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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 and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 750 Hematology Analyzer utilizes the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. It uses COULTER VCS (volume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzer uses 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. For body fluids analysis, the specimen is aspirated into the LH 750 Analyzer via the manual mode and is diluted in separate WBC and RBC baths. The Coulter Method of counting cells is used to detect and measure changes in electrical resistance when a cell, suspended in a conductive diluent, passes through a small aperture.

The provided document K061574, a 510(k) summary for the COULTER® LH 750 Hematology Analyzer, is primarily a notification of a modification to the device, specifically a revised MCV accuracy specification. It does not contain detailed information about a comprehensive study proving the device meets acceptance criteria for all its listed functions (e.g., differential leukocyte count, reticulocyte analysis, NRBC enumeration, body fluid analysis).

The document mentions that the modification relates to the "draft labeling submitted in the original Premarket notification (K011342) to reflect a revised MCV accuracy specification." This implies that the initial and comprehensive studies would have been part of the K011342 and K030606 submissions, which are referenced as legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not available in the provided text. The following table and explanations reflect the information that can be extracted from the given document, focusing on the modification rather than a complete re-evaluation of the entire device.

Acceptance Criteria and Reported Device Performance (Focused on MCV Accuracy Specification)

Missing Information:

• The actual numerical value of the original MCV accuracy specification.
• The actual numerical value of the revised MCV accuracy specification.
• The specific data and statistical analysis demonstrating that the device meets the revised MCV accuracy specification.

Study Information (Based on the available document)

Given the nature of the document (a 510(k) for a revised MCV accuracy specification), the details of a full study often found in original 510(k) submissions are not present. The focus here is on what can be inferred about the change rather than a complete de novo study validation.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in this document. Information on the number of samples used to validate the revised MCV accuracy is absent.
   • Data Provenance: Not specified. It's likely that data would be from internal Beckman Coulter studies, but details on country of origin or whether it was retrospective or prospective are not provided for this specific modification. For the original device, it would have been part of K011342 and K030606.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of a hematology analyzer, ground truth for MCV would typically involve reference methods and quality controls, potentially with expert oversight for sample preparation and analysis.

3. Adjudication method for the test set:

   • Not specified. This is typically relevant for subjective assessments (e.g., image review), which MCV measurement is not. For quantitative measurements like MCV, validation usually involves comparison to a reference method or validated control materials.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is an automated hematology analyzer, not an AI-assisted diagnostic imaging tool with human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The COULTER® LH 750 Hematology Analyzer is an automated device, meaning its primary function is standalone performance (algorithm only). The document describes it as "a quantitative, automated hematology analyzer."
   • The modifications to its MCV accuracy specification would inherently relate to its standalone performance.

6. The type of ground truth used:

   • Likely Reference Methods and Calibrated Controls: For MCV, ground truth would typically be established using validated reference methods (e.g., manual packed cell volume, or highly calibrated reference instruments) and internationally recognized hematology calibrators and internal quality control materials (some of which are mentioned as qualified reagents, such as COULTER S-CAL® Hematology Calibrator).

7. The sample size for the training set:

   • Not applicable/Not specified for this modification. This document pertains to a specification revision for an existing, already-marketed device. It's not a de novo algorithm development that would explicitly describe a "training set" in the context of machine learning. The device's underlying principles (Coulter Principle, VCS technology) are well-established. Any "training" or calibration would have occurred during the original device development (K011342) and subsequent routine calibration of individual instruments.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified for this modification. As above, the concept of a training set in the AI/ML sense isn't directly applicable here. For the original development, ground truth for calibration would have been established using reference methods and calibrated materials.

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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) in whole blood and white blood cells (WBCs) and red blood cells (RBCs) in body fluids.

The LH 700 Series Body Fluid Application is a procedure for obtaining in vitro quantitative determinations of leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid, using a COULTER LH 700 Series Hematology Analyzer.

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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the COULTER® LH 750 Hematology Analyzer's body fluids application:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a modification to the existing COULTER® LH 750 Hematology Analyzer, specifically related to the stability of synovial and serous fluid samples. It doesn't detail the full acceptance criteria for the original device's general performance (e.g., accuracy, precision for all blood cell analysis), but rather focuses on the extended sample stability for specific fluid types.

Therefore, the table below reflects the specific acceptance criteria and reported performance relevant to this modification.

Note: The document states: "...to indicate a sample stability of eight (8) hours for synovial fluid analysis (rather than 1 hour) and eight (8) hours for serous fluid analysis (rather than 24 hours) to reflect actual validated performance." This implies that for serous fluid, while the proposed labeling change was from 24 hours to 8 hours, the new validated performance is 8 hours. This isn't an improvement in stability for serous fluids compared to the prior claim, but rather a correction to reflect actual validated performance, which now matches synovial fluid.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the validation study that established the new sample stability times.

It also does not directly specify the provenance (country of origin, retrospective/prospective) of the data. However, as it's an FDA submission for a device marketed in the US, it's highly probable the data was generated within the US or under US regulatory guidelines. Given the context of "actual validated performance," it implies a prospective validation study was conducted to determine these new stability parameters.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish ground truth in the context of this sample stability study. This type of validation typically involves laboratory experiments comparing measurements taken at different time points, rather than subjective expert interpretation of results. The "ground truth" would be objective measurements from fresh samples. If clinicians were involved, it would likely be for reviewing the clinical implications, not for establishing the instrument's analytical performance on stability.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Adjudication is usually relevant when multiple experts provide subjective assessments that need to be reconciled. In a study validating sample stability of a hematology analyzer, the "ground truth" (i.e., whether a sample's parameters changed significantly over time) is determined by quantitative measurements and statistical analysis, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done, nor is it applicable here. This submission is for a modification to an automated hematology analyzer, not an AI-powered diagnostic imaging tool or a system involving human interpretation with AI assistance. The device fully automates the analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire operation of the COULTER® LH 750 Hematology Analyzer for cell counting and differentiation is standalone (algorithm only without human-in-the-loop performance). The device is the algorithm and analytical system; human interaction is for sample loading, maintenance, and result interpretation, but not for the primary measurement process itself. The modification discussed here (sample stability) directly pertains to the standalone performance of the analyzer with respect to sample integrity over time.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the sample stability study, the ground truth would be established through quantitative laboratory measurements on fresh samples and samples stored for different durations. The "ground truth" for a stable sample is that its measured parameters (e.g., WBC, RBC counts) do not significantly deviate from the initial measurement taken at time zero, within pre-defined analytical variation limits. This is an objective, measurement-based ground truth, not dependent on expert consensus or pathology in the conventional sense.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of this sample stability modification. Hematology analyzers, especially those based on electrical impedance (Coulter Principle) and VCS technology, are generally rule-based or empirically developed, not typically "trained" using machine learning in the way an AI algorithm for image recognition would be. The validation described is about confirming the analytical stability of samples over time when processed by the existing device software and hardware.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for this specific modification and device type, this question is not applicable. The device's core functionality and its initial ground truth for cell identification and counting would have been established through extensive analytical validation against reference methods (e.g., manual microscopy, other established technologies) during its original development. This particular submission concerns a change in labeling claim based on new validation data regarding sample stability.

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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:

• 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.

• Sample Size, Test Set, and Data Provenance: Not provided.

• Number and Qualifications of Experts for Ground Truth: Not provided.

• Adjudication Method: Not provided.

• Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not mentioned as performed.

• 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.

• Type of Ground Truth: Not provided.

• Sample Size for Training Set: Not provided.

• How Ground Truth for Training Set was Established: Not provided.

Summary Table of Available Information:

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