(373 days)
The UniCel® DxH 800 COULTER® Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The UniCel® DxH 800 COULTER® Analyzer identifies and enumerates the parameters indicated below on the following sample types:
- Whole Blood (Venous and Capillary)
- o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY%, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET%, RET#, MRV, IRF
- 이 Pre-Diluted Whole Blood (Venous and Capillary)
- WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, o PLT, MPV
- Body Fluids (cerebrospinal, serous and synovial) ■ o TNC and RBC
The updated DxH 800 with software version 2.0, the subject of this submission, uses the same principles of operation, reagents, controls and calibrators as the original cleared device.
The UniCel® DxH 800 COULTER® Cellular Analysis System (DxH 800) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, nucleated red blood cell (NRBC) enumeration and reticulocyte analysis as well as an automated method for enumeration of the Total Nucleated Cells (TNC) and Red Blood Cells (RBC) in body fluids.
The DxH 800 System is intended to separate patients with normal hematological parameters from patients who need additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
The DxH 800 system is comprised of the analyzer, an optional floor stand, and a suite of analytical reagents, quality control and calibration reagents, and reagents for system cleaning.
Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter UniCel® DxH 800 COULTER® Cellular Analysis System, based on the provided document:
Acceptance Criteria and Device Performance
The general acceptance criteria are that the updated DxH 800 system meets the performance requirements (within acceptance limits) for its claimed parameters, demonstrating comparability or equivalency to the predicate device and/or manual reference methods. Specific numerical acceptance limits are not provided in this summary, but the "510(k) Testing Summary" column indicates that the device met these unstated performance requirements.
Table of Acceptance Criteria (Generic) and Reported Device Performance
| Study Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Accuracy - Comparability (Whole Blood & Body Fluid) | Meets accuracy claims (Bias and/or Difference) limits over defined measuring ranges. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides results within acceptance limits for parameters reported from whole blood, when compared to the predicate device and for differential parameters when compared to manual reference results. In addition, the updated DxH 800 meets the performance requirements and provides results within acceptance limits for parameters reported from body fluid, when compared to the manual chamber count. |
| Accuracy - Comparability (Analytical Cycles) | Equivalency of results (within defined limits) between different analytical cycles and between whole blood and pre-dilute specimens. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides comparable results for all parameters reported from specimens analyzed as whole blood in the available analytical cycles and when analyzed as whole blood and pre-dilute samples. |
| Accuracy - Comparability (Sampling Modes) | Comparability between automated closed vial, manual closed vial, and manual open vial sampling methods. | Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements to provide comparable results for all parameters reported, for specimens analyzed using the sampling methods available (automated closed vial, manual closed vial and manual single tube open vial). |
| Reproducibility | Meets performance requirements (within acceptance limits) for long-term imprecision using control products. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements (within acceptance limits) for reproducibility (long term imprecision) using control products. |
| Repeatability | Meets performance requirements (within acceptance limits) for short-term imprecision. | Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements for repeatability, (within acceptance limits) for all parameters reported. |
| Performance - LoB, LLoD, LLoQ | Meets performance requirements (within acceptance limits) for Limit of Blank, Lower Limit of Detection, and Lower Limit of Quantitation. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements for LoB, LLoD and LLOQ results (within acceptance limits), for the WBC and PLT parameters in whole blood and the BF-TNC and BF-RBC parameters in body fluids. |
| Performance - Clinical Sensitivity and Specificity | Equivalent or improved performance for WBC Differential Suspect message flagging capability compared to the predicate device. | Analysis of the data collected demonstrates that the updated DxH 800 provided equivalent or improved performance for Clinical Sensitivity and Specificity as compared to the predicate device analyzing the same data set. |
| Linearity | Meets performance requirements and provides linear results (within acceptance limits) for whole blood and body fluid. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides linear results, within acceptance limits, for Whole blood and Body Fluid. |
| Carryover | Meets whole blood and body fluid carryover performance requirements (within acceptance limits). | Analysis of the data collected demonstrates that the updated DxH 800 meets the whole blood and body fluid carryover performance requirements (within acceptance limits), for the parameters measured. |
| Specimens - Anticoagulant | Meets performance requirements and provides comparable results for specimens collected into K₂ and K₃EDTA. | Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements and provides comparable results, for all parameters reported, from specimens collected into K₂ and K₃EDTA. |
| Specimens - Collection Method | Meets performance requirements and provides comparable results for specimens collected by venipuncture and capillary methods. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides comparable results, for all parameters reported from specimens collected by venipuncture and capillary collection methods and analyzed using the CBC, Differential and Reticulocyte analytical cycle. |
| Specimens - Stability | Meets performance requirements and claims with respect to whole blood long term, short term, and pre-dilute sample stability. | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and claims with respect to whole blood long term, short term and pre-dilute sample stability. |
| Reference Ranges | Comparability of whole blood reference ranges for an adult population to the ranges established for the predicate device. | The reference ranges established for the predicate DxH 800 are applicable for the updated DxH 800. The updated DxH 800 labeling will provide the reference ranges as currently presented in the predicate labeling. |
Study Details:
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Sample Sizes Used for the Test Set and Data Provenance:
- The document does not explicitly state specific sample sizes for each test set. It mentions "analysis of the data collected" for each performance study.
