XN-L CHECK
Device Facts
| Record ID | K160586 |
|---|---|
| Device Name | XN-L CHECK |
| Applicant | Streck |
| Product Code | JPK · Hematology |
| Decision Date | Dec 22, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8625 |
| Device Class | Class 2 |
Indications for Use
XN-L CHECK™ is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include: RBC (10⁶/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10³/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10³/μL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10³/μL), LYMPH# (10³/μL), MONO# (10³/μL), EO# (10³/μL), BASO# (10³/μL), IG# (10³/μL), RET# (10⁶/μL), RET%, IRF%, RET-He (pg).
Device Story
XN-L CHECK™ is an in-vitro diagnostic hematology control; contains stabilized red blood cells, white blood cells, and platelets in preservative medium. Used in clinical laboratories to verify accuracy and precision of Sysmex XN-L analyzers; provides three levels of control material. Laboratory professionals process vials on the analyzer; output consists of assayed hematology parameters. Results allow clinicians to verify instrument performance and ensure reliability of patient sample analysis. Benefits include quality assurance for hematology testing.
Clinical Evidence
No clinical data. Bench testing only. Multi-site reproducibility study (3 sites, 3 operators, 3 lots) evaluated precision across 90 measurements per lot/level. Internal precision study evaluated performance over 21 days. Stability studies (open and closed-vial) performed per CLSI EP25-A.
Technological Characteristics
Tri-level hematology control; stabilized RBC, WBC, and platelet components in preservative medium. Packaged in 3 mL polypropylene vials. Storage 2–8°C. No energy source. Standalone control material.
Indications for Use
Indicated for use by laboratory professionals as a tri-level hematology control to evaluate the accuracy and precision of Sysmex XN-L analyzers.
Regulatory Classification
Identification
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Special Controls
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Predicate Devices
- XN-CHECK™ (K141964)
Related Devices
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
K160586
B. Purpose for Submission:
Clearance of a new device
C. Measurand:
Assayed parameters: RBC (10⁶/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10³/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10³/μL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10³/μL), LYMPH# (10³/μL), MONO# (10³/μL), EO# (10³/μL), BASO# (10³/μL), IG# (10³/μL), RET# (10⁶/μL), RET%, IRF%, RET-He (pg).
D. Type of Test:
Quantitative
E. Applicant:
Streck, Inc.
F. Proprietary and Established Names:
XN-L CHECK™
G. Regulatory Information:
1. Regulation section:
21 CFR § 864.8625, Hematology quality control mixture
2. Classification:
Class II
3. Product code:
JPK, Mixture, hematology quality control
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4. Panel:
Hematology (81)
H. Intended Use:
1. Intended use(s):
XN-L CHECK™ is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer.
Assayed parameters include: RBC (10⁶/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10³/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10³/μL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10³/μL), LYMPH# (10³/μL), MONO# (10³/μL), EO# (10³/μL), BASO# (10³/μL), IG# (10³/μL), RET# (10⁶/μL), RET%, IRF%, RET-He (pg).
2. Indication(s) for use:
Same as intended use
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Sysmex XL-N analyzer
I. Device Description:
XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology control that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be packaged in four-welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage temperature is 2 – 8°C.
J. Substantial Equivalence Information:
1. Predicate device name(s):
XN-CHECK™
2. Predicate 510(k) number(s):
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K141964
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device: XN-L CHECK™ | Predicate: XN-CHECK™ |
| Storage Conditions | 2 – 8°C | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device: XN-L CHECK™ | Predicate: XN-CHECK™ |
| Intended Use | XN-L CHECK™ is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include: RBC (106/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (103/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (103/μL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (103/μL), LYMPH# (103/μL), MONO# (103/μL), EO# (103/μL), BASO# (103/μL), IG# (103/μL), RET# (106/μL), RET%, IRF%, RET-He (pg). Product is a control for XN-L analyzer. The following measurands are not available on XN-L CHECK or the XN-L analyzer: IPF(#) IPF(%) NRBC#(103/μL) NRBC%(/100WBC) | XN CHECK™ is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XL-N) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/μL), NEUT(%), LYMPH(%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/μL), LYMPH#(103/μL), MONO#(103/μL), EO#(103/μL), BASO#(103/μL), IG#(103/μL), IPF(%), IPF # (103/μL) RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#(103/μL), NRBC% (/100 WBC) |
