(59 days)
The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.
LH 750 Hematology Analyzer with Ver. 2B Software is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Ver. 2B Software 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, biochemical investigations, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
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 NRBC enumeration.
The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting and sizing, reticulocyte determination, quality control, calibration and cleaning.
The documentation provided does not contain a study that proves the device meets specific acceptance criteria. This submission is an abbreviated 510(k) for a software update (Ver. 2B Software) for the Coulter LH 750 Hematology Analyzer, claiming substantial equivalence to the existing LH 750.
The document highlights "Improved NRBC performance for False Negatives" as a difference from the predicate device, implying that this specific performance metric was a focus of the software update. However, it does not provide details on the acceptance criteria for this improvement or the study conducted to demonstrate it.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can be inferred or stated from the provided text:
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Acceptance Criteria and Reported Device Performance: Not explicitly stated. The document mentions "Improved NRBC performance for False Negatives" as a difference from the predicate, but no quantitative criteria or reported performance data are given.
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Sample Size, Test Set, and Data Provenance: Not provided.
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Number and Qualifications of Experts for Ground Truth: Not provided.
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Adjudication Method: Not provided.
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Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not mentioned as performed.
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Standalone (algorithm only) Performance: Not explicitly stated as performed. While the device is an automated analyzer, the document doesn't present a standalone performance study with specific metrics and acceptance criteria for the software update. The focus is on substantial equivalence to the predicate device.
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Type of Ground Truth: Not provided.
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Sample Size for Training Set: Not provided.
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How Ground Truth for Training Set was Established: Not provided.
Summary Table of Available Information:
| Feature | Description (as per provided text) |
|---|---|
| Acceptance Criteria & Device Performance | Not explicitly stated. The document indicates "Improved NRBC performance for False Negatives" as a difference/improvement over the predicate device, but no quantitative acceptance criteria or performance metrics are provided in the given text. |
| Sample size (test set) & Data Provenance | Not provided. |
| Number & Qualifications of Experts for Ground Truth | Not provided. |
| Adjudication Method | Not provided. |
| MRMC Comparative Effectiveness Study | Not mentioned. |
| Standalone Performance Study | Not explicitly detailed for the software update. The device itself is an automated analyzer that performs standalone measurements. However, no specific study data or acceptance criteria for the software's standalone performance (e.g., comparing it to a gold standard) are presented in this context, beyond the general claim of improved NRBC performance. |
| Type of Ground Truth Used | Not provided. |
| Sample Size for Training Set | Not provided. |
| How Ground Truth for Training Set was Established | Not provided. |
| Device Type | Automated Hematology Analyzer with Ver. 2B Software |
| Intended Use | For In Vitro Diagnostic Use in clinical laboratories. Provides automated complete blood count, leukocyte differential, NRBC enumeration, and reticulocyte analysis. Separates normal patients from those needing further studies. |
| Key Difference from Predicate (related to performance) | The Ver. 2B Software offers "Improved NRBC performance for False Negatives" and "Added additional Fail safe" for WBC correction, in addition to being qualified for use with cyanide-free reagents and consistent with IVDD regulation. These are presented as differences from the predicate, suggesting improvements. However, the details of how these improvements were measured against acceptance criteria are not in the provided text. |
§ 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.”