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The s LDL-EX"SEIKEN" test is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma. The s LDL-EX"SEIKEN" test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease.

The assay consists of two steps and is based on the technique to use well-characterized surfactants and enzymes that selectively react with certain groups of lipoproteins.

In the first step, non-sd LDL lipoproteins, that is, chylomicrons, VLDL, IDL, L-LDL and HDL are decomposed by a surfactant and sphingomyelinase in Reagent-1 that is reactive to those non-sd LDL lipoproteins. The cholesterol released from such non-sd LDL lipoproteins is then degraded to water and oxygen by the action of enzymes. Cholesterol ester is hydrolyzed by the cholesterol esterase (CHE) and then oxidized by the cholesterol oxidase (CO). Produced hydrogen peroxides are finally decomposed to water and oxygen by the catalase.

In the second step, another surfactant in Reagent-2 releases cholesterol only from sd LDL particles and cholesterol released from sd LDL is then subject to the enzymatic reactions. As catalase in the reaction mixture is inhibited by sodium azide in Reagent-2, hydrogen peroxides, produced from the reaction with the cholesterol esterase and cholesterol oxidase, develop a purple-red color with the coupler in the presence of peroxidase (POD).

The provided text describes the acceptance criteria and a study demonstrating that the device meets these criteria. The device is the s LDL-EX "SEIKEN" test, which is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document details performance characteristics rather than explicit "acceptance criteria" for a specific disease detection task, as this is a quantitative diagnostic test. The acceptance is based on the device's analytical performance and its ability to distinguish risk groups for CHD.

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The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

This is a 510(k) premarket notification for in vitro diagnostic calibrators and controls used with the ARCHITECT® i System for quantitative determination of human insulin. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for device performance as would be expected for a diagnostic algorithm. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's the information that can be extracted, along with explanations for the missing data:

Acceptance Criteria and Device Performance

This submission does not define specific performance metrics like sensitivity, specificity, accuracy, or AUC for an algorithm. Instead, it demonstrates similarity in intended use, methodology, binding protein, assay protocols, and traceability/standardization to legally marketed predicate devices. The "acceptance criteria" are implicitly met by demonstrating these similarities and the fact that the FDA granted substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Note: The "performance" here refers to the characteristics that make the device equivalent to existing devices, not clinical performance metrics typical of a diagnostic AI.

Additional Information

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

   • This document does not specify a "test set" in the context of an algorithm evaluation. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and intended use, not through a performance study on a specific dataset. Therefore, N/A.
   • There is no mention of specific data provenance (e.g., country of origin, retrospective/prospective) because individual patient data samples are not the focus of this type of submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This type of submission (for in vitro diagnostic calibrators and controls) does not involve establishing ground truth from experts for a diagnostic algorithm.

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

   • N/A. Not applicable for this type of medical device submission.

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

   • N/A. This device is a calibrator and control for an automated immunoassay system, not an AI-assisted diagnostic algorithm that involves human reader interpretation. Therefore, no MRMC study or effect size related to human reader improvement is relevant or performed.

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

   • The "device" itself (calibrators and controls) is used to ensure the performance of an automated immunoassay system (ARCHITECT® i System). The performance of the calibrators and controls is inherently "standalone" in that they are materials used by an instrument, not an algorithm being evaluated for clinical diagnostic interpretation. However, the concept of "standalone performance" as it applies to a diagnostic algorithm is N/A here.

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

   • For calibrators, the "ground truth" implicitly refers to the accuracy of the assigned values, which are traceable to the World Health Organization (WHO) Insulin 1st. International Reference Preparation, 66/304. This is a reference standard.
   • For controls, the "ground truth" refers to the expected values (targets of 8, 40, 120 μU/mL) used to verify accuracy and precision, which are established against primary controls. This is a reference standard/primary control assignment.

7. The sample size for the training set:

   • N/A. This submission is for calibrators and controls, not a machine learning model. There is no concept of a "training set" in this context.

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

   • N/A. As there is no training set, this question is not applicable.

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The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The LDL-EX SEIKEN Assay Kit is a homogeneous method for directly measuring LDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

The provided text describes the 510(k) summary for the "LDL-EX SEIKEN Assay Kit." Here's a breakdown of the requested information:

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: 100 donor samples
• Data Provenance: The document does not specify the country of origin for the donor samples or whether the study was retrospective or prospective.

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 information is not applicable as the ground truth was established by comparison with a legally marketed predicate device, not through expert consensus on diagnostic images or pathology.

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

This information is not applicable. The study involved direct comparison of quantitative results between the new device and a predicate device, not human review and adjudication of findings.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.

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

A standalone performance study was done for the device, where its measurements were directly compared against a predicate device. The device itself (the "LDL-EX SEIKEN Assay Kit") is an automated assay, meaning it operates without human intervention once the sample is loaded.

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

The ground truth was established by comparison to a legally marketed predicate device (N-Geneous LDL Cholesterol Reagent [Genzyme Corp.]). The assumption is that the predicate device provides accurate measurements of LDL-C, thereby serving as the "ground truth" for the new device's performance evaluation.

8. The sample size for the training set

This information is not applicable. This device is a chemical assay kit, not a machine learning or AI model, thus it does not have a "training set" in the conventional sense. Its performance is characterized through direct comparison and precision studies.

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

This information is not applicable as there is no "training set" for this type of device.

