INTENDED USE

Intended Use

The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anti-coagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#.

It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/disorders, oncology patients, critically ill patients, or children under the age of 2.

Critical Illness Contraindication

CMS defines a critical illness or injury as one which “acutely impairs one or more vital organ systems such that there is a high probability of imminent or life-threatening deterioration in the patient’s condition.” (Medicare Claims Processing manual, Chapter 12, Section 30.6.12A).

The indication excluding critically ill patients is clearly explained in the Clinician’s Quick Guide and the analyzer Instructions for Use (IFU), which all users are required to follow. In addition, our sales representatives have been specifically instructed not to sell an XW-100 for use in a clinical area which cares for only critically ill patients, such as intensive care units. However, in some environments, clinicians will encounter critically ill patients as well as those who are not. In those cases, it is important for the physician to follow the IFU and only use the XW-100 for patients who are not critically ill.

Use in critically ill patient populations is not only contraindicated, but is likely to result in suppression of a large portion of the results.

Challenge Study

A sample challenge study was conducted to determine if the XW-100 will flag and/or suppress results for samples with abnormal findings that could lead to the reporting of erroneous results in the CLIA waived setting. For all samples, the XW-100 results were appropriately suppressed per the suppression rules and the presence of potentially interfering substances did not result in the reporting of erroneous results when compared to the pocH-100i.

Samples were successfully flagged or suppressed with the following abnormalities: cold agglutinins; fragmented RBCs; high lipids; high WBC count; hyperglycemia; hypernatremia; hypochromic anemia; hyponatremia; immunoglobulin; immunosuppressive drugs; in vivo hemolysis; large and giant platelets; microcytes; microorganisms (bacterial aggregates, parasites, fungi); nucleated RBCs; platelet agglutination; platelet aggregates; sample coagulation; warm agglutinins; and other abnormalities (high MCV, immature granulocytes, and atypical lymphocytes).