| Open Vial Stability | 15 days | 7 days |
| Closed Vial Stability | 100 days | 84 days |
| Reagents | XN-L CHECK™ contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. | XN CHECK™ contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. |
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K. Standard/Guidance Document Referenced (if applicable):
CLSI H26-A2, Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, October 2010
CLSI EP5-A3 Methods, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Third Edition.
L. Test Principle:
Tri-level XN-L CHECK™ was designed to evaluate the accuracy and precision of the Sysmex XN-L instrument. XN-L CHECK™ is for in-vitro diagnostic use only by laboratory professionals.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision:
i. Multi-site reproducibility study: The multisite precision study was conducted at three separate sites, Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein, with three different operators. Three separately manufactured lots of XN-L CHECK were tested on each XN-L analyzer. Each site was instructed to run each lot and level of control for 5 days with 2 runs per day and 3 replicates per run. The final dataset resulted in a total of 90 measurements per lot and control level (level 1, level 2, and level 3). The total reproducibility estimates for each parameter for each lot include the repeatability (within-run), between-run, between-day, and between-site precision estimates. Total reproducibility numbers for each parameter are used to calculate the acceptable range for each parameter of control. The results of the precision studies met the performance specifications for each XN-L CHECK Hematology Control level.
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6106) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Within-Lab Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | level 1 | 2.62 | 0.06 | 2.2 | 0.02 | 0.7 | 0.02 | 0.8 | 0.06 | 2.5 | 0.08 | 3.0 |
| | level 2 | 6.85 | 0.10 | 1.4 | 0.01 | 0.2 | 0.05 | 0.7 | 0.11 | 1.6 | 0.16 | 2.4 |
| | level 3 | 16.34 | 0.17 | 1.0 | 0.06 | 0.4 | 0.04 | 0.2 | 0.18 | 1.1 | 0.40 | 2.4 |
| NEUT% | level 1 | 45.7 | 1.0 | 2.1 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 2.1 | 1.0 | 2.2 |
| | level 2 | 48.3 | 0.7 | 1.4 | 0.3 | 0.6 | 0.0 | 0.0 | 0.7 | 1.5 | 0.8 | 1.6 |
| | level 3 | 52.5 | 0.7 | 1.4 | 0.0 | 0.0 | 0.3 | 0.5 | 0.8 | 1.5 | 0.8 | 1.4 |
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| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6106) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Within-Lab Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| LYMPH% | level 1 | 27.8 | 0.9 | 3.3 | 0.6 | 2.1 | 0.4 | 1.4 | 1.1 | 4.1 | 1.2 | 4.2 |
| | level 2 | 24.4 | 0.5 | 2.0 | 0.4 | 1.7 | 0.3 | 1.4 | 0.7 | 3.0 | 0.8 | 3.3 |
| | level 3 | 19.2 | 0.4 | 2.3 | 0.0 | 0.1 | 0.3 | 1.6 | 0.5 | 2.8 | 0.5 | 2.8 |
| MONO% | level 1 | 8.7 | 0.6 | 7.2 | 0.6 | 6.6 | 0.5 | 6.2 | 1.0 | 11.5 | 1.1 | 12.1 |
| | level 2 | 8.5 | 0.4 | 5.2 | 0.2 | 2.0 | 0.5 | 5.5 | 0.7 | 7.8 | 0.7 | 8.1 |
| | level 3 | 8.1 | 0.2 | 2.7 | 0.3 | 3.6 | 0.4 | 4.9 | 0.5 | 6.7 | 0.5 | 6.8 |
| EO% | level 1 | 11.8 | 0.6 | 5.1 | 0.0 | 0.0 | 0.1 | 1.1 | 0.6 | 5.2 | 0.6 | 5.1 |
| | level 2 | 12.6 | 0.5 | 4.3 | 0.1 | 1.0 | 0.0 | 0.0 | 0.6 | 4.5 | 0.6 | 4.6 |
| | level 3 | 13.4 | 0.5 | 3.7 | 0.0 | 0.0 | 0.3 | 1.9 | 0.6 | 4.2 | 0.6 | 4.3 |
| BASO% | level 1 | 5.9 | 0.3 | 5.7 | 0.0 | 0.0 | 0.1 | 1.8 | 0.4 | 6.0 | 0.4 | 6.0 |
| | level 2 | 6.2 | 0.3 | 4.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.3 | 4.4 | 0.3 | 4.4 |
| | level 3 | 6.7 | 0.3 | 3.8 | 0.1 | 1.4 | 0.0 | 0.3 | 0.3 | 4.0 | 0.3 | 4.0 |
| NEUT# | level 1 | 1.20 | 0.04 | 2.9 | 0.02 | 1.3 | 0.01 | 1.0 | 0.04 | 3.3 | 0.04 | 3.6 |
| | level 2 | 3.31 | 0.07 | 2.1 | 0.03 | 0.9 | 0.02 | 0.5 | 0.08 | 2.3 | 0.09 | 2.6 |
| | level 3 | 8.58 | 0.14 | 1.7 | 0.00 | 0.0 | 0.04 | 0.5 | 0.15 | 1.7 | 0.25 | 2.9 |
| LYMPH# | level 1 | 0.73 | 0.03 | 3.9 | 0.01 | 1.7 | 0.01 | 1.8 | 0.03 | 4.6 | 0.04 | 5.0 |
| | level 2 | 1.67 | 0.04 | 2.6 | 0.03 | 1.5 | 0.03 | 1.6 | 0.06 | 3.4 | 0.07 | 4.1 |
| | level 3 | 3.13 | 0.08 | 2.6 | 0.01 | 0.4 | 0.04 | 1.4 | 0.09 | 3.0 | 0.12 | 3.7 |
| MONO# | level 1 | 0.23 | 0.02 | 7.9 | 0.01 | 6.2 | 0.01 | 5.9 | 0.03 | 11.7 | 0.03 | 12.6 |
| | level 2 | 0.58 | 0.03 | 4.9 | 0.01 | 2.4 | 0.03 | 5.6 | 0.05 | 7.8 | 0.05 | 8.5 |
| | level 3 | 1.33 | 0.04 | 2.7 | 0.05 | 3.5 | 0.07 | 5.0 | 0.09 | 6.7 | 0.10 | 7.4 |
| EO# | level 1 | 0.31 | 0.02 | 5.4 | 0.00 | 1.1 | 0.01 | 2.0 | 0.02 | 5.8 | 0.02 | 5.9 |
| | level 2 | 0.86 | 0.04 | 4.4 | 0.00 | 0.5 | 0.01 | 1.2 | 0.04 | 4.6 | 0.05 | 5.4 |
| | level 3 | 2.20 | 0.08 | 3.7 | 0.01 | 0.4 | 0.04 | 2.0 | 0.09 | 4.3 | 0.09 | 4.3 |
| BASO# | level 1 | 0.16 | 0.01 | 6.5 | 0.00 | 1.5 | 0.00 | 0.0 | 0.01 | 6.7 | 0.01 | 7.1 |
| | level 2 | 0.42 | 0.02 | 5.0 | 0.00 | 0.0 | 0.00 | 0.0 | 0.02 | 4.6 | 0.02 | 5.0 |
