(30 days)
The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The PENTRA 80 Hematology analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven, with an internal PC that performs further data processing and hosts the user interface.
The provided text describes the ABX PENTRA 80 Hematology Analyzer and its performance in a 510(k) premarket notification. However, it does not contain a detailed table of acceptance criteria or performance metrics with specific numerical values for a direct comparison. The information is presented in a narrative format, highlighting that the device met certain standards and showed good correlation with a predicate device.
Here's an attempt to extract the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Acceptable for all parameters (in accordance with EP5-A NCCLS guidelines) | "good precision... and is entirely acceptable for all available parameters." (No specific numerical values provided in the summary, only a general statement of compliance with guidelines.) |
| Linearity | Supported by clinical data | WBC (0-120 x 10^3/μL), RBC (0 - 8.0 x 10^6/uL), HGB (0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/1 (0 - 1,900 x 10^3/μL), and PLT with Hgb 0.95 with predicate device) |
| Leukocyte Differentiation | Good results on differentiation between true & false positives and true & false negatives | "provided good results on the differentiation between true & false positives and true & false negatives." (No specific sensitivity, specificity, or accuracy metrics provided.) |
| Sample Stability | Relative sample stability over a 48-hour period at 4°C | "assures a relative sample stability over a 48 hour period at 4°C." |
| Carry Over |
§ 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.”