided for the test sets of other non-clinical tests (software, functional bench testing, biocompatibility, usability, reprocessing).

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

For the phantom accuracy testing, the "ground truth" would be the known, pre-defined target location within the phantom. This ground truth is inherent to the experimental setup rather than established by experts.

For usability/human factors evaluation, the evaluation would typically involve user testing, but the number and qualifications of "experts" (users or evaluators) are not specified.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1 consensus) is not applicable to the non-clinical phantom accuracy testing. The ground truth is objectively defined by the phantom's design and measurement setup. For usability, a formal adjudication method for "use errors" or "problems" is not described, but typically involves observation and expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted according to the provided text. The document explicitly states: "Clinical Data was not required for this submission." The studies described are non-clinical, primarily bench and phantom testing.

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

The IGAR System is described as a "tool-positioning system" that guides a biopsy tool. Its components include a "Workstation" where a clinician selects a biopsy target and plans the needle path, and a "Manipulator" that positions tools. This strongly implies a human-in-the-loop system. The phantom accuracy testing evaluates the system's ability to guide the tool to the target, which is an assessment of the algorithm's performance within the human-operated workflow, but not in a fully standalone diagnostic capacity. The text does not describe any standalone algorithm performance studies for diagnosis or interpretation without human interaction.

7. The Type of Ground Truth Used

For the primary performance study mentioned (phantom accuracy testing), the ground truth used was predefined target locations within a simulated tissue phantom. This is an objective, known ground truth derived from the experimental setup.

8. The Sample Size for the Training Set

The document does not mention any "training set" or "training data." The device is verified through non-clinical testing against design inputs and acceptance criteria. As there are no AI algorithms described that learn from data, the concept of a training set is not applicable in the provided description. The software verification and validation is focused on design output meeting requirements, not on a learning algorithm's performance on a training dataset.

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

As no training set is mentioned or implied for an AI algorithm, no ground truth establishment method for a training set is applicable or described.

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The Aptiva Celiac Disease IgA Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-tissue transglutaminase IgA autoantibodies and anti-deamidated gliadin peptide IgA autoantibodies in human serum. The presence of these autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis. The Aptiva Celiac Disease IgA Reagent is intended for use with the Inova Diagnostics Aptiva System.

The Aptiva Celiac Disease IgA reagent utilizes particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (tissue transglutaminase [tTG] and deamidated gliadin peptide [DGP]) in the Aptiva Celiac Disease IgA reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgA capture antibody (IgA Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.

The Aptiva instrument is a fully automated, random access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.

The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that preserve the proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using buffer located within the cartridge.

A patient's serum is diluted 1:46 with Aptiva system rinse by the instrument in a disposable cuvette. A small amount of the diluted sample is combined with assay buffer and the microparticle suspension in a second cuvette, and mixed (final serum dilution: 1:230). This reaction cuvette is incubated for 9 ½ minutes at 37°C. The cuvette is then exposed to a small magnet that holds the microparticles in place. The liquid is aspirated, and the microparticles are resuspended as system rinse is added to the cuvette and the magnet is removed. This wash cycle is repeated one more time. During the third wash, no system rinse is added after the aspiration step. After the third wash, phycoerythrin conjugated polyclonal anti-human IgA (known as PE Tracer IgA) is added to the microparticles in the cuvette, and mixed. Again, the cuvette is incubated for 9 ½ minutes at 37℃. Three wash steps, as described above, are performed on the microparticles. Following the wash steps, the microparticles are transferred to the of the instrument, where a charge coupled device (CCD) camera takes multiple images in order to identify and count the three unique microparticle regions, as well as determine the amount of conjugate on the microparticles. A third particle, coated with goat antibodies, is present in the reagent as a control to flag low concentrations of IgA in the sample as an assay verification step. The median fluorescent intensity (MFI) is proportional to the amount of PE Tracer that is bound to the human IgA, which is proportional to the amount of IgA antibodies bound to the corresponding microparticle regions.

For quantitation, the DGP IgA and tTG IgA assays (together as part of the Aptiva Celiac Disease IgA Reagent) each utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge RFID tag. Every new lot of reagent cartridge must be calibrated before first use with the reagent specific calibrators. Based on the results obtained with the calibrators included in the Aptiva Celiac Disease IgA Calibrator kit (sold separately), an instrument specific Working Curve is created for each assay, which is used to calculate reported fluorescent light units (FLU) from the median fluorescent intensity (MFI) instrument signal obtained for each sample, on each of the two assays within the reagent.