| | level 3 | 1.10 | 0.04 | 4.0 | 0.01 | 1.2 | 0.00 | 0.4 | 0.05 | 4.2 | 0.05 | 5.0 |
| IG% | level 1 | 12.8 | 0.8 | 6.2 | 0.0 | 0.0 | 0.1 | 0.9 | 0.8 | 6.3 | 0.8 | 6.4 |
| | level 2 | 13.2 | 0.8 | 6.3 | 0.3 | 2.4 | 0.0 | 0.0 | 0.9 | 6.7 | 0.9 | 6.8 |
| | level 3 | 14.5 | 0.8 | 5.7 | 0.3 | 1.9 | 0.6 | 4.3 | 1.1 | 7.4 | 1.1 | 7.4 |
| IG# | level 1 | 0.33 | 0.02 | 6.1 | 0.01 | 1.7 | 0.01 | 1.8 | 0.02 | 6.6 | 0.02 | 7.2 |
| | level 2 | 0.91 | 0.06 | 6.4 | 0.03 | 3.0 | 0.01 | 1.1 | 0.06 | 7.1 | 0.07 | 7.3 |
| | level 3 | 2.37 | 0.13 | 5.6 | 0.06 | 2.3 | 0.10 | 4.4 | 0.18 | 7.5 | 0.18 | 7.6 |
| RBC | level 1 | 2.24 | 0.01 | 0.6 | 0.01 | 0.3 | 0.01 | 0.3 | 0.02 | 0.8 | 0.03 | 1.2 |
| | level 2 | 4.15 | 0.02 | 0.5 | 0.02 | 0.4 | 0.00 | 0.1 | 0.03 | 0.7 | 0.04 | 1.0 |
| | level 3 | 5.20 | 0.03 | 0.5 | 0.01 | 0.2 | 0.02 | 0.3 | 0.03 | 0.6 | 0.04 | 0.9 |
| HGB | level 1 | 5.9 | 0.0 | 0.7 | 0.0 | 0.5 | 0.0 | 0.4 | 0.1 | 1.0 | 0.1 | 1.5 |
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| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6106) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Within-Lab Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | level 2 | 12.5 | 0.1 | 0.4 | 0.0 | 0.1 | 0.0 | 0.1 | 0.1 | 0.5 | 0.1 | 1.0 |
| | level 3 | 16.9 | 0.1 | 0.4 | 0.0 | 0.2 | 0.0 | 0.1 | 0.1 | 0.5 | 0.2 | 1.0 |
| HCT% | level 1 | 17.2 | 0.1 | 0.6 | 0.1 | 0.5 | 0.1 | 0.8 | 0.2 | 1.1 | 0.6 | 3.6 |
| | level 2 | 35.4 | 0.2 | 0.5 | 0.1 | 0.4 | 0.2 | 0.5 | 0.3 | 0.8 | 1.1 | 3.0 |
| | level 3 | 46.4 | 0.2 | 0.5 | 0.2 | 0.4 | 0.2 | 0.4 | 0.3 | 0.7 | 1.4 | 3.0 |
| MCV | level 1 | 76.8 | 0.2 | 0.3 | 0.3 | 0.4 | 0.4 | 0.6 | 0.6 | 0.7 | 2.0 | 2.6 |
| | level 2 | 85.2 | 0.1 | 0.2 | 0.5 | 0.6 | 0.4 | 0.5 | 0.7 | 0.8 | 1.9 | 2.3 |
| | level 3 | 89.2 | 0.2 | 0.2 | 0.4 | 0.4 | 0.4 | 0.5 | 0.6 | 0.7 | 2.2 | 2.5 |
| MCH | level 1 | 26.2 | 0.3 | 1.1 | 0.0 | 0.0 | 0.1 | 0.5 | 0.3 | 1.2 | 0.3 | 1.2 |
| | level 2 | 30.2 | 0.2 | 0.7 | 0.2 | 0.6 | 0.0 | 0.1 | 0.3 | 0.9 | 0.3 | 0.9 |
| | level 3 | 32.4 | 0.2 | 0.6 | 0.1 | 0.3 | 0.1 | 0.4 | 0.2 | 0.8 | 0.3 | 0.8 |
| MCHC | level 1 | 34.0 | 0.3 | 1.0 | 0.1 | 0.4 | 0.3 | 0.8 | 0.5 | 1.4 | 0.9 | 2.6 |
| | level 2 | 35.4 | 0.2 | 0.7 | 0.2 | 0.5 | 0.1 | 0.4 | 0.3 | 0.9 | 0.8 | 2.3 |
| | level 3 | 36.4 | 0.2 | 0.6 | 0.2 | 0.4 | 0.2 | 0.4 | 0.3 | 0.8 | 0.9 | 2.4 |
| RDW-SD | level 1 | 47.8 | 0.3 | 0.5 | 0.7 | 1.4 | 0.3 | 0.5 | 0.8 | 1.6 | 1.4 | 2.8 |
| | level 2 | 47.0 | 0.2 | 0.5 | 0.5 | 1.1 | 0.2 | 0.5 | 0.6 | 1.3 | 1.1 | 2.3 |
| | level 3 | 46.3 | 0.3 | 0.6 | 0.1 | 0.3 | 0.2 | 0.4 | 0.3 | 0.8 | 1.2 | 2.7 |
| RDW-CV | level 1 | 17.2 | 0.1 | 0.5 | 0.2 | 1.3 | 0.2 | 0.9 | 0.3 | 1.7 | 0.3 | 1.8 |
| | level 2 | 15.1 | 0.1 | 0.5 | 0.1 | 0.4 | 0.0 | 0.3 | 0.1 | 0.6 | 0.1 | 0.8 |
| | level 3 | 14.3 | 0.1 | 0.6 | 0.1 | 0.7 | 0.0 | 0.3 | 0.1 | 0.9 | 0.2 | 1.1 |
| PLT | level 1 | 58 | 2 | 4.3 | 2 | 2.7 | 1 | 2.4 | 3 | 5.6 | 3 | 5.9 |
| | level 2 | 224 | 6 | 2.5 | 4 | 1.9 | 3 | 1.4 | 8 | 3.4 | 9 | 4.2 |
| | level 3 | 561 | 7 | 1.3 | 3 | 0.5 | 4 | 0.6 | 9 | 1.5 | 20 | 3.6 |
| MPV | level 1 | 10.7 | 0.3 | 2.4 | 0.2 | 1.8 | 0.1 | 0.8 | 0.3 | 3.1 | 0.5 | 4.3 |
| | level 2 | 10.1 | 0.1 | 1.2 | 0.1 | 0.9 | 0.1 | 0.8 | 0.2 | 1.7 | 0.2 | 2.3 |
| | level 3 | 9.8 | 0.1 | 0.6 | 0.1 | 0.6 | 0.0 | 0.4 | 0.1 | 0.9 | 0.2 | 1.8 |
| RET(%) | level 1 | 5.40 | 0.15 | 2.8 | 0.15 | 2.8 | 0.13 | 2.4 | 0.25 | 4.6 | 0.34 | 6.3 |
| | level 2 | 2.03 | 0.05 | 2.7 | 0.02 | 1.0 | 0.02 | 0.8 | 0.06 | 3.0 | 0.13 | 6.3 |
| | level 3 | 0.79 | 0.04 | 4.5 | 0.02 | 2.2 | 0.01 | 1.9 | 0.04 | 5.3 | 0.05 | 6.6 |
| RET# | level 1 | 0.1208 | 0.0033 | 2.7 | 0.0031 | 2.5 | 0.0031 | 2.6 | 0.0055 | 4.5 | 0.0084 | 6.9 |
| | level 2 | 0.0845 | 0.0022 | 2.6 | 0.0010 | 1.2 | 0.0007 | 0.8 | 0.0025 | 3.0 | 0.0057 | 6.7 |
| | level 3 | 0.0410 | 0.0017 | 4.2 | 0.0012 | 2.8 | 0.0009 | 2.2 | 0.0023 | 5.6 | 0.0028 | 6.8 |
| IRF(%) | level 1 | 16.8 | 1.3 | 7.6 | 0.8 | 4.9 | 1.2 | 7.1 | 1.9 | 11.5 | 1.9 | 11.5 |
| | level 2 | 19.6 | 1.4 | 7.3 | 1.6 | 8.1 | 1.5 | 7.5 | 2.6 | 13.3 | 2.7 | 13.6 |
| | level 3 | 17.2 | 1.8 | 10.3 | 1.9 | 11.2 | 1.2 | 7.1 | 2.9 | 16.8 | 3.1 | 17.8 |
| RET-He | level 1 | 22.3 | 0.1 | 0.5 | 0.2 | 0.9 | 0.2 | 0.7 | 0.3 | 1.2 | 0.9 | 4.1 |
| | level 2 | 23.1 | 0.2 | 0.8 | 0.1 | 0.5 | 0.1 | 0.5 | 0.2 | 1.1 | 0.9 | 3.9 |
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| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6106) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Within-Lab Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | level 3 | 24.0 | 0.3 | 1.4 | 0.1 | 0.6 | 0.0 | 0.0 | 0.4 | 1.5 | 1.0 | 4.3 |
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6134) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between-Site Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | level 1 | 2.50 | 0.06 | 2.4 | 0.01 | 0.5 | 0.02 | 0.8 | 0.06 | 2.6 | 0.08 | 3.1 |
| | level 2 | 6.94 | 0.11 | 1.5 | 0.00 | 0.0 | 0.06 | 0.8 | 0.12 | 1.7 | 0.19 | 2.7 |
| | level 3 | 16.54 | 0.18 | 1.1 | 0.04 | 0.2 | 0.02 | 0.1 | 0.18 | 1.1 | 0.41 | 2.5 |
