Search Results
Found 1 results
510(k) Data Aggregation
(28 days)
The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi- automated reticulocyte analysis.
LH 500 hematology analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 500 provides automated complete blood count and leukocyte differential and semiautomated reticulocyte analysis. The purpose of the LH 500 hematology analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
The provided text describes a 510(k) premarket notification for a software modification to the COULTER® LH 500 Hematology Analyzer, not a study presenting detailed acceptance criteria and performance data in the typical sense for a new AI/ML device. This submission focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, a direct mapping to all requested elements (like sample size for training, number of experts for ground truth, MRMC study, etc.) is not fully possible given the nature of the document.
However, I can extract the relevant information and present what is available, inferring acceptance criteria and performance based on the context of a hematology analyzer.
Acceptance Criteria and Device Performance (Inferred from a Hematology Analyzer Context):
For a hematology analyzer, performance is typically assessed by its ability to accurately count and differentiate various blood cell types. The "acceptance criteria" for a modified version would generally relate to maintaining or improving the performance characteristics of the predicate device, especially for the parameters affected by the software change (e.g., differential counts and reticulocyte analysis).
Given the document is a 510(k) for a software modification to allow cyanide-free reagents and to mitigate observed anomalies of earlier versions, the primary performance assessment would involve demonstrating that the device with the new software and reagents performs comparably to the predicate device with its original reagents and software for key hematological parameters. Specific quantitative acceptance criteria are not explicitly listed in this summary, but would typically involve metrics like:
- Accuracy/Bias: Comparison of counts and differentials to a reference method or predicate device.
- Precision/Reproducibility: Consistency of measurements.
- Correlation: Statistical correlation of results with a reference or predicate device.
- Carryover: Minimal transfer of cells/material between samples.
- Linearity: Accurate measurement across a range of cell concentrations.
Since the document mentions "various corrections, clarifications and minor performance testing results were added to operator labeling," this implies that some performance testing was conducted, likely demonstrating that the modifications did not negatively impact the device's accuracy or reliability for its intended use.
Table of Acceptance Criteria and Reported Device Performance (Inferred/Generic for Hematology Analyzers):
| Acceptance Criteria Category (Inferred) | Specific Metric (Inferred) | Acceptance Threshold (Typical for Hema Analyzer) | Reported Device Performance (Based on "substantially equivalent") |
|---|---|---|---|
| Accuracy of CBC Parameters | White Blood Cell (WBC) Count Bias | Within +/- 5% of reference | Deemed substantially equivalent to predicate |
| Red Blood Cell (RBC) Count Bias | Within +/- 3% of reference | Deemed substantially equivalent to predicate | |
| Hemoglobin (Hgb) Bias | Within +/- 2% of reference | Deemed substantially equivalent to predicate | |
| Platelet (Plt) Count Bias | Within +/- 15% of reference (at low counts) | Deemed substantially equivalent to predicate | |
| Accuracy of Differential Counts | Neutrophil % Bias | Within +/- 5% of reference | Deemed substantially equivalent to predicate |
| Lymphocyte % Bias | Within +/- 5% of reference | Deemed substantially equivalent to predicate | |
| Monocyte % Bias | Within +/- 3% of reference | Deemed substantially equivalent to predicate | |
| Eosinophil % Bias | Within +/- 2% of reference | Deemed substantially equivalent to predicate | |
| Basophil % Bias | Within +/- 1% of reference | Deemed substantially equivalent to predicate | |
| Reticulocyte Analysis | Reticulocyte % Bias | Within +/- 20% of reference (at low counts) | Deemed substantially equivalent to predicate |
| Reproducibility/Precision | %CV for various parameters | Typically |
Ask a specific question about this device
Page 1 of 1