(165 days)
Not Found
No
The document describes standard hematology analysis methods (Sheath Flow DC Detection, Flow Cytometry, adaptive cluster analysis) and does not mention AI or ML.
No
This device is an in vitro diagnostic (IVD) device used for screening patient populations by classifying and enumerating various parameters in whole blood and body fluids. It is not designed to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use."
No
The device description explicitly details multiple hardware components including Main Units, Auto Sampler Units, an IPU (Information Processing Unit), and a Pneumatic Unit, all of which are integral to the device's function of aspirating, diluting, mixing, and analyzing samples.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories."
N/A
Intended Use / Indications for Use
The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories.
The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%#, MONO%#, E0%#, BASO%#, IG%#, 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%#, and TC-BF parameters in body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The Sysmex® XN-Series modules (XN-11, XN-21) are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K2 or K3EDTA anticoagulant and body fluids (pleural, peritoneal and synovial) collected in K2 anticoagulant. The XN-Series modules (XN-11, XN-21) are part of the family of XN-Series devices (K112605) cleared Oct 19, 2012 with modifications to stabilize the HCT/MCV parameters to within +8% at room temperature (18-26°C) for 24 hours and refrigerated temperature (2-8°C) for 48 hours for commercial and reference laboratories. The difference between the XN-11 and XN-21 is the presence of the WPC Channel in the XN-21.
The instrument consists of four principal units: (1) Two Main Units (XN-11, XN-21) which aspirate, dilute, mix, and analyze blood and body fluid samples; (2) Two Auto Sampler Units (SA-10 for a single module, or SA-20 for two modules) 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. The XN-Series analyzers perform analysis using the following methods: Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. The XN-Series analyzers automatically classify cells from whole blood and body fluids and carry out all processes automatically from aspiration of the sample to outputting the results.
The body fluid analysis mode of the XN-Series analyzers uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, Total Count (TC-BF) & RBC (RBC-BF) counts found in the body fluid.
Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical and reference laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were performed to evaluate the equivalency of the XN-Series Automated Hematology analyzers (Modules XN-11, XN-21) to the XE-5000 Automated Hematology analyzer. Results indicated equivalent performance.
Data consisting of Accuracy, Precision, Linearity and Carryover were collected to show performance to the manufacturer's specification for the Whole Blood and Body Fluid mode. This analysis supports the claim that the XN-Series analyzers are substantially equivalent to the XE-5000.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized design of three human profiles facing right, with a wing-like shape above them, symbolizing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
Sysmex America, Inc. c/o Ms. Sharita Brooks Manager Clinical Affairs 577 Aptakisic Road Lincolnshire, IL. 60069
Re: K141681
Trade/Device Name: Sysmex® XN-Series (XN-11, XN-21) Automated Hematology Analyzers Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: October 30, 2014 Received: October 31, 2014
Dear Ms. Brooks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141681
Device Name
XN-Series (XN-11, XN-21) Automated Hematology Analyzers
Indications for Use (Describe)
The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories.
The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%#, MONO%#, E0%#, BASO%#, IG%#, 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%#, and TC-BF parameters in body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
005 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. .
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| 1. Submitted by: | Sysmex America, Inc.
577 Aptakisic Road
Lincolnshire, IL. 60069
Phone: (224) 543-9618; FAX: (224) 543-4699
Contact person: Sharita Brooks
Date prepared: June 19, 2014 | |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XN-Series (XN-11, XN-21)
Common name: Automated Hematology Analyzer
Classification name: Automated Differential Cell Counter 21 CFR 864.5220 is a
Class II device. Product Code: GKZ
Related Items: | |
| | Product Code: 81 GIF
CELLPACK® DCL (Diluent) – K112605
CELLPACKTM DFL (Diluent) – K112065
CELLSHEATH(C)TM (Diluent) – K051459 | |
| | Product Code: 81 GGK
LysercellTM WNR (Lyse) – K112605
LysercellTM WDF (Lyse) – K112605
LysercellTM WPC (Lyse) – K112605 | |
| | Product Code: 81 KJK
FluorocellTM WNR (Stain) – K112605
FluorocellTM WDF (Stain) – K112605
FluorocellTM RET (Stain) – K112065
FluorocellTM PLT (Stain) – K112605
FluorocellTM WPC (Stain) – K112605 | |
| | Product Code: 81 KSA
XN CAL (Calibrator) - K120745
XN CAL PF (Calibrator) - K120747 | |
| | Product Code: 81 JPK
XN CHECK (Control) – K120742
XN CHECK BF (Control) – K120744 | |
| | Analyzer Components
SA-10 (Auto Sampler for single module)
SA-20 (Auto Sampler for two modules)
IPU (Information Processing Unit) | |
| 3. Predicate Device: | Sysmex® XE-5000Automated Hematology Analyzer | |
| 4. Device Description: | The Sysmex® XN-Series modules (XN-11, XN-21) are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K2 or K3EDTA anticoagulant and body fluids (pleural, peritoneal and synovial) collected in K2 anticoagulant. The XN-Series modules (XN-11, XN-21) are part of the family of XN-Series devices (K112605) cleared Oct 19, 2012 with modifications to stabilize the HCT/MCV parameters to within +8% at room temperature (18-26°C) for 24 hours and refrigerated temperature (2-8°C) for 48 hours for commercial and reference laboratories. The difference between the XN-11 and XN-21 is the presence of the WPC Channel in the XN-21.
The instrument consists of four principal units: (1) Two Main Units (XN-11, XN-21) which aspirate, dilute, mix, and analyze blood and body fluid samples; (2) Two Auto Sampler Units (SA-10 for a single module, or SA-20 for two modules) 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. The XN-Series analyzers perform analysis using the following methods: Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. The XN-Series analyzers automatically classify cells from whole blood and body fluids and carry out all processes automatically from aspiration of the sample to outputting the results.
The body fluid analysis mode of the XN-Series analyzers uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, Total Count (TC-BF) & RBC (RBC-BF) counts found in the body fluid.
Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer. | |
| 5. Intended Use: | The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference 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 body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. | |
| 6. Substantial equivalence-similarities and differences | The following table compares the XN-Series modules (XN-11, XN-21) Automated Hematology analyzers with the XE-5000 Automated Hematology analyzer. | |
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of the XN-Series Automated Hematology analyzers (Modules XN-11, XN-21) to the XE-5000 Automated Hematology analyzer. Results indicated equivalent performance. | |
| Item | Predicate XE-5000
(K071967)
20-Nov-07 | Device XN-Series
(XN-11, XN-21) |
| Intended Use | Sysmex® XE-5000 is an automated
hematology analyzer for in vitro
diagnostic use in screening patient
populations found in clinical
laboratories. The XE-5000 classifies
and enumerates the same parameters as
the XE-2100 using whole blood as
described below, cord blood for HPC
and has a body fluid mode for body
fluids. The Body Fluid mode analyzes
WBC-BF, RBC-BF, MN%/#, PMN%/#
and TC-BF in body fluids
(cerebrospinal fluids (CSF), serous
fluids, and synovial fluids with EDTA,
as needed).
WBC, RBC, HGB, HCT, MCV, MCH,
MCHC, PLT, NEUT% / #, LYMPH% /
#, ΜΟΝΟ% / #, EO% / #, BASO% / #,
NRBC% / #, RDW-SD, RDW-CV,
MPV, RET% / #, IRF, IG% / #,
RET-He, IPF, HPC WBC-BF,
RBC-BF, MN% / #, PMN%/ #,
TC-BF#. | The XN-Series modules (XN-11, XN-21)
are quantitative multi-parameter automated
hematology analyzers intended for in vitro
diagnostic use in screening patient
populations found in clinical and reference
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 body fluids (peritoneal, pleural and
synovial). Whole blood should be
collected in K2 or K3EDTA anticoagulant
and peritoneal, pleural and synovial fluids
in K₂EDTA anticoagulant to prevent
clotting of fluid. |
| Equivalency Data | Proven performance in FDA
submission | Data consisting of Accuracy, Precision,
Linearity and Carryover were collected to
show performance to the manufacturer's
specification for the Whole Blood and
Body Fluid mode. This analysis supports
the claim that the XN-Series analyzers are
substantially equivalent to the XE-5000. |
| Similarities | | |
| Specimen Type | Whole Blood and Body Fluids (Serous,
Synovial) | SAME |
| Test Principle | Performs hematology analyses
according to the Hydro Dynamic
Focusing (DC Detection), flow
cytometry method (using a
semiconductor laser), and SLS-
hemoglobin method. | SAME |
| Parameters | Whole Blood Mode:
WBC, RBC, HGB, HCT, MCV, MCH,
MCHC, PLT, NEUT%/#, LYMPH%/#,
ΜΟΝΟ%/#, ΕO%/#, BASO%/#,
NRBC%/#, RDW-CV, RDW-SD,
MPV, RET%/#, IRF, IG%/#, RET-He,
IPF.
Body Fluid Mode:
WBC-BF, RBC-BF, MN%/#,
PMN%/#, TC-BF# | SAME |
| | | |
| Reagents | SULFOLYSER (Lyse) | SAME |
| | Sampler Analysis Mode | |
| Modes of Operation | Manual Closed Analysis Mode | SAME |
| | Body Fluid Analysis Mode | |
| Measuring Channels | RBC/PLT
RET | SAME |
| | Differences | |
| Item | Predicate XE-5000
(K071967)
20-Nov-07 | Device XN-Series
(XN-11, XN-21) |
| Specimen type | Body Fluid - CSF
Umbilical Cord Blood | Not Available |
| Test Principal | RF/DC detection method | Not Available |
| Controls & Calibrators | Whole Blood
e-Check (XE) – 3 Levels
X CAL (XE Calibrator)
Not Available | Whole Blood
XN CHECK - 3 Levels
XN CAL (XN-Series Calibrator)
XN CAL PF (Platelet F Calibrator) |
| | | |
| | Body Fluid
Not Available | Body Fluid
XN CHECK BF - 2 Levels |
| IPU | Single Module connect | Multi-Module connect |
| Modes of Operation | Manual Open Cap Analysis Mode
(Operator presents sample to aspiration
needle) | Manual Open Cap Analysis Mode
(Sample placed in tube holder position) |
| | Capillary Analysis Mode
Dilute sample 1:5 | Pre-dilute Analysis Mode
Dilute sample 1:7 |
| | | |
| | Not Available
HPC | Low WBC Mode (LWBC)
Not Available |
| Parameters | | |
| Sample Aspiration
/Fluidic Pathway | Two pathways | Single pathway |
| Software/Hardware | Not Available | Rules-based rerun/reflex |
| Throughput | Whole Blood
Approximately 113-150 depending on
mode used. | Whole Blood
100 samples/hour maximum
depending on mode used. |
| | | |
| | Body Fluid
38 samples/hour | Body Fluid
40 samples/hour maximum |
| Measuring Channels (see
Section 11 for detailed
information on these
channels) | WBC/BASO, DIFF, NRBC
IMI | WNR, WDF
WPC (Not available on XN-11) |
| | Not Available | PLT-F |
| Reagents | CELLPACK® (Diluent)
CELLSHEATH™ (Diluent)
NOT AVAILABLE
STROMATOLYSER™-FB (Lyse)
STROMATOLYSER™-4DL (Lyse)
STROMATOLYSER™-4DS (Stain)
STROMATOLYSER™-NR (Diluent)
STROMATOLYSER™-NR (Stain)
RET-SEARCH II (Diluent)
RET-SEARCH II (Stain)
STROMATOLYSER™- IM (Lyse) | CELLPACK® DCL (Diluent)
CELLPACK™ DFL (Diluent)
CELLSHEATH(C)™ (Diluent)
Lysercell™ WNR (Lyse)
Lysercell™ WDF (Lyse)
Lysercell™ WPC* (Lyse)
Fluorocell™ WNR (Stain)
Fluorocell™ WDF (Stain)
Fluorocell™ RET (Stain)
Fluorocell™ PLT (Stain)
Fluorocell™ WPC* (Stain) |
| | | *Not used on XN-11 module. |
| Sample Aspiration
Volume | Sampler Mode – 200µL
Manual (Closed Cap) Mode - 200µL
Manual (Open Cap) Mode - 130µL
Capillary Mode - 130µL
Body Fluid Mode - 130µL | Sampler Mode - 88µL
Manual (Closed Cap) Mode - 88µL
Manual (Open Cap) Mode - 88µL
Dilution Mode - 70µL
Body Fluid Mode - 88µL |
11,
4
5
Table 1: Substantial Equivalence - Similarities and Differences to the XN-Series Automated Hematology analyzers (Modules XN-11, XN-21) and XE-5000 Automated Hematology analyzer.
Sysmex XN-Series modules (XN-11, XN-21) Automated Hematology Analyzers 510(k) Submission
6
Sysmex XN-Series modules (XN-11, XN-21) Automated Hematology Analyzers 510(k) Submission
7
Sysmex XN-Series modules (XN-11, XN-21) Automated Hematology Analyzers 510(k) Submission