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N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Polystyrene particles coated with monoclonal antibodies to CRP are agglutinated when mixed with samples containing CRP. The intensity of the scattered light in the nephelometer depends on the CRP content of the sample and therefore the CRP concentration can be determined versus dilutions of a standard of a known concentration. The method is standardized against the IFCC/BCR/CAP reference preparation (Lot No.91/0619 = CRM 470 = RPPHS 91/0619 [Lot 5]).

The provided text is a 510(k) summary for an in vitro diagnostic (IVD) device, specifically the N High Sensitivity CRP assay. IVD devices, especially those for quantitative measurements like this, are typically evaluated differently from AI/ML-based diagnostic imaging devices. The document explicitly states: "All performance characteristics were previously established under 510(k) Premarket Notification K991385." This indicates that the current submission (K033908) is not for a new device requiring extensive new performance studies, but rather a modification to the intended use statement of an already cleared device.

Therefore, the provided text does not contain the detailed acceptance criteria or the study information in the format requested for an AI/ML-based medical device. It describes an updated intended use for a previously cleared immunlogical test system.

Consequently, I cannot fill out the requested table and answer the study-specific questions based on the provided text. The information requested (multi-reader multi-case studies, ground truth establishment, sample sizes for training/test sets for AI models, expert qualifications, adjudication methods) is not relevant or present in this 510(k) summary for an immunological assay.

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HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases,

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

The HS-CRP is a latex particle enhanced immunoturbidimetric assay to quantify CRP in When a plasma containing CRP is mixed with the Latex Reagent and the Reaction plasma. Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. The test range is well suited to cover apparent normality as well as the requirements as a marker of infectious and inflammatory diseases.

Here's a breakdown of the acceptance criteria and study information for the HemosIL High Sensitivity - C Reactive Protein device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it presents performance data in comparison to a predicate device and precision data. The implicit acceptance criterion is "substantial equivalence" to the predicate device.

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The Wampole HS-CRP ELISA is an in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitative measurement of C-reactive protein (CRP) levels in human serum and plasma. CRP measurements aid in the evaluation of the extent of injury to body tissues.

The Wampole™ HS-CRP ELISA is a Class II in vitro medical diagnostic device that utilizes conventional enzyme-linked immunosorbent assay technology to quantitatively measure the level of C-reactive protein (CRP) in a serum or plasma specimen. The assay kit consists of plastic microwell strips, containing adsorbed monoclonal anti-CRP antibody. CRP in the specimen is captured by the immobilized antibody, forming immobilized immune complexes. After washing away excess specimen, polyclonal anti-CRP antibody that has been conjugated to horseradish peroxidase is added, forming a "sandwich" of monoclonal antibody, CRP antigen, and conjugated polyclonal antibody. After washing, the immobilized CRP sandwich is exposed to tetremethlybenzidine (TMB), a chromogenic substrate that turns from clear to blue in the presence of peroxidase reaction products. The peroxidase reaction is stopped by the addition of dilute sulfuric acid, which also changes the color of the solution from blue to yellow. The optical density of the yellow end product is directly proportional to the amount of bound CRP antigen, and is quantitated on an ELISA reader at 450 nm. Specimen CRP levels are then determined by interpolation from a standard curve of optical density versus CRP concentration.

The provided text does not contain explicit acceptance criteria tables or a detailed study description with all the requested information for the Wampole HS-CRP ELISA device. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance study report with specific acceptance criteria that the device must meet in a formal table with reported performance.

However, based on the information provided, I can infer some aspects and highlight what is missing.

Here's an attempt to answer your request given the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance in the typical format you requested (e.g., analytical precision, accuracy, limit of detection, etc., against specific numerical targets). The document states the device has "the same technological features, characteristics and intended use as the predicate device," implying that its performance is expected to be comparable to or meet the standards established for the predicate.

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

This information is not explicitly stated in the provided text. The document mentions "human serum and plasma" specimens, but not the number of samples used in any specific test set or their origin (country, retrospective/prospective).

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

This information is not explicitly stated in the provided text. For an in vitro diagnostic (IVD) like an ELISA, ground truth is typically established by reference methods or clinical diagnosis rather than expert consensus on images.

4. Adjudication Method for the Test Set

This information is not applicable or explicitly stated in the provided text, as the device is an ELISA for measuring CRP levels, not a diagnostic imaging device requiring expert adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. This device is an in vitro diagnostic assay.

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

The Wampole HS-CRP ELISA is a standalone in vitro diagnostic assay. Its performance is evaluated biochemically and quantitatively, not as an algorithm assisting a human interpreter. Therefore, its performance is inherently "standalone" in the context of laboratory testing. The document focuses on the assay's ability to quantitatively measure CRP.

7. The Type of Ground Truth Used

For an ELISA like the Wampole HS-CRP ELISA, the "ground truth" would typically be established by:

• Reference materials/calibrators: Known concentrations of CRP used to generate standard curves.
• Comparison to established reference methods: Testing patient samples and comparing results to a gold standard CRP measurement method or a highly accurate predicate device.
• Clinical outcomes/diagnosis: While not directly mentioned for establishing the "ground truth" for the assay's analytical performance, CRP levels themselves aid in the "evaluation of the extent of injury to body tissues," which relates to clinical outcomes.

The document states "Specimen CRP levels are then determined by interpolation from a standard curve of optical density versus CRP concentration," indicating the use of reference materials/calibrators as part of establishing the measurement ground truth. The comparison to the predicate device (Dade Behring N High Sensitivity CRP - K991385) implies that the performance of the Wampole ELISA was benchmarked against an existing, legally marketed device that serves as a standard for CRP measurement.

8. The Sample Size for the Training Set

This information is not explicitly stated in the provided text. For ELISA assays, a "training set" in the context of machine learning isn't directly applicable. Instead, the assay is developed and optimized using a variety of samples and conditions to establish its analytical characteristics (e.g., linearity, precision, accuracy). The document does not specify the number of samples used during this development and validation phase.

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

This information is not explicitly stated in the provided text, and the concept of a "training set" with ground truth as defined for AI/ML models is not directly applicable to a traditional ELISA. The development and optimization of an ELISA involve using known concentrations of purified analyte (CRP standards) and well-characterized human serum and plasma samples to ensure the assay performs as expected across its analytical range. These known concentrations and characterized samples serve as the basis for establishing the assay's analytical performance.

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