Aptiva Celiac Disease IgA Calibrators and Aptiva Celiac Disease IgA Controls are sold separately.

The Aptiva Celiac Disease IgA Reagent kit contains the following materials:

One (1) Aptiva Celiac Disease IgA Reagent Cartridge, containing the following reagents for 250 determinations:

• a. Aptiva Celiac IgA microparticle containing 3 unique microparticle regions coated with recombinant tissue transglutaminase, deamidated gliadin peptide, or goat anti-human IgA antibody.
• b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
• PE Tracer IgA phycoerythrin (PE) labeled anti-human IgA antibody, containing buffer, C. protein stabilizers and preservative.
• d. Rehydration Buffer - containing protein stabilizers and preservatives.

The provided text is a 510(k) Summary for the Aptiva Celiac Disease IgA Reagent, an in vitro diagnostic device. It describes the analytical and clinical performance of the device to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or the establishment of ground truth by expert consensus. Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device studies.

However, I can extract the acceptance criteria and reported performance for analytical aspects of this specific in vitro diagnostic device, as well as details regarding sample size, data provenance, and the type of ground truth used for performance evaluation.

Acceptance Criteria and Reported Device Performance

The device under review is an in vitro diagnostic (IVD) test, not an AI/ML-based medical imaging device. As such, the acceptance criteria and performance evaluation are based on typical analytical validation parameters for immunological assays, such as precision, limit of detection, linearity, interference, and clinical sensitivity/specificity against established reference methods or patient diagnoses.

Table of Acceptance Criteria and Reported Device Performance:

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This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents:

Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives.

Calibrator and Controls: These consist of pooled human serum and are supplied in stabilised liquid form. The concentration of IgA given on the quality control certificate has been obtained by comparison with European Reference Material ERM-DA470k. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.

Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The provided document describes the "Human IgA liquid reagent kit for use on SPAPLUS" by The Binding Site Group Ltd. This device is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin, or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyzer. The submission is a special 510(k) for a modification to an existing device (K103824), specifically a change in the source of the detection antibody from sheep to goat.

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

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

The document does not explicitly present acceptance criteria in a dedicated table format with corresponding reported device performance for all aspects. Instead, acceptance criteria are described within the context of each study and then a conclusion about meeting those criteria is stated. I will extract and present this information in a table format where possible.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Studies:
  • Repeatability and Within Laboratory: 4 different samples, 80 data points for each level (total 320 data points).
  • Between Instrument: 4 different samples, 24 data points for each level (total 96 data points).
  • Between Lot: 4 different samples, 24 data points for each level (total 96 data points).
• Linearity Study: A high pool (8.19g/L) and a low pool (0.12 g/L) were used to create a dilution series. Each diluted sample was tested in 3 replicates.
• Accelerated Stability: 6 replicates of controls, internal reference, and 3 different samples were tested.
• Limit of Quantitation (LoQ) Validation: 4 samples were tested using two reagent lots.
• Method Comparison with Predicate Device: 102 serum samples and 42 plasma samples (total 144 samples).
• Expected Values/Reference Range Transfer: 20 samples from "apparently healthy US donors".

Data Provenance:

• For the Expected Values/Reference Range Transfer study, samples were from "apparently healthy US donors".
• For other studies, the country of origin or whether the data was retrospective or prospective is not explicitly stated. The studies were carried out by The Binding Site Group Ltd., which is based in the UK, so it's likely testing was conducted there unless otherwise specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is an in vitro diagnostic (IVD) reagent kit for quantitative Immunoglobulin A (IgA) determination. The "ground truth" in this context refers to the accurate measurement of IgA concentration. The document mentions traceability to European Reference Material ERM-DA470k/IFCC for calibration. This implies that the standard itself serves as the "ground truth" reference, rather than independent expert consensus on clinical interpretation. There are no mentions of experts establishing ground truth in the sense of clinical diagnosis or image interpretation.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation by multiple human readers (e.g., in radiology studies) to resolve discrepancies and establish a consensus "ground truth." Since this device is a quantitative IVD assay and its performance is validated against analytical standards, reference materials, and comparative measurements, such adjudication methods are not applicable and therefore not used.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. This device is a standalone quantitative laboratory test kit, not an AI or imaging diagnostic aid, so an MRMC study is not applicable.

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

Yes, the performance studies described are for the standalone device (reagent kit on the SPAPLUS analyzer) without human-in-the-loop performance influencing the measurement part of the device's function. The analytical performance, stability, and comparison studies evaluate the kit's ability to accurately measure IgA concentrations. The device's output is a quantitative value, not an interpretation of data that requires human feedback for performance assessment.

