Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

K230887 · Sysmex America, Inc. · GKZ · Dec 21, 2023 · Hematology

Device Facts

• Record ID: K230887
• Device Name: Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

Device Story

The Sysmex XQ-320 is an automated, multi-parameter hematology analyzer for clinical laboratory use. It processes venous and capillary whole blood samples collected in K2 or K3 EDTA. The operator manually mixes the sample, introduces the tube to an aspiration pipette, and initiates analysis via a start switch. The device uses DC detection for cell counting and a non-cyanide colorimetric method for hemoglobin analysis. It performs a 3-part WBC differential. The system includes a built-in monitor for data processing and operation. Output consists of quantitative hematological parameters and flagging for distributional or morphological abnormalities. These results assist clinicians in screening patient populations and identifying samples requiring further investigation or manual blood smear review, potentially facilitating faster diagnosis of hematological conditions.

Clinical Evidence

Bench testing included precision, linearity, interference, carry-over, and sample stability. Method comparison study (N=628) compared XQ-320 to XN-10 predicate; regression analysis showed high correlation (r > 0.99 for most parameters). Clinical flagging performance evaluated against manual microscopy: Distributional/Morphological flag sensitivity 88.8% (95% CI: 84.9%-91.7%), specificity 73.9% (95% CI: 67.7%-79.2%). Reference intervals verified for adult and pediatric populations.

Technological Characteristics

Multi-parameter hematology analyzer. Sensing: Direct Current (DC) detection for cell counting/sizing; colorimetric method for non-cyanide hemoglobin. Modes: Whole Blood and Pre-Dilution. Connectivity: Built-in monitor, manual barcode entry. Reagents: Diluent, Lyse, Cleaning solution. Software: Microprocessor-based calculation of parameters from measured values. Sterilization: N/A (instrument).

Indications for Use

Indicated for in vitro diagnostic screening of patient populations in clinical laboratories. Analyzes venous and capillary whole blood (K2/K3 EDTA) for CBC and 3-part leukocyte differential (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, MXD%/#). For prescription use only.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers (K112605)

Reference Devices

• Sysmex pocH-100i (K032677)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K230887

B Applicant

Sysmex America, Inc.

C Proprietary and Established Names

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GKZ | Class II | 21 CFR 864.5220 - Automated Differential Cell Counter | HE - Hematology |

## II Submission/Device Overview:

A Purpose for Submission:

New device

B Measurand:

WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#

C Type of Test:

Quantitative complete blood count (CBC) with 3-part leukocyte differential: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#

## III Intended Use/Indications for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

D Special Instrument Requirements:
Sysmex XQ-320 analyzer

IV Device/System Characteristics:

A Device Description:

The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters on whole blood samples collected in K₂ or K₃EDTA anticoagulant. The XQ-320 analyzer consists of one principal unit, which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data. The operator mixes the sample manually, then introduces the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis.

The XQ-320 automated hematology analyzer consists of two principal analysis modes:
1. Whole Blood Analysis Mode is used for testing K₂EDTA or K₃EDTA whole blood samples.
2. Pre-Dilution Analysis Mode is used for testing of microvolumes of K₂EDTA or K₃EDTA whole blood samples. Venous whole blood containing anticoagulant is directly added to diluent to create a 1:7 dilution (1 part sample and 6 parts diluent).

B Principle of Operation:

The XQ-320 analyzer performs analysis by means of Direct Current (DC) detection method and non-cyanide hemoglobin (HGB) analysis method (colorimetric method). The sample is aspirated, measured, and delivered into a mixing chamber where it is diluted. Then lysing reagent is added to dissolve red cells and release the hemoglobin. The lysed sample is transferred to the transducer, where the volume and number of blood cells are determined by the DC detection

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method. Then remaining parameters are calculated by a microprocessor, based upon the measured values.

The leukocyte 3-part differential is determined by size particle distribution. WBC particle size distribution is separated into small white blood cells, medium white blood cells, and large white blood cells by the 3-fractional method.

## C Instrument Description Information:

1. Instrument Name:
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

2. Specimen Identification:
Sample number is manually entered or scanned using a handheld barcode reader.

3. Specimen Sampling and Handling:
Venous and capillary whole blood samples are collected in K₂ or K₃EDTA anticoagulant. Samples should be analyzed within 4 hours after collection. If the sample is not analyzed within 4 hours, the sample should be stored at 2–8°C for 24 hours. Refrigerated samples should remain at room temperature for at least 15 minutes prior to analysis. Perform gentle inversion prior to analysis.

4. Calibration:
The SCS-1000 Calibrator (K943268) is used for calibration of the instrument for WBC, RBC, HGB, HCT, and PLT. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system.

5. Quality Control:
There are three levels of quality control material (low, normal, and high; EIGHTCHECK-3WP X-TRA, K852992) to be used to monitor the performance of the XQ-320 analyzer. Quality control should be performed at the appropriate timing according to the operation of the facility.

