Search Results

Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only.

epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.

epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.

Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit.

Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System.

Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box.

The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html

The provided text describes a 510(k) submission for "Eurotrol Hct Control and epoc® Hematocrit Verification Fluids," which are quality control materials for hematocrit measurements. This document is a premarket notification for a medical device that verifies the precision and accuracy of another device (the epoc Blood Analysis System). It is not a diagnostic device that performs a clinical diagnosis; thus, the concepts of sensitivity, specificity, human reader performance, MRMC studies, or training/test sets for AI models as typically applied to image-based diagnostic AI devices are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to the characteristics and performance of the control fluid itself in demonstrating its suitability for verifying other devices.

Here's the breakdown based on the provided text, adapted for a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a quality control material revolve around its ability to provide stable and accurate reference values. The "performance" is demonstrated by its inherent properties and its equivalence to a predicate device.

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

This is not applicable in the typical sense of a diagnostic device's test set for patient data. For this quality control material, the "test set" would refer to the samples of the QC fluid itself tested during its development and validation.

• Test Samples: The document states "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of the products to support stability. b) Test precision." The exact number of ampules or batches tested for these purposes is not specified in the summary but would have been part of the non-clinical testing data submitted to the FDA.
• Data Provenance: The testing was conducted by Eurotrol B.V. in The Netherlands. This is a non-clinical, controlled laboratory setting, not patient data. It is inherently prospective testing of the manufactured QC material.

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

Not applicable. The ground truth for a quality control material is established by:

• Its chemical formulation.
• The highly precise and accurate methods used to assign values to each lot/batch in a reference laboratory setting (e.g., using reference methods and highly calibrated instruments).
• Comparative testing against established predicate devices.

There are no "experts" in the sense of clinical reviewers establishing diagnoses as ground truth for this type of device.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or diagnostic decision-making involved that would require adjudication.

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

No. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially in the context of AI assistance. A quality control material does not involve human readers for diagnostic interpretation.

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

Not applicable. This device is a fluid, not an algorithm. Its "performance" is its chemical stability and its ability to act as a reliable reference standard for an analytical instrument.

7. The Type of Ground Truth Used

The ground truth for this quality control material is its precisely manufactured and characterized chemical composition and its assigned hematocrit values, which are determined by highly accurate reference measurement procedures. This is essentially a "reference standard" or "master value" derived from rigorous chemical and metrological characterization. Its primary evidence for substantial equivalence relies on comparison to a predicate device (RNA Medical QC 900 Hematocrit Control) that is already legally marketed and accepted as a reliable standard.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require training sets of data.

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

Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity. For In Vitro Diagnostic Use

Medica EasyQC Hematocrit Control is a specially formulated, two-level, aqueous liquid material intended to monitor hematocrit measurement by the Medica EasyStat analyzer. Medica EasyQC Hematocrit Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. Medica EasyQC Hematocrit Control is an electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the Medica EasyStat Analyzer. Medica EasyQC Hematocrit Control is a non-hazardous aqueous solution containing no biological materials.

The provided document for the Medica EasyQC Hematocrit Control is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving performance against those criteria. As such, much of the requested information (like specific acceptance criteria, sample sizes, ground truth methodologies derived from expert consensus or pathology, MRMC studies, or detailed standalone performance) is not present in the provided text.

The document states that "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of products with the same formulation and failure mode to support stability. b) Test precision", but it does not elaborate on the specific acceptance criteria for these tests nor the results in a quantitative manner.

Based on the provided information, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria or detailed-performance results for the Medica EasyQC Hematocrit Control itself beyond its characteristics. The comparison table below highlights characteristics used to establish substantial equivalence, not performance against specific criteria.

Detailed Study Information (Based on availability in the document)

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

   • Test Set Sample Size: Not specified. The document mentions "Tests were conducted" for stability and precision but does not provide details on the number of samples or measurements in these tests.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/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. The device is a quality control material, not a diagnostic device that requires ground truth established by medical experts in the same way an AI diagnostic algorithm would.

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

   • This information is not applicable/provided. As a quality control material and not a diagnostic tool requiring interpretation, this type of adjudication would not be relevant.

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. This device is a hematocrit control material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant and were not performed.

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

   • This concept is not applicable to a hematocrit control solution.

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

   • For a control material, the "ground truth" would typically refer to the known, assigned value of the control material (e.g., its target hematocrit concentration). The document does not specify how these target values were established or verified, beyond stating it's an "electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations."

7. The sample size for the training set:

   • This information is not applicable/provided. This device is a manufactured chemical control solution, not a machine learning algorithm that requires a training set.

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

   • This information is not applicable/provided for the reasons mentioned above.

Summary of the Study:

The provided document describes a 510(k) premarket notification for the "Medica EasyQC Hematocrit Control." The "study" presented is primarily a comparison of the new device's technological characteristics, formulation, and intended use against legally marketed predicate devices (specifically, RNA QC900 Hematocrit Control, K955630) to establish substantial equivalence.

The document states that "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of products with the same formulation and failure mode to support stability. b) Test precision." However, no quantitative data, methods, or results of these tests are provided in this summary. The conclusion drawn is that the "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."

This 510(k) summary focuses on demonstrating that the new control device is as safe and effective as existing legally marketed devices, rather than establishing its performance against a detailed set of quantitative acceptance criteria through extensive clinical trials or complex AI model validation studies.

Ask a specific question about this device

The Aalto Scientific Micro Hematocrit Control are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit.

The Aalto Scientific Micro Hematocrit Controls are prepared using human blood and chemicals, including less than 0.1% sodium azide as preservative. The Aalto Scientific Micro Hematocrit Controls are for in vitro diagnostic use only. The human components used in the manufacture of the product have been tested and found to be non reactive by FDA approved methods for HIV 1/2, HbsAg HCV and HTLV 1/2.

This document is a 510(k) summary for the Aalto MicroHematocrit Control, a device used to monitor the precision of laboratory testing procedures for hematocrit. It claims substantial equivalence to STI Hematachek Separation Technology. This submission does not contain a study with acceptance criteria for device performance.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on describing the device, its intended use, and its technological characteristics compared to a predicate device, as required for a 510(k) submission seeking substantial equivalence, rather than presenting a performance study with detailed acceptance criteria and results.

Ask a specific question about this device

Ask a specific question about this device

The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges.

Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.

This looks like a 510(k) premarket notification for a hematocrit quality control and calibration verification material, not a medical device in the typical sense of a diagnostic or therapeutic tool that relies on complex algorithms or human interpretation of images/data.

Therefore, many of the requested categories in your prompt (such as "number of experts," "adjudication method," "MRMC study," "standalone performance," "training set size") are not applicable to this type of product. The focus for this submission would be on the analytical performance of the control material itself, often demonstrated through precision, linearity, and stability studies.

Here's how I can address the applicable parts of your request based on the provided text:

Description of the Acceptance Criteria and Study:

The provided text K961807 is a "Summary of Safety and Effectiveness" for a quality control and calibration verification material for hematocrit analyzers. It describes the product (Certain® Hct and CVM™ Hct) and its intended use. However, the provided excerpt does not contain the specific acceptance criteria or the study details that demonstrate the device meets those criteria.

A typical 510(k) submission for a quality control material would include:

• Acceptance Criteria for Analytical Performance: This would likely involve specifications for parameters like:
  • Precision/Reproducibility: How consistently the material yields the same Hct value over repeated measurements. (e.g., %CV

Ask a specific question about this device