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

The ground truth for this quantitative assay is primarily based on:

• Reference Materials: Calibration traceability to ERM-DA470k/IFCC. This is the international standard for immunoglobulin measurements.
• Reference Methods: The predicate device itself (K103824) serves as a comparative "ground truth" for method comparison studies, demonstrating substantial equivalence.
• Defined Concentrations: For linearity and precision studies, samples with known or precisely diluted concentrations are used.
• Clinical Reference Intervals: The ability to transfer established reference intervals (based on a healthy population) is also part of the "ground truth" for clinical usability.

8. The sample size for the training set

This document describes a special 510(k) submission for a modification to an existing device, which mostly involves re-validation studies to ensure the modification (change in antibody source from sheep to goat) does not alter performance compared to the cleared predicate. It does not describe the development of a novel algorithm or AI model that requires a distinct "training set." The studies performed are validation studies, not training. Therefore, a "training set" in the context of machine learning is not applicable here.

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

As there is no "training set" in the machine learning sense for this device submission, this question is not applicable. The device's underlying principles (immunoturbidimetry) are well-established, and its performance is validated against analytical standards rather than learned from a dataset.

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The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

Here's a breakdown of the acceptance criteria and study detailed in the provided document for the Optilite IgA Kit, organized according to your requested information.

It's important to note that this document is a 510(k) summary for a modification to an existing device (Optilite IgA Kit, K103824). Therefore, the study presented here primarily focuses on confirming that the modified device (with a change from sheep to goat antibody) performs comparably to the predicate device (the original cleared kit) and that the performance characteristics detailed in the original submission still hold true. This is not a study to establish initial performance characteristics, but rather to demonstrate equivalence after a modification.

Acceptance Criteria and Device Performance Study for Optilite IgA Kit (K191985)

This study was conducted to demonstrate that the modified Optilite IgA Kit, with a change in the source of the detection antibody from sheep to goat, maintains comparable performance to the predicate device (Optilite IgA Kit, K103824). The acceptance criteria were primarily based on demonstrating no significant change in performance compared to the previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

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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

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EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTA-plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IgG uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA GliadinDP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgG uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells (EliA Celikey IgG Wells, EliA GliadinDP IgA Wells, EliA GliadinDP IgG Wells), EliA Sample Diluent, EliA IgG reagents (EliA IgG Conjugate, EliA IgG Calibrator Strips, EliA IgG Curve Control Strips, EliA IgG Calibrator Well), and EliA IgA reagents (EliA IgA Conjugate, EliA IgA Calibrator Strips, EliA IgA Curve Control Strips, EliA IgA Calibrator Well). 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 EliA Celikey IgG and EliA GliadinDP IgA and EliA GliadinDP IgG tests.

The provided document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence determination for the Phadia AB EliA Immunoassays (Celikey IgG, GliadinDP IgA, GliadinDP IgG) for use on the Phadia 2500/5000 instrument. The document primarily focuses on demonstrating that the performance of these assays on the new instrument platform is substantially equivalent to their performance on a previously cleared instrument (Phadia 250).

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

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

The document does not explicitly present a single table outlining "acceptance criteria" alongside "reported device performance" for the overall substantial equivalence determination. Instead, it details performance characteristics for various analytical aspects, and the acceptance criteria are implied by the ranges and thresholds specified for these studies. The primary "acceptance criteria" for the overall submission appear to be demonstrating equivalence to the predicate device and meeting specific statistical thresholds for precision and linearity.

However, based on the sections "M. Performance Characteristics (if/when applicable)" and "2. Comparison studies: - Instrument comparison C.", we can construct a table for the analytical performance and comparative study results:

Table: Acceptance Criteria (Implied) and Reported Device Performance

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The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Lit-heparin, Na+citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgC class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.

Not Found

This document is a 510(k) clearance letter from the FDA for an In Vitro Diagnostic (IVD) device, specifically an ELISA test for anti-tissue transglutaminase antibodies. These types of regulatory documents typically do not contain the detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would be found in a clinical trial report or a submission summary.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This determination of substantial equivalence relies on the manufacturer providing adequate data, but the letter itself does not present that data in a public-facing way.

Therefore, I cannot extract the requested information from the provided text. The document is an FDA clearance letter and not a detailed clinical study report.

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The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.

