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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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Dimension Vista® A2MAC Flex® reagent cartridge: The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® Systems. Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.

Dimension Vista® PROT 1 CAL: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: a1-Acid Glycoprotein (A1AG), a-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), b2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT),Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG, IGG-C*), Immunoglobulin G subclass 1(IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR). Transferrin (TRF) *For cerebrospinal fluid

Dimension Vista® Protein 1 Control L: PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma

Dimension Vista® Protein 1 Control M and H: PROTI CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a]-Macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4),Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA),Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF). *For serum and plasma

Dimension Vista® A2MAC Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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.

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing; ar-acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2 -microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E,, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin.

Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1-antitrypsin, a2 -macroglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2. immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein,homocysteine, soluble transferrin receptor and transferrin

Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human scrum based products containing: aj -acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G Subclass . immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® A2MAC Flex® reagent cartridge:

The document describes a medical device, the Dimension Vista® A2MAC Flex® reagent cartridge, and its associated calibrator and controls, which are intended for the quantitative measurement of alpha-2-macroglobulin (A2MAC) in human serum and plasma. The study presented is a method comparison study to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, in method comparison studies for substantial equivalence, the implicit acceptance criteria are typically a slope statistically close to 1, an intercept statistically close to 0, and a high correlation coefficient (usually >0.975 or >0.98, depending on the analyte and regulatory guidance). The reported performance (slope 1.042, intercept +6.3 mg/dL, correlation 0.993) is stated to demonstrate correlation and equivalent performance. The context of a 510(k) submission implies that these results met the FDA's unstated (or internal) acceptance criteria for substantial equivalence.

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

• Sample Size: 143 samples (n=143)
• Data Provenance: The data used were human serum and plasma samples, with concentrations ranging from 28 - 637 mg/dL. The document does not specify the country of origin or whether the samples were retrospective or prospective.

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

This type of study does not utilize experts to establish ground truth in the way an imaging or diagnostic algorithm might. Instead, the "ground truth" for each sample is the quantitative value obtained from the predicate device (Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System). This is a comparison between two instruments/reagents, not a subjective interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study compares quantitative measurements from two automated systems. There is no human adjudication process involved in establishing the "ground truth" for the test set or for managing discrepancies between human readers.

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 conducted. This study compares the performance of a new in vitro diagnostic reagent and system to a predicate device, not the performance of human readers or the impact of AI assistance.

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

Yes, this is a standalone performance study of the Dimension Vista® A2MAC assay. The comparison is between the new device and the predicate device, both operating as automated systems without direct human interpretation in the results generation. Human involvement is limited to sample handling, instrument operation, and data analysis, not diagnostic interpretation of raw data for each test.

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

The "ground truth" for comparison was the quantitative measurement obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System. This is a reference method comparison.

8. The Sample Size for the Training Set

The document does not specify a training set or its size. This is common for traditional in vitro diagnostic device submissions like this one, as they typically involve analytical performance validation (e.g., method comparison, precision, accuracy) rather than machine learning algorithm development which requires distinct training, validation, and test sets. The assay, calibrator, and controls are likely developed and optimized internally by the manufacturer, but the specific "training set" in an AI/ML context is not disclosed or applicable here.

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

Not applicable, as a distinct "training set" with established ground truth in the context of an AI/ML device is not mentioned or relevant to this type of traditional IVD submission. The assay's performance characteristics (linearity, sensitivity, etc.) would have been established during its development using internal methods, but this is not equivalent to "ground truth establishment for a training set" as understood in AI/ML validation studies.

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In vitro diagnostic reagents for the quantitative determination of a2-macroglobulin in human serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of a>-macroglobulin may aid in the diagnosis of blood clotting or clot lysis disorders.

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

The provided text describes a 510(k) submission for the "N Antisera to Human α2-Macroglobulin" device. However, it only presents a single performance characteristic related to the device, with no mention of specified acceptance criteria.

Therefore, the following information is based on the limited data available and significant gaps exist due to the absence of the requested details in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The text states, "To demonstrate equivalence in measurement between serum and heparinized plasma, a method comparison was performed." It does not specify the sample size used for this study or the provenance of the data (e.g., country of origin, retrospective or prospective).