## V Substantial Equivalence Information:

A Predicate Device Name(s):
Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers

B Predicate 510(k) Number(s):
K112605

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K230887 | K112605 |
| --- | --- | --- |
| Device Trade Name | Sysmex XQ-320 Automated Hematology Analyzer | Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#. | The XN-Series modules (XN-10, XN20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, 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 K2 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. |
| Parameters | Whole Blood Mode: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, RDW-CV, RDW-SD, MPV, | Same |
| | NXD%/#, LYMPH%/#, MCHC, PLT, NEUT%/#, IRF, RET-He, 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 K2 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. | |

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| Device & Predicate Device(s): | K230887 | K112605 |
| --- | --- | --- |
| | NEUT%/#, and LYMPH%/# | |
| Analysis Modes | Manual Analysis Mode [Whole Blood] mode [Pre-Dilute] mode | Same |
| Sample Aspiration/Fluidsic Pathway | Single Pathway | Same |
| Measuring Channels | RBC/PLT, HGB | Same |
| Specimen Type | K2EDTA/K3EDTA venous and capillary | Same |
| General Device Characteristic Differences | K230887 | K112605 |
| Specimen Type | Not available | Body Fluids Analysis Mode (CSF, Peritoneal, Pleural, and Synovial Fluids) |
| Test Principle | DC detection method, non-cyanide hemoglobin analysis method | Flow cytometry method (using a semiconductor laser) and SLS hemoglobin method |
| Parameters | MXD%/# (MONO+EO+BASO combined) | MONO%/#, EO%/#, and BASO%/# separately |
| | Not available | IG%/#, RET%/#, IPF, IRF, RET-He PLT (PLT-F), NRBC%/#, WBC BF, RBC-BF, MN%/#, PMN%/#, and TC-BF |
| Reagents | Not available | FLUOROCELL WNR (Stain) FLUOROCELL WDF (Stain) FLUOROCELL RET (Stain) FLUOROCELL PLT (Stain) |
| | CELLPACK (Diluent) | CELLPACK DFL (Diluent) CELLPACK DCL (Diluent) |
| | STROMATOLYSER-WH (Lyse) | SULFOLYSER® (Lyse) LYSERCELL WNR (Lyse) LYSERCELL WDF (Lyse) |
| | CELLCLEAN (Cleaning solution) | CELLCLEAN AUTO (Cleaning solution) |

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| Device & Predicate Device(s): | K230887 | K112605 |
| --- | --- | --- |
| Measured Channels | Not available | WNR, WPC, WDF, PLT-F, RET |
| WBC differentials | 3-Part | 6-Part |
| Controls | EIGHTCHECK-3WP_X-TRA (3 levels) | XN-Check (3 levels)
XN Check BF (2 levels) |
| Calibrators | SCS-1000 | XN CAL, XN CAL PF |
| Analysis Modes | Sampler Analysis: Mode: Not available
Manual Analysis Mode: Not Available | Sampler Analysis: Mode: Sample rack Sampler
Manual Analysis Mode: [LWBC] Mode Body Fluid Mode |
| Throughput | Whole Blood Mode:
Approximately 70 samples/hour
Pre-Dilution mode:
Approximately 60 samples/hour | Whole Blood Mode:
100 samples/hour maximum depending on mode used.
Pre-Dilution mode:
Approximately 90 samples/hour maximum depending on mode used. |
| Sample Aspiration Volumes | Whole Blood Mode: 16 μL
Pre-Dilution Mode: 65 μL
Body Fluid Mode: Not available | Whole Blood Mode: 88 μL
Pre-Dilution Mode: 70 μL
Body Fluid Mode: 88 μL |
| Software-based Rules | No rules-based rerun/reflux | Rules-based rerun/reflex |

VI Standards/Guidance Documents Referenced:

- CLSI EP05-A3 (R2019): Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
- CLSI H26-A2 Vol. 30 No. 14: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition.
- CLSI EP07-ED3: Interference Testing in Clinical Chemistry; Approved Guideline – Third Edition.
- CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition.
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition.
- CLSI EP06: CLSI. Evaluation of Linearity of Quantitative Measurement Procedures – 2nd Edition.
- CLSI H20-A2: Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard – Second Edition.
- CLSI EP37-Ed1: Supplemental Tables for Interference Testing in Clinical Chemistry – 1st Edition.
- CLSI EP12-Ed3 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline – Third Edition.

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- IEC 61326-2-6 Ed 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements.
- IEC 61010-1:2010+A1Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General req.

## VII Performance Characteristics (if/when applicable):

## A Analytical Performance:

### 1. Precision/Repeatability Study

#### Repeatability Study

Within-run repeatability studies were performed for all claimed parameters using residual venous whole blood samples collected in K2EDTA anticoagulant. Samples included in the study targeted the low, normal, and upper end of the analytical measuring range of direct measured parameters (WBC, RBC, HGB, HCT, and PLT) and medical decision levels (MDLs) of WBC and PLT parameters. Each sample was tested in one run with ten replicates by the same operator on the same day in the whole blood mode at four U.S. sites (three external clinical sites and one internal site). A total of 11 operators were enrolled across the sites. The mean, standard deviation (SD), and coefficient of variation were calculated for each parameter. All results met the pre-defined acceptance criteria.