- Data Provenance: The document does not explicitly state the country of origin. It refers to "patient samples" and "control materials." Given Beckman Coulter is based in Miami, Florida (USA), clinical studies are often conducted within the US or aligned with US regulatory standards. The CLSI (Clinical and Laboratory Standards Institute) standards cited are internationally recognized but a primary focus in the US. The studies are retrospective in the sense that the performance data for the updated DxH 800 is being compared to an existing predicate device (K081930), which would imply using comparable data sets or collecting new data for comparison. The document states, for clinical sensitivity and specificity, the comparison was made "analyzing the same data set" as the predicate, suggesting some retrospective analysis of existing data. However, the performance studies themselves likely involved prospective collection of samples for the updated device's testing.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document explicitly mentions comparison to "manual reference results" for differential parameters and "manual chamber count" for body fluid parameters.
- However, it does not specify the number of experts used or their qualifications (e.g., "radiologist with 10 years of experience").
- The CLSI H20-A2 standard ("Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods") is cited, which typically outlines procedures for establishing manual differential counts, often involving trained morphologists or medical technologists.
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Adjudication Method for the Test Set:
- The document does not explicitly describe adjudication methods for the test set. For manual reference methods, standard practice often involves review by a trained expert, possibly with a second review in cases of discrepancy, but this is not detailed in the summary.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is an automated hematology analyzer, not an AI-assisted diagnostic imaging device that typically involves human readers. The comparative studies focus on the device's performance against a predicate device or manual reference methods, not human reader performance.
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Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, the studies described are primarily standalone performance evaluations of the UniCel® DxH 800 system itself. This device is the algorithm, providing automated results for various hematologic parameters. The "human-in-the-loop" aspect exists in clinical practice (e.g., reviewing flagging results, performing manual differentials when indicated), but the performance studies focus on the automated system's accuracy, precision, and other analytical specifications. The "Clinical Sensitivity and Specificity" study for WBC differential flagging assesses the algorithm's ability to correctly identify cases needing further review, which can be seen as a measure of its standalone utility in a screening context.
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Type of Ground Truth Used:
- Expert Consensus/Manual Reference Methods: For differential parameters, "manual reference results" were used. For body fluid parameters, "manual chamber count" was the ground truth.
- Predicate Device Data: For many parameters, the updated DxH 800 was compared against the "predicate device" (UniCel® DxH 800, K081930). This implies the predicate device's established performance served as a form of "ground truth" or a benchmark for equivalency.
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Sample Size for the Training Set:
- The document is a 510(k) summary for an update to an existing device (software version 2.0 of the DxH 800). The underlying principles (Coulter Principle, VCSn technology) and reagents are the same as the predicate device. Therefore, a separate "training set" in the modern machine learning sense is not explicitly mentioned or likely relevant for this software update submission. The "algorithms using advanced mathematical methods for population differentiation and flagging" would have been developed and "trained" during the original device's development (K081930), and this submission focuses on demonstrating that the updated software maintains or improves performance.
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How the Ground Truth for the Training Set Was Established:
- As noted above, a distinct "training set" for the software update is not detailed. For the original device's algorithms, the ground truth would have been established through extensive studies comparing automated counts and differentiation with expert-reviewed manual microscopy (e.g., manual differential counts performed by experienced morphologists) and possibly other reference methods over a large and diverse set of patient samples. This process would involve adhering to standards like CLSI H20-A2, which describes the reference leukocyte differential count method.
§ 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.”