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

Not applicable. The study described is a method comparison for an in vitro diagnostic reagent, not a diagnostic imaging device requiring expert interpretation of images for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. The study described is a method comparison for an in vitro diagnostic reagent. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in interpreting diagnostic images or clinical outcomes, which is not applicable here.

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 evaluating the impact of AI assistance on human readers for diagnostic tasks (e.g., image interpretation), which is not the function of this in vitro diagnostic reagent.

6. If a Standalone Performance Study was Done

The reported "correlation coefficient of 0.98" refers to a comparison between serum and heparinized plasma samples using the device. While this demonstrates the device's consistency across different sample types, it is a method comparison for equivalence, not a standalone performance study against a definitive gold standard for α2-macroglobulin measurement. The document states it is "substantially equivalent to the N Antisera to Human α2-Macroglobulin currently marketed (K860894)," implying its performance is compared to an existing device rather than assessed in absolute terms.

7. The Type of Ground Truth Used

The ground truth used for the method comparison appears to be the measurements obtained from the same N Antisera to Human α2-Macroglobulin assay, specifically comparing its performance when used with serum versus heparinized plasma. The objective was to demonstrate equivalence in measurement between these two sample types. There is no mention of an external gold standard (e.g., pathology, outcomes data) for the α2-macroglobulin levels themselves, but rather an internal consistency check for different sample matrices.

8. The Sample Size for the Training Set

Not applicable. The device described is an in vitro diagnostic reagent—an immunological test system—not a machine learning or AI-based device that typically requires a training set.

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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For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to dsDNA in human serum by enzyme immunoassay, as an aid in the diagnosis systemic lupus erythematosus (SLE). For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

For in vitro diagnostic use only.
For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to dsDNA in human serum by enzyme immunoassay.
For use as an aid in the diagnosis of systemic lupus erythematosus (SLE).
For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

The SeraQuest Anti-dsDNA test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against dsDNA, in human serum.

The Calibrators in the SeraQuest Anti-dsDNA test set have been assigned IU/ml values which are traceable to the WHO First International Standard for Anti-Double-Stranded DNA, Wo-80, and Index values which based on an in-house standard anti-dsDNA serum. Test results are reported as IU/ml or as Index values.

Diluted samples are incubated in wells coated with dsDNA antibodies against ds DNA (if present) are immobilized in the wells. Residual sample is eliminated by washing and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to DSDNA are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or agreement percentages that the SeraQuest Anti-dsDNA device must meet. Instead, the study's performance is presented relative to a predicate device (Shield DIASTAT Anti-dsDNA kit). The de facto acceptance criteria appears to be a demonstration of substantial equivalence to this predicate.

Based on the "Summary of Clinical Testing" and "TABLE 1" which presents the comparative results between the SeraQuest Anti-dsDNA and the predicate Shield DIASTAT Anti-dsDNA, here's a table of the reported device performance:

*Excluding equivocal results.

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

• Sample Size for Test Set: 215 serum specimens.
• Data Provenance: The study was performed "at Quest International, Inc. Miami, FL." The document does not specify the country of origin of the patients from which these specimens were obtained. It is a retrospective study comparing a new device against an existing one using collected specimens.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense (e.g., independent adjudication of disease status). Instead, the comparison is made against a predicate device (Shield DIASTAT Anti-dsDNA kit). The predicate device's results are used as the reference point for calculating relative sensitivity, specificity, and agreement.

However, the context for some samples is mentioned: "{ } Number of patients with clinically diagnosed SLE." This implies a clinical diagnosis made by medical professionals, but the specific number of experts or their qualifications for establishing these clinical diagnoses are not detailed.

4. Adjudication Method for the Test Set

There was no explicit adjudication method described for the test set. The study directly compares the results of the SeraQuest Anti-dsDNA assay with the Shield DIASTAT Anti-dsDNA assay. Discrepancies between the two tests were reported (e.g., 25 specimens equivocal in SeraQuest, 11 equivocal in Shield, 3 positive in SeraQuest and negative in Shield, 5 positive in Shield and negative in SeraQuest), but no adjudication process to resolve these was detailed or used to modify the reported performance metrics. The metrics were calculated based on direct comparison.

