(16 days)
The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 60 and 60C+ Hematology Analyzer are able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The ABX PENTRA 60 & PENTRA 60C+ are 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 PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.
The ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers underwent a study to demonstrate their performance against pre-defined acceptance criteria, primarily focusing on expanded linearity ranges and maintaining accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | In accordance with EP5-A (NCCLS guidelines) | Good precision for all parameters, "entirely acceptable". |
| Linearity Range (WBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0-120 x 10^3/μL |
| Linearity Range (RBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 8.0 x 10^5/μL |
| Linearity Range (HGB) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 24g/dl |
| Linearity Range (HCT) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 67% |
| Linearity Range (PLT with Hgb>2g/dl) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 1,900 x 10^3/μL |
| **Linearity Range (PLT with Hgb 0.95 | ||
| Accuracy (Inter-procedural Correlation for other parameters) | Not explicitly stated, but implies historical good correlation from previous submissions. | Good correlation demonstrated in previous submissions. |
| 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.”