(300 days)
Not Found
Yes
The device description explicitly mentions "adaptive cluster analysis" as a method used for particle characterization and identification, which is a form of machine learning.
No
The device is an in vitro diagnostic (IVD) device used for screening patient populations by classifying and enumerating hematology parameters, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use."
No
The device description clearly outlines hardware components including a "Main Unit" and a "Pneumatic Unit" which perform physical functions like aspiration, dilution, mixing, and analysis using methods like electrical impedance and laser light scattering. While it includes software for operation and data processing, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%4, MONO%#, EO%#, BASO%#, IG%#, RDW-CV, RDW-SD, MPV, RET%#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, PMN%#, and TC-BF# parameters in cerebrospinal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDT A anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
The performance of this device has not been established in pediatric patients under the age of 2 years.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and bodyfluid parameters by means of electrical impedance, laser light scattering, and fluorescentlabeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS- hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.
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
The performance of this device has not been established in pediatric patients under the age of 2 years.
Intended User / Care Setting
clinical 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)
Clinical testing was conducted on the XN-L analyzer to show equivalent performance to the XN-Series analyzers. Testing included:
- Whole Blood Analysis
- Accuracy Evaluation
- Precision Evaluation: Reproducibility
- Precision Evaluation: Repeatability
- Linearity Evaluation
- Carryover Evaluation
- Stability Evaluation
- Verification of Reference Intervals
- Limits of Blank, Detection, and Quantitation
- Body Fluid Analysis
- Accuracy Evaluation
- Precision Evaluation: Reproducibility
- Precision Evaluation: Repeatability
- Linearity Evaluation
- Carryover Evaluation
- Stability Evaluation
- Limits of Blank, Detection, and Quantitation
Evaluation of the performance characteristics establishes that the performance, functionality, and reliability of the XN-L analyzer are substantially equivalent to the predicate device. The evaluation included accuracy, precision, linearity, carryover, stability, and Limits of Blank, Detection and Quantitation on whole blood and body fluid and verification of reference intervals on whole blood.
The XN-L Automated Hematology analyzer and its predicate device, XN-Series modules (XN-10, XN-20) Automated Hematology analyzers (K112605), have similar Indications for Use, fundamental technology, principles of operation, and comparable performance characteristics. The modifications consist of a smaller analyzer with a slower throughput and smaller sample aspiration volumes.
Performance, verification, and validation testing were conducted to characterize the performance of the XN-L analyzer and the predetermined acceptance criteria were met. Results of this testing have documented that the XN-L analyzer is substantially equivalent to the XN-Series analyzers and is suitable for the labeled indication for use.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Sysmex America, Inc. Ms. Sharita Brooks Sr. Manager, Regulatory Affairs 577 Aptakistic Road Lincolnshire, IL 60069
Re: K160538
Trade/Device Name: Sysmex® XN-L Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: December 12, 2016 Received: December 13, 2016
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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical 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.
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160538
Device Name
Sysmex ® XN-L Automated Hematology Analyzer
Indications for Use (Describe)
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%4, MONO%#, EO%#, BASO%#, IG%#, RDW-CV, RDW-SD, MPV, RET%#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, PMN%#, and TC-BF# parameters in cerebrospinal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDT A anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
The performance of this device has not been established in pediatric patients under the age of 2 years.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Sysmex. The logo features a stylized graphic element in shades of blue and green, resembling a wave or abstract shape. To the right of the graphic is the word "sysmex" in a bold, sans-serif font, colored in a matching shade of blue.
5. 510(K) SUMMARY
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: K160538
Submitter's name, address, telephone number, a contact person, and date the summary was prepared:
| Submitter's Name: | Sysmex America, Inc. |
|---|---|
| Submitter's Address: | 577 Aptakistic Road |
| Lincolnshire, IL 60069 | |
| Submitter's Telephone: | (224) 543-9618 |
| Submitter's FAX: | (224) 543-9699 |
| Submitter's Contact: | Sharita Brooks |
| Date 510(k) Summary Prepared: | February 25, 2016 |
Name of the device, including the trade or proprietary name, the common or usual name, and the classification name:
| Proprietary Name: | Sysmex® XN-L Automated Hematology Analyzer |
|---|---|
| Common Name: | Automated Hematology Analyzer |
| Regulation Description: | Automated Differential Cell Counter |
| Regulation Section: | 21 CFR 864.5220 |
| Device Class: | 2 |
| Product Code: | GKZ |
Related Items:
Product Code: 81GIF
CELLPACK®DCL (Diluent) CELLPACK® DST (Diluent) CELLPACK®DFL (Diluent)
Product Code: 81KJK
Fluorocell" WDF (Dye) Fluorocell™ RET (Dye)
Product Code: 81JPK
XN CHECK™ (Control) XN CHECK™ BF (Control) XN-L CHECK™ (Control)
Product Code: 81GGK
SULFOLYSER® (Lyse) Lysercell™ WDF (Lyse)
Product Code: 81KSA
XN CAL™ (Calibrator)
Product Code: 81JCB
CELLCLEAN™ AUTO
Predicate Device and 510(k) number: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605
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Image /page/4/Picture/0 description: The image contains the Sysmex logo. The logo features an abstract graphic in shades of blue and green, resembling a stylized wave or ribbon. To the right of the graphic, the word "sysmex" is written in lowercase, using a bold, sans-serif font and a blue color that matches the graphic.