| Measurand | Sample level | N | Interval | Mean | SD | %CV |
| --- | --- | --- | --- | --- | --- | --- |
| WBC (x 10³/uL) | MDL | 30 | 0.67 – 0.84 | 0.75 | 0.04 | 4.45 |
| | Low | 30 | 1.21 – 1.91 | 1.64 | 0.04 | 2.44 |
| | Normal | 30 | 9.81 – 10.65 | 10.28 | 0.15 | 1.45 |
| | High | 30 | 70.97 – 93.53 | 83.94 | 0.61 | 0.73 |
| RBC (x 10⁶/uL) | Low | 30 | 2.03 – 2.85 | 2.53 | 0.02 | 0.99 |
| | Normal | 30 | 4.41 – 4.94 | 4.70 | 0.04 | 0.84 |
| | High | 30 | 6.16 – 6.80 | 6.43 | 0.07 | 1.05 |
| HGB (g/dL) | Low | 30 | 6.1 – 6.9 | 6.49 | 0.06 | 0.92 |
| | Normal | 30 | 13.5 – 15.5 | 14.36 | 0.11 | 0.79 |
| | High | 30 | 17.4 – 19.2 | 18.05 | 0.07 | 0.38 |
| HCT(%) | Low | 30 | 18.2 – 23.0 | 20.50 | 0.24 | 1.16 |
| | Normal | 30 | 40.2 – 44.6 | 42.10 | 0.39 | 0.93 |
| | High | 30 | 52.3 – 58.7 | 54.99 | 0.48 | 0.87 |
| PLT (10³/μL) | MDL | 30 | 9 – 26 | 14.33 | 2.60 | 17.11 |
| | Low | 30 | 30 – 44 | 37.10 | 3.06 | 8.28 |
| | Normal | 30 | 216 – 311 | 271.57 | 6.50 | 2.46 |
| | High | 30 | 618 – 982 | 815.30 | 13.02 | 1.67 |
| MCV (fL) | Low | 30 | 66.4 – 88.0 | 77.73 | 0.26 | 0.33 |
| | Normal | 30 | 82.2 – 91.1 | 86.50 | 0.43 | 0.50 |
| | High | 30 | 102.9 – 112.6 | 108.77 | 0.52 | 0.47 |
| MCH (pg) | Low | 30 | 20.3 – 25.7 | 23.50 | 0.30 | 1.26 |
| | Normal | 30 | 26.4 – 31.0 | 28.33 | 0.29 | 1.02 |
| | High | 30 | 30.7 – 41.8 | 35.73 | 0.54 | 1.45 |
| MCHC (g/dL) | Low | 30 | 26.2 – 28.9 | 27.80 | 0.36 | 1.31 |
| | Normal | 30 | 28.6 – 32.2 | 30.87 | 0.31 | 1.00 |

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| Measurand | Sample level | N | Interval | Mean | SD | %CV |
| --- | --- | --- | --- | --- | --- | --- |
| | High | 30 | 32.1 – 36.9 | 34.50 | 0.47 | 1.35 |
| RDW-SD (fL) | Low | 30 | 33.7 – 45.5 | 38.87 | 0.64 | 1.67 |
| | Normal | 30 | 41.1 – 58.2 | 47.77 | 0.76 | 1.60 |
| | High | 30 | 72.6 – 96.0 | 81.40 | 1.46 | 1.80 |
| RDW-CV (%) | Low | 30 | 9.5 – 12.6 | 11.20 | 0.58 | 1.04 |
| | Normal | 30 | 13.1 – 15.5 | 14.37 | 0.67 | 1.17 |
| | High | 30 | 17.2 – 29.9 | 22.60 | 0.69 | 1.13 |
| MPV (fL) | Low | 30 | 8.2 – 8.8 | 8.53 | 0.95 | 1.75 |
| | Normal | 30 | 8.3 – 10.4 | 9.50 | 1.10 | 2.01 |
| | High | 30 | 11.1 – 13.0 | 11.97 | 1.40 | 2.50 |
| NEUT (x 103/uL) | Low | 30 | 0.39 – 1.37 | 0.91 | 3.99 | 7.91 |
| | Normal | 30 | 1.21 – 8.70 | 4.69 | 1.85 | 3.56 |
| | High | 30 | 3.36 – 41.53 | 16.38 | 1.58 | 2.85 |
| NEUT (%) | Low | 30 | 21.0 – 57.2 | 38.40 | 4.88 | 7.16 |
| | Normal | 30 | 45.9 – 86.2 | 61.20 | 1.91 | 2.50 |
| | High | 30 | 72.5 – 95.9 | 84.83 | 2.47 | 2.72 |
| LYMPH (x 103/uL) | Low | 30 | 0.34 – 0.73 | 0.49 | 0.01 | 4.31 |
| | Normal | 30 | 0.67 – 48.39 | 16.47 | 0.40 | 3.15 |
| | High | 30 | 2.23 – 75.29 | 26.63 | 0.33 | 2.29 |
| LYMPH (%) | Low | 30 | 3.4 – 9.9 | 5.70 | 0.37 | 5.95 |
| | Normal | 30 | 19.8 – 32.9 | 27.97 | 0.85 | 3.10 |
| | High | 30 | 61.0 – 87.6 | 77.67 | 0.71 | 0.99 |
| MXD (x 103/uL) | Low | 30 | 0.39 – 1.70 | 0.81 | 0.08 | 10.60 |
| | Normal | 30 | 0.59 – 2.39 | 1.27 | 0.15 | 13.11 |
| | High | 30 | 0.39 – 15.45 | 5.85 | 0.27 | 7.47 |
| MXD (%) | Low | 30 | 2.6 – 14.5 | 6.87 | 0.65 | 10.11 |
| | Normal | 30 | 6.7 – 19.2 | 11.67 | 1.60 | 13.00 |
| | High | 30 | 10.0 – 31.6 | 22.03 | 1.55 | 7.17 |

# Reproducibility

A reproducibility studies was performed at three U.S. clinical sites. The study was performed over five days with three Sysmex XQ-320 Automated Hematology Analyzers (one per site) using a single calibrator and one lot of quality control materials (low, normal, high) by seven operators. Two runs per day and three replicates per run were performed at each site for each control level. The SD and $\% \mathrm{CV}$ were calculated for within-run, between-run, between-day, between-site, and total imprecision for each control level. All results met pre-defined acceptance criteria.