The Optilite IgA CSF Kit comprises the following reagents: Latex Reagent, Calibrator and Controls, and Reaction Buffer.

The provided text describes the performance characteristics of the Optilite IgA CSF Kit. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision/Reproducibility: 4 different samples were used. The number of runs (two per day for 5 days) and analysts (two) suggest multiple measurements for each sample. Data provenance is not explicitly stated but is implicitly from an internal laboratory study (prospective).
• Linearity: One serially diluted sample was used. Data provenance is implicitly from an internal laboratory study (prospective).
• Analytical Specificity: A CSF sample close to the medical decision point and an elevated CSF sample were tested. Data provenance is implicitly from an internal laboratory study (prospective).
• Method Comparison: 130 CSF samples (including 40 samples with analyte levels within the reference interval) were used. Data provenance is not explicitly stated, but it's likely from a collection of clinical samples. It is retrospective in nature as these are "samples" analyzed, not patients prospectively enrolled.

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

This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker. The "ground truth" for the test set is established by the reference methods or the true concentration of the analyte, not by expert interpretation in the same way an imaging or pathology device would involve human experts.

• For precision, the ground truth is the true concentration of IgA in the sample, measured repeatedly to assess variation.
• For linearity, the ground truth is the expected concentration based on the serial dilution.
• For traceability, the ground truth is the value assigned by the international reference material (ERM-DA470k/IFCC).
• For method comparison, the ground truth is the measurement obtained from the alternative commercially available assay (predicate device).

Therefore, the concept of "number of experts used" or their "qualifications" for establishing ground truth is not directly applicable in the context of this type of quantitative IVD performance study.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative IVD, the results are numerical values, and adjudication by experts is not a standard practice for assessing performance metrics like precision, linearity, or method correlation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. The Optilite IgA CSF Kit is a standalone automated quantitative assay, not an AI-assisted interpretation tool.

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

Yes, the performance studies described are intrinsically standalone performance evaluations of the Optilite IgA CSF Kit (the "algorithm/device only" in this context) without human-in-the-loop performance. The device provides a quantitative measurement directly.

7. The Type of Ground Truth Used

• Precision and Linearity: The ground truth is based on the known or reference concentrations of the samples used in the study.
• Traceability: The ground truth is the value assigned by the international reference material (ERM-DA470k/IFCC).
• Method Comparison: The ground truth for comparative purposes is the result obtained from an alternative commercially available assay (predicate device).

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is an in vitro diagnostic kit based on immunoturbidimetry, which is a chemical/biological reaction and measurement system, not a machine learning model that requires a training set. The term "training set" is not applicable here.

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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EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

EliA Cardiolipin IgA is intended for the in vitro sem-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K112414 (EliA B2-Glycoprotein I IqA) and K131821 (EliA Cardiolipin IqA), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of:
-Test Wells: EliA ß2-Glycoprotein I IqA Wells are coated with human ß2-Glycoprotein I antigen - 2 carriers (12 wells each), ready to use;

• EliA Cardiolipin IgA Wells are coated with bovine cardiolipin antigen and boyine ß2-glycoprotein I as co-factor - 2 carriers (12 wells each), ready to use;
• -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 IqA Conjuqate 50 or 200: ß-Galactosidase labeled anti-IgA (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 IgA Calibrator Strips: Human IgA (0, 0.3, 1.5, 5, 15, 80 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 IgA Curve Control Strips: Human IgA (20 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 IgA 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 EliA ß2-Glycoprotein I IgA and EliA Cardiolipin IgA tests.

Here's a breakdown of the acceptance criteria and study particulars for the EliA Beta2-Glycoprotein I IgA and EliA Cardiolipin IgA Immunoassays on the Phadia 2500/5000 instrument, based on the provided FDA 510(k) summary (K181329):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily for method comparison (regression analysis against the predicate device/instrument) and for the performance metrics of Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Total Percent Agreement (TPA) when comparing the new instrument platforms (Phadia 2500/5000) to the predicate Phadia 250.

EliA ß2-Glycoprotein I IgA on Phadia 2500/5000

EliA Cardiolipin IgA on Phadia 2500/5000

Note: The document primarily outlines how the studies were performed and what the results were, rather than explicit pre-defined quantitative acceptance criteria for all metrics. For method comparison, it states: "The acceptance criteria for the method comparison (the slope for the regression lines should be 0.9 - 1.1 for single replicate to single replicate and intercept close to 0) were met." For LoQ, it mentions "a target uncertainty goal of 20%." For PPA/NPA/TPA, the high reported values and FDA clearance imply acceptance.

