(55 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 also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The system also provides an automated method for enumeration of RBCs and WBCs in body fluids.
The COULTER® LH 750 Body Fluids Application is an automated method for enumeration of RBCs and WBCs in body fluids on the COULTER LH 750 Hematology Analyzer, an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The LH 750 also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs).
The provided text describes a 510(k) summary for the COULTER® LH 750 Body Fluids Application, which is an automated method for enumerating RBCs and WBCs in body fluids on the COULTER LH 750 Hematology Analyzer.
The submission claims substantial equivalence to a manual cell count method, and the document focuses on outlining the device's intended use, principle of method, and comparison to the predicate. However, it does not contain detailed information about acceptance criteria, specific study results, sample sizes for test or training sets, ground truth establishment methods for training data, number of experts, adjudication methods, or MRMC studies for comparative effectiveness.
Therefore, based solely on the provided text, I cannot complete many of the requested fields. The information below reflects what is available in the document.
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document is a 510(k) summary for a substantial equivalence claim based on a pre-amendment predicate, it does not specify explicit numerical acceptance criteria and does not present detailed performance data in the format of a clinical study report with specific metrics. The "device performance" in this context is implied to be substantially equivalent to the predicate.
The table below reflects descriptive aspects from the "Comparison to Predicate" section, which broadly outlines similarities and differences rather than specific performance metrics against an acceptance threshold.
| Metric/Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (COULTER® LH 750 Body Fluids Application) |
|---|---|---|
| Intended Use | To provide a quantitative determination of blood cells in cerebrospinal fluid, serous fluid, and synovial fluid | Same as manual method |
| Specimen Analyzed | Body Fluids collected in a container with or without anti-coagulant | Same as manual method |
| WBC Count (cells/µL) | Manual cell count performed in a counting chamber by a skilled competent technician | Automated count |
| RBC Count (cells/µL) | Manual cell count performed in a counting chamber by a skilled competent technician | Automated count |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not specify the number of experts used to establish ground truth for a test set or their qualifications. The predicate method refers to a "skilled competent technician" for manual cell counts, implying a human expert performed the reference method.
4. Adjudication Method for the Test Set
The provided document does not specify any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is an automated counter, not an AI-assisted diagnostic tool for human readers in the traditional sense of image interpretation.
6. Standalone (Algorithm Only) Performance Study
The entire submission is focused on the performance of the automated device (algorithm only) for enumeration of RBCs and WBCs in body fluids. The "Conclusion" states: "The COULTER LH 750 Body Fluids Application is substantially equivalent to the manual microscopic predicate method for enumeration of RBCs and WBCs in body fluids." This implies a standalone study where the device's output was compared to the predicate. However, detailed results of this comparison (e.g., accuracy, precision studies) are not included in the summary.
7. Type of Ground Truth Used
The ground truth implicitly used for comparison is the "manual cell count method in a counting chamber by a skilled competent technician". This is essentially an expert consensus/reference method (assuming the "skilled competent technician" embodies the reference standard for manual counting).
8. Sample Size for the Training Set
The provided document does not specify the sample size used for any training set.
9. How the Ground Truth for the Training Set Was Established
The provided document does not specify how the ground truth for any training set was established. Given the nature of the predicate, it would likely involve manual counts by skilled technicians, but this is not explicitly stated for a training set.
§ 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.”