Description of the Device:
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and bodyfluid parameters by means of electrical impedance, laser light scattering, and fluorescentlabeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS- hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.
Statement of Intended Use:
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#. MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
The performance of this device has not been established in pediatric patients under the age of 2 years.
Summary of Substantial Equivalence:
Table 5-1 compares the Sysmex XN-L Automated Hematology analyzer with the XN-Series (XN-10, XN-20) Automated Hematologyanalyzer.
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Image /page/5/Picture/0 description: The image shows the Sysmex logo. The logo features a stylized graphic element in shades of blue and green, resembling a wave or abstract shape. To the right of the graphic is the word "sysmex" in lowercase, using a bold, sans-serif font and a blue color that matches the graphic element.
Table 5-1: Comparison of the Predicate XN-10 and the Proposed XN-L Automated Hematology Analyzers
| Item | Predicate Analyzer
XN-Series (XN-10)a
K112605 | Proposed Analyzer
XN-L |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The XN-Series modules (XN-10, XN-20)
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. | The Sysmex® XN-L analyzer is a
quantitative multi-parameter automated
hematology analyzer intended for in vitro
diagnostic use in screening patient
populations found in clinical laboratories.
The XN-L analyzer classifies and
enumerates the following parameters in
venous and capillary whole blood: WBC,
RBC, HGB, HCT, MCV, MCH, MCHC,
PLT, NEUT%/#, LYMPH%/#, MONO%/
#, EO%/#, BASO%/#, IG%/#, RDW-CV,
RDW-SD, MPV, RET%/#, IRF, RET-He
and has a Body Fluid mode for body
fluids. The Body Fluid mode enumerates
the WBC-BF, RBC-BF, MN%/#, PMN%/
#, and TC-BF# parameters in CSF,
peritoneal, pleural and synovial fluids.
Whole blood should be collected in K2 or
K3 EDTA anticoagulant and peritoneal,
pleural and synovial fluids in K2EDTA
anticoagulant to prevent clotting of fluid.
The use of anticoagulants with CSF
specimens is neither required nor
recommended.
The performance of this device has not
been established in pediatric patients
under the age of 2 years. |
| Specimen
Type | Whole Blood and Body Fluids (CSF and
Peritoneal, Pleural, Synovial Fluids) | 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%/#,
MONO%/#, EO%/#, BASO%/#, RDW-
CV, RDW-SD, MPV, RET%/#, IRF,
IG%/#, RET-He#
Body Fluid Mode:
WBC-BF, RBC-BF, MN%/#, PMN%/#,
TC-BF# | SAME |
| | Predicate Analyzer
XN-Series (XN-10)a
K112605 | Proposed Analyzer
XN-L |
| Item | | |
| Reagents | K112605
CELLPACK® DCL (Diluent)
CELLPACK® DFL (Diluent)
Lysercell™ WDF (Lyse)
Fluorocell™ WDF (Stain)
Fluorocell™ RET (Stain)
SULFOLYSER® (Lyse) | SAME |
| Analysis
Modes | Sampler Analysis Mode
(rack autoloader)
Whole Blood Mode
Manual Analysis Mode
Whole Blood Mode
LWBC Analysis Mode
Pre-Dilute Analysis Mode
Body Fluid Mode | SAME |
| Sample
Aspiration/
Fluidic
Pathway | Single Pathway | SAME |
| Measuring
Channels | RBC/PLT, HGB, RET, WDF | SAME |
| Controls/
Calibrators/
Linearity
Material | Whole Blood
XN CHECK™ 3 Levels (K120742)
XN CAL™ (K120745)
Body Fluid
XN CHECK™ BF 2 Levels (K120744)
Whole Blood Linearity
Range Check X III (K960557)
Retic Chex (K000115) | SAME |
| Cleaning
Detergent | CELLCLEAN AUTO™ | SAME |
| Software/
Hardware | Rules based rerun/reflex | SAME |
| Differences | | |
| Parameters | PLT (PLT-F), NRBC%/#, IPF | Not Available |
| Reagents | K112605
Lysercell™ WNR (Lyse)
Fluorocell™ WNR (Stain)
Fluorocell™ PLT (Stain) | Not Available
Not Available
Not Available |
| Measuring
Channels | WNR, PLT-F | Not Available |
| Item | Predicate Analyzer
XN-Series (XN-10)a
K112605 | Proposed Analyzer
XN-L |
| Controls/
Calibrators | XN CAL™ PF – (K120747) | Not Available |
| | Not Available | XN-L CHECK™ b |
| Throughput | Whole Blood Mode
100 samples/hour maximum depending
on mode used. | Whole Blood Mode
60 samples/hour maximum depending on
mode used. |
| | Body Fluid Mode | Body Fluid Mode |
| | 40 samples/hour maximum | 30 samples/hour maximum |
| Sample
Aspiration
Volumes | Sampler Mode - 88 μL | Sampler Mode - 25 μL |
| | Manual (Closed Cap) Mode - 88 μL | Manual (Closed Cap) Mode - 25 μL |
| | Manual (Open Cap) Mode - 88 μL | Manual (Open Cap) Mode - 25 μL |
| | Dilution Mode - 70 μL | Dilution Mode - 70 μL |
| | Body Fluid Mode - 88 μL | Body Fluid Mode - 70 μL |
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Image /page/6/Picture/0 description: The image shows the Sysmex logo. The logo features a stylized graphic element in shades of blue and green, resembling a wave or a flowing ribbon. To the right of the graphic is the word "sysmex" in a sans-serif font, with the letters in a dark blue color.