| NEUT% | level 1 | 44.9 | 1.0 | 2.2 | 0.5 | 1.1 | 0.1 | 0.3 | 1.1 | 2.5 | 1.1 | 2.5 |
| | level 2 | 47.7 | 0.7 | 1.6 | 0.0 | 0.0 | 0.2 | 0.4 | 0.8 | 1.6 | 0.8 | 1.6 |
| | level 3 | 52.1 | 0.7 | 1.3 | 0.1 | 0.2 | 0.1 | 0.2 | 0.7 | 1.3 | 0.7 | 1.3 |
| LYMPH% | level 1 | 28.7 | 1.2 | 4.1 | 0.3 | 1.0 | 0.6 | 1.9 | 1.3 | 4.6 | 1.3 | 4.7 |
| | level 2 | 24.6 | 0.6 | 2.4 | 0.0 | 0.2 | 0.2 | 0.7 | 0.6 | 2.5 | 0.7 | 3.0 |
| | level 3 | 18.9 | 0.3 | 1.7 | 0.1 | 0.5 | 0.2 | 0.9 | 0.4 | 1.9 | 0.4 | 2.1 |
| MONO% | level 1 | 8.8 | 0.7 | 7.7 | 0.4 | 4.8 | 0.2 | 1.7 | 0.8 | 9.2 | 0.8 | 9.6 |
| | level 2 | 9.0 | 0.4 | 4.2 | 0.1 | 0.9 | 0.1 | 0.9 | 0.4 | 4.4 | 0.4 | 4.6 |
| | level 3 | 8.5 | 0.3 | 3.2 | 0.2 | 2.0 | 0.1 | 1.2 | 0.3 | 3.9 | 0.3 | 4.0 |
| EO% | level 1 | 11.7 | 0.5 | 4.4 | 0.1 | 0.7 | 0.0 | 0.0 | 0.5 | 4.4 | 0.5 | 4.4 |
| | level 2 | 12.5 | 0.5 | 4.1 | 0.1 | 1.1 | 0.1 | 0.9 | 0.5 | 4.4 | 0.5 | 4.4 |
| | level 3 | 13.7 | 0.5 | 3.5 | 0.2 | 1.6 | 0.2 | 1.2 | 0.6 | 4.0 | 0.6 | 4.1 |
| BASO% | level 1 | 5.9 | 0.4 | 6.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.4 | 6.6 | 0.4 | 6.6 |
| | level 2 | 6.3 | 0.3 | 5.1 | 0.0 | 0.5 | 0.1 | 1.4 | 0.3 | 5.4 | 0.3 | 5.4 |
| | level 3 | 6.9 | 0.3 | 4.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.3 | 4.7 | 0.3 | 4.8 |
| NEUT# | level 1 | 1.12 | 0.04 | 3.3 | 0.01 | 0.6 | 0.00 | 0.0 | 0.04 | 3.4 | 0.04 | 3.9 |
| | level 2 | 3.31 | 0.07 | 2.1 | 0.00 | 0.0 | 0.03 | 1.0 | 0.08 | 2.3 | 0.11 | 3.2 |
| | level 3 | 8.61 | 0.13 | 1.5 | 0.01 | 0.1 | 0.00 | 0.0 | 0.13 | 1.5 | 0.22 | 2.6 |
| LYMPH# | level 1 | 0.72 | 0.04 | 5.0 | 0.00 | 0.0 | 0.02 | 2.3 | 0.04 | 5.5 | 0.04 | 5.6 |
| | level 2 | 1.71 | 0.04 | 2.5 | 0.00 | 0.0 | 0.01 | 0.4 | 0.04 | 2.6 | 0.06 | 3.7 |
| | level 3 | 3.13 | 0.06 | 2.0 | 0.03 | 0.9 | 0.03 | 1.0 | 0.08 | 2.4 | 0.10 | 3.3 |
| MONO# | level 1 | 0.22 | 0.02 | 7.6 | 0.01 | 5.6 | 0.00 | 2.2 | 0.02 | 9.7 | 0.02 | 10.2 |
| | level 2 | 0.62 | 0.03 | 4.6 | 0.01 | 1.3 | 0.01 | 1.6 | 0.03 | 5.0 | 0.04 | 5.7 |
| | level 3 | 1.40 | 0.05 | 3.3 | 0.02 | 1.7 | 0.02 | 1.4 | 0.06 | 4.0 | 0.06 | 4.6 |
| EO# | level 1 | 0.29 | 0.01 | 4.5 | 0.00 | 1.0 | 0.00 | 0.0 | 0.01 | 4.6 | 0.01 | 4.8 |
| | level 2 | 0.87 | 0.04 | 4.7 | 0.00 | 0.0 | 0.01 | 1.6 | 0.04 | 5.0 | 0.04 | 5.2 |
{7}
8
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6134) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between-Site Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | level 3 | 2.27 | 0.08 | 3.7 | 0.04 | 1.6 | 0.03 | 1.3 | 0.10 | 4.3 | 0.11 | 5.0 |
| BASO# | level 1 | 0.15 | 0.01 | 7.2 | 0.00 | 1.2 | 0.00 | 0.0 | 0.01 | 7.3 | 0.01 | 7.5 |
| | level 2 | 0.44 | 0.02 | 5.3 | 0.00 | 0.7 | 0.01 | 1.6 | 0.02 | 5.6 | 0.03 | 5.9 |
| | level 3 | 1.14 | 0.06 | 4.9 | 0.00 | 0.0 | 0.00 | 0.0 | 0.06 | 4.9 | 0.07 | 5.9 |
| IG% | level 1 | 12.3 | 0.8 | 6.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.8 | 6.2 | 0.8 | 6.2 |
| | level 2 | 13.2 | 0.8 | 6.1 | 0.4 | 3.1 | 0.0 | 0.0 | 0.9 | 6.9 | 0.9 | 6.9 |
| | level 3 | 14.6 | 0.8 | 5.6 | 0.3 | 1.9 | 0.4 | 2.4 | 0.9 | 6.4 | 0.9 | 6.5 |
| IG# | level 1 | 0.31 | 0.02 | 6.4 | 0.00 | 0.0 | 0.00 | 0.6 | 0.02 | 6.4 | 0.02 | 6.7 |
| | level 2 | 0.91 | 0.06 | 6.6 | 0.03 | 3.0 | 0.00 | 0.0 | 0.07 | 7.2 | 0.07 | 7.6 |
| | level 3 | 2.41 | 0.13 | 5.6 | 0.05 | 2.0 | 0.07 | 2.7 | 0.16 | 6.6 | 0.16 | 6.6 |
| RBC | level 1 | 2.27 | 0.02 | 0.7 | 0.01 | 0.3 | 0.00 | 0.1 | 0.02 | 0.8 | 0.02 | 1.0 |
| | level 2 | 4.20 | 0.02 | 0.5 | 0.02 | 0.5 | 0.04 | 0.9 | 0.05 | 1.1 | 0.06 | 1.4 |
| | level 3 | 5.12 | 0.02 | 0.4 | 0.01 | 0.2 | 0.01 | 0.2 | 0.03 | 0.5 | 0.04 | 0.8 |
| HGB | level 1 | 6.1 | 0.0 | 0.7 | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 | 0.7 | 0.1 | 1.3 |
| | level 2 | 12.4 | 0.0 | 0.4 | 0.0 | 0.0 | 0.1 | 0.9 | 0.1 | 1.0 | 0.2 | 1.4 |
| | level 3 | 16.9 | 0.1 | 0.4 | 0.0 | 0.1 | 0.0 | 0.3 | 0.1 | 0.5 | 0.2 | 1.0 |
| HCT% | level 1 | 17.4 | 0.1 | 0.8 | 0.0 | 0.2 | 0.1 | 0.6 | 0.2 | 1.0 | 0.6 | 3.2 |
| | level 2 | 35.0 | 0.2 | 0.5 | 0.2 | 0.5 | 0.4 | 1.2 | 0.5 | 1.4 | 1.2 | 3.5 |
| | level 3 | 46.1 | 0.2 | 0.4 | 0.2 | 0.4 | 0.3 | 0.6 | 0.4 | 0.8 | 1.4 | 3.1 |
| MCV | level 1 | 76.8 | 0.2 | 0.2 | 0.2 | 0.2 | 0.5 | 0.6 | 0.5 | 0.7 | 2.0 | 2.6 |
| | level 2 | 83.2 | 0.1 | 0.2 | 0.3 | 0.3 | 0.4 | 0.5 | 0.5 | 0.6 | 2.1 | 2.5 |
| | level 3 | 90.1 | 0.1 | 0.1 | 0.3 | 0.3 | 0.5 | 0.5 | 0.6 | 0.6 | 2.2 | 2.5 |
| MCH | level 1 | 26.8 | 0.3 | 0.9 | 0.1 | 0.5 | 0.0 | 0.0 | 0.3 | 1.1 | 0.3 | 1.2 |
| | level 2 | 29.5 | 0.2 | 0.6 | 0.1 | 0.4 | 0.0 | 0.0 | 0.2 | 0.7 | 0.2 | 0.8 |
| | level 3 | 32.9 | 0.2 | 0.6 | 0.1 | 0.2 | 0.1 | 0.2 | 0.2 | 0.7 | 0.3 | 0.8 |
| MCHC | level 1 | 34.9 | 0.3 | 0.9 | 0.2 | 0.5 | 0.2 | 0.6 | 0.4 | 1.2 | 0.8 | 2.4 |
| | level 2 | 35.4 | 0.2 | 0.6 | 0.2 | 0.5 | 0.2 | 0.5 | 0.3 | 0.9 | 0.8 | 2.3 |
| | level 3 | 36.6 | 0.2 | 0.6 | 0.1 | 0.3 | 0.2 | 0.5 | 0.3 | 0.9 | 0.9 | 2.4 |
| RDW-SD | level 1 | 45.4 | 0.3 | 0.7 | 0.2 | 0.4 | 0.3 | 0.6 | 0.4 | 1.0 | 1.0 | 2.3 |
| | level 2 | 45.0 | 0.3 | 0.6 | 0.1 | 0.2 | 0.3 | 0.6 | 0.4 | 0.8 | 1.1 | 2.4 |
