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This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only. This glucose test system is a device intended to measure glucose quantitatively in serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.

Glucose test system

This is a 510(k) premarket notification for a Glucose Test System. The provided document does not contain a detailed study report with acceptance criteria and device performance as typically expected for a full medical device evaluation. Instead, it is a letter from the FDA confirming substantial equivalence to a predicate device, based on information provided in the original 510(k) submission (K041052), which is not fully included here.

However, based on the Indications for Use (Page 2), we can infer the primary function of the device and thus, conceptualize what typical acceptance criteria and study designs would entail for such a device.

Here's an interpretation and hypothetical construction of the requested information, given the limitations of the provided document.

Understanding the Device: The device is a "Glucose Test System" intended for the "quantitative enzymatic determination of glucose in serum or plasma." It's for "in vitro diagnostic use only" and its measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, gestational diabetes, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumors." The intended patient population is "adult, pediatric, and neonatal."

1. Table of Acceptance Criteria and Reported Device Performance

Since specific acceptance criteria and detailed performance data are not explicitly stated in this FDA letter, the following table represents typical performance characteristics and acceptance criteria for a glucose test system, along with hypothetical "reported device performance" values that would generally be expected for a device receiving FDA clearance. These are inferred based on standard practices for such devices.

Note: The FDA letter indicates this is a "Glucose Test System" for serum or plasma, suggesting it's likely a lab-based or professional-use system, which typically has stricter accuracy and precision requirements than home-use blood glucose meters. The "enzymatic determination" further points to a robust analytical method.

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

• Sample Size: The document does not specify the sample size for any test set. For a glucose test system evaluating accuracy, typical studies involve hundreds to thousands of patient samples (e.g., 100-200 samples per comparison, if comparing to a reference method across the clinical range, with additional samples for interference, precision, and other studies). For FDA submission, it would likely involve a sufficient number of samples to cover the entire clinically reportable range from low to high glucose concentrations, usually with adequate representation across different patient populations (e.g., diabetic, non-diabetic, pediatric, neonatal, as indicated).
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Typically, clinical studies for FDA submissions are prospective and conducted in the United States, though multi-center international studies are also common.

3. Number of Experts Used to Establish Ground Truth and Qualifications

For a glucose test system, "ground truth" is typically established by a highly accurate and precise reference method, not by human expert interpretation in the same way as imaging studies.

• Ground Truth Establishment: Ground truth for glucose measurements is typically established using a primary measurement procedure such as isotope dilution-mass spectrometry (ID-MS) or a well-validated secondary reference method like a hexokinase reference method performed on a highly calibrated and quality-controlled laboratory analyzer.
• "Experts": The "experts" in this context would be highly trained clinical chemists or laboratory personnel with extensive experience in operating and maintaining these reference methods, ensuring their accuracy, calibration, and quality control. There isn't a "number of experts" in the sense of inter-rater agreement for diagnosis; rather, it's about the rigor of the reference laboratory and method.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of device described. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert interpretations, particularly in qualitative or semi-quantitative assessments (e.g., reading medical images, clinical event classification). For a quantitative diagnostic device like a glucose meter, "ground truth" is an objective numerical value obtained from a reference method, not a subjective interpretation requiring adjudication.

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

• Not applicable. MRMC studies are typically performed for devices that involve human interpretation, such as diagnostic imaging AI tools, to assess how an AI system might improve human reader performance. A glucose test system provides a quantitative numerical output that doesn't inherently involve human "reading" or "interpretation" in the same way. The device's output is directly used by healthcare professionals.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study is fundamental. For a glucose test system, the primary performance evaluation is a standalone study of the algorithm/device itself. This involves:
  • Comparing the device's quantitative glucose measurements against those obtained from a recognized reference method.
  • Evaluating precision (repeatability and reproducibility).
  • Testing for linearity, limits of detection/quantitation, and interferences.
  • These studies assess the device's inherent analytical performance without human intervention in the result generation process.

7. Type of Ground Truth Used

• As described in Section 3, the ground truth is established by a highly accurate and precise reference method, typically a hexokinase reference method or isotope dilution-mass spectrometry (ID-MS), recognized as the gold standard for glucose measurement. This is essentially an objective laboratory measurement from a certified reference laboratory.