| Measurand | Control level | N | Mean | Within-run | | Between-run | | Between-day | | Between-site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC (103/μL) | Low | 90 | 3.42 | 0.000 | 0.00 | 0.064 | 1.87 | 0.042 | 1.23 | 0.000 | 0.00 | 0.077 | 2.24 |
| | Normal | 90 | 7.38 | 0.000 | 0.00 | 0.120 | 1.60 | 0.050 | 0.68 | 0.056 | 0.75 | 0.140 | 1.89 |
| | High | 90 | 19.3 | 0.040 | 0.21 | 0.190 | 0.97 | 0.100 | 0.54 | 0.110 | 0.59 | 0.250 | 1.28 |
| RBC (106/μL) | Low | 90 | 2.45 | 0.000 | 0.00 | 0.034 | 1.39 | 0.014 | 0.56 | 0.000 | 0.00 | 0.037 | 1.49 |
| | Normal | 90 | 4.59 | 0.000 | 0.00 | 0.047 | 1.01 | 0.023 | 0.51 | 0.000 | 0.00 | 0.052 | 1.13 |
| | High | 90 | 5.58 | 0.000 | 0.00 | 0.065 | 1.16 | 0.027 | 0.48 | 0.000 | 0.00 | 0.070 | 1.25 |
| HGB (g/dL) | Low | 90 | 6.61 | 0.000 | 0.00 | 0.05 | 0.77 | 0.06 | 0.92 | 0.04 | 0.71 | 0.09 | 1.40 |
| | Normal | 90 | 13.3 | 0.040 | 0.33 | 0.04 | 0.36 | 0.05 | 0.39 | 0.12 | 0.90 | 0.15 | 1.09 |
| | High | 90 | 17.3 | 0.000 | 0.00 | 0.08 | 0.49 | 0.06 | 0.39 | 0.11 | 0.61 | 0.15 | 0.88 |
| HCT (%) | Low | 90 | 18.5 | 0.000 | 0.00 | 0.26 | 1.39 | 0.09 | 0.53 | 0.11 | 0.62 | 0.30 | 1.61 |
| | Normal | 90 | 37.4 | 0.000 | 0.00 | 0.40 | 1.06 | 0.14 | 0.37 | 0.22 | 0.59 | 0.47 | 1.27 |

