Search Results

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

This is a liquid product composed of stabilized human red blood cells suspended in a buffered fluid with added constituents of animal origin and preservatives.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Laboratories Liquichek Reticulocyte Control (A), formatted to address your specific questions:

Device: Bio-Rad Laboratories Liquichek Reticulocyte Control (A)
Study Purpose: To demonstrate substantial equivalence to a predicate device (Liquichek Reticulocyte Control, K993496) and support product claims for stability.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on substantial equivalence rather than a full performance study report with detailed quantitative acceptance criteria and results. The "reported device performance" are primarily the claims made based on internal studies.

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

The document does not explicitly state the sample size used for the stability studies. It only mentions that "Stability studies have been performed..."

The data provenance is internal to Bio-Rad Laboratories, as stated: "All supporting data is retained on file at Bio-Rad Laboratories." This implies the data would be generated within their facilities. The document does not specify country of origin for data or whether it was retrospective or prospective. Given it's a new device, the studies would logically be prospective.

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

This information is not applicable or not provided in the context of this 510(k) summary. The device is a quality control material intended to evaluate the precision of automated methods of reticulocyte counting. It is not a diagnostic device that requires expert interpretation to establish a clinical ground truth for a test set of patient samples. The "ground truth" for a control material would be its manufacturing specifications and reference values.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the device is a quality control material and not a diagnostic tool requiring interpretation of clinical data, there would be no adjudication of diagnostic results.

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 typically performed for diagnostic imaging devices or other tools where human readers interpret patient cases, and the AI's impact on their performance is being evaluated. The Liquichek Reticulocyte Control (A) is a quality control material, not a diagnostic AI system with human interpretation involved.

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

No, a standalone algorithm-only performance study was not done because the device is a quality control material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device, a quality control material, would be its established reference values determined through manufacturing processes and validation methodologies. These values ensure the control material performs consistently and within expected ranges, allowing laboratories to assess the precision of their reticulocyte counting instruments. The document does not specify the exact methods for establishing these "truth" values, but they would derive from internal laboratory testing and characterization.

8. The Sample Size for the Training Set

This information is not applicable or not provided. The device is a quality control material, not an AI or algorithm that would require a "training set" of data for machine learning. Its development involves manufacturing processes, formulation, and analytical validation rather than algorithmic training.

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

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

Ask a specific question about this device