(36 days)
The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.
The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.
The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.
The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count, reticulocyte and NRBC count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven.
Controlled by the PENTRA 120 the optional device SPS Evolution (Slide Preparation System) smears and stains the slides.
The provided text describes the ABX PENTRA DX 120 Hematology Analyzer and its associated SPS Evolution (Slide Preparation System). Here's a breakdown of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (NRBC Parameter)
The text focuses primarily on the Nucleated Red Blood Cell (NRBC) parameter as the new feature and provides limited, high-level performance statements rather than specific numerical acceptance criteria.
| Performance Metric | Acceptance Criteria (Implicit/General Statement) | Reported Device Performance |
|---|---|---|
| Precision (NRBC) | "good precision in accordance with EP5-A (NCCLS guidelines)" | "good precision ... and is entirely acceptable for the NRBC" |
| Linearity (NRBC/100 WBC Count) | "linearity limits claim... are entirely supported" | "entirely supported by the clinical data provided in this submission." |
| Accuracy (Inter-procedural Correlation - NRBC) | No specific numerical criteria stated, but implied to show no significant bias. | "showed no evidence of significant bias between the HoribaABX PENTRA DX 120 and the Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry with r^2 ranging between 0.96 - 0.98." |
| Differentiation (True/False Positives/Negatives - NRBC) | Implied to be comparable to predicate systems. | "provided good results on the differentiation between true & false positives and true & false negatives, comparable to other predicate systems." |
| Sample Stability (NRBC) | Implied to assure relative sample stability over 24 hours. | "assures a relative sample stability over a 24 hour period at both room temperature and 4°C." |
| Carry Over (NRBC) | Implied to be less than 1%. | "supporting a Carry Over claim of |
§ 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.”