(143 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the technology focuses on traditional methods like electrical impedance, laser light scattering, and fluorescent labeling with "adaptive cluster analysis," which is not necessarily AI/ML.
No.
The device is an in vitro diagnostic hematology analyzer used for screening and enumerating blood and body fluid parameters, not for treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Sysmex XN-L analyzer is "intended for in vitro diagnostic use."
No
The device description clearly outlines hardware components like the "Main Unit" and "Pneumatic Unit" which perform physical actions like aspirating, diluting, mixing, and analyzing samples using methods like electrical impedance and laser light scattering. This indicates it is a hardware device with integrated software, not a software-only device.
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."
This statement clearly indicates that the device is designed to be used outside of the body to examine specimens (like blood and body fluids) for diagnostic purposes.
N/A
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 venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%#, MON0%#, EO%#, 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, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
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 body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. 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
Not Found. However, the submission includes a "Proposing removal of the limitation to pediatric patients under the age of 2 years from our current intended use." And "Real World Data had been collected for additional samples that included the pediatric population for patients less than 2 years of age."
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. Real World Data had been collected for additional samples that included the pediatric population for patients less than 2 years of age.
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. This information can be found in K160538.
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 25, 2019
Sysmex America, Inc. Sharita Brooks Sr. Manager, Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069
Re: K182389
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: August 31, 2018 Received: September 4, 2018
Dear Sharita 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Leonthena R. Carrington -S
Lea Carrington 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) K182389
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 venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%#, MON0%#, EO%#, 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, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
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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Image /page/3/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 abstract shape. 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.
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:________________________________________________________________________________________________________________________________________________
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: |
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 CALTM (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 shows the Sysmex logo. The logo consists of a stylized graphic element in blue and green, resembling a wave or abstract shape. To the right of the graphic is the word "sysmex" in lowercase, using a sans-serif font and colored in blue.
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 body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. 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%/#, 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.
Proposing removal of the limitation to pediatric patients under the age of 2 years from our current intended use.
Summary of Substantial Equivalence:
Table 5-1 compares the Sysmex XN-L Automated Hematology analyzer with the XN-Series (XN-10, XN-20) Automated Hematology analyzer.
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Image /page/5/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in shades of blue and green, resembling waves or abstract shapes. To the right of the graphic is the word "sysmex" in a sans-serif font, colored in blue. The logo appears to be clean and modern in design.
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. | | |
| | 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 |
| | | | Item | Predicate Analyzer
XN-Series (XN-10)a
K112605 |
| | Reagents | | K112605 | SAME |
| | | | CELLPACK® DCL (Diluent) | |
| | | | CELLPACK® DFL (Diluent) | |
| | | | Lysercell™ WDF (Lyse) | |
| Fluorocell™ WDF (Stain) | | | | |
| Fluorocell™ RET (Stain)
SULFOLYSER® (Lyse) | | | | |
| Analysis
Modes | Sampler Analysis Mode
(rack autoloader)
Whole Blood Mode | SAME | | |
| | Manual Analysis Mode | | | |
| | Whole Blood Mode
LWBC Analysis Mode
Pre-Dilute Analysis Mode
Body Fluid Mode | | | |
| | | | | |
| 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 (K160590)
XN CAL™ (K160585) | SAME | | |
| | Body Fluid | | | |
| | XN CHECK™ BF 2 Levels (K160588) | | | |
| | Whole Blood Linearity | | | |
| | Range Check X III (K960557)
Retic Chex (K000115) | | | |
| Cleaning
Detergent | CELLCLEAN AUTO™ | SAME | | |
| Software/
Hardware | Rules based rerun/reflex | SAME | | |
| Differences | | | | |
| Parameters | PLT (PLT-F), NRBC%/#, IPF | Not Available | | |
| Reagents | K112605 | Not Available | | |
| | Lysercell™ WNR (Lyse) | | | |
| | Fluorocell™ WNR (Stain)
Fluorocell™ PLT (Stain) | | | |
| 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 | Whole Blood Mode | | |
| | 100 samples/hour maximum depending
on mode used. | 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 consists of 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 dark blue.
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a Intended use for the predicate analyzer was cleared in submission K112605. All information listed for the predicate analyzer refers to the XN-10 module.
6 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 data collection 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-L CHECK™ 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: See K160538
- . Whole Blood Analysis
- o Accuracy Evaluation
- Precision Evaluation: Reproducibility o
- o Precision Evaluation: Repeatability
- o Linearity Evaluation
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Image /page/8/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element above the word "sysmex" in lowercase letters. The graphic element is composed of blue and green shapes, possibly representing waves or abstract forms. The word "sysmex" is written in a blue sans-serif font.
- Carryover Evaluation O
- Stability Evaluation O
- Verification of Reference Intervals O
- Limits of Blank, Detection, and Quantitation o
- Body Fluid Analysis
- Accuracy Evaluation o
- Precision Evaluation: Reproducibility O
- Precision Evaluation: Repeatability о
- Linearity Evaluation O
- Carryover Evaluation о
- Stability Evaluation o
- o Limits of Blank, Detection, and Ouantitation
Evaluation of the performance characteristics establishes that the performance, functionality, and reliability of the XN-L analyzer are substantially equivalent to the predicate device. Real World Data had been collected for additional samples that included the pediatric population for patients less than 2 years of age.
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. This information can be found in K160538.