(638 days)
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No
The document describes a standard electrical resistance type blood cell counter and does not mention AI, ML, or related concepts.
No
The device is an in vitro diagnostic hematology analyzer used to classify and enumerate blood parameters; it does not directly treat or diagnose patients.
Yes
The "Intended Use" section explicitly states that the device is "intended for in vitro diagnostic use."
No
The device description explicitly states it is an "electrical resistance type blood cell counter" and uses "human whole blood specimen," indicating it is a hardware device that analyzes physical samples.
Yes, this device is an IVD (In Vitro Diagnostic).
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..."
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 for CLIA Waived Use 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not for use in children under the age of 2.
Intended User / Care Setting
The XW-100 is intended to be used by operators with a minimum of an earned high school diploma or equivalent.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document mentions "well-established methods of verification and validation activities" for the software update, indicating performance studies were conducted, but does not provide specific details on study type, sample size, AUC, MRMC, standalone performance, or key results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 8, 2022
Sysmex America, INC. Yvonne Doswell Senior Scientist, Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069-4325
Re: K210346
Trade/Device Name: Sysmex XW-100 Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: June 20, 2022 Received: June 21, 2022
Dear Yvonne Doswell:
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Min Wu-S" in a large, bold, sans-serif font. The text is black and is set against a white background. There is a light blue watermark in the background that is partially obscuring the text.
Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
XW-100 Automated Hematology Analyzer for CLIA Waived Use
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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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: | Yvonne Doswell |
|---|---|
| Submitter's Address: | 577 Aptakisic Road |
| Lincolnshire, IL 60069 | |
| Submitter's Telephone: | 224-543-9708 |
| Submitter's Email: | Doswelly@sysmex.com |
| Date 510(k) Prepared: | 09/29/2022 |
Name of the device, including the trade or proprietary name, the common or usual name, and the classification name:
| Proprietary Name: | XW-100 Automated Hematology Analyzer for CLIA Waived Use | |
|---|---|---|
| Common Name: | Automated Hematology Analyzer | |
| Regulation Description: | Automated Differential Cell Counter | |
| Regulation Section: | 21 CFR 864.5220 | |
| Device Class: | 2 | |
| Product Code: | GKZ | |
| Predicate Device/510(k): |
XW-100 Automated Hematology Analyzer for CLIA Waived Use K172604, dual submission CLIA Waiver by Application CW170012
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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, 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.
Special Conditions for Use Statement(s):
The XW-100 is intended to be used by operators with a minimum of an earned high school diploma or equivalent.
DEVICE DESCRIPTION
The XW-100 Automated Hematology Analyzer for CLIA Waived Use 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.
Principles of Operation
The XW-100 uses direct current with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer 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 one direction, one at a time. When a cell passes through the aperture, it causes a change in the direct current 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.
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Quality Controls
The quality controls that are used with the XW-100 Automated Hematology Analyzer for CLIA Waived Use 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 OC 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).
SUMMARY OF SUBSTANTIAL EQUIVALENCE
The proposed modified device, XW-100 Automated Hematology Analyzer for CLIA Waived Use has the same intended use, labeling, and fundamental scientific technology as the predicate device, the XW-100 Automated Analyzer for CLIA Waived Use.
| Similarities | ||
|---|---|---|
| Item | Predicate Device | Modified Device |
| 510(k) Number | K172604 | N/A |
| Device Name | XW-100 Automated Hematology | |
| Analyzer for CLIA Waived Use | Same | |
| Intended Use | The XW-100 Automated Hematology | |
| Analyzer (XW-100) is a quantitative | ||
| automated hematology analyzer intended | ||
| for in vitro diagnostic CLIA waived 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. | Same | |
| 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 |
Comparison to the Predicate Device:
Sysmex America, Inc. XW-100 Automated Hematology Analyzer for CLIA Waived Use
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| Similarities | ||
|---|---|---|
| Item | Predicate Device | Modified Device |
| 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 | |
| Differences | ||
| Item | Predicate Device | Modified Device |
| Software | Version 1.03 | Version 1.14 |
Differences:
There is no difference between the XW-100 Automated Hematology Analyzer for CLIA Waived Use and the modified device aside from a software update from Version 1.03 to Version 1.14.
CONCLUSION:
The proposed software update was implemented in accordance to design controls and risk management. The risk analysis and well-established methods of verification and validation activities conducted, demonstrate that the XW-100 Automated Hematology Analyzer for CLIA Waived Use with the proposed software version 1.14 is as safe and effective as the predicate device. The results of the design control activities demonstrate that the device is substantially equivalent to the predicate device, XW-100 Automated Hematology Analyzer for CLIA Waived Use (K172604/CW170012).