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Image /page/7/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element above the word "sysmex". The graphic element is a combination of blue and green shapes, with the blue shapes resembling waves and the green shape resembling a mountain. The word "sysmex" is written in blue, sans-serif font.
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Image /page/8/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in shades of blue and green, resembling a wave or a stylized leaf. To the right of the graphic is the word "sysmex" in lowercase, using a sans-serif font and a blue color that matches the graphic element.
8 Intended use for the predicate analyzer was cleared in submission K112605. All information listed for the predicate analyzer refers to the XN-10 module.
b Control material specific for the XN-L analyzer.
The XN-L analyzer's Indications for Use statement is similar to the predicate device with minor variation. The XN-L analyzer also has similar technological characteristics as the predicate device with minor variation. Both devices measure similar parameters and utilize most of the same reagents, controls, calibrators, and cleaning detergent. The datacollection software functionality, communication method with data management software functionality, monitor software, connectivity, and communication are similar to the predicate device with minor variation.
The XN-L analyzer differs from the predicate with a slower throughput and smaller sample aspiration volumes, fewer measuring channels, and fewer parameters measured, it is very similar in all other electronic and technological characteristics related to automated hematology measurements of the predicate device to assure equivalence. In addition. XN-L CHECK™is a control material which is specific for the XN-L analyzer. The XN-LCHECK™ or the XN CHECK™ may be used with the XN-L analyzer. Performance data are provided to support this. The results of all performance testing demonstrate substantial equivalence.
Summary of Performance Testing:
Clinical testing was conducted on the XN-L analyzer to show equivalent performance to the XN-Series analyzers. Testing included:
- . Whole Blood Analysis
- o Accuracy Evaluation
- Precision Evaluation: Reproducibility o
- o Precision Evaluation: Repeatability
- o Linearity Evaluation
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Image /page/9/Picture/0 description: The image contains the Sysmex logo. The logo features a stylized graphic element in shades of blue and green, resembling a wave or a leaf. To the right of the graphic is the word "sysmex" in a sans-serif font, with the letters in a blue color that matches the graphic element.
- Carryover Evaluation O
- Stability Evaluation O
- Verification of Reference Intervals O
- o Limits of Blank, Detection, and Quantitation
- Body Fluid Analysis
- o Accuracy Evaluation
- Precision Evaluation: Reproducibility O
- o Precision Evaluation: Repeatability
- o Linearity Evaluation
- o Carryover Evaluation
- o Stability Evaluation
- o Limits of Blank, Detection, and Quantitation
Evaluation of the performance characteristics establishes that the performance, functionality, and reliability of the XN-L analyzer are substantially equivalent to the predicate device. The evaluation included accuracy, precision, linearity, carryover, stability, and Limits of Blank, Detection and Quantitation on whole blood and body fluid and verification of reference intervals on whole blood.
Conclusions:
The XN-L Automated Hematology analyzer and its predicate device, XN-Series modules (XN-10, XN-20) Automated Hematology analyzers (K112605), have similar Indications for Use, fundamental technology, principles of operation, and comparable performance characteristics. The modifications consist of a smaller analyzer with a slower throughput and smaller sample aspiration volumes.
Performance, verification, and validation testing were conducted to characterize the performance of the XN-L analyzer and the predetermined acceptance criteria were met. Results of this testing have documented that the XN-L analyzer is substantially equivalent to the XN-Series analyzers and is suitable for the labeled indication for use. The XN-L analyzer and the predicate device do not raise any questions regarding safety and effectiveness.