(75 days)
The ABX PENTRA 120 RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.
The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.
The ABX PENTRA 120 RETIC Automated Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leucocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light scattering, and fluorescence. The instrument is microprocessor driven.
The provided 510(k) summary for the ABX PENTRA 120 RETIC Automated Hematology Analyzer describes its performance against a predicate device, rather than explicit acceptance criteria and device performance in a table format. However, the document states that "All studies confirmed that the IRF clinical parameter of the ABX PENTRA 120 RETIC Automated Hematology Analyzer is substantially equivalent to the Sysmex IRF clinical parameter."
Here's an attempt to structure the information based on your request, acknowledging that specific numerical acceptance criteria and reported performance values are not detailed in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Immature Reticulocyte Fraction (IRF) Parameter | Substantial equivalence to the Sysmex R-Series IRF parameter. | "All studies confirmed that the IRF clinical parameter of the ABX PENTRA 120 RETIC Automated Hematology Analyzer is substantially equivalent to the Sysmex IRF clinical parameter." |
| Precision | Not explicitly stated, but expected to be acceptable for a diagnostic device. | "Additional studies were conducted to assess the precision... of the ABX PENTRA 120 RETIC Automated Hematology Analyzer." (Results not detailed) |
| Accuracy | Not explicitly stated, but expected to be acceptable for a diagnostic device. | "Additional studies were conducted to assess the... accuracy of the ABX PENTRA 120 RETIC Automated Hematology Analyzer." (Results not detailed) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: 203 patients.
- 100 patients with normal reticulocyte counts.
- 103 patients with abnormal reticulocyte counts.
- Data Provenance: Retrospective or prospective is not explicitly stated. The study involved "whole blood samples from 100 patients with normal reticulocyte counts and 103 patients with abnormal counts." The country of origin is not specified but is presumably where the clinical study was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The comparison is made against the Sysmex R-3000 analyzer, which serves as the reference, rather than against expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. The study compares the device's output directly to a predicate device (Sysmex R-3000 analyzer), not against expert adjudication of individual cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
Not applicable. This is a study comparing an automated hematology analyzer to a predicate device, not an MRMC study involving human readers with and without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone study was performed. The "Discussion of Performance Data" describes a clinical study where "samples were processed in the ABX PENTRA 120 RETIC Automated Hematology Analyzer and the SYSMEX R-3000 analyzer." This indicates the performance of the ABX PENTRA 120 RETIC as an automated system.
7. Type of Ground Truth Used
The "ground truth" for the performance study establishing substantial equivalence was the results obtained from a legally marketed predicate device, the Sysmex R-3000 analyzer, specifically its IRF parameter.
8. Sample Size for the Training Set
The document does not specify a separate training set. The performance data discussed relates to a clinical study used to demonstrate substantial equivalence, implying it was the main "test set" for this purpose.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is mentioned, this information is not provided. The comparison was against the predicate device.
§ 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.”