Search Results

The COULTER® GEN-S system is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The GEN-S System also provides automated Reticulocyte analysis. The COULTER GEN-S SMM INTEGRATED SLIDEMAKER Option prepares a blood film on a clean microscope slide.

The product is an Automated Differential Cell Counter which like the predicate device COULTER® STKS Analyzer with Reticulocyte Analysis uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates particle count, the size of the electrical pulse is proportional to the cell volume.

WBC differential analysis and classification occurs in the flow cell where low-frequency current measures volume, highfrequency current senses cellular internal content, and light from the laser bouncing off the individual WBC cells characterizes cellular surface, shape and reflectivity.

To measure the number of Reticulocytes in the sample, a supravital dye, is incubated with whole blood samples. The dye precipitates the basophilic RNA network found in reticulocytes. Hemoglobin and unbound stain are removed by adding a clearing reagent, leaving clear spherical mature RBCs and darkly stained reticulocytes. Stained Reticulocytes are differentiated from mature red cells and other cell populations by light scatter, direct current measurements and opacity characteristics when using the GEN-S with volume, conductivity, light scatter and reticulocyte counting technology.

The provided text describes the COULTER® GEN-S™ System, an automated hematology analyzer. However, it does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.

The text states: "Testing included in this submission focuses on attributes of precision, accuracy, linearity and carryover. Testing met all acceptance criteria." This is a general statement and does not provide the specific numerical acceptance criteria or the reported device performance against those criteria.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving their fulfillment as the necessary data is not present in the provided document.

To answer your request, the input text would need to contain:

• Specific numerical acceptance criteria for precision, accuracy, linearity, and carryover (e.g., "Accuracy for WBC count must be within +/- 5% of reference method").
• Reported device performance against those specific criteria (e.g., "Reported WBC accuracy was 3.2%").
• Details of the study methodology including sample sizes, data provenance, ground truth establishment, etc.

Without this information, I cannot generate the requested table and detailed study description.

Ask a specific question about this device