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| Measurand | Control level | N | Mean | Within-run | | Between-run | | Between-day | | Between-site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | High | 90 | 48.5 | 0.190 | 0.39 | 0.53 | 1.10 | 0.05 | 0.11 | 0.24 | 0.50 | 0.62 | 1.28 |
| MCV (fL) | Low | 90 | 75.3 | 0.000 | 0.00 | 0.37 | 0.49 | 0.37 | 0.48 | 0.36 | 0.48 | 0.64 | 0.84 |
| | Normal | 90 | 81.4 | 0.000 | 0.00 | 0.30 | 0.37 | 0.45 | 0.55 | 0.41 | 0.50 | 0.67 | 0.83 |
| | High | 90 | 86.9 | 0.070 | 0.08 | 0.33 | 0.38 | 0.30 | 0.34 | 0.41 | 0.47 | 0.61 | 0.70 |
| MCH (pg) | Low | 90 | 27.0 | 0.000 | 0.00 | 0.43 | 1.59 | 0.13 | 0.48 | 0.25 | 0.92 | 0.51 | 1.90 |
| | Normal | 90 | 29.0 | 0.000 | 0.00 | 0.29 | 1.01 | 0.07 | 0.27 | 0.28 | 0.98 | 0.42 | 1.43 |
| | High | 90 | 31.0 | 0.120 | 0.40 | 0.34 | 1.09 | 0.00 | 0.00 | 0.21 | 0.67 | 0.42 | 1.34 |
| MCHC (g/dL) | Low | 90 | 35.8 | 0.00 | 0.00 | 0.56 | 1.57 | 0.33 | 0.93 | 0.51 | 1.43 | 0.83 | 2.32 |
| | Normal | 90 | 35.6 | 0.02 | 0.08 | 0.35 | 1.00 | 0.23 | 0.65 | 0.52 | 1.46 | 0.67 | 1.89 |
| | High | 90 | 35.7 | 0.25 | 0.71 | 4.31 | 5.48 | 0.00 | 0.00 | 0.42 | 1.16 | 0.61 | 1.70 |
| PLT (x10/μL) | Low | 90 | 78 | 0.00 | 0.00 | 4.31 | 5.48 | 1.80 | 2.29 | 1.05 | 1.33 | 4.79 | 6.09 |
| | Normal | 90 | 238 | 0.00 | 0.00 | 6.99 | 2.94 | 2.68 | 1.13 | 2.03 | 0.85 | 7.76 | 3.26 |
| | High | 90 | 560 | 0.00 | 0.00 | 13.80 | 2.47 | 8.94 | 1.60 | 5.49 | 0.98 | 17.30 | 3.10 |
| RDW-SD (fL) | Low | 90 | 26.1 | 0.00 | 0.00 | 0.52 | 1.99 | 0.24 | 0.93 | 0.51 | 1.96 | 0.77 | 2.95 |
| | Normal | 90 | 28.3 | 0.00 | 0.00 | 0.47 | 1.65 | 0.26 | 0.91 | 0.22 | 0.78 | 0.58 | 2.04 |
| | High | 90 | 30.8 | 0.24 | 0.78 | 0.37 | 1.22 | 0.12 | 0.40 | 0.62 | 2.00 | 0.77 | 2.50 |
| RDW-CV (%) | Low | 90 | 9.41 | 0.00 | 0.00 | 0.26 | 2.75 | 0.20 | 2.11 | 0.08 | 0.92 | 0.34 | 3.58 |
| | Normal | 90 | 8.77 | 0.00 | 0.00 | 0.18 | 2.01 | 0.24 | 2.77 | 0.00 | 0.00 | 0.30 | 3.42 |
| | High | 90 | 8.58 | 0.00 | 0.00 | 0.17 | 2.02 | 0.20 | 2.28 | 0.08 | 0.94 | 0.27 | 3.19 |
| MPV (fL) | Low | 90 | 9.08 | 0.00 | 0.00 | 0.16 | 1.81 | 0.11 | 1.20 | 0.16 | 1.78 | 0.26 | 2.81 |
| | Normal | 90 | 8.90 | 0.00 | 0.00 | 0.09 | 1.10 | 0.01 | 0.21 | 0.18 | 2.07 | 0.21 | 2.36 |
| | High | 90 | 8.84 | 0.00 | 0.00 | 0.10 | 1.15 | 0.05 | 0.59 | 0.18 | 0.21 | 0.21 | 2.39 |
| NEUT (x 103/uL) | Low | 90 | 2.40 | 0.000 | 0.00 | 0.075 | 3.13 | 0.008 | 0.32 | 0.021 | 0.89 | 0.078 | 3.27 |
| | Normal | 90 | 4.20 | 0..46 | 1.10 | 0.100 | 2.44 | 0.000 | 0.00 | 0.050 | 1.19 | 0.120 | 2.93 |
| | High | 90 | 9.10 | 0.000 | 0.00 | 0.200 | 2.15 | 0.000 | 0.00 | 0.093 | 1.02 | 0.220 | 2.38 |
| NEUT% (%) | Low | 90 | 70.1 | 0.00 | 0.00 | 1.75 | 2.50 | 0.40 | 0.57 | 0.37 | 0.53 | 1.84 | 2.62 |
| | Normal | 90 | 57.0 | 0.24 | 0.43 | 1.15 | 2.01 | 0.00 | 0.00 | 0.21 | 0.36 | 1.19 | 2.09 |
| | High | 90 | 47.3 | 0.00 | 0.00 | 0.90 | 1.90 | 0.19 | 0.41 | 0.31 | 0.65 | 0.97 | 2.05 |
| LYMPH (x 103/uL) | Low | 90 | 0.65 | 0.009 | 1.34 | 0.031 | 4.83 | 0.015 | 2.25 | 0.000 | 0.00 | 0.036 | 5.49 |
| | Normal | 90 | 2.26 | 0.000 | 0.00 | 0.072 | 3.19 | 0.022 | 0.96 | 0.000 | 0.00 | 0.075 | 3.33 |
| | High | 90 | 6.96 | 0.000 | 0.00 | 0.130 | 1.90 | 0.076 | 1.10 | 0.059 | 0.85 | 0.160 | 2.35 |
| LYMPH% (%) | Low | 90 | 19.0 | 0.00 | 0.00 | 0.86 | 4.54 | 0.24 | 1.24 | 0.00 | 0.00 | 0.89 | 4.70 |
| | Normal | 90 | 30.6 | 0.00 | 0.00 | 0.83 | 2.70 | 0.00 | 0.00 | 0.30 | 0.98 | 0.88 | 2.87 |
| | High | 90 | 36.1 | 0.00 | 0.00 | 0.55 | 1.51 | 0.14 | 0.40 | 0.21 | 0.58 | 0.60 | 1.67 |
| MXD (x 103/uL) | Low | 90 | 0.37 | 0.000 | 0.00 | 0.060 | 16.20 | 0.000 | 0.00 | 0.012 | 3.10 | 0.061 | 16.50 |
| | Normal | 90 | 0.91 | 0.000 | 0.00 | 0.079 | 8.60 | 0.020 | 2.16 | 0.011 | 1.23 | 0.082 | 8.95 |
| | High | 90 | 3.20 | 0.000 | 0.00 | 0.170 | 5.32 | 0.000 | 0.00 | 0.000 | 0.00 | 0.170 | 5.32 |
| MXD% (%) | Low | 90 | 10.9 | 0.00 | 0.00 | 1.76 | 16.20 | 0.00 | 0.00 | 0.40 | 3.69 | 1.81 | 16.60 |
| | Normal | 90 | 12.4 | 0.23 | 1.84 | 1.02 | 8.27 | 0.00 | 0.00 | 0.00 | 0.00 | 1.05 | 8.47 |
| | High | 90 | 16.6 | 0.00 | 0.00 | 0.89 | 5.35 | 0.00 | 0.00 | 0.03 | 0.18 | 0.89 | 5.35 |

# 2. Linearity:

Linearity testing by serial dilution was conducted at one internal site using three Sysmex XQ-320 Automated Hematology Analyzers. A single calibrator lot, control material (WRP CHECK; K960557) and system diluent (CELLPACK) were used to create serial dilutions of sample concentration which spanned the target measurement range of all direct measured parameters (WBC, RBC, HGB, HCT and PLT). Each sample dilutions were measured in replicates of three. All results met predefined acceptance criteria.