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The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The HDL-EX SEIKEN Assay is a homogeneous method for directly measuring HDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

The provided text describes a 510(k) summary for the "HDL-EX SEIKEN Assay Kit," a device for quantitatively determining high-density lipoprotein cholesterol (HDL-C). The study presented is a comparative performance study against a predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the comparison to the predicate device, Ultra N-Geneous HDL Cholesterol Reagent. The key metrics evaluated are correlation, slope, and y-intercept for comparative performance, and Coefficient of Variation (CVs) for precision.

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

• Test Set Sample Size: 150 donor samples.
• Data Provenance: Not explicitly stated, but the submission is from a Japanese company (Denka Seiken Co., Ltd.). It is likely these samples were collected in Japan or a similar region, but this is not confirmed. The study appears to be prospective in the sense that the samples were analyzed specifically for this comparison.

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

• This study evaluates an in vitro diagnostic (IVD) assay (a laboratory test), not an imaging device or a clinical outcome-based assessment. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) does not directly apply here.
• The "ground truth" for comparison is the performance of the legally marketed predicate device (Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]) on the same samples. The predicate device itself has established performance characteristics, and its results are used as the reference against which the new device is measured.
• No information is provided about experts interpreting the results beyond the intrinsic performance of the predicate device.

4. Adjudication Method for the Test Set:

• Not applicable in the context of this type of IVD comparative performance study. The comparison is objective, based on quantitative measurements.

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

• No, an MRMC study was not done. This is an IVD device measuring a biomarker, not a device requiring human interpretation of medical images or diagnostic outputs.

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

• Yes, this study represents a standalone performance evaluation of the HDL-EX SEIKEN Assay Kit. As an automated chemistry analyzer test, it operates without human intervention in the interpretive phase. The study directly compares the results of the new assay to the predicate assay.

7. The Type of Ground Truth Used:

• The ground truth (or reference standard) used for the comparative performance study is the results obtained from the legally marketed predicate device, the "Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]." This is a common practice for demonstrating substantial equivalence for IVD devices.

8. The Sample Size for the Training Set:

• The document does not mention a "training set" or any machine learning/AI components. This is a traditional IVD assay, not an AI/ML-based device. Therefore, the concept of a training set is not applicable.

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

• As there is no training set for this traditional IVD device, this question is not applicable.

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The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex (II)X2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples.

The CRP(II) Calibrator is intended to be used for the calibration of the CRP-Latex(II)X2 SEIKEN

The provided text describes a 510(k) submission for the "CRP(II) Calibrators" device. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.).

The document primarily focuses on the regulatory submission process and states that the calibrators are intended for use with the CRP-Latex(II)X2 SEIKEN assay kit. It mentions "Performance data" but then immediately states: "The CRP-Latex (II) "Seiken"X2 High Sensitivity Assay and the predicate device, N High Sensitivity CRP Assay have only minor difference that do not affect the performance, safety or effectiveness of the measurement." This implies that a detailed study demonstrating the calibrator's performance against specific acceptance criteria, as one would typically expect for a device, is not explicitly provided in this summary. Instead, it relies on substantial equivalence to a predicate device for the assay performance.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's an attempt to answer based on the limited information given:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not available. The document does not describe a specific test set for the calibrator's performance. It relies on the substantial equivalence of the CRP-Latex(II)X2 SEIKEN High Sensitivity Assay to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not available. There is no mention of a test set requiring expert ground truth establishment for the calibrator.

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

• Not available.

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

• Not applicable. This device is a calibrator for a laboratory assay, not an AI-assisted diagnostic tool that would involve human readers.

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

• Not applicable. This is a calibrator, not an algorithm or AI.

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

• Not available. Since no specific study details are provided for the calibrators, the type of ground truth for performance assessment is not mentioned. For the assay itself, typically, established reference methods or primary standards would serve as ground truth for accuracy and precision studies, but such studies are not detailed here for the calibrator.

8. The sample size for the training set:

• Not available. The document does not describe a training set for the calibrator.

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

• Not available.

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The CRP-Latex (II)X2 SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

The CRP-Latex (II)X2 SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Antigen in the sample bonds to the specific anti-CRP antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on an automated chemistry analyzer (the Hitachi 917 was used for these studies), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

Here's a breakdown of the acceptance criteria and the study details for the CRP-Latex (II)X2 SEIKEN Assay Kit, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 451 donor samples were used for the comparative performance studies.
   • Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the given text. The "ground truth" for the comparative study was the measurement given by the predicate device (N High Sensitivity CRP Assay).

3. Adjudication method for the test set:

   • This information is not applicable as the "ground truth" was established by a predicate device's measurements, not by human expert assessment requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunoassay, not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

   • Yes, the performance reported is a standalone (algorithm only) performance, comparing the output of the CRP-Latex (II)X2 SEIKEN Assay Kit to a legally marketed predicate device. The device itself is an automated immunoassay, not one that typically involves a human-in-the-loop for its basic measurement function.

6. The type of ground truth used:

   • The "ground truth" for the comparative performance study was the measurements obtained from the legally marketed predicate device, the N High Sensitivity CRP Assay (Dade Behring Inc.).

7. The sample size for the training set:

   • This information is not provided in the text. The study describes performance testing against a predicate device, not the development or training of an algorithm that would typically require a separate training set.

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

   • This information is not provided as a separate training set and its ground truth establishment are not discussed in the context of this 510(k) submission.

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