(299 days)
Sysmex pocH-100i™ Automated Hematology Analyzer, Para® Check (K852992)
No
The device description details a traditional electrical resistance and photometric method for blood cell analysis, with no mention of AI or ML techniques for data processing, analysis, or interpretation.
No.
The device is an in vitro diagnostic hematology analyzer used for classifying and enumerating blood parameters, which aids in diagnosis but does not provide therapy or treatment.
Yes
The device is an "in vitro diagnostic point of care" hematology analyzer, which directly implies its purpose is diagnostic, despite stating what it is "not for use in diagnosing." It quantifies various blood parameters, which are used by healthcare professionals to diagnose and monitor medical conditions.
No
The device description clearly details hardware components such as an electrical resistance type blood cell counter, transducer chamber, aperture, electrodes, and a photometric measurement system for hemoglobin. It is a physical analyzer, not solely software.
Yes, the Sysmex XW-100 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "The Sysmex XW-100™ is a quantitative automated hematology analyzer in vitro diagnostic point of care use..." This directly identifies it as an IVD.
- Device Description: The description details how the device analyzes human whole blood specimens to produce results for hematology parameters. This process of analyzing biological samples outside of the body is the core function of an IVD.
- XW QC CHECK: The description of the quality control material, XW QC CHECK, also refers to it as being used with the analyzer and describes its composition as stabilized blood components. Quality control materials for IVD devices are also considered part of the IVD system.
Therefore, based on the provided text, the Sysmex XW-100 clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sysmex XW-100™ is a quantitative automated hematology analyzer in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD. RDW-CV. and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients.
XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV.
Product codes
GKZ, JPK
Device Description
The XW-100 is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 17 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and commonly used CBC indices. The analyzer uses DC with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, measured, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer chamber by means of a hydrodynamic focusing nozzle. The transducer chamber has a minute hole, or aperture. Electrodes are mounted on both sides of the aperture chamber, through which flows the DC. Blood cells suspended in the diluted sample are injected through the aperture by the hydrodynamic focusing nozzle. The hydrodynamic focusing nozzle is positioned in front of the aperture and in line with the aperture's center. This method improves cell counting accuracy because all blood cells are separated from each other and can only pass through the aperture in 1 direction, 1 at a time. When a cell passes through the aperture, it causes a change in the DC resistance that is directly proportional to its size. These resistance changes are captured as electric pulses. The various blood cell counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell volume and identifies rare and pathological cells by creating and analyzing histograms of the various cell populations using their respective pulse heights. Hemoglobin is measured photometrically using a noncyanide methodology, which reduces the presence of hazardous materials in the analyzer waste stream. The quality controls that are used with the XW-100 Automated Hematology Analyzer comprise XW QC CHECK, which contains stabilized red blood cell component(s), stabilized WBC component(s), and stabilized platelet component(s) in a preserving medium. XW QC CHECK components are packaged in glass vials with screw caps containing 2 mL. The vials are packaged in a welled vacuum-formed clamshell container. XW QC CHECK is stored at room temperature (15°C-25°C or 59°F-77°F).
XW QC CHECK is an in vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preserving medium. The product is packaged in glass vials with screw caps containing 2 mL. The vials will be packaged in a welled vacuum-formed clamshell container. The product is stored at (15°C-25°C or 59°F-77°F) subsequent to shipment.
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
It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients.
Intended User / Care Setting
point of care use
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 Sysmex XW-100 in the point-of-care (POC) setting with the Sysmex pocH-100i automated hematology analyzer. Results indicated equivalent performance.
Open-vial stability, closed-vial stability, and precision performance studies were conducted to establish performance of XW QC CHECK; all testing showed that XW QC CHECK met clinical performance acceptability criteria and demonstrated stability for the shelf-life claimed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sysmex pocH-100i™ Automated Hematology Analyzer, Para® Check (K852992)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2015
Sysmex America, Inc. Peter Shearstone VP, RA/QA/Clinical and Medical Affairs 577 Aptakisic Road Lincolnshire, IL 60069
Re: K143577
Trade/Device Name: Sysmex XW-100™, XW QC CHECK Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ, JPK Dated: September 24, 2015 Received: September 28, 2015
Dear Mr. Shearstone:
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
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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,
Leonthena R. Carrington -S
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
Indications for Use
510(k) Number (if known) K143577
Device Name Sysmex XW-100 XW QC CHECK
Indications for Use (Describe)
The Sysmex XW-100™ is a quantitative automated hematology analyzer in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD. RDW-CV. and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients.
XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV.
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 the upper left and the word "sysmex" in blue to the right of the graphic. The graphic element is composed of two overlapping shapes, one in blue and the other in green, creating a sense of movement or flow.
The 510(k) summary for the Sysmex XW-100 Automated Hematology Analyzer instrument is presented in Table 5.1, and the similarities and differences between the Sysmex XW-100 and predicate pocH-100i devices are provided in Table 5.2.
