(143 days)
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%#, MON0%#, EO%#, IG%#, RDW-CV, RDW-SD, MPV, RET%#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, PMN%#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS-hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.
The provided text describes the Sysmex XN-L Automated Hematology Analyzer and its substantial equivalence to a predicate device, the Sysmex XN-Series (XN-10, XN-20). The document focuses on regulatory approval rather than a detailed study report. Therefore, some information requested might not be explicitly present or might require inference.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "predetermined acceptance criteria were met" but does not explicitly list the specific quantitative acceptance criteria for each measured parameter. It generally describes performance evaluations conducted.
| Parameter Category | Acceptance Criteria (Not explicitly stated quantity, but implied to be met for equivalence) | Reported Device Performance |
|---|---|---|
| General | Performance, functionality, and reliability are substantially equivalent to the predicate device. | "Performance, verification, and validation testing were conducted to characterize the performance of the XN-L analyzer and the predetermined acceptance criteria were met." |
| Whole Blood Analysis | Equivalent accuracy, precision (reproducibility and repeatability), linearity, carryover, stability, reference intervals, limits of blank, detection, and quantitation compared to predicate. | Conducted and met criteria. |
| Body Fluid Analysis | Equivalent accuracy, precision (reproducibility and repeatability), linearity, carryover, stability, limits of blank, detection, and quantitation compared to predicate. | Conducted and met criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "Real World Data had been collected for additional samples that included the pediatric population for patients less than 2 years of age."
The provenance of the data (country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is a performance evaluation of an automated analyzer against a predicate device, focusing on analytical performance rather than expert-based ground truth for interpretation.
4. Adjudication Method for the Test Set
Adjudication methods are typically employed when expert interpretation or consensus is required for ground truth establishment. As the document does not detail expert involvement for ground truth, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The study described focuses on the analytical performance of the automated analyzer itself, comparing it to a predicate device, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was conducted. The entire document describes the performance testing of the Sysmex XN-L Automated Hematology Analyzer (algorithm/device only) to demonstrate its substantial equivalence to the predicate device. The performance characteristics of the analyzer itself were evaluated.
7. Type of Ground Truth Used
The ground truth used for this type of analytical performance study would generally be:
- Reference laboratory methods or highly accurate comparative methods.
- The results from the predicate device (Sysmex XN-Series) for comparative purposes, as the study aims to show substantial equivalence.
- Known concentrations for linearity and limit of detection/quantitation studies.
The document implies the use of these types of reference measurements but does not explicitly detail the specific ground truth for each parameter.
8. Sample Size for the Training Set
The document does not provide details on a "training set" sample size. This type of regulatory submission for an automated hematology analyzer typically focuses on verification and validation studies (test sets) rather than separate training and testing sets in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
As a training set is not explicitly mentioned in the context of machine learning model development, the method for establishing its ground truth is not provided. The study focuses on demonstrating the analytical performance of the device itself.
§ 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.”