| | level 3 | 45.9 | 0.3 | 0.5 | 0.1 | 0.2 | 0.3 | 0.6 | 0.4 | 0.8 | 1.4 | 3.0 |
| RDW-CV | level 1 | 16.2 | 0.1 | 0.4 | 0.1 | 0.3 | 0.1 | 0.6 | 0.1 | 0.8 | 0.1 | 0.9 |
| | level 2 | 14.9 | 0.1 | 0.4 | 0.0 | 0.1 | 0.0 | 0.2 | 0.1 | 0.5 | 0.1 | 0.6 |
| | level 3 | 13.8 | 0.1 | 0.5 | 0.0 | 0.0 | 0.1 | 0.4 | 0.1 | 0.6 | 0.1 | 1.0 |
| PLT | level 1 | 58 | 2 | 4.3 | 1 | 2.4 | 1 | 2.3 | 3 | 5.4 | 3 | 5.4 |
| | level 2 | 225 | 5 | 2.2 | 4 | 1.7 | 3 | 1.2 | 7 | 3.0 | 8 | 3.6 |
| | level 3 | 542 | 7 | 1.2 | 6 | 1.1 | 5 | 1.0 | 10 | 1.9 | 21 | 3.8 |
{8}
9
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6134) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between-Site Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| MPV | level 1 | 10.3 | 0.2 | 2.3 | 0.0 | 0.0 | 0.0 | 0.3 | 0.2 | 2.3 | 0.3 | 2.8 |
| | level 2 | 9.7 | 0.1 | 1.1 | 0.1 | 0.7 | 0.1 | 0.6 | 0.1 | 1.4 | 0.2 | 1.8 |
| | level 3 | 9.4 | 0.1 | 0.6 | 0.0 | 0.4 | 0.0 | 0.3 | 0.1 | 0.8 | 0.1 | 1.2 |
| RET(%) | level 1 | 4.29 | 0.13 | 3.1 | 0.04 | 0.9 | 0.08 | 1.9 | 0.16 | 3.8 | 0.56 | 12.9 |
| | level 2 | 1.96 | 0.06 | 3.1 | 0.00 | 0.0 | 0.02 | 1.0 | 0.06 | 3.2 | 0.17 | 8.4 |
| | level 3 | 0.72 | 0.04 | 5.5 | 0.01 | 1.4 | 0.01 | 1.5 | 0.04 | 5.9 | 0.06 | 8.9 |
| RET# | level 1 | 0.0973 | 0.0032 | 3.2 | 0.0000 | 0.0 | 0.0020 | 2.0 | 0.0037 | 3.8 | 0.0131 | 13.5 |
| | level 2 | 0.0824 | 0.0024 | 3.0 | 0.0000 | 0.0 | 0.0015 | 1.8 | 0.0029 | 3.5 | 0.0077 | 9.4 |
| | level 3 | 0.0368 | 0.0020 | 5.4 | 0.0006 | 1.6 | 0.0006 | 1.6 | 0.0022 | 5.9 | 0.0033 | 9.1 |
| IRF(%) | level 1 | 10.8 | 0.9 | 8.1 | 0.5 | 4.2 | 0.9 | 8.5 | 1.4 | 12.5 | 1.5 | 13.5 |
| | level 2 | 11.7 | 1.0 | 8.4 | 0.5 | 4.4 | 0.7 | 5.7 | 1.3 | 11.1 | 1.5 | 13.2 |
| | level 3 | 9.7 | 1.1 | 11.3 | 0.3 | 2.7 | 1.1 | 11.3 | 1.6 | 16.2 | 1.8 | 18.7 |
| RET-He | level 1 | 23.2 | 0.1 | 0.5 | 0.0 | 0.1 | 0.1 | 0.6 | 0.2 | 0.7 | 1.0 | 4.2 |
| | level 2 | 23.9 | 0.2 | 0.6 | 0.0 | 0.0 | 0.1 | 0.4 | 0.2 | 0.8 | 1.0 | 4.3 |
| | level 3 | 25.0 | 0.3 | 1.2 | 0.1 | 0.5 | 0.1 | 0.6 | 0.4 | 1.4 | 1.1 | 4.4 |
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6190) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between-Site Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | level 1 | 2.50 | 0.06 | 2.3 | 0.00 | 0.0 | 0.01 | 0.5 | 0.06 | 2.3 | 0.10 | 3.9 |
| | level 2 | 6.79 | 0.09 | 1.4 | 0.00 | 0.0 | 0.05 | 0.7 | 0.10 | 1.5 | 0.20 | 2.9 |
| | level 3 | 16.13 | 0.13 | 0.8 | 0.04 | 0.2 | 0.10 | 0.6 | 0.17 | 1.1 | 0.45 | 2.8 |
| NEUT% | level 1 | 45.8 | 1.1 | 2.4 | 0.0 | 0.0 | 0.0 | 0.0 | 1.1 | 2.4 | 1.1 | 2.4 |
| | level 2 | 47.7 | 0.9 | 1.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.9 | 1.9 | 0.9 | 1.9 |
| | level 3 | 52.4 | 0.8 | 1.5 | 0.2 | 0.3 | 0.0 | 0.1 | 0.8 | 1.5 | 0.8 | 1.5 |
| LYMPH% | level 1 | 28.4 | 1.1 | 3.8 | 0.6 | 2.0 | 0.0 | 0.0 | 1.2 | 4.3 | 1.2 | 4.3 |
| | level 2 | 25.0 | 0.6 | 2.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.6 | 2.6 | 0.7 | 2.6 |
| | level 3 | 19.0 | 0.4 | 2.2 | 0.1 | 0.7 | 0.2 | 0.8 | 0.5 | 2.4 | 0.5 | 2.5 |
| MONO% | level 1 | 8.2 | 0.6 | 7.8 | 0.3 | 4.0 | 0.2 | 2.1 | 0.7 | 9.0 | 0.7 | 9.0 |
| | level 2 | 8.5 | 0.4 | 4.6 | 0.1 | 1.6 | 0.0 | 0.0 | 0.4 | 4.9 | 0.4 | 4.9 |
| | level 3 | 8.4 | 0.2 | 2.8 | 0.0 | 0.0 | 0.1 | 0.7 | 0.2 | 2.9 | 0.2 | 2.9 |
| EO% | level 1 | 11.6 | 0.7 | 5.9 | 0.0 | 0.0 | 0.2 | 1.6 | 0.7 | 6.1 | 0.7 | 6.1 |
| | level 2 | 12.5 | 0.7 | 5.2 | 0.2 | 1.4 | 0.0 | 0.0 | 0.7 | 5.4 | 0.7 | 5.4 |
| | level 3 | 13.3 | 0.7 | 5.3 | 0.1 | 0.8 | 0.3 | 2.0 | 0.8 | 5.7 | 0.8 | 5.7 |
{9}
10
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6190) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between-Site Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| BASO% | level 1 | 6.0 | 0.4 | 6.7 | 0.1 | 2.3 | 0.0 | 0.0 | 0.4 | 7.1 | 0.4 | 7.1 |
| | level 2 | 6.3 | 0.3 | 4.9 | 0.0 | 0.6 | 0.1 | 1.9 | 0.3 | 5.3 | 0.3 | 5.3 |
| | level 3 | 7.0 | 0.4 | 5.5 | 0.1 | 1.0 | 0.0 | 0.0 | 0.4 | 5.6 | 0.4 | 5.6 |
| NEUT# | level 1 | 1.15 | 0.04 | 3.3 | 0.00 | 0.0 | 0.00 | 0.3 | 0.04 | 3.3 | 0.05 | 4.7 |
| | level 2 | 3.24 | 0.08 | 2.4 | 0.00 | 0.0 | 0.00 | 0.0 | 0.08 | 2.4 | 0.11 | 3.5 |
| | level 3 | 8.45 | 0.15 | 1.8 | 0.05 | 0.6 | 0.06 | 0.7 | 0.17 | 2.0 | 0.27 | 3.2 |
| LYMPH# | level 1 | 0.71 | 0.03 | 4.5 | 0.01 | 1.5 | 0.00 | 0.0 | 0.03 | 4.8 | 0.04 | 5.9 |
| | level 2 | 1.70 | 0.05 | 2.9 | 0.01 | 0.6 | 0.00 | 0.0 | 0.05 | 2.9 | 0.07 | 4.1 |
| | level 3 | 3.06 | 0.07 | 2.4 | 0.02 | 0.7 | 0.04 | 1.4 | 0.09 | 2.9 | 0.13 | 4.3 |
| MONO# | level 1 | 0.21 | 0.02 | 8.4 | 0.01 | 3.9 | 0.00 | 2.4 | 0.02 | 9.6 | 0.02 | 9.6 |
| | level 2 | 0.58 | 0.03 | 4.8 | 0.01 | 1.7 | 0.01 | 1.0 | 0.03 | 5.2 | 0.03 | 5.5 |
| | level 3 | 1.35 | 0.04 | 2.9 | 0.00 | 0.0 | 0.01 | 0.8 | 0.04 | 3.0 | 0.05 | 4.0 |
| EO# | level 1 | 0.29 | 0.02 | 5.8 | 0.00 | 0.0 | 0.00 | 1.1 | 0.02 | 5.9 | 0.02 | 6.3 |
| | level 2 | 0.85 | 0.04 | 5.3 | 0.00 | 0.4 | 0.00 | 0.0 | 0.05 | 5.3 | 0.05 | 5.9 |
| | level 3 | 2.14 | 0.11 | 5.1 | 0.02 | 1.0 | 0.04 | 1.8 | 0.12 | 5.5 | 0.12 | 5.7 |