8. Sample Size for the Training Set

The document does not provide information on a training set size.

• For enzymatic glucose test systems, specifically for the reagent itself, there isn't a "training set" in the machine learning sense. The device's underlying chemical and enzymatic reactions are based on known spectrophotometric or electrochemical principles. Manufacturers would perform extensive development and validation using a large number of samples, analytical studies, and calibration sets to optimize the reagent formulation, instrument parameters, and ensure robust performance across various conditions. This development might involve hundreds to thousands of samples, but it's not typically categorized as a "training set" for an algorithm in the way AI/ML devices do. If there were any sophisticated signal processing or calibration algorithms, those would be developed on proprietary datasets.

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

• As mentioned above, for a traditional enzymatic glucose test system, the concept of a "training set" with ground truth (as in AI/ML) is not directly applicable.
• Instead, during the development phase, manufacturers would use well-characterized glucose solutions of known concentrations (often traceable to NIST standards) and patient samples whose glucose levels have been verified by a reference method to:
  • Calibrate the device.
  • Optimize reagent formulations and reaction conditions.
  • Verify basic analytical performance (e.g., linearity, sensitivity).
  • This "ground truth" for development and calibration would similarly be derived from highly accurate reference methods or certified reference materials.

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This reaqent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction.

This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Urea Nitrogen (BUN) test system

The provided document is a 510(k) clearance letter from the FDA for a Urea Nitrogen (BUN) test system. It does not contain information regarding detailed acceptance criteria, device performance studies, or specifics about a test set (like sample size, data provenance, expert consensus, etc.).

Therefore, I cannot fulfill the request to provide:

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 used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone performance study.
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.

This document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. The specific performance data and study details requested are typically found in the 510(k) submission itself, not in the clearance letter.

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This reagent is intended for the quantitative determination of Calcium in serum, heparinized plasma, or urine. For in vitro diagnostic use only.

This calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. The intended patient population may be adult, pediatric, and neonatal.

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Response to Request for Information on Device Acceptance Criteria and Study Details:

This document, K041009, is a 510(k) premarket notification for a Calcium (oCPC) test system. The information provided in this 510(k) letter is limited to the clearance of the device based on substantial equivalence to a predicate device. It does not contain the detailed study information or acceptance criteria that would typically be found in a more comprehensive submission or a clinical study report.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment cannot be extracted from this document alone. A 510(k) primarily focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (the predicate).

However, I can extract what is explicitly stated or indirectly implied:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not report specific acceptance criteria or detailed device performance metrics such as sensitivity, specificity, accuracy, or precision. It states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that its performance (accuracy, precision, linearity, etc.) is expected to be comparable to or within acceptable limits of the predicate device, but those specific values aren't listed here.

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

• Sample Size for Test Set: Not specified in this document.
• Data Provenance: Not specified in this document. 510(k) submissions often include in-house validation data, but the details are not provided here.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

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

• MRMC Study: Not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). MRMC studies are typically used for imaging devices where human readers interpret results.

6. Standalone Performance Study (Algorithm Only):

• Standalone Performance: While the "Calcium (oCPC) test system" is an in vitro diagnostic device that produces a quantitative result, the document does not provide standalone performance data in terms of accuracy, precision, or other performance characteristics. The 510(k) process primarily evaluates substantial equivalence rather than requiring a detailed standalone clinical performance study to establish de novo effectiveness. Performance data would have been part of the full 510(k) submission, but is not included in this letter.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not specified in this document. For an in vitro diagnostic like a calcium test, the ground truth would typically be established by a reference method (e.g., atomic absorption spectroscopy) or comparison to an accepted, well-established clinical chemistry analyzer.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable in the context of this device and the information provided. This device is a chemical reagent-based test system, not an AI/algorithm-based system that uses a "training set" in the machine learning sense. Its performance is based on the chemical reactions and optical detection methods it employs.

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

• How Ground Truth for Training Set Was Established: Not applicable (see point 8).

