(149 days)
The UniCel® DxH 800 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 Analyzer identifies and enumerates the parameters indicated below on the following sample types:
Whole Blood (venous and capillary) - 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#, MRV, IRF
Pre-Diluted Whole Blood (venous and capillary) - WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC
The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
The DxH 800 and DxH SMS form a family of integrated and interactive modular products that are scalable to meet the specific laboratory workflow and workload needs. Currently these products are offered as stand-alone devices only.
DxH 800: The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a Complete Blood Count (CBC), Leukocyte Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)
DxH SMS: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
The upgrade of these devices with software v3.0 will allow for these stand-alone devices to be configured into five workcell configurations through physical and virtual connections. Physically, the instruments are connected via hardware and the virtual connection is accomplished by means of the new control system software that provides integrated process control, data consolidation and sample transport to the various instruments in the workcell in order to facilitate and improve laboratory efficiency. This will yield a total of seven product configurations, including:
Stand-alone DxH 800 with software v3.0
Stand-alone DxH SMS with software v3.0
Five customizable workcell configurations comprised of DxH 800 and DxH SMS with software v3.0
DxH 801 - one DxH 800 + one DxH SMS
DxH 1600 two DxH 800
DxH 1601 two DxH 800 + one DxH SMS
DxH 2400 three DxH 800
DxH 2401 three DxH 800 + one DxH SMS
These workcell configurations allow for increased system efficiencies through workload balancing between available instruments within the workcell, and automated pass through processing of selected slide preparation and stain test orders.
This document describes the 510(k) premarket notification for the UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis System, specifically referring to the update to software version 3.0.
Here's an analysis of the acceptance criteria and supporting studies, as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance characteristics and testing results rather than explicit "acceptance criteria" in a numerical or categorical format within a single table. It states that the device "meets the performance requirements." Based on the studies summarized, the implied acceptance criterion for each study is that the device demonstrates compliance with the respective performance requirement.
| Study Type | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility (EMC) Interference | EMC interference of individual DxH 800 instruments is not impacted when configured in a workcell configuration. | "The analysis demonstrated that it is unlikely that EMC interference would be increased in the connected DxH workcell as compared to a stand-alone DxH 800." |
| Vibration Testing | Vibration introduced from interconnection of multiple DxH 800 and/or DxH SMS instruments in a workcell configuration does not impact the performance of the individual DxH 800 instruments. | "The analysis demonstrated that it is unlikely that vibration in the connected DxH workcell would impact performance." |
| Measurement Procedure Comparison: Whole Blood and Body Fluids | Bias between the test instruments (DxH 800 v3.0) versus the predicate DxH 800 v2.0 meets performance requirements, adhering to CLSI EP9-A3 and FDA Special Controls Guidance. | "Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the performance requirements for whole blood and body fluids bias when compared to the predicate device." |
| Imprecision (Repeatability): Whole Blood and Body Fluids | Repeatability of the DxH 800 meets performance specifications, adhering to CLSI H26-A2 and FDA Special Controls Guidance. | "Analysis of the data collected demonstrates that the DxH 800 v3.0 meets performance requirements for repeatability for whole blood and body fluids." |
| Limits (LoB, LLoD, LLOQ) | The DxH 800 meets the performance requirements for Limit of Blank (LoB), Lower Limit of Detection (LLoD), and Lower Limit of Quantitation (LLOQ), adhering to CLSI H26-A2 and EP17-A2. | "Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the performance requirements for LoB, LLoD, and LLoQ in whole blood and body fluids." |
| Linearity: Whole Blood and Body Fluids | Linearity of WBC, RBC, Hgb, Plt parameters for whole blood and TNC and BF-RBC parameters for body fluids meets performance requirements, adhering to CLSI H26-A2, EP06-A, and FDA Special Controls Guidance. | "Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the linearity performance requirements for whole blood and body fluids." |
| Carryover: Whole Blood and Body Fluid | Carryover for whole blood and body fluids on the DxH 800 meets performance specifications, adhering to CLSI H26-A2 and FDA Special Controls Guidance. | "Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the whole blood and body fluid carryover performance requirements." |
| Slide Quality (DxH SMS) | The DxH SMS produces slides that meet the slide quality specifications, adhering to CLSI H20-A2. | "The DxH SMS meets the performance requirements for slide quality." |
| Carryover (DxH SMS) | Carryover of the DxH SMS meets performance specifications for blood smear carryover. | "Analysis of the data collected demonstrates that the DxH SMS meets the performance requirements for blood smear carryover." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the various performance tests (e.g., for measurement procedure comparison, imprecision, linearity, carryover, slide quality).
The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, the studies are described as "Verification" or "Evaluation" and refer to "patient samples," implying that the testing was conducted with biological samples in a laboratory setting. The predicate device (v2.0) was manufactured by Beckman Coulter, suggesting the studies would likely be linked to their research and development activities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For the DxH SMS, the reference method is "Manually prepared blood films per the manual wedge-pull film technique as described in CLSI H20-A2," which implies human expert review, but the number and qualifications of these experts are not specified.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. For a device like an automated differential cell counter and slidemaker/stainer, ground truth is typically established against established manual methods and/or expert morphological review, but the specific adjudication process is not detailed.
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
The document describes an automated hematology analyzer and slidemaker/stainer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance is not applicable and was not performed or reported. The studies evaluate the device's technical performance against a predicate device or established manual methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are for the standalone performance of the UniCel DxH 800 and DxH SMS devices. The document focuses on the device's ability to accurately enumerate and identify blood parameters and prepare quality slides directly, without an explicit human-in-the-loop component being evaluated for its performance metrics. The performance characteristics compare the device's outputs to a predicate device (DxH 800 v2.0) or a manual reference method (for DxH SMS), assessing the algorithm's accuracy in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used varies by the study:
- For the UniCel DxH 800 (measuring parameters like WBC, RBC, etc.): The ground truth for bias evaluation was established by comparison against a predicate device (UniCel DxH 800 Software 2.0), which itself would have been previously validated against established methods. The guidance documents (CLSI H26-A2, EP9-A3) also imply accepted reference measurement procedures.
- For the UniCel DxH Slidemaker Stainer (DxH SMS): The ground truth for slide quality was established against the manual wedge-pull film technique as described in CLSI H20-A2. This CLSI standard is likely considered the gold standard for manual blood film preparation, implying that the "ground truth" for slide quality aligns with the criteria outlined in that standard, which would typically be assessed by trained laboratory professionals.
8. The Sample Size for the Training Set
The document does not provide information regarding a separate "training set" or its sample size. This type of regulatory submission (510(k)) for an automated hematology analyzer typically focuses on verification and validation studies on a test set, demonstrating equivalence to an existing device or method. If machine learning was used in the development of the algorithms, information about the training set might be proprietary or not deemed necessary for this level of regulatory submission, especially if the changes are primarily integration and software.
9. How the Ground Truth for the Training Set was Established
As no information on a specific "training set" is provided, how its ground truth was established is not detailed in this document.
§ 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.”