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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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This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM 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.

The SPAPlus IgM Kit comprises the following reagents:

Antiserum: Goat Anti-IgM is 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.

The provided document (K191465 - Human IgM Kit for use on SPAPlus Special 510(k) Submission Summary) describes the analytical and performance characteristics of a quantitative in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the questions regarding acceptance criteria for AI/ML performance, ground truth establishment by experts, MRMC studies, and training/test set details are not applicable.

This submission is for a modification to an existing device (Human IgM Kit for Use on SPAPlus, K082129), specifically changing the source of the detection antibody from sheep to goat and altering the antibody resting buffer. The primary goal of the studies presented is to demonstrate that these changes do not adversely affect the device's performance compared to the original cleared device and that the new kit is substantially equivalent.

Here's an attempt to answer the questions based on the available information, noting when a question is not applicable to this type of device:

Acceptance Criteria and Device Performance

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

Since this is a chemistry assay device, the "acceptance criteria" are more about demonstrating comparable performance to the predicate device and meeting established analytical performance standards for in vitro diagnostics rather than an AI/ML output metric like accuracy or AUC.

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

• Precision Studies:
  • Repeatability & Within Laboratory: 3 different samples, 80 replicates each (20 working days, 2 runs/day, 2 reps/run).
  • Between Instrument: 3 different samples, 24 replicates each (6 working days, 2 instruments/day, 2 reps/instrument).
  • Between Lot: 3 different samples, 24 replicates each (6 working days, 2 lots/day, 2 reps/lot).
  • Provenance: Not explicitly stated, but likely retrospective lab testing from the manufacturer (The Binding Site Group Ltd. in UK). Dates of testing are implied by "over 20 working days" etc.
• Linearity Study: High and low pools, dilution series, 6 replicates per diluted sample.
  • Provenance: Not explicitly stated, likely retrospective lab testing.
• Stability Studies:
  • Accelerated Stability: 6 replicates of controls, internal reference, and samples.
  • Provenance: Not explicitly stated, likely retrospective lab testing.
• Detection Limit (LoQ) Study: Four samples, two reagent lots.
  • Provenance: Not explicitly stated, likely retrospective lab testing.
• Method Comparison Study: 89 serum samples and 44 plasma samples.
  • Provenance: Performed "in accordance with pre-submission meeting Q171503." Not explicitly stated, but likely retrospective from clinical laboratories or biobanks.
• Reference Range Transfer Study: 20 samples from "apparently healthy US donors."
  • Provenance: Prospective collection from apparently healthy US donors appears to be implied given the mention of "US donors" and the purpose of transferring the reference interval.

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 is an in vitro diagnostic device that measures a quantitative analyte (IgM). "Ground truth" for this type of device is established by the analytical measurement itself, traceable to an international reference material (ERM-DA470k/IFCC). Clinical expert consensus is not a method for establishing the "ground truth" concentration of an analyte in a sample for this type of device.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or clinical diagnosis, often when human expert variability is a factor. This submission is for a turbidimetric assay, where the "ground truth" is a quantitative measurement traceable to a reference standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and does not involve human readers interpreting images or data.

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

Not applicable. This is not an AI/ML device. The "performance" is the analytical performance of the assay itself.

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

The "ground truth" for the quantitative measurement of IgM in this IVD is established by its traceability to a recognized international reference material (ERM-DA470k/IFCC). This standard provides the authoritative value for IgM concentration against which the device's measurements are calibrated and compared.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a "kit" of reagents and controls used on an analyser.

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

Not applicable (as above, no "training set" in the AI/ML sense). The calibration of the assay (which could be conceptually analogous to "training" a traditional assay) is traceable to ERM-DA470k/IFCC, an international reference material.

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The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.

The C-Reactive Protein Kit for use on SPAPLUS is comprised of the following reagents:

Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.

Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The concentration given on the quality control certificate has been obtained by comparison with the international reference standard ERM-DA474.

Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.