In summary: This 510(k) clearance letter confirms that the Calcium (oCPC) test system was deemed "substantially equivalent" to a predicate device for its intended use (quantitative determination of Calcium in serum, heparinized plasma, or urine, for in vitro diagnostic use, to aid in diagnosis and treatment of conditions like parathyroid disease). However, it does not provide the detailed study results, specific performance metrics, or method validation data that would be found within the full 510(k) submission.

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The RAICHEM Assayed Control Serum is a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays.

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I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for a device called "RAICHEM® Assayed Control Serum Level 1 & 2".

This document is a regulatory approval letter and does not contain any information about:

• Acceptance criteria for a study.
• The results of any study demonstrating device performance.
• Details about sample sizes, data provenance, experts, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types for testing or training, or how ground truth was established.

The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. Its "Indications for Use" are described as "a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays."

Therefore, I cannot provide the requested information based on the text provided.

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Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

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This is a 510(k) premarket notification for a Class I in vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML device studies, such as acceptance criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment, are not applicable.

The document indicates that the device, "Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer," has been determined to be substantially equivalent to legally marketed predicate devices. This means that the FDA has agreed that the device is as safe and effective as a device already on the market.

Here's a breakdown of the relevant information provided for this specific submission:

1. A table of acceptance criteria and the reported device performance:
   Not applicable in this document. Substantial equivalence for this type of device typically relies on demonstrating comparable performance to a predicate device, as opposed to meeting pre-defined acceptance criteria for novel AI/ML performance metrics.

2. Sample size used for the test set and the data provenance:
   Not applicable in this document. This submission does not detail a clinical study with a "test set" in the context of AI/ML validation data. Performance is likely demonstrated through analytical studies (e.g., accuracy, precision, linearity) comparing the device to a predicate, not through a prospective clinical study using a specified patient sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The concept of "ground truth" established by experts for a diagnostic algorithm is not relevant for this Class I lipoprotein test system.

4. Adjudication method for the test set:
   Not applicable.

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 an in vitro diagnostic assay, not an AI-powered diagnostic imaging or interpretation tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable.

7. The type of ground truth used:
   Not applicable. The performance of this device would be evaluated against established analytical methods and reference standards for HDL cholesterol measurement, not against an "expert consensus" or "pathology" ground truth as understood in AI/ML validation.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of the K023784 Submission:

• Device Name: Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer
• Indication(s) For Use: To separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease.
• Regulatory Class: Class I
• Product Code: LBR (Lipoprotein test system)
• Decision: Substantial Equivalence to legally marketed predicate devices.
• Date: December 10, 2002

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This reagent is intended for the quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples. LDL-Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

RAICHEM® LDL – Cholesterol Direct Reagent

This document is a 510(k) clearance letter from the FDA for a medical device called "RAICHEM® LDL - Cholesterol Direct Reagent." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text.

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The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.

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The provided text is related to an FDA 510(k) premarket notification for a medical device called "RAICHEM® LIPID Calibrator." This document is a clearance letter and does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria.

The information you've requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in the 510(k) submission itself, or in supporting validation studies referenced within the submission, not in the FDA's clearance letter.

The clearance letter primarily states that the FDA has reviewed the submission (K022767) and determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use (calibration of Raichem LDL and HDL Cholesterol Direct assay).

Therefore, based solely on the provided text, I cannot fulfill your request for details on acceptance criteria and study data.

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Reagent: This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. Calibrator: The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.

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This an in-vitro diagnostic device, and the provided text does not contain the detailed study information typically associated with the acceptance criteria and performance evaluation of AI/ML-driven devices. The document is a 510(k) clearance letter for a C-reactive protein (CRP) test system, indicating it's a traditional medical device rather than an AI/ML product.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria using AI/ML methodologies.

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RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).

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This document is a 510(k) clearance letter for the Raichem® Calcium Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot provide the requested information based on the provided text.

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This reagent is for the quantitative in vitro enzymatic determination of urea nitrogen (BUN) in serum or plasma. For in vitro diagnostic use only.

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The provided text is a 510(k) clearance letter for a medical device (Raichem® BUN Rate Reagent) and its indications for use. It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a performance study. These details are typically found in the 510(k) submission summary or the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested table and study details based on the given input. The document focuses on regulatory approval rather than the technical performance evaluation study.

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