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

No, an MRMC comparative effectiveness study was not conducted. This study is an in vitro diagnostic device assessment comparing the performance of two laboratory assays, not a study evaluating human reader performance with or without AI assistance.

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

Yes, a standalone performance assessment was done. The "SeraQuest Anti-dsDNA" device itself is an enzyme immunoassay (a laboratory test) that provides results (qualitative, semi-quantitative, and quantitative detection of IgG antibodies to dsDNA). Its performance as a standalone assay was evaluated by comparing its results directly to those of a predicate assay, not by evaluating human interaction with the device.

7. The Type of Ground Truth Used

The primary "ground truth" for evaluating the SeraQuest Anti-dsDNA device's performance was the results from the predicate device, the Shield DIASTAT Anti-dsDNA kit. This is a comparative study against a legally marketed device.

Secondary information, such as "Number of patients with clinically diagnosed SLE" (mentioned in brackets in Table 1), indicates that some samples had an associated clinical diagnosis (outcomes data/expert consensus for disease status). This clinical diagnosis data helps contextualize the results for some samples but is not the primary "ground truth" against which the device's numerical performance metrics (sensitivity, specificity, agreement) were calculated in this table.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or algorithm development. This is a traditional in vitro diagnostic device submission for an immunoassay. Therefore, this concept is not applicable here. The assay's parameters would have been developed and optimized prior to this validation study, but no specific "training set" size for that optimization is provided.

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

As noted in point 8, the concept of a "training set" with established ground truth is not applicable to this type of device submission. The device is a laboratory assay, and its performance is validated against a predicate device using a test set of specimens.

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The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry. Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.

This is an in vitro diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, and training set information, are not applicable.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The submission primarily focuses on establishing "substantial equivalence" to a predicate device, as opposed to defining explicit performance acceptance criteria with numerical targets. Equivalence is demonstrated through "method comparison, stability, and imprecision experiments."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state numerical acceptance criteria. Instead, it refers to the demonstration of "substantial equivalence" through method comparison, stability, and imprecision experiments. Therefore, the "Reported Device Performance" is inferred from the results presented as part of demonstrating this equivalence, rather than direct numerical comparisons to pre-defined thresholds.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not explicitly stated in the provided text for method comparison, stability, or imprecision studies. The tables showing "Method Comparison Study Results," "Stability Study Results," and "Estimated Imprecision" are largely corrupted and do not provide clear numerical data on sample sizes.
• Data Provenance: Not explicitly stated. Given that it's a Beckman Instruments submission, it's likely internal company data, but the geographical origin or whether it's retrospective or prospective is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is an in vitro diagnostic device measuring a quantitative analyte, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for such devices typically refers to the true concentration of the analyte, often determined by reference methods or gravimetric preparation of calibrators/controls.

4. Adjudication Method

• Not Applicable. As this is an in vitro diagnostic device measuring a quantitative analyte, an adjudication method (like 2+1 or 3+1 used for expert consensus in image interpretation) is not relevant.

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

• Not Applicable. This is an in vitro diagnostic device, not an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only)

• Yes, in spirit. The performance data presented (method comparison, stability, imprecision) assesses the "algorithm only" in the sense that it measures the performance of the IMMAGE Immunochemistry System AMG Reagent as a standalone diagnostic assay on the IMMAGE system, without human interpretive input that would be common in AI/ML clinical decision support. The device is intended for quantitative determination by rate nephelometry, which is an automated process.

7. Type of Ground Truth Used

• For Method Comparison: The ground truth is established by the predicate device (Beckman Alpha₂-Macroglobulin (AMG) using the Array System) or another established method against which the new device's results are compared.
• For Stability and Imprecision: The ground truth is typically the known concentration of the analyte in control materials or patient samples, or the expected measurement derived from robust, repetitive testing.

8. Sample Size for Training Set

• Not Applicable. This is an in vitro diagnostic device with reagents and a defined measurement principle (rate nephelometry), not a machine learning algorithm that requires a "training set" in the AI/ML sense. Data is used for characterization, calibration, and validation rather than training a model.

9. How Ground Truth for Training Set Was Established

• Not Applicable. See reasoning for "Sample Size for Training Set."

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