(156 days)
The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automatology 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%, BA%, BA#, NRBC%, NRBC%, RET%, RET#, MRV, IRF
Pre-Diluted Whole Blood (Venous and Capillary) - WBC, RBC, HGB, HCT, MCH, MCHC, RDW, RDW-SD, PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC
The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.
MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.
MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.
MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.
The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.
The DxH 800 System is a quantitative, automated hematology analyzer designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal. serous and synovial). The DxH 800 also includes the Monocyte Distribution Width (MDW) parameter shown to aid in the early detection of Sepsis in emergency room adult patients.
The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).
I am sorry, but the provided text does not contain detailed information about acceptance criteria for the Early Sepsis Indicator (MDW) application, nor does it describe a specific study that proves the device meets such criteria.
The 510(k) summary focuses on design changes to the UniCel DxH 800 Coulter Cellular Analysis System, primarily addressing a software update due to a previously identified issue with erroneously elevated platelet results. While the document mentions that the Early Sepsis Indicator application is part of the UniCel DxH 800 system, the performance testing section briefly lists "Carryover, Linearity, Precision, Method Comparison" as design performance verification analyses for the overall system, but it does not specify acceptance criteria or detailed results for the MDW parameter or the Early Sepsis Indicator application.
Therefore, I cannot provide the requested information from the given 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.”