(58 days)
Sysmex XE-2100, Sysmex XT-Series
No
The summary describes standard hematology analysis methods and does not mention AI or ML.
No
The device is described as an "automated hematology analyzer for in vitro diagnostic use," which means it is used to diagnose conditions, not treat them.
Yes
The "Intended Use / Indications for Use" states, "The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories." This explicitly identifies it as a diagnostic device.
No
The device description explicitly states it is an "automated hematology analyzer" and describes physical methods like "Sheath Flow DC Detection Method" and "Flow Cytometry Methods using a Semiconductor Laser," indicating it is a hardware device with integrated software, not a software-only device.
Yes, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories."
N/A
Intended Use / Indications for Use
The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.
Product codes
GKZ
Device Description
The XE-2000 and XT-Series are automated hematology analyzers previously cleared by the FDA.
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
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
Studies were performed to evaluate the equivalency of XS to the predicate method. The performance data demonstrated substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
The Sysmex® XS, Automated Hematology Analyzer, is substantially equivalent to the Sysmex XE-2100 and Sysmex XT-Series, Automated Hematology Analyzers.
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.”
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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: HOLOOLO 5 V
| 1. Submitted by: | Sysmex America, Inc.
One Nelson C. White Parkway
Mundelein, IL 60060
Phone: (847) 996-4675; FAX: (847) 996-4655
Contact person: Nina Gamperling
Date prepared: March 10, 2006 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XS, Automated
Hematology Analyzer.
Common name: XS
Classification name: Automated Differential Cell Counter,
Sysmex® XS-1000i and XS-800i (21 CFR 864.5220) |
| 3. Predicate Device: | The Sysmex® XS, Automated Hematology Analyzer, is
substantially equivalent to the Sysmex XE-2100 and Sysmex XT-
Series, Automated Hematology Analyzers. |
| 4. Device Description: | The XE-2000 and XT-Series are automated hematology analyzers
previously cleared by the FDA. |
| 5. Intended Use: | The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. |
| 6. Substantial
equivalence-similarities
and differences | The following table compares the XS with the predicate method. |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Comparison Table to Predicate Method | ||
|---|---|---|
| Sysmex XE-2100 | ||
| Predicate | Sysmex XS-Series | |
| New Instrument | ||
| Intended Use | The SysmexTM XE-2100 is a multi- | |
| parameter hematology analyzer | ||
| intended to classify formed elements | ||
| in anti-coagulated blood. The XE- | ||
| 2100 can provide accurate and precise | ||
| test results for up to 32 analysis | ||
| parameters in whole blood. | The Sysmex® XS-Series is an | |
| automated hematology analyzer for in | ||
| vitro diagnostic use in clinical | ||
| laboratories. | ||
| Methodology | The XE-2100 performs hematology | |
| analyses using the following methods: | ||
| RF/DC Detection Method, Sheath | ||
| Flow DC Detection Method, Flow | ||
| Cytometry Methods using a | ||
| Semiconductor Laser and SLS- | ||
| hemoglobin method. | The XS performs hematology | |
| analyses using the following methods: | ||
| Sheath Flow DC Detection Method, | ||
| Flow Cytometry Methods using a | ||
| Semiconductor Laser and SLS- | ||
| hemoglobin method. | ||
| Type of | ||
| Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Performance was established in the | |
| previous 510(k) submission. | Comparison to the XE-2100 and XT- | |
| Series analysers demonstrated | ||
| excellent correlation. |
Comparison Table to Predicate Method
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of
XS to the predicate method. |
|-------------------------------|--------------------------------------------------------------------------------------|
| 8. Conclusions: | The performance data demonstrated substantial
equivalence. |
:
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway 1 1 0 2006 Mundelein, Illinois 60060
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K060656
Trade/Device Name: Sysmex® XS, Automated Hematology Analyzer Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: March 10, 2006 Received: March 13, 2006
Dear Ms. Gamperling:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Robert Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
KOLOGGE 510(k) Number (if known):_
Device Name: Sysmex® XSTM, Automated Hematology Analyzer
Indications For Use:
The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _ fice of In Vitro Diagnostic Device valuation and Safe Sysmex America, Inc. 510(k) XS Submission