| BASO# | level 1 | 0.15 | 0.01 | 7.0 | 0.00 | 1.3 | 0.00 | 0.0 | 0.01 | 7.1 | 0.01 | 7.6 |
| | level 2 | 0.43 | 0.02 | 5.4 | 0.00 | 0.0 | 0.01 | 1.9 | 0.02 | 5.7 | 0.02 | 5.7 |
| | level 3 | 1.13 | 0.06 | 5.7 | 0.01 | 0.6 | 0.00 | 0.0 | 0.07 | 5.8 | 0.07 | 6.2 |
| IG% | level 1 | 12.8 | 1.0 | 8.1 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 8.1 | 1.0 | 8.1 |
| | level 2 | 13.6 | 0.8 | 6.1 | 0.2 | 1.6 | 0.0 | 0.0 | 0.9 | 6.3 | 0.9 | 6.3 |
| | level 3 | 14.7 | 1.0 | 6.5 | 0.4 | 3.0 | 0.1 | 0.8 | 1.1 | 7.2 | 1.1 | 7.4 |
| IG# | level 1 | 0.32 | 0.03 | 8.6 | 0.00 | 0.0 | 0.00 | 0.0 | 0.03 | 8.6 | 0.03 | 9.3 |
| | level 2 | 0.92 | 0.06 | 6.4 | 0.02 | 1.7 | 0.01 | 1.1 | 0.06 | 6.7 | 0.06 | 6.8 |
| | level 3 | 2.37 | 0.16 | 6.7 | 0.07 | 2.8 | 0.01 | 0.3 | 0.17 | 7.2 | 0.18 | 7.4 |
| RBC | level 1 | 2.20 | 0.02 | 0.8 | 0.00 | 0.1 | 0.00 | 0.2 | 0.02 | 0.9 | 0.02 | 1.1 |
| | level 2 | 4.38 | 0.02 | 0.5 | 0.01 | 0.2 | 0.02 | 0.4 | 0.03 | 0.6 | 0.04 | 0.9 |
| | level 3 | 5.17 | 0.03 | 0.5 | 0.01 | 0.2 | 0.01 | 0.1 | 0.03 | 0.6 | 0.05 | 1.0 |
| HGB | level 1 | 5.6 | 0.0 | 0.7 | 0.0 | 0.0 | 0.0 | 0.2 | 0.0 | 0.7 | 0.1 | 1.5 |
| | level 2 | 12.5 | 0.1 | 0.5 | 0.0 | 0.0 | 0.0 | 0.3 | 0.1 | 0.6 | 0.1 | 1.1 |
| | level 3 | 16.5 | 0.1 | 0.4 | 0.0 | 0.1 | 0.0 | 0.2 | 0.1 | 0.5 | 0.2 | 1.1 |
| HCT% | level 1 | 15.8 | 0.1 | 0.8 | 0.1 | 0.3 | 0.1 | 0.4 | 0.1 | 0.9 | 0.5 | 3.1 |
| | level 2 | 34.5 | 0.2 | 0.4 | 0.1 | 0.4 | 0.2 | 0.5 | 0.3 | 0.8 | 1.0 | 3.0 |
| | level 3 | 44.8 | 0.2 | 0.5 | 0.2 | 0.4 | 0.2 | 0.4 | 0.3 | 0.7 | 1.4 | 3.1 |
| MCV | level 1 | 71.9 | 0.2 | 0.3 | 0.1 | 0.2 | 0.2 | 0.3 | 0.3 | 0.4 | 1.6 | 2.2 |
| | level 2 | 78.8 | 0.1 | 0.2 | 0.2 | 0.2 | 0.1 | 0.2 | 0.3 | 0.3 | 1.8 | 2.3 |
| | level 3 | 86.5 | 0.1 | 0.2 | 0.4 | 0.4 | 0.2 | 0.2 | 0.4 | 0.5 | 2.0 | 2.3 |
| MCH | level 1 | 25.4 | 0.2 | 0.9 | 0.0 | 0.1 | 0.1 | 0.2 | 0.2 | 1.0 | 0.3 | 1.1 |
{10}
| MULTI-SITE PRECISION | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK (Lot 6190) | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between-Site Precision | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | level 2 | 28.4 | 0.2 | 0.6 | 0.1 | 0.3 | 0.1 | 0.2 | 0.2 | 0.7 | 0.2 | 0.8 |
| | level 3 | 31.8 | 0.2 | 0.6 | 0.0 | 0.0 | 0.1 | 0.2 | 0.2 | 0.6 | 0.2 | 0.6 |
| MCHC | level 1 | 35.3 | 0.3 | 0.9 | 0.1 | 0.4 | 0.2 | 0.5 | 0.4 | 1.1 | 0.7 | 2.0 |
| | level 2 | 36.1 | 0.2 | 0.6 | 0.2 | 0.5 | 0.1 | 0.3 | 0.3 | 0.8 | 0.8 | 2.1 |
| | level 3 | 36.8 | 0.2 | 0.6 | 0.1 | 0.3 | 0.1 | 0.3 | 0.3 | 0.7 | 0.8 | 2.2 |
| RDW-SD | level 1 | 46.1 | 0.3 | 0.7 | 0.0 | 0.0 | 0.1 | 0.1 | 0.3 | 0.7 | 0.6 | 1.3 |
| | level 2 | 48.7 | 0.3 | 0.6 | 0.0 | 0.0 | 0.1 | 0.2 | 0.3 | 0.6 | 0.8 | 1.5 |
| | level 3 | 44.5 | 0.3 | 0.6 | 0.2 | 0.5 | 0.1 | 0.2 | 0.3 | 0.8 | 0.9 | 2.1 |
| RDW-CV | level 1 | 17.4 | 0.1 | 0.6 | 0.0 | 0.0 | 0.1 | 0.4 | 0.1 | 0.7 | 0.3 | 1.6 |
| | level 2 | 16.8 | 0.1 | 0.6 | 0.0 | 0.1 | 0.0 | 0.3 | 0.1 | 0.6 | 0.3 | 1.5 |
| | level 3 | 14.1 | 0.1 | 0.4 | 0.1 | 0.5 | 0.0 | 0.2 | 0.1 | 0.7 | 0.2 | 1.2 |
| PLT | level 1 | 58 | 2 | 3.9 | 0 | 0.0 | 1 | 1.7 | 2 | 4.3 | 3 | 5.5 |
| | level 2 | 218 | 5 | 2.2 | 2 | 1.0 | 1 | 0.5 | 5 | 2.4 | 9 | 4.2 |
| | level 3 | 541 | 8 | 1.4 | 1 | 0.1 | 3 | 0.6 | 8 | 1.5 | 22 | 4.1 |
| MPV | level 1 | 10.2 | 0.2 | 2.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 2.2 | 0.2 | 2.2 |
| | level 2 | 9.9 | 0.1 | 1.3 | 0.0 | 0.0 | 0.0 | 0.1 | 0.1 | 1.3 | 0.1 | 1.5 |
| | level 3 | 9.6 | 0.1 | 0.6 | 0.0 | 0.0 | 0.0 | 0.3 | 0.1 | 0.6 | 0.1 | 1.1 |
| RET(%) | level 1 | 5.07 | 0.13 | 2.5 | 0.06 | 1.2 | 0.08 | 1.6 | 0.16 | 3.2 | 0.42 | 8.3 |
| | level 2 | 2.15 | 0.06 | 3.0 | 0.03 | 1.5 | 0.02 | 1.0 | 0.07 | 3.4 | 0.18 | 8.6 |
| | level 3 | 0.85 | 0.04 | 5.2 | 0.02 | 2.4 | 0.01 | 0.8 | 0.05 | 5.7 | 0.09 | 10.4 |
| RET# | level 1 | 0.1114 | 0.0032 | 2.8 | 0.0013 | 1.2 | 0.0020 | 1.8 | 0.0040 | 3.6 | 0.0100 | 9.0 |
| | level 2 | 0.0943 | 0.0030 | 3.2 | 0.0013 | 1.4 | 0.0009 | 1.0 | 0.0034 | 3.6 | 0.0086 | 9.1 |
| | level 3 | 0.0438 | 0.0022 | 5.1 | 0.0012 | 2.6 | 0.0006 | 1.3 | 0.0026 | 5.9 | 0.0047 | 10.8 |
| IRF(%) | level 1 | 16.1 | 1.5 | 9.1 | 0.1 | 0.5 | 1.1 | 6.8 | 1.8 | 11.4 | 2.5 | 15.7 |
| | level 2 | 11.3 | 1.1 | 9.8 | 0.4 | 4.0 | 0.4 | 3.6 | 1.3 | 11.2 | 2.0 | 17.9 |
| | level 3 | 10.8 | 1.4 | 12.9 | 0.2 | 1.5 | 0.4 | 4.0 | 1.5 | 13.6 | 2.4 | 21.8 |
| RET-He | level 1 | 22.7 | 0.1 | 0.5 | 0.0 | 0.0 | 0.1 | 0.4 | 0.1 | 0.7 | 0.9 | 3.8 |
| | level 2 | 23.4 | 0.2 | 0.9 | 0.0 | 0.2 | 0.1 | 0.4 | 0.2 | 1.0 | 1.0 | 4.1 |
| | level 3 | 25.1 | 0.4 | 1.4 | 0.1 | 0.3 | 0.1 | 0.4 | 0.4 | 1.5 | 1.1 | 4.2 |
ii. Single site (internal) precision: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three lots of XN-L CHECK was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. Running two vials per day was determined to be an appropriate substitute for two runs per day. The internal precision for each lot of XN-L CHECK was consistent across lots for each assayed parameter. Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and
{11}
between-day.
