(57 days)
No
The summary describes a standard hematology analyzer parameter and does not mention any AI or ML components or methodologies.
No
This device is an in vitro diagnostic (IVD) device used in clinical laboratories to determine the hemoglobin of reticulocytes; it is not directly used for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "determines the hemoglobin of reticulocytes for in vitro diagnostic use in clinