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510(k) Data Aggregation
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, 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 fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous 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 XR-Series module (XR-10) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Units (XR-10) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-01) which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
This document describes the acceptance criteria and the studies conducted to prove that the Sysmex XR-Series (XR-10) Automated Hematology Analyzer meets these criteria, demonstrating substantial equivalence to its predicate device, the Sysmex XN-20.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) clearance letter does not explicitly present a neatly formatted table of acceptance criteria alongside the reported performance for all parameters. Instead, it describes various performance studies (Precision, Linearity, Analytical Specificity/Interferences, Sample Stability, Detection Limit, Carry-Over, Comparison Studies, Matrix Studies, Bridging Studies, Clinical Studies, and Expected Values/Reference Range) and states that the XR-10 met "manufacturer's specifications or predefined acceptance criteria requirements" for each.
However, based on the provided data, we can infer some general acceptance criteria, particularly from the method comparison study which uses correlation coefficient (r) and percent bias (%Bias) as metrics. The clinical sensitivity and specificity tables also present implied acceptance criteria based on the demonstrated performance.
Inferred Acceptance Criteria & Reported Performance (Selection of Key Metrics)
| Study Type / Parameter Category | Acceptance Criteria (Inferred) | Reported Device Performance (Summary from text) |
|---|---|---|
| Whole Blood Precision (Analyte-specific %CV) | Met manufacturer's specifications or predefined acceptance criteria requirements. | WBC: 0.30% to 2.76% CV (Repeatability); 0.97% to 1.98% (Reproducibility, within run) |
| RBC: 0.45% to 0.97% CV (Repeatability); 0.73% to 1.03% (Reproducibility, within run) | ||
| HGB: 0.38% to 0.79% CV (Repeatability); 0.40% to 0.98% (Reproducibility, within run) | ||
| PLT-I: 1.30% to 8.32% CV (Repeatability); 1.59% to 3.70% (Reproducibility, within run) | ||
| Body Fluid Precision (Analyte-specific %CV) | Met manufacturer's specifications or predefined acceptance criteria requirements. | WBC-BF: 2.01% to 3.91% CV (Repeatability); 2.01% to 3.91% (Reproducibility, within run) |
| RBC-BF: 1.87% to 3.49% CV (Repeatability); 1.87% to 3.49% (Reproducibility, within run) | ||
| Linearity (Whole Blood & Body Fluid) | Linear from lower limit to upper limit and within measured maximum allowable deviation from linearity for each interval. (All results met predefined acceptance criteria). | WBC (WB): 0.03 – 440.00 x10³/μL |
| RBC (WB): 0.01 – 8.60 x10⁶/μL | ||
| HGB (WB): 0.1 – 26.0 g/dL | ||
| PLT (WB): 2 – 5,000 x10³/μL | ||
| WBC-BF: 0.003 – 10.000 x10³/μL | ||
| Method Comparison (Whole Blood: r-value) | ≥0.95 (explicitly stated for HGB, implied for others) | WBC: 0.9997 |
| RBC: 0.9900 | ||
| HGB: 0.9915 | ||
| PLT-I: 0.9991 | ||
| Method Comparison (Whole Blood: %Bias) | Within predefined bias limits (e.g., ±2% or 0.2g/dL for HGB) | HGB: -1.41% (Note: One site showed -2.10% for HGB, slightly exceeding ±2% but deemed acceptable due to high r-value) |
| WBC: 0.52% | ||
| RBC: -0.83% | ||
| Method Comparison (Body Fluid: r-value) | Acceptance criteria not explicitly stated, but high correlation values reported (e.g., >0.99 for WBC-BF, RBC-BF, TC-BF) | CSF WBC-BF: 0.9968 |
| Peritoneal WBC-BF: 0.9989 | ||
| Abnormal Flagging (Sensitivity/Specificity vs. Manual Microscopy) | No explicit numerical acceptance criteria given for these. | Any Distributional Abnormalities: Sensitivity 74.37%, Specificity 79.48%, OPA 76.31% |
| Any Morphological Flag: Sensitivity 83.26%, Specificity 65.25%, OPA 70.77% | ||
| Any Distributional and/or Morphological Abnormalities: Sensitivity 82.25%, Specificity 62.64%, OPA 75.38% | ||
| Abnormal Flagging (PPA/NPA vs. Predicate XN-20) | No explicit numerical acceptance criteria given for these. | Any Distributional Abnormalities: PPA 94.74%, NPA 95.88%, OPA 95.20% |
| Any Morphological Flag: PPA 92.29%, NPA 86.01%, OPA 89.10% | ||
| Any Distributional and/or Morphological Abnormalities: PPA 96.37%, NPA 88.01%, OPA 93.73% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size & Provenance:
- Precision (Repeatability - Whole Blood): Residual K2EDTA whole blood samples for 10 replicates for target values, and three samples for other parameters. This was across three US clinical sites (Site 01, 05, 24).
- Precision (Reproducibility - Whole Blood): XN CHECK whole blood control material, 90 results per control level (3 levels x 3 replicates x 2 runs x 5 days). Conducted at three US clinical sites.
- Precision (Body Fluid): Residual peritoneal, pleural, and synovial fluid samples (K2EDTA) and CSF (no anticoagulant) for 10 replicates for target values. Conducted at three US clinical sites.
- Linearity (Whole Blood & Body Fluid): Minimum of seven sample dilutions. Performed at one internal site.
- Analytical Specificity/Interferences: Whole blood K2EDTA samples from donors. Number of samples not specified, but collected for this study purpose.
- Sample Stability (Whole Blood): 8 unique leftover samples and 12 prospectively collected K2EDTA venous whole blood samples (20 samples total). Conducted at one internal site.
- Sample Stability (Body Fluid): 12 unique de-identified leftover body fluid samples (3-CSF, 3-peritoneal, 3-pleural, 3-synovial). Conducted at 1 external site.
- Detection Limit: Four blank samples and four low concentration samples for each parameter. Conducted across 2 XR-10 analyzers (implied internal or multi-site for the overall study context).
- Carry-Over: High and low target concentration samples (number not specified). Conducted at three US clinical sites.
- Comparison Studies (Whole Blood): 865 unique residual whole blood samples from pediatrics (
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