2. Sample Size and Data Provenance for Test Set

• Method Comparison (Instrument Comparison):

  • Sample Size: More than 100 serum samples (for each immunoassay).
  • Data Provenance: Not explicitly stated, but serum samples were used. It is implied to be from patient populations relevant to the intended use. The samples included "≥20% of the samples within ±25% of the medical decision point," suggesting a distribution covering diagnostically relevant ranges.
  • Retrospective/Prospective: Not specified, but typically such comparison studies use retrospectively collected samples for method validation.

• Precision/Reproducibility:

  • Sample Size: 5 serum samples. Each sample tested in 21 runs (3 instruments x 7 runs) with 4 replicates per run, totaling 84 replicates per serum sample.
  • Data Provenance: Serum samples. Country of origin not specified.
  • Retrospective/Prospective: Retrospective, as these are pre-collected serum samples.

• Linearity/Assay Reportable Range:

  • Sample Size: 4 patient serum samples.
  • Data Provenance: Patient serum samples. Country of origin not specified.
  • Retrospective/Prospective: Retrospective.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size:
    • LoB: One blank sample measured in 33 replicates in each of two runs.
    • LoD & LoQ: Three low-level serum samples measured in 11 replicates in each of two runs.
  • Data Provenance: Blank samples and low-level serum samples. Country of origin not specified.
  • Retrospective/Prospective: Retrospective.

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

• This device is an in-vitro diagnostic (IVD) immunoassay, not an AI or imaging device requiring human expert adjudication for ground truth. The "ground truth" for these studies refers to the reference method's result (e.g., predicate device Phadia 250 for method comparison) or the known characteristics of the samples (e.g., spiking for linearity, known concentration for precision controls).
• Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth in the context of an IVD assay's analytical performance studies is not applicable here.

4. Adjudication Method for the Test Set

• Not applicable as this is an IVD immunoassay, not an AI or imaging device requiring human subjective interpretation and adjudication. The "adjudication" is based on instrumental readings and comparison to defined calibrators and predicate device results.

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

• No, an MRMC comparative effectiveness study was not done. This is an IVD immunoassay, not a device that involves human "readers" interpreting cases in the context of medical imaging or clinical decision-making with or without AI assistance.
• The study involved comparing instrumental results of the new Phadia 2500/5000 platform to the predicate Phadia 250 platform.

6. Standalone Performance Study

• Yes, standalone performance studies were done. The precision, linearity, and detection limit studies are examples of standalone performance evaluations of the EliA immunoassays on the Phadia 2500/5000 instrument.
• The primary scope of this 510(k) submission was to introduce these previously cleared assays onto a new instrument platform (Phadia 2500/5000), meaning the "algorithm" (assay chemistry and measurement principle) itself was already established as effective and safe. The studies here demonstrate that this established assay performs equivalently on the new instrument.

7. Type of Ground Truth Used

• Method Comparison: The predicate device's results (EliA ß2-Glycoprotein I IgA on Phadia 250 instrument, K112414; EliA Cardiolipin IgA on Phadia 250 instrument, K131821) served as the "ground truth" or reference for assessing equivalence of the new instrument platform.
• Precision and Linearity: The values obtained from the predicate device or a well-characterized reference are used to establish control ranges and expected values. For linearity, known dilutions are used against expected concentrations.
• Detection Limit: Controlled blank samples and low-level spiked/characterized samples are used.
• Clinical Studies (reference): For clinical utility and cut-off determination mentioned as reviewed in K112414 and K131821, the ground truth would have been clinical diagnosis (e.g., confirmed APS or SLE) and outcomes data. This summary itself does not include new clinical ground truth studies for K181329.

8. Sample Size for the Training Set

• This type of submission (510(k) for a new instrument platform for existing assays) generally does not involve a "training set" in the context of machine learning or AI.
• For IVD assays, optimization and method development would involve numerous samples, but these are part of product development rather than a formal "training set" that would be distinct from a "test set" in the way AI/ML studies define them. The stability and calibration curves are established using a series of known calibrators and controls.

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

• Not applicable in the AI/ML sense. For standard IVD assay development, ground truth for calibrators and controls is established through rigorous characterization, often against international reference materials or highly purified substances, and validated using established analytical methods and statistical approaches. The clinical cut-offs were derived from "clinical studies (s. K112414 and K131821)", meaning the previous submissions involved clinical data and patient diagnoses to define the clinically relevant ranges.

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