(113 days)
The Sysmex XE-2100DC is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XE-2100DC analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperatures (18-26°C).
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. XE-2100DC will extend MCV stability to 48 hours. (Note: XE pro software is required to obtain results described.)
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Sysmex® XE-2100DC™ Automated Hematology Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criterion for the Sysmex XE-2100DC is the extended stability of the Mean Corpuscular Volume (MCV) parameter.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Extend MCV stability to 48 hours in EDTA anticoagulated whole blood | The XE-2100DC demonstrated extended stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperatures (18-26°C). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample size used for the clinical performance studies. It mentions "Studies were performed to evaluate the equivalency of XE-2100DC to the predicate method."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts or a ground truth established by them for the stability study. The study focused on comparing the performance of the new device (XE-2100DC) against its predicate (XE-2100) for MCV stability.
4. Adjudication Method for the Test Set
Not applicable. The study design involved directly comparing MCV values obtained from the XE-2100DC at different time points and temperatures against the predicate. No adjudication by human experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an automated hematology analyzer, and the study was focused on the analytical performance (stability) of a specific parameter, not on human reader performance with or without AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance study of the automated hematology analyzer. It evaluates the device's ability to maintain MCV stability without human intervention in the analysis process beyond standard sample handling.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate device (Sysmex XE-2100) and the expected stability of the MCV parameter based on established laboratory practices, particularly in relation to the 48-hour stability claim. The study aimed to show equivalency to the predicate and the extended stability itself as the desired outcome.
8. The Sample Size for the Training Set
Not applicable. This device is an analytical instrument, not an AI/machine learning algorithm requiring a separate training set in the conventional sense. The "training" would be the engineering and calibration of the instrument itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this isn't an AI/ML context with a training set and corresponding ground truth in the typical understanding. The device's operational parameters and measurement accuracy would have been established during its development and calibration processes.
§ 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.”