| SINGLE SITE PRECISION ANALYSIS (POOLED RESULTS) | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between Lot | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC | level 1 | 2.42 | 0.06 | 2.6 | 0.01 | 0.3 | 0.01 | 0.4 | 0.07 | 2.8 | 0.06 | 2.7 |
| | level 2 | 6.73 | 0.10 | 1.5 | 0.02 | 0.3 | 0.02 | 0.3 | 0.10 | 1.5 | 0.11 | 1.6 |
| | level 3 | 15.35 | 0.18 | 1.2 | 0.05 | 0.3 | 0.05 | 0.3 | 0.10 | 0.6 | 0.19 | 1.3 |
| NEUT% | level 1 | 45.3 | 1.1 | 2.3 | 0.2 | 0.5 | 0.2 | 0.4 | 0.0 | 0.0 | 1.1 | 2.4 |
| | level 2 | 48.5 | 0.8 | 1.6 | 0.3 | 0.6 | 0.2 | 0.4 | 0.3 | 0.7 | 0.8 | 1.7 |
| | level 3 | 52.5 | 0.6 | 1.2 | 0.1 | 0.1 | 0.2 | 0.5 | 0.3 | 0.7 | 0.7 | 1.3 |
| LYMPH% | level 1 | 28.9 | 1.1 | 3.8 | 0.4 | 1.3 | 0.0 | 0.0 | 0.3 | 1.0 | 1.2 | 4.1 |
| | level 2 | 24.3 | 0.5 | 2.3 | 0.2 | 0.9 | 0.2 | 0.7 | 0.3 | 1.3 | 0.6 | 2.5 |
| | level 3 | 19.6 | 0.4 | 1.9 | 0.2 | 0.9 | 0.1 | 0.6 | 0.3 | 1.6 | 0.4 | 2.2 |
| MONO% | level 1 | 7.8 | 0.6 | 7.5 | 0.2 | 2.1 | 0.2 | 2.3 | 0.5 | 5.8 | 0.6 | 8.1 |
| | level 2 | 7.9 | 0.4 | 4.9 | 0.1 | 1.0 | 0.1 | 1.6 | 0.5 | 6.1 | 0.4 | 5.2 |
| | level 3 | 7.2 | 0.3 | 3.9 | 0.0 | 0.0 | 0.1 | 1.4 | 0.5 | 6.7 | 0.3 | 4.2 |
| EO% | level 1 | 11.8 | 0.5 | 3.9 | 0.2 | 1.8 | 0.0 | 0.0 | 0.1 | 0.7 | 0.5 | 4.4 |
| | level 2 | 12.7 | 0.5 | 4.0 | 0.1 | 0.9 | 0.2 | 1.2 | 0.2 | 1.5 | 0.5 | 4.3 |
| | level 3 | 13.7 | 0.5 | 3.7 | 0.2 | 1.2 | 0.2 | 1.2 | 0.2 | 1.4 | 0.6 | 4.1 |
| BASO% | level 1 | 6.1 | 0.4 | 7.3 | 0.1 | 1.4 | 0.1 | 2.1 | 0.0 | 0.6 | 0.5 | 7.7 |
| | level 2 | 6.5 | 0.3 | 5.2 | 0.1 | 1.8 | 0.0 | 0.7 | 0.1 | 0.8 | 0.4 | 5.4 |
| | level 3 | 7.0 | 0.3 | 4.9 | 0.0 | 0.2 | 0.0 | 0.7 | 0.1 | 0.8 | 0.3 | 4.9 |
| NEUT# | level 1 | 1.10 | 0.04 | 3.8 | 0.00 | 0.0 | 0.01 | 0.5 | 0.03 | 2.6 | 0.04 | 3.8 |
| | level 2 | 3.27 | 0.07 | 2.2 | 0.01 | 0.3 | 0.02 | 0.6 | 0.02 | 0.7 | 0.08 | 2.3 |
| | level 3 | 8.05 | 0.14 | 1.8 | 0.02 | 0.3 | 0.05 | 0.6 | 0.02 | 0.3 | 0.15 | 1.9 |
| LYMPH# | level 1 | 0.70 | 0.03 | 4.1 | 0.01 | 2.1 | 0.00 | 0.0 | 0.01 | 1.8 | 0.03 | 4.6 |
| | level 2 | 1.64 | 0.04 | 2.7 | 0.02 | 1.0 | 0.01 | 0.8 | 0.04 | 2.6 | 0.05 | 3.0 |
| | level 3 | 3.01 | 0.07 | 2.4 | 0.03 | 0.8 | 0.02 | 0.7 | 0.00 | 0.0 | 0.08 | 2.6 |
| MONO# | level 1 | 0.19 | 0.01 | 7.7 | 0.00 | 2.0 | 0.00 | 2.6 | 0.02 | 8.6 | 0.02 | 8.4 |
| | level 2 | 0.53 | 0.03 | 5.0 | 0.01 | 1.2 | 0.01 | 1.5 | 0.04 | 7.3 | 0.03 | 5.3 |
| | level 3 | 1.11 | 0.04 | 3.8 | 0.01 | 1.1 | 0.01 | 1.1 | 0.04 | 3.5 | 0.05 | 4.1 |
| EO# | level 1 | 0.29 | 0.01 | 5.0 | 0.00 | 0.9 | 0.00 | 0.8 | 0.01 | 1.9 | 0.01 | 5.1 |
| | level 2 | 0.86 | 0.04 | 4.4 | 0.00 | 0.4 | 0.01 | 1.3 | 0.00 | 0.0 | 0.04 | 4.6 |
| | level 3 | 2.11 | 0.08 | 3.9 | 0.02 | 1.2 | 0.02 | 1.1 | 0.00 | 0.0 | 0.09 | 4.1 |
| BASO# | level 1 | 0.15 | 0.01 | 7.9 | 0.00 | 2.3 | 0.00 | 2.5 | 0.00 | 2.3 | 0.01 | 8.6 |
| | level 2 | 0.44 | 0.02 | 5.2 | 0.01 | 2.3 | 0.00 | 0.6 | 0.00 | 0.4 | 0.03 | 5.7 |
| | level 3 | 1.07 | 0.05 | 4.9 | 0.00 | 0.0 | 0.01 | 1.0 | 0.00 | 0.2 | 0.05 | 5.0 |
| IG% | level 1 | 12.3 | 0.7 | 5.6 | 0.2 | 1.9 | 0.2 | 1.3 | 0.0 | 0.3 | 0.7 | 6.0 |
| | level 2 | 13.1 | 0.6 | 4.7 | 0.1 | 0.5 | 0.1 | 0.8 | 0.0 | 0.3 | 0.6 | 4.8 |
{12}
| SINGLE SITE PRECISION ANALYSIS (POOLED RESULTS) | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between Lot | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | level 3 | 14.2 | 0.6 | 4.1 | 0.1 | 0.9 | 0.3 | 1.8 | 0.0 | 0.3 | 0.6 | 4.6 |
| IG# | level 1 | 0.30 | 0.02 | 6.0 | 0.00 | 1.3 | 0.00 | 1.3 | 0.01 | 3.2 | 0.02 | 6.2 |
| | level 2 | 0.88 | 0.04 | 5.0 | 0.00 | 0.5 | 0.01 | 0.8 | 0.01 | 1.0 | 0.05 | 5.1 |
| | level 3 | 2.17 | 0.09 | 4.3 | 0.02 | 0.8 | 0.04 | 1.8 | 0.01 | 0.4 | 0.10 | 4.8 |
| RBC | level 1 | 2.24 | 0.02 | 0.8 | 0.00 | 0.0 | 0.02 | 0.7 | 0.01 | 0.5 | 0.02 | 1.0 |
| | level 2 | 4.23 | 0.02 | 0.5 | 0.00 | 0.0 | 0.03 | 0.7 | 0.05 | 1.1 | 0.04 | 0.8 |
| | level 3 | 5.18 | 0.02 | 0.5 | 0.01 | 0.1 | 0.03 | 0.5 | 0.05 | 0.9 | 0.04 | 0.7 |
| HGB | level 1 | 6.0 | 0.0 | 0.6 | 0.0 | 0.3 | 0.0 | 0.5 | 0.1 | 1.6 | 0.0 | 0.8 |
| | level 2 | 12.6 | 0.0 | 0.4 | 0.0 | 0.1 | 0.1 | 0.4 | 0.3 | 2.6 | 0.1 | 0.6 |
| | level 3 | 16.8 | 0.0 | 0.3 | 0.0 | 0.1 | 0.1 | 0.3 | 0.3 | 1.9 | 0.1 | 0.4 |
| HCT% | level 1 | 17.4 | 0.1 | 0.8 | 0.0 | 0.0 | 0.1 | 0.8 | 0.4 | 2.1 | 0.2 | 1.1 |
| | level 2 | 35.7 | 0.2 | 0.5 | 0.0 | 0.0 | 0.3 | 0.9 | 0.5 | 1.5 | 0.4 | 1.0 |
| | level 3 | 46.3 | 0.2 | 0.4 | 0.0 | 0.1 | 0.4 | 0.9 | 0.5 | 1.2 | 0.5 | 1.0 |
| MCV | level 1 | 77.7 | 0.2 | 0.3 | 0.1 | 0.1 | 0.7 | 0.9 | 1.5 | 1.9 | 0.8 | 1.0 |
| | level 2 | 84.4 | 0.1 | 0.2 | 0.0 | 0.0 | 0.8 | 0.9 | 1.9 | 2.2 | 0.8 | 1.0 |
| | level 3 | 89.5 | 0.1 | 0.2 | 0.0 | 0.0 | 0.9 | 1.0 | 1.9 | 2.1 | 0.9 | 1.0 |
| MCH | level 1 | 26.6 | 0.3 | 0.9 | 0.1 | 0.2 | 0.2 | 0.8 | 0.3 | 1.2 | 0.3 | 1.2 |
| | level 2 | 29.7 | 0.2 | 0.6 | 0.1 | 0.2 | 0.2 | 0.7 | 0.9 | 2.9 | 0.3 | 1.0 |
| | level 3 | 32.4 | 0.2 | 0.5 | 0.1 | 0.2 | 0.2 | 0.6 | 0.9 | 2.7 | 0.3 | 0.9 |
| MCHC | level 1 | 34.2 | 0.3 | 0.9 | 0.1 | 0.2 | 0.3 | 0.8 | 0.3 | 0.8 | 0.4 | 1.3 |
| | level 2 | 35.2 | 0.2 | 0.6 | 0.1 | 0.2 | 0.3 | 1.0 | 0.4 | 1.2 | 0.4 | 1.2 |
| | level 3 | 36.2 | 0.2 | 0.5 | 0.1 | 0.2 | 0.3 | 0.9 | 0.4 | 1.2 | 0.4 | 1.1 |
| RDW-SD | level 1 | 45.1 | 0.3 | 0.7 | 0.2 | 0.4 | 0.4 | 0.9 | 0.2 | 0.4 | 0.5 | 1.2 |
| | level 2 | 44.5 | 0.3 | 0.7 | 0.0 | 0.0 | 0.7 | 1.5 | 0.6 | 1.2 | 0.8 | 1.7 |
| | level 3 | 46.4 | 0.3 | 0.6 | 0.1 | 0.2 | 0.9 | 1.9 | 0.6 | 1.2 | 0.9 | 2.0 |