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| Parameter | Linear Range |
| --- | --- |
| WBC (x103/μL) | 0.20–99.90 |
| RBC (x106/μL) | 0.01–7.00 |
| HGB (g/dL) | 0.1–25.0 |
| HCT (%) | 0.2–60.0 |
| PLT(x103/μL) | 5–999 |

# 3. Analytical Specificity/Interference:

Interfering substances studies were conducted for Bilirubin F, Bilirubin C, Chyle, Hemolytic Hemoglobin, Lipids, and high WBC, RBC, and platelet counts to determine the concentration that impact all claimed parameters on the Sysmex XQ-320 Automated Hematology analyzer. Whole blood $\mathrm{K}_2\mathrm{EDTA}$ samples were collected from donors for this study and varying concentrations of interferent was added to obtain concentrations. The tubes were mixed, and measurements were repeated in four consecutive batches on the XQ-320 automated hematology analyzer. The following table includes the results of the study:

| Interferent | Conclusion |
| --- | --- |
| Bilirubin F | There was no significant Bilirubin F interference up to a concentration of 40.0 mg/dL for all parameters. |
| Bilirubin C | There was no significant Bilirubin C interference up to a concentration of 40 mg/dL for all parameters. |
| Chyle | There was no significant Chyle interference up to a concentration of 2,880 FTU (Formazine Turbidity Unit) for WBC, up to a concentration of 1,440 FTU for NEUT%, LYMPH%, and MXD% and up to a concentration of 720 FTU for LYMPH#. There was no significant Chyle interference up to a concentration of 3,600 FTU for the other parameters. Significant Chyle interference was observed for MXD# at a concentration of 720 FTU. |
| Hemolytic Hemoglobin | There was no significant Hemolysis interference up to a concentration of 800 mg/dL for HGB and 400 mg/dL for MCHC. For the other parameters, no significant interference was observed up to a concentration of 1,000 mg/dL. |
| Lipids | There was no significant Lipid interference up to a concentration of 0.20 g/dL for HGB, MCH, and MCHC. There was no significant Lipid interference up to a concentration of 1.00 g/dL for MPV. There was no significant Lipid interference up to a concentration of 2.00 g/dL for the other parameters. |
| High white blood cell counts | There was no significant WBC interference up to a concentration of 93.53 x 103cells/μL for RBC, HGB, HCT and MCV. There was no significant WBC interference up to a concentration of 72.08 x 103cells/μL for PLT. |
| High red blood cell counts | There was no interference from high RBCs at the upper measuring range in measuring WBC, RBC, HGB, and PLT. |

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| | There was no significant RBC interference up to a concentration of 6.64 x 10^6 cells/μL for HCT. |
| --- | --- |
| High platelet counts | There was no significant PLT interference up to a concentration of 955 x 10^3 cells/μL for WBC, RBC, HGB, HCT, PLT, and MPV. |

4. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Sample Stability:

The evaluation of whole blood sample stability was conducted at one site using twenty (10 normal and 10 abnormal) residual $\mathrm{K}_2\mathrm{EDTA}$ whole blood samples. Samples were split into two sets stored at room temperature $(18 - 26^{\circ}\mathrm{C})$ and refrigerated temperature $(2 - 8^{\circ}\mathrm{C})$ . Room temperature samples were tested in duplicate at baseline (T0), 4, 8, 12, and 13 hours and refrigerated samples were tested at baseline T0, 8, 12, 24, and 25 hours in singlet. The mean, standard deviation, mean difference and percent difference from the baseline mean of each sample result were calculated for each parameter at each time interval for both conditions. All results were within the established acceptance criteria. The data support a whole blood sample stability of 12 hours at room temperature $(18 - 26^{\circ}\mathrm{C})$ and 24 hours at refrigerated temperature $(2 - 8^{\circ}\mathrm{C})$ .

5. Detection Limit:

Limits of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were determined for the direct measured WBC, RBC, HGB, HCT and PLT parameters on the Sysmex XQ-320 Automated Hematology Analyzer.

In LoB testing, four blank samples were measured in replicates of five, over a period of three days using two reagent lots, to yield 120 total measurement results per parameter. To determine the LoD and LoQ, four low concentration samples were analyzed on the Sysmex XN-10 automated hematology analyzer (K112605) to assign the reference value. The low-level samples were then measured in replicates of five over a period of three days using two reagent lots, to yield 120 total measurement results per parameter.

The results of the LoB, LoD, and LoQ are provided in the table below.

| Parameter | LoB | LoD | LoQ |
| --- | --- | --- | --- |
| WBC (x10^6/μL) | 0.00 | 0.03 | 0.17 |
| RBC (x10^6/μL) | 0.00 | 0.01 | 0.01 |
| HGB (g/dL) | 0.00 | 0.1 | 0.1 |
| HCT (%) | 0.00 | 0.1 | 0.1 |
| PLT (x10^3/μL) | 0 | 1 | 2 |

6. Assay Cut-Off:

Not applicable.

7. Carry-Over:

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Carryover on the Sysmex XQ-320 Automated Hematology analyzer was evaluated by assaying venous whole blood collected in $\mathrm{K}_2\mathrm{EDTA}$ with high WBC, RBC, HGB, HCT, and PLT counts three consecutive times followed immediately by testing samples with low target values around medical decision levels three consecutive times. Three sets of carryover sequences were run for each measurand in the whole blood mode at three clinical sites. The results of the carryover study demonstrated the Sysmex XQ-320 Automated Hematology Analyzer is not impacted by carryover.