The provided document is a 510(k) premarket notification for a C-Reactive Protein Kit for use on the SPAPLUS analyzer. It details the device's intended use, comparison to a predicate device, and performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

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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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Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the SPAPLUS analyser for the measurement of IgG kappa (IgG heavy chain and kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Hevylite Human IgG Lambda is a quantitative in vitro assay performed on the SPAPLUS analyser for the measurement of IgG lambda (IgG heavy chain and kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human lgG Lambda is used alongside Hevylite Human IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

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This document is a 510(k) clearance letter from the FDA for two devices: Hevylite Human IgG Kappa Kit for use on the SPAPLUS and Hevylite Human IgG Lambda Kit for use on the SPAPLUS. It discusses the regulatory classification and general controls applicable to these devices. However, this document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document only states the "Indications for Use" for each device, which describes what the device is intended to measure and for what purpose (e.g., monitoring previously diagnosed IgG multiple myeloma, used in conjunction with other tests). It does not provide details on performance metrics, sample sizes, ground truth establishment, or any other information related to a study proving acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

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The provided text is a 510(k) premarket notification letter from the FDA, along with the device's Indications for Use. It describes a diagnostic device, the Hevylite Human IgA Kappa Kit and Hevylite Human IgA Lambda Kit, which are quantitative in vitro assays performed on the Binding Site SPAPLUS for measuring IgA Kappa and IgA Lambda in serum. These measurements are used to calculate the IgA Kappa/IgA Lambda ratio for monitoring previously diagnosed IgA multiple myeloma patients.

This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies. It primarily focuses on the regulatory aspects of the device's clearance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information is typically found in the accompanying technical documentation, such as the 510(k) summary or detailed clinical study reports, which are not present here.

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The Human Microalbumin kit for use on SPAPLUS kit is intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not include detailed information about acceptance criteria or specific study results that prove the device meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document primarily states the FDA's determination that the device, "Human Microalbumin kit for use on SPAPLUS kit," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the device, which is "intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only."

To obtain the information you requested, you would typically need to consult the full 510(k) submission summary or associated clinical/analytical study reports, which are not included in this decision letter.

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Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined u heavy and k light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia in conjunction with other clinical findings. This assay has not been established for the diagnosis of Waldenstrom's macroglobulinaemia.

Hevylite Human IgM Lambda kit for use on SPAPLUS is intended for the in-vitro quantification of IgM lambda (combined u heavy and A light chain) in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrom's macroglobulinaemia. The test result is to be used in conjunction with other clinical findings.

This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.

Evaluating the concentration of a soluble antigen (e.g. IgM Kappa and IgM Lambda) by turbidimetry involves the addition of the test sample to a solution containing the appropriate antibody (anti-IgM kappa and anti-IgM lambda) in a reaction vessel or cuvette. A beam of light id passed through the cuvette and, as the antigen-antibody reaction proceeds, the light passing through the cuvette is scattered increasingly as insoluble immune complexes are formed. Light scatter is monitored by measuring the decrease in intensity of the incident beam of light. The antibody in the cuvette is in excess so the amount of immune complex formed is proportional to the antigen concentration. A series of calibrators of known antigen concentration are assayed initially to produce a calibration curve of measured light scatter versus antigen concentration. Samples of unknown antigen concentration can then be assayed and the results read from the calibration curve.

This document describes the Hevylite Human IgM Kappa Kit for use on SPAPLUS and the Hevylite Human IgM Lambda Kit for use on SPAPLUS, which are in-vitro quantification assays for IgM kappa and IgM lambda concentrations in human serum. The primary study presented is a substantial equivalence comparison to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily linked to its analytical performance, specifically precision, linearity, and agreement with the predicate device. The document explicitly states acceptance criteria for repeatability, reproducibility, linearity (recovery and CV), and agreement with the predicate.

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This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

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The provided text is a 510(k) premarket notification document for a medical device. It is a regulatory approval, not a scientific study document. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document:

• Identifies the device: Human alpha-2-Macroglobulin kit for use on SPAPLUS.
• States its intended use: Quantitative in vitro measurement of alpha-2-Macroglobulin in human serum to aid in the diagnosis of blood-clotting or clot lysis disorders.
• Declares substantial equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, nor data provenance.
3. Information on experts or ground truth for the test set.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
6. Information on standalone algorithm performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific document. The information you're asking for would typically be found in a separate study report or technical documentation submitted as part of the 510(k) application, but it is not present in the FDA's decision letter itself.

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The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Human alpha-1 Antitrypsin Kit for use on SPAPLUS". It states that the device is substantially equivalent to a predicate device. However, it does not contain any information about the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested information based on the input document.

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