(35 days)
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis, enumeration of nucleated red blood cells (NRBCs) in whole blood and leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid. The COULTER LH 750 Hematology Analyzers utilizes the Coulter Principle for enumerating and sizing blood cells, automatic and manual modes for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume, conductivity, light scatter) technology for leukocyte differentiation and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent, lytic reagents, and instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.
The provided text describes a 510(k) submission for a modification to the COULTER® LH 750 Hematology Analyzer, specifically related to the NRBC QC method. However, the document does not contain an independent clinical study that establishes acceptance criteria and then demonstrates the device meets those criteria through performance data.
Instead, this 510(k) is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology or intended use, and the performance data necessary to demonstrate substantial equivalence can be found in the original premarket notification or in recognized standards. In this case, the modification is to the NRBC QC method, suggesting an administrative or minor technical change rather than a re-evaluation of the core performance of the analyzer itself.
Therefore, many of the requested sections (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable or extractable from this specific document, as those would typically be part of a full 510(k) submission for a new device or a significant modification requiring extensive re-validation.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided document. The document refers to a modification to the "NRBC QC Method" and states "The modified COULTER® LH 750 Hematology Analyzer claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer." This implies that the performance characteristics (accuracy, precision, etc.) for the NRBC enumeration itself would have been established and accepted under the original clearance (K011342). This submission focuses on the QC method for those NRBC determinations, not on the underlying performance specifications of the NRBC enumeration itself.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable/Not provided. This submission is for a modification to a QC method, not a re-evaluation of the device's overall performance that would typically involve a test set for clinical accuracy. The original 510(k) (K011342) would contain this information for the device's initial clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable/Not provided. Similar to the above, this information would be relevant to the original clearance of the device's performance, not this specific modification to a QC method.
4. Adjudication Method for the Test Set:
Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is typically done for diagnostic imaging or interpretation tasks where multiple human readers are involved. A hematology analyzer, while performing complex analysis, is generally evaluated through its analytical performance (accuracy, precision, linearity) against reference methods, not typically in an MRMC setting for human reader improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
The COULTER® LH 750 Hematology Analyzer is an automated device, so its primary function is standalone (without human-in-the-loop performance for the core analysis). However, this document does not present a study demonstrating its standalone performance for the NRBC QC method modification. The standalone performance of the NRBC enumeration would have been established during the original K011342 submission.
7. The Type of Ground Truth Used:
For the original clearance of a hematology analyzer, ground truth for cell counts and differentials typically involves:
- Reference methods: Manual microscopy by trained technologists/pathologists, often with differential counts performed on stained blood smears.
- Certified reference materials: Materials with known values for specific analytes (e.g., cell counts).
- Comparison to predicate devices: Performance compared to existing, legally marketed devices.
This specific document related to the modification of the NRBC QC method doesn't discuss the ground truth for NRBC enumeration itself, but rather how the quality control for that enumeration is monitored.
8. The Sample Size for the Training Set:
Not applicable/Not provided. The COULTER® LH 750 (and its underlying technology) was developed prior to the widespread use of "training sets" in the context of machine learning algorithms as we understand them today for image recognition, etc. While the instrument relies on algorithms, these are more in the realm of signal processing and pattern recognition engineered based on established hematological principles rather than deep learning requiring large, labeled training datasets in the contemporary sense. Any "training" or calibration would typically involve a smaller set of known samples to fine-tune instrument parameters.
9. How the Ground Truth for the Training Set Was Established:
Not applicable/Not provided. If "training set" refers to calibration materials, their ground truth would be established through a combination of reference methods and certified values.
In summary, the provided document is a notification for a minor modification to a previously cleared device's QC method. It does not contain an independent study with acceptance criteria and performance data for the device itself because the original device's performance was already established and cleared under a prior 510(k).
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”