# B Comparison Studies:

# 1. Method Comparison with Predicate Device:

A method comparison study was conducted to assess the performance of the Sysmex XQ-320 Automated Hematology analyzer compared to the predicate device, Sysmex XN-10 (K112605). A total of 628 (611 native and 17 contrived) residual and prospectively collected venous whole blood samples in K2EDTA anticoagulant from pediatrics (<21 years) and adult (≥21 years) subjects including a variety of disease states (e.g., chronic leukemia (lymphocytic), pathological WBCs, hepatocellular carcinoma, bacterial infection, acute encephalopathy etc.) were enrolled in the study. Sample demographics from all sites included 172 pediatric subjects and 433 adults and 23 subjects with age not reported. Of this total, $43.8\%$ were male, $52.2\%$ female and $4.0\%$ with sex not reported. The results of the regression analyses including $95\%$ confidence interval (CI) for the slope, intercept and correlation coefficient were computed for each parameter using the Deming method with results from the Sysmex XQ-320 Automated Hematology Analyzer against the results from the Sysmex XN-10 analyzer. All results were within predefined acceptance criteria.

| Measurand (unit) | N | Result Range | Correlation Coefficient | Slope (95%CI) | Intercept 95% CI |
| --- | --- | --- | --- | --- | --- |
| WBC (x 103/μL) | 378 | (0.31–98.67) | 0.9994 | 0.992 (0.988, 0.996) | 0.215 (0.144, 0.285) |
| RBC (x 106/μL) | 385 | (1.10–6.78) | 0.9984 | 0.970 (0.965, 0.976) | 0.107 (0.083, 0.130) |
| HGB (g/dL) | 385 | (3.2–23.8) | 0.9987 | 0.974 (0.969, 0.979) | 0.45 (0.39, 0.52) |
| HCT (%) | 379 | (11.1–59.1) | 0.9965 | 0.964 (0.956, 0.972) | 0.62 (0.30, 0.93) |
| MCV (fL) | 385 | (52.5–131.6) | 0.9881 | 1.005 (0.990, 1.021) | -1.98 (-3.43, -0.53) |
| MCH (pg) | 385 | (13.1–40.9) | 0.9861 | 0.997 (0.981, 1.014) | 0.57 (0.08, 1.06) |
| MCHC (g/dL) | 385 | (22.4–40.2) | 0.8914 | 0.880 (0.839, 0.922) | 4.83 (3.52, 6.13) |
| PLT (x 103/uL) | 382 | (6–941) | 0.9960 | 0.989 (0.980, 0.998) | -1.9 (-4.9, 1.0) |
| RDW-SD (fL) | 384 | (33.6–105.5) | 0.9467 | 1.028 (0.995, 1.062) | -5.03 (-6.83, -3.23) |
| RDW-CV (%) | 385 | (11.2–26.5) | 0.9645 | 1.167 (1.136, 1.198) | -3.15 (-3.65, -2.65) |
| MPV (fL) | 359 | (8.2–14.5) | 0.9027 | 0.912 (0.870, 0.954) | 0.40 (-0.05, 0.86) |
| MPC (fL) | 385 | (1.1–1.4) | 0.8914 | 0.880 (0.839, 0.922) | 0.01 (-0.05, 0.05) |

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| Measurand (unit) | N | Result Range | Correlation Coefficient | Slope (95%CI) | Intercept 95% CI |
| --- | --- | --- | --- | --- | --- |
| NEUT# (x 103/uL) | 262 | (0.36–57.75) | 0.9959 | 1.020 (1.009, 1.031) | -0.176 (-0.299, -0.052) |
| LYMPH# (x 103/uL) | 363 | (0.10–99.84) | 0.9962 | 1.012 (1.003, 1.021) | 0.109 (-0.005, 0.222) |
| MXD# (x 103/uL) | 262 | (0.02–3.00) | 0.8525 | 1.280 (1.197, 1.364) | -0.247 (-0.394, -0.101) |
| NEUT (%) | 262 | (15.9–96.7) | 0.9600 | 1.017 (0.981, 1.052) | -2.32 (-4.58, -0.06) |
| LYMPH (%) | 364 | (0.5–95.2) | 0.9827 | 1.031 (1.011, 1.051) | 0.18 (-0.56, 0.91) |
| MXD (%) | 262 | (1.0–18.0) | 0.5933 | 1.415 (1.268, 1.562) | -4.25 (-6.06, -2.44) |

# 2. Matrix Studies

# Anticoagulant Comparison Study (K2EDTA versus K3EDTA) - Whole Blood

Anticoagulant comparison study was performed to evaluate comparability between $\mathrm{K}_2\mathrm{EDTA}$ versus $\mathrm{K}_3\mathrm{EDTA}$ anticoagulated whole blood samples on the Sysmex XQ-320 Automated Hematology analyzer. A total of 53 paired whole blood samples ( $\mathrm{K}_2\mathrm{EDTA}$ versus $\mathrm{K}_3\mathrm{EDTA}$ ) were collected from adult ( $>21$ years) donors. The samples were run in singlet within 8 hours of collection in the whole blood mode. The results from the $\mathrm{K}_2\mathrm{EDTA}$ whole blood samples were compared to the corresponding results of the $\mathrm{K}_3\mathrm{EDTA}$ sample for the same donor. The results of the regression analysis and bias estimates between $\mathrm{K}_2\mathrm{EDTA}$ versus $\mathrm{K}_3\mathrm{EDTA}$ anticoagulated whole blood samples met the acceptance criteria for all applicable parameters and suggest there is no difference in performance between $\mathrm{K}_2\mathrm{EDTA}$ and $\mathrm{K}_3\mathrm{EDTA}$ whole blood samples.

