(67 days)
Sysmex® XE-2100
Not Found
No
The document describes a standard automated hematology analyzer with no mention of AI or ML in its description, intended use, or performance studies.
No
The device is described as an in vitro diagnostic multi-parameter hematology analyzer, meaning it analyzes blood samples for diagnostic purposes rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Sysmex® XT-Series is intended for in vitro diagnostic use."
No
The device description clearly outlines multiple hardware components (Main Unit, Sampler Unit, IPU, Pneumatic Unit) that are integral to the device's function as an automated hematology analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer."
This statement directly identifies the device as being intended for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.
Product codes
GKZ
Device Description
The XT-Series is an automated hematology analyzer which consists of four principle units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which supplies samples to the Main Unit automatically: (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system: (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
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 laboratory
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 the XT-Series to the XE-2100. Results indicated equivalent performance.
Key Metrics
Not Found
Predicate Device(s)
Sysmex® XE-2100
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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Image /page/0/Picture/0 description: The image shows the word "Sysmex" in a stylized font. The letters are outlined with a pattern that resembles small, irregular shapes, giving the word a textured appearance. The overall design is simple and monochromatic, with the word standing out against a plain background.
SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile
JUN 2 5 2002
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: KO312-41
| 1. Submitted by: | Sysmex Corporation of America
6699 Wildlife Way | | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | Long Grove, IL 60047-9596 | | | | |
| | Phone: (847) 726-3675; FAX: (847) 726-3559 | | | | |
| | Contact person: Nina Gamperling | | | | |
| | Date prepared: April 18, 2002 | | | | |
| | | | | | |
| 2. Name of Device: | Trade or proprietary name: Sysmex® XT-Series | | | | |
| | Common name: Automated Hematology Analyzer | | | | |
| | Classification name: Automated Differential Cell Counter
21 CFR 864.5220 | | | | |
| 3. Predicate Device: | Sysmex® XE-2100 | | | | |
| 4. Device Description: | The XT-Series is an automated hematology analyzer which
consists of four principle units: (1) Main Unit which aspirates,
dilutes, mixes, and analyzes whole blood samples; (2) Sampler
Unit which supplies samples to the Main Unit automatically: (3)
IPU (Information Processing Unit) which processes data from the
Main Unit and provides the operator interface with the system:
(4) Pneumatic Unit which supplies pressure and vacuum from the
Main Unit. Additional information on the XT is presented in the
following table. | | | | |
| 5. Intended Use: | The Sysmex® XT-Series is intended for in vitro diagnostic use in
the clinical laboratory as a multi-parameter hematology analyzer. | | | | |
| 6. Substantial | The following table compares the XT-Series with the XE- | | | | |
| equivalence-similarities | 2100. | | | | |
| and differences | | | | | |
| 7. Clinical Performance | Studies were performed to evaluate the equivalency of the | | | | |
| Data: | XT-Series to the XE-2100. Results indicated equivalent | | | | |
| | performance. | | | | |
| 8. Conclusions: | The performance data demonstrated substantial equivalence. | | | | |
| | Page 9 | | | | |
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Image /page/1/Picture/0 description: The image shows the word "SYSMEX" in a stylized font. The letters are made up of multiple parallel lines, giving them a layered or circuit board-like appearance. The overall design is simple and monochromatic.
SYSMEX CORPORATION
of america 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsımıle
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Comparison Table to Predicate Device
| Features | XT-Series | XE-2100 | SF-3000 | |
|---|---|---|---|---|
| (Submission #) | (K992875) | (K950508) | ||
| FDA Clearance | 3-Nov-99 | 3-Nov-95 | ||
| Intended Use | Automated blood cell | Automated blood cell | Automated blood cell | |
| analyzer | analyzer | analyzer | ||
| Sample Type | Whole blood | Whole blood | Whole blood | |
| Sample Volume | 150uL- Cap piercer | 200 L- Cap piercer | 270uL- Cap piercer | |
| 85 µL -Manual | 130uL -Manual | 170uL -Manual | ||
| 40 L-Capillary dilution | 40uL-Capillary dilution | 40uL-Capillary dilution | ||
| Performance | Same | Proven performance in | Proven performance in | |
| FDA submission | FDA submission | |||
| Parameters | WBC, Neut%/#, | WBC, Neut%/#, | WBC, Neut%/#. | |
| Lymph%/ #, Mono%/#, | Lymph%/ #, Mono%/#, | Lymph%/#, Mono%/#, | ||
| Eos%/#, Baso%/#, | Eos%/#, Baso%/#, | Eos%/#, Baso%/#, | ||
| RBC, HGB, HCT, | NRBC%/#, RBC, HGB, | RBC, HGB, HCT, | ||
| MCV, MCH, MCHC, | HCT, MCV, MCH, | MCV, MCH, MCHC, | ||
| RDW-CV, RDW-SD, | MCHC, RDW-CV, | RDW-CV, RDW-SD, | ||
| RET%/#, IRF, HFR*, | RDW-SD, RET%/#, | PLT, PDW, MPV, P- | ||
| MFR*, LFR*, PLT, | IRF, HFR*, MFR*, | LCR. | ||
| MPV, PDW*, P-LCR*, | LFR*, PLT, MPV, | |||
| PCT* | PDW*, P-LCR*, PCT* | |||
| *Not reportable in USA | *Not reportable in USA | |||
| Reagents | Cellpack. | Cellpack, Cellsheath | Cellpack, Sulfolyzer, | |
| Stromatolyser-FB, | Stromatolyser-FB, | StromatolyserFD(I), | ||
| Stromatolyser-4DL, | Stromatolyser-4DL, | StromatolyserFD(II). | ||
| Stromatolyser-4DS, | Stromatolyser-4DS, | Stromatolyser-FB | ||
| Sulfolyser, | Stromatolyser, NR, | |||
| Ret-Search II | Stromatolyser-IM, | |||
| Sulfolyser, | ||||
| Ret-Search II | ||||
| Principles | RBC, PLT: DC | RBC, PLT: Sheath-flow | RBC, PLT: DC | |
| detection method, | DC detection method, | detection method. | ||
| WBC: Flow Cytometry | ||||
| method using | WBC: Flow Cytometry | WBC: Flow using | ||
| semiconductor laser | method using | |||
| semiconductor laser | semiconductor laser | |||
| detection method | detection method | |||
| HGB: SLS-Hgb method | HGB: SLS-Hgb method | HGB: SLS-Hgb method | ||
| Dimensions | 630x520x720 | 711x706x912 | 600x580x450 | |
| (HxWxD) (mm) | ||||
| Weight (kg) | ਟ ਰੇ | ਹੇਤੇ | 60 | |
| QC System | L-J: 20 Files with 300 | L-J: 10 Files with 300 | L-J: 12 Files with 180 | |
| points per file | points per file | points per file | ||
| Bar Code | Yes | Yes | Yes | |
| No. of Test / Hr | Approx 80 | Approx 113-150 | Approximately 80 |
- Page 10
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DEPARTMENT OF HEALTH & HUMAN SERVICES
'JUN 2 5 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America 6699 Wildlife Way Long Grove, Illinois 60047-9596
Re: K021241
Trade/Device Name: Sysmex® XT-Series Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: June 17, 2002 Received: June 18, 2002
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 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); 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.
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Page 2
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: XT-Series, Automated Hematology Analyzer
Indications For Use:
The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.
(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 | |
|---|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- | -- |
| (Division Sign-Off) |
|---|
| Division of Clinical Laboratory Devices K121241 |
510(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------
XT-Series, Automated Hematology Analyzer 510(k) FDA Submission