| RDW-CV | level 1 | 16.0 | 0.1 | 0.6 | 0.0 | 0.1 | 0.1 | 0.7 | 0.2 | 1.3 | 0.1 | 0.9 |
| | level 2 | 14.6 | 0.1 | 0.6 | 0.0 | 0.2 | 0.1 | 0.8 | 0.4 | 2.9 | 0.2 | 1.0 |
| | level 3 | 14.2 | 0.1 | 0.5 | 0.0 | 0.0 | 0.2 | 1.2 | 0.4 | 3.0 | 0.2 | 1.3 |
| PLT | level 1 | 56 | 2 | 3.8 | 1 | 1.5 | 1 | 1.6 | 0 | 0.7 | 2 | 4.4 |
| | level 2 | 223 | 4 | 1.7 | 2 | 0.8 | 2 | 0.7 | 2 | 0.8 | 5 | 2.0 |
| | level 3 | 527 | 7 | 1.3 | 2 | 0.4 | 3 | 0.5 | 2 | 0.4 | 8 | 1.4 |
| MPV | level 1 | 10.9 | 0.3 | 2.3 | 0.1 | 0.7 | 0.0 | 0.4 | 0.3 | 2.3 | 0.3 | 2.5 |
| | level 2 | 10.4 | 0.1 | 1.0 | 0.0 | 0.1 | 0.0 | 0.2 | 0.2 | 2.3 | 0.1 | 1.0 |
| | level 3 | 10.2 | 0.1 | 0.6 | 0.0 | 0.1 | 0.0 | 0.5 | 0.2 | 2.3 | 0.1 | 0.8 |
| RET(%) | level 1 | 6.30 | 0.16 | 2.5 | 0.07 | 1.1 | 0.06 | 0.9 | 0.09 | 1.4 | 0.18 | 2.9 |
| | level 2 | 2.71 | 0.08 | 2.8 | 0.03 | 1.1 | 0.04 | 1.6 | 0.08 | 3.1 | 0.09 | 3.4 |
| | level 3 | 1.05 | 0.05 | 4.7 | 0.00 | 0.4 | 0.04 | 3.4 | 0.08 | 8.1 | 0.06 | 5.8 |
{13}
| SINGLE SITE PRECISION ANALYSIS (POOLED RESULTS) | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| XN-L CHECK | | | | | | | | | | | | |
| | | | Repeatability | | Between Run | | Between Day | | Between Lot | | Reproducibility | |
| Sample | Control level | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| RET# | level 1 | 0.1412 | 0.0039 | 2.7 | 0.0016 | 1.2 | 0.0018 | 1.3 | 0.0027 | 1.9 | 0.0046 | 3.2 |
| | level 2 | 0.1144 | 0.0034 | 2.9 | 0.0014 | 1.2 | 0.0023 | 2.0 | 0.0045 | 3.9 | 0.0043 | 3.8 |
| | level 3 | 0.0542 | 0.0025 | 4.6 | 0.0000 | 0.0 | 0.0021 | 3.9 | 0.0045 | 8.3 | 0.0033 | 6.0 |
| IRF(%) | level 1 | 19.9 | 1.4 | 6.9 | 0.9 | 4.3 | 1.4 | 6.8 | 0.7 | 3.8 | 2.1 | 10.6 |
| | level 2 | 23.7 | 1.5 | 6.2 | 0.0 | 0.0 | 1.5 | 6.3 | 1.1 | 4.8 | 2.1 | 8.9 |
| | level 3 | 20.4 | 1.6 | 7.9 | 0.4 | 2.1 | 0.8 | 4.1 | 1.1 | 5.6 | 1.9 | 9.1 |
| RET-He | level 1 | 22.0 | 0.1 | 0.5 | 0.0 | 0.0 | 0.5 | 2.5 | 0.1 | 0.4 | 0.6 | 2.5 |
| | level 2 | 22.7 | 0.2 | 0.7 | 0.1 | 0.2 | 0.6 | 2.4 | 0.1 | 0.6 | 0.6 | 2.6 |
| | level 3 | 24.2 | 0.3 | 1.2 | 0.2 | 0.8 | 0.7 | 2.9 | 0.1 | 0.6 | 0.8 | 3.3 |
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Value Assignments
Value assignment for XN-L CHECK™ was based on data collected across three XN-L instruments conducted at three separate sites, Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein, with three different operators. Three separately manufactured lots of XN-L CHECK were tested on each analyzer. Each site was instructed to run each lot and level of control for 5 days with 2 runs per day and 3 replicates per run. The final dataset resulted in a total of 90 measurements per lot and control level (level 1, level 2, and level 3). Standard deviation from the multi-site total reproducibility was used to determine the range of each parameter of XN-L CHECK. Future control lots will be value assigned at one site by a minimum of one operator. Five repeat measurements are taken from two separate vials of control material and assayed in a single run on each of 2 days. The average of the 20 individual results will be used for value assignment.
Open-Vial Stability
Open-vial stability testing was performed real-time for the 15-day open-vial stability claim throughout the stated product life. One vial of control per level from each lot was analyzed four times over a period of 16 days (n=16). Testing was conducted at day 0, 7, 15, and 16. Day 0 is the baseline value that was observed on the first day of the study. Day 16 was collected one day after the stated open vial stability claim to ensure that the open vial stability claim was fully encompassed. Throughout the
{14}
collection of the open-vial stability data each vial of control was stored in accordance with the Instructions for Use. Each vial was stored between 2° to 8° C and removed from the refrigerator for testing. After testing, the vial was returned to the refrigerator until the next testing event.
Stability performance of each control lot was assessed in terms of parameter drift over time (for each parameter), as described in CLSI EP25-A – “Evaluation of Stability of In Vitro Diagnostic Agents; Approved Guideline”. Values associated with each parameter, for each lot, and at each time point were within the acceptable value range, supportive of a 15-day open vial stability claim.
## Closed-Vial Stability
The 100-day closed-vial stability claim was verified on the XN-L instrument with three lots of control (5015, 5046, and 5074). Two vials of control per level from each reference lot were used at each testing interval for this study. A minimum of four data points were collected at each testing event over the 100-day closed-vial stability claim. Data was collected internally with one operator. Day 0 is the baseline value that was observed on the first day of the study. One data point was collected after the stated closed-vial stability claim to ensure that the closed vial stability claim was fully encompassed.
Results of the closed-vial stability testing were assessed for each lot and level in terms of measurand drift as stated in CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostics Reagents, Approved Guideline.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
{15}
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The end-user is instructed to refer to the product assay sheet accompanying the instructions for use.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
16