# Comparison of Venous Whole Blood versus Capillary Whole Blood

A study was performed to evaluate comparability between venous whole blood and capillary whole blood samples on the Sysmex XQ-320 Automated Hematology analyzer. A total of 42 paired venous whole blood and capillary whole blood samples (K2EDTA) were drawn from adult (>21 years) donors for this study. The venous whole blood sample results were compared to the corresponding results of the capillary sample for the same donor. The results of the regression analysis and bias estimates met the acceptance criteria for all applicable parameters and suggest there is no difference in performance between venous whole blood and capillary whole blood samples.

# Whole Blood K2EDTA Normal Tube versus Micro-collection tube

A comparison study of $\mathrm{K}_2\mathrm{EDTA}$ tubes and micro-collection tubes without anticoagulant were performed to determine the presence or absence of matrix effect between the sample tubes on the Sysmex XQ-320 Automated Hematology analyzer. A total of 183 residual $\mathrm{K}_2\mathrm{EDTA}$ (4 mL tubes) whole blood samples with analyte concentrations spanning the analytical measuring range were run in singlet in the whole blood mode. Within two hours of analysis of the 4 mL $\mathrm{K}_2\mathrm{EDTA}$ tubes, the samples were remixed, then transferred to micro collection tubes (without anticoagulant additive), then analyzed in singlet in the whole blood mode. The results from the $\mathrm{K}_2\mathrm{EDTA}$ whole blood samples were compared to the corresponding results of the micro-collection sample tube for the same patient sample. The

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results of the regression analysis and bias estimates met the acceptance criteria for all applicable parameters and suggest there is no matrix effect between samples tubes on the Sysmex XQ-320 Automated Hematology Analyzer.

## Whole Blood K₂EDTA mode versus Predilute mode

A total of 35 residual K₂EDTA (4 mL tubes) anticoagulated whole blood samples were evaluated to determine comparability between the whole blood and predilute mode on Sysmex XQ-320 Automated Hematology analyzer. Following the analysis of the whole blood samples, a 1:7 predilute sample was prepared for each whole blood sample by adding 120 μL of system diluent (CELLPACK) and 20 μL of whole blood into plain micro-collection tubes. The prediluted samples were thoroughly mixed by gentle inversion and run in the predilute mode of the Sysmex XQ-320 Automated Hematology Analyzer with caps off. The results from the predilute mode are automatically multiplied by 7 before results are displayed, therefore no additional calculation is required. The results from the K₂EDTA whole blood samples were compared to the corresponding results of the prediluted sample for the same patient sample. The results of the regression analysis and bias estimates met the acceptance criteria for all applicable parameters.

## C Clinical Studies:

### 1. Clinical Sensitivity:

Sensitivity/specificity studies were conducted to evaluate the flagging capabilities of the Sysmex XQ-320 Automated Hematology analyzer using patient samples representing a variety of abnormal conditions in comparison to manual differential counts and peripheral blood smear review by experienced examiners using light microscopy (reference method) at each of the three external clinical sites and one internal site from the method comparison study. Three blood film slides were prepared for each sample for manual measurement. The flagging results from the Sysmex XQ-320 Automated Hematology Analyzers for normal (no flags) and abnormal (flags present) were compared to manual differential counts and peripheral blood smear review using light microscopy. A 2x2 table was constructed to determine sensitivity and specificity for both distributional and morphological abnormalities. The sample size (N), number of true positives (TP), false positives (FP), true negative (TN), false negatives (FN), sensitivity, specificity, and overall percent agreement are presented in the following table.

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Distributional and Morphological Abnormal Flagging Summary – All Sites Combined

| Abnormal Flag | N | TP | FP | TN | FN | Sensitivity (95% CI) | Specificity (95% CI) | Overall % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Distributional Flag | 437 | 202 | 32 | 181 | 22 | 90.2% (85.6%, 93.4%) | 85.0% (79.6%, 89.2%) | 87.6% (84.2%, 90.4%) |
| Morphological Flag | 542 | 131 | 55 | 287 | 69 | 65.5% (58.7%, 71.7%) | 83.9% (79.7%, 87.4%) | 77.1% (73.4%, 80.5%) |
| Distributional and/or Morphological Flag | 560 | 300 | 58 | 164 | 38 | 88.8% (84.9%, 91.7%) | 73.9% (67.7%, 79.2%) | 82.9% (79.5%, 85.8%) |

2. Clinical Specificity:

See sensitivity above.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable.

D Expected Values/Reference Range:

Verification of Adult Reference Intervals

Verification of adult reference intervals was conducted on the Sysmex XQ-320 Automated Hematology analyzer to demonstrate comparability of whole blood reference intervals for an adult male and female population (>21 years) to ranges established for the Sysmex pocH-100i (K032677). Ninety-nine samples (56 females and 43 males) were tested and compared to pre-established reference intervals to determine if the ranges were applicable for use with the Sysmex XQ-320 Automated Hematology analyzer. The results of the proposed reference intervals overlapped the 95% confidence intervals (lower and upper limit) of the adult male and female and were determined to be acceptable.

Verification of Pediatric Reference Intervals

Using Pediatric Reference Interval literature source (Wong, E., Brugnara, C., Straseski, J., Kellogg, M., & Adeli, K. 2021. Pediatric Reference Intervals. 8th ed., Hematology Tests (pp. 209-267), Academic Press.), reference interval verification study was performed for the pediatric population. A total of 226 pediatric samples including each subpopulation: 34 neonates (birth–1 month); 63 infants (>1 month–2 years); 63 children (>2 years–12 years); and 66 adolescents (>12 years–21 years) were used in the study. The results of the proposed reference intervals overlapped the 95% confidence intervals (lower and upper limit) of the pediatric datasets and were determined to be acceptable.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.