(68 days)
No
The device description details a traditional impedance-based cell counting method and photometric hemoglobin measurement, with no mention of AI or ML techniques for analysis or classification.
No
The device is an in vitro diagnostic (IVD) device used to classify and enumerate blood parameters for diagnostic purposes, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states: "The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use..."
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 that processes blood samples.
Yes, the XW-100 Automated Hematology Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use Statement: The very first sentence of the "Intended Use / Indications for Use" section explicitly states: "The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use..." This is the most direct confirmation.
- Nature of the Device: The device analyzes human whole blood specimens to classify and enumerate various blood parameters. This process is performed in vitro (outside of the living body) on biological samples to provide information for diagnostic purposes.
- Parameters Measured: The parameters measured (WBC, RBC, HGB, HCT, MCV, PLT, etc.) are standard hematological values used in the diagnosis and monitoring of various medical conditions.
- Use of Quality Controls: The description mentions the use of "quality controls that are used with the XW-100 CLIA Waived Automated Hematology Analyzer comprise XW QC CHECK". Quality controls are a standard component of IVD testing to ensure the accuracy and reliability of the results.
Therefore, based on the provided text, the XW-100 Automated Hematology Analyzer clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The XW-100 Automated Hematology Analyzer 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 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV.
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 CLIA Waived 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).
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 patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.
Intended User / Care Setting
Not Found
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)
Please reference K143577 for clinical performance data and CW170004 for clinical field data and flex studies. The performance data demonstrated substantial equivalence to the predicate device.
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.
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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November 6, 2017
Sysmex America, Inc. Michelle Abraham Manager. Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069
Re: K172604
Trade/Device Name: XW-100 Automated Hematology Analyzer for CLIA Waived Use Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 28, 2017 Received: August 30, 2017
Dear Michelle Abraham:
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 and Part 809); medical device 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
1
Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) K172604
Device Name
XW-100 Automated Hematology Analyzer
Indications for Use (Describe)
The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.
| 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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The 510(k) summary for the Sysmex XW-100 CLIA Waived Automated Hematology Analyzer instrument is presented in Table 1.0, and the similarities and differences between the Sysmex XW-100 Automated Hematology Analyzer for CLIA Waived use and predicate XW-100 Point of Care devices are provided in Table 2.0.
| Table 1.0 Sysmex XW-100 Automated Hematology Analyzer 510(k) Summary | |
|---|---|
| 1. Submitted by | Sysmex America, Inc. |
| 577 Aptakisic Rd | |
| Lincolnshire, IL 60069 | |
| Phone: 224.543.9639 | |
| Fax: 224.543.4699 | |
| Contact person: Michelle Abraham | |
| Date prepared: August 28, 2017 | |
| 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 XW-100 Automated Hematology Analyzer for Point of |
| Care Use | |
| 4. Device description | The XW-100 Automated Hematology Analyzer 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 12 hematology parameters, including the basic | |
| complete blood count (CBC), 3 part white blood cell (WBC) | |
| differential, and MCV. | |
| 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 1.0 Sysmex XW-100 Automated Hematology Analyzer Use 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 CLIA | |
| Waived 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). | |
| 5. Substantial equivalence- | |
| similarities and differences | Table 2.0 compares the Sysmex XW-100 Automated |
| Hematology Analyzer for CLIA Waived Use with the | |
| Sysmex XW-100 Automated Hematology Analyzer | |
| for Point of Care Use. | |
| 6. Clinical performance data | Please reference K143577 for clinical performance data and |
| CW170004 for clinical field data and flex studies. | |
| 7. Conclusions | The performance data demonstrated substantial equivalence to the |
| predicate device. |
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5
| Table 2.0 Similarities and Differences Table | ||
|---|---|---|
| Item | Device | Predicate |
| (K143577) | ||
| Intended Use | The XW-100 Automated Hematology | |
| Analyzer (XW-100) is a quantitative | ||
| automated hematology analyzer | ||
| intended for in vitro diagnostic use to | ||
| classify and enumerate the following | ||
| parameters for venous whole blood | ||
| anticoagulated with K2/K3 EDTA: | ||
| WBC, RBC, HGB, HCT, MCV, PLT, | ||
| LYM%, Other WBC%, NEUT%, | ||
| LYM#, Other WBC#, and NEUT#. It | ||
| is not for use in diagnosing or | ||
| monitoring patients with primary or | ||
| secondary chronic hematologic | ||
| diseases/disorders, oncology patients, | ||
| critically ill patients, or children under | ||
| the age of 2. | The Sysmex XW-100TM is a | |
| quantitative automated | ||
| hematology analyzer intended for | ||
| 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. | ||
| Test Principle | Impedance technology (direct current | |
| detection) with hydrodynamic focusing | ||
| for all parameters except hemoglobin, | ||
| which is measured photometrically. | Same | |
| Measuring Channel | Single hydrodynamic focused | |
| impedance chamber | Same | |
| Sample Type | Anticoagulated (K2EDTA or K3EDTA) | |
| venous whole blood | Same | |
| Sample aspiration | ||
| volume | 15 μL | Same |
| Analysis Reagents | XW Pack L (lyse) | |
| XW Pack D (diluent) | Same | |
| System Throughput | 20 cycles per hour | Same |
| Test System | ||
| Dimensions | Width: 7 inches | |
| Height: 14 inches | ||
| Depth: 18 inches | Same | |
| Mode of Operation | Whole blood mode | Same |
| Calibration and | ||
| Quality Control | XW QC CHECK (K143577) | |
| SCSTM-1000 calibrator (K943268) | Same |