| Table 5.1 | Sysmex XW-100 Automated Hematology Analyzer 510(k) Summary |
|---|---|
| 1. Submitted by | Sysmex America, Inc. |
| 577 Aptakisic Rd | |
| Lincolnshire, IL 60069 | |
| Phone: 224.543.9514 | |
| Fax: 224.543.4699 | |
| Contact person: Peter Shearstone | |
| Date prepared: December 16, 2014 | |
| 2. Name of device | Trade or proprietary name: Sysmex XW-100™ |
| Common name: XW-100 Automated Hematology Analyzer | |
| Classification name: Automated Differential Cell Counter | |
| Regulation number: 21 CFR 864.5220 | |
| Classification: Class 2 | |
| Product Code: GKZ | |
| 3. Predicate device | Sysmex pocH-100i™ Automated Hematology Analyzer |
| 4. Device description | The XW-100 is an electrical resistance type blood cell counter. |
| This technology may be variously referred to as direct current | |
| (DC) or impedance. The analyzer uses a human whole blood | |
| specimen and produces results for 17 hematology parameters, | |
| including the basic complete blood count (CBC), 3 part white | |
| blood cell (WBC) differential, and commonly used CBC indices. | |
| The analyzer uses DC with hydrodynamic focusing for all | |
| parameters except hemoglobin, which is measured | |
| photometrically. The patient sample is aspirated, measured, | |
| diluted with diluent (and Lyse for WBC measurement), then fed | |
| into a transducer chamber by means of a hydrodynamic focusing | |
| nozzle. The transducer chamber has a minute hole, or aperture. | |
| Electrodes are mounted on both sides of the aperture chamber, | |
| through which flows the DC. Blood cells suspended in the | |
| diluted sample are injected through the aperture by the | |
| hydrodynamic focusing nozzle. The hydrodynamic focusing | |
| nozzle is positioned in front of the aperture and in line with the | |
| aperture's center. This method improves cell counting accuracy | |
| because all blood cells are separated from each other and can only | |
| pass through the aperture in 1 direction, 1 at a time. When a cell | |
| passes through the aperture, it causes a change in the DC | |
| resistance that is directly proportional to its size. These resistance | |
| changes are captured as electric pulses. The various blood cell | |
| counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell | |
| Table 5.1 | Sysmex XW-100 Automated Hematology Analyzer 510(k) Summary |
| volume and identifies rare and pathological cells by creating and | |
| analyzing histograms of the various cell populations using their | |
| respective pulse heights. Hemoglobin is measured | |
| photometrically using a noncyanide methodology, which reduces | |
| the presence of hazardous materials in the analyzer waste stream. | |
| The quality controls that are used with the XW-100 Automated | |
| Hematology Analyzer comprise XW QC CHECK, which contains | |
| stabilized red blood cell component(s), stabilized WBC | |
| component(s), and stabilized platelet component(s) in a | |
| preserving medium. XW QC CHECK components are packaged | |
| in glass vials with screw caps containing 2 mL. The vials are | |
| packaged in a welled vacuum-formed clamshell container. | |
| XW QC CHECK is stored at room temperature (15°C-25°C or | |
| 59°F-77°F). | |
| 5. Substantial equivalence- | |
| similarities and differences | Table 5.2 compares the Sysmex XW-100 with the |
| Sysmex pocH-100i automated hematology | |
| 6. Clinical performance data | Studies were performed to evaluate the equivalency of the |
| Sysmex XW-100 in the point-of-care (POC) setting with the | |
| Sysmex pocH-100i automated hematology analyzer. Results | |
| indicated equivalent performance. | |
| Open-vial stability, closed-vial stability, and precision | |
| performance studies were conducted to establish performance of | |
| XW QC CHECK; all testing showed that XW QC CHECK met | |
| clinical performance acceptability criteria and demonstrated | |
| stability for the shelf-life claimed. | |
| 7. Conclusions | The performance data demonstrated substantial equivalence to the |
| predicate device. |
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Image /page/4/Picture/0 description: The image contains the logo for Sysmex. The logo features a stylized wave-like graphic in shades of blue and green above the company name. The company name "sysmex" is written in lowercase, bold, blue letters.
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Image /page/5/Picture/2 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in the upper left and the word "sysmex" in blue, sans-serif font to the right of the graphic. The graphic element is composed of two shapes, one in blue and one in green, that appear to be intertwined or overlapping.
Sysmex XW QC CHECK
The 510(k) summary for the control material, XW QC CHECK, is presented in Table 5.3, and the similarities and differences between the XW-QC CHECK and predicate Para Check control material are provided in Table 5.4.
| Table 5.3 | XW QC CHECK |
|---|---|
| 1. Submitted by | Sysmex America, Inc. |
| 577 Aptakisic Rd | |
| Lincolnshire, IL 60069 | |
| Telephone: 224.543.9514 | |
| Fax: 224.543.4699 | |
| Contact person: Peter Shearstone | |
| Date prepared: December 16, 2014 | |
| 2. Name of device | Trade or proprietary name: XW QC CHECK |
| Common Name: XW Quality Controls | |
| Classification Name: Hematology quality control mixture | |
| (864.8625) | |
| Product Code: JPK | |
| 3. Predicate device | Para® Check (K852992) |
| 4. Device description | XW QC CHECK is an in vitro diagnostic product that contains |
| the following: stabilized red blood cell component(s), stabilized | |
| white blood cell component(s), and stabilized platelet | |
| component(s) in a preserving medium. The product is packaged | |
| in glass vials with screw caps containing 2 mL. The vials will be | |
| packaged in a welled vacuum-formed clamshell container. The | |
| product is stored at (15°C-25°C or 59°F-77°F) subsequent to | |
| shipment. | |
| 5. Substantial equivalence- | |
| similarities and differences | Table 5.4 compares XW QC CHECK with the Para® Check. |
| 6. Clinical performance data | Open-vial stability, closed-vial stability, and precision |
| performance studies were conducted to establish performance of | |
| XW QC CHECK. All testing showed that XW QC CHECK met | |
| clinical performance acceptability criteria and demonstrated | |
| stability for the shelf-life claimed. | |
| 7. Conclusions | The performance data demonstrated substantial equivalence to the |
| predicate device |