(26 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 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 and enumeration of nucleated red blood cells (NRBCs). The COULTER LH 750 Hematology Analyzer with Version 2A software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer with Version 1A software. Both devices utilize the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume. conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent. lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.
The provided text is limited and primarily focuses on the regulatory information, device description, and indications for use of the COULTER® LH 750 Hematology Analyzer with Version 2A Software. It explicitly states that this submission is a "Summary of Safety and Effectiveness," usually followed by a more detailed report or study.
Based on the provided text, a comprehensive acceptance criteria table and the study to prove it cannot be fully constructed because the detailed study results and specific acceptance criteria values are not included. The document acts as a 510(k) submission summary, indicating substantial equivalence to a predicate device, rather than a full study report with detailed performance metrics against predefined acceptance criteria.
However, I can extract the available information and highlight what is missing based on your request.
Acceptance Criteria and Device Performance
Due to the lack of specific performance data and predefined acceptance criteria in the provided text, this table will show what the document claims the device does (performance characteristics) and what would typically be expected as acceptance criteria for such a device.
| Performance Metric (Acceptance Criteria) | Reported Device Performance (from text) |
|---|---|
| Accuracy / Correlation with predicate device | The document's core claim is "substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer with Version 1A software." This implies that the performance (accuracy, precision, linearity, etc.) of the new version is comparable to the predicate device, which would have had its own established performance metrics. Specific numerical values for agreement or correlation are not provided. |
| Precision / Reproducibility | Not explicitly stated in numerical terms within the provided text. However, the use of quality control materials (e.g., 5C® -ES Cell Control, COULTER RETIC-C™ Cell control, COULTER® S-CAL® Hematology Calibrator) indicates an intention to maintain and monitor precision. |
| Linearity / Reportable Range | The text mentions "COULTER® LIN-C® linearity control (K955334) verifies reportable range of the CBC parameters." Specific reportable ranges or linearity statistics (e.g., R-squared values) are not provided. |
| Interference (Specificity) | Not explicitly stated in the provided text. |
| Carryover | Not explicitly stated in the provided text. |
| Reference Range (WBC Differential, Reticulocytes, NRBCs, etc.) | The device "supplies a complete blood cell analysis and includes a differential leukocyte cell count" and "provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs)." Specific reference ranges or cut-offs for these are not provided; these would typically be established by the clinical lab using the device, or by larger population studies referenced in the full submission. |
| Reliability / Stability | The modification includes "software and minor hardware changes to improve performance characteristics and reliability." No specific metrics or studies demonstrating improved reliability are detailed here. |
Study Details (Based on available information in the document)
Given the nature of a 510(k) for a software/minor hardware update to an existing device, the "study" described is primarily focused on demonstrating substantial equivalence to the predicate device. The provided text is a summary and therefore lacks the granular detail of a full study report.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. It's common for such studies to involve samples from clinical laboratories, potentially across various demographics, but this information is absent here. The submission is from Beckman Coulter, Inc., Miami, FL, USA, suggesting the primary regulatory interaction and potentially the core development location.
- Retrospective or Prospective: Not specified.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not specified. For automated differential cell counters, ground truth is typically established through manual microscopic review by trained technologists or hematopathologists.
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Adjudication Method for the Test Set:
- Not specified.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not explicitly mentioned or described. This type of study is more common for diagnostic imaging AI where human interpretation (readers) is a key part of the workflow. For an automated hematology analyzer, the focus is on the device's analytical performance (accuracy, precision, correlation to a reference method, or the predicate device), not typically on how it "improves" human reader performance in a diagnostic read, as the device itself provides the result.
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Standalone (Algorithm Only) Performance Study:
- Yes, implicitly. The device is an "automated differential cell counter" and provides "automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs)." This means the algorithm performs these analyses without human intervention for each count. The "study" for a 510(k) of this nature would involve evaluating how well the device's automated counts agree with a reference method (e.g., manual microscopy) or with the predicate device. Specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for flagging abnormal cells, or correlation coefficients for cell counts) are not provided in this summary.
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Type of Ground Truth Used:
- Not explicitly stated, but for hematology analyzers, typical ground truth involves:
- Manual microscopy (expert review): For cell differentials, morphology, and difficult-to-classify cells.
- Reference methods: For precise cell counts (e.g., flow cytometry for certain subpopulations or highly calibrated manual counts).
- Predicate device results: For demonstrating substantial equivalence, direct comparison to the previous version's results is critical.
- Not explicitly stated, but for hematology analyzers, typical ground truth involves:
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Sample Size for the Training Set:
- The term "training set" is not mentioned, as this document describes a conventional medical device modification, not necessarily an AI/machine learning model in the modern sense that requires a distinct training phase. If the software improvements involved algorithmic adjustments, it implies development and testing data, but no specific "training set" size is provided.
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How the Ground Truth for the Training Set was Established:
- Not applicable as "training set" for an AI model is not described. For general software development and validation, ground truth would typically be established by established laboratory methods, manual review, or comparison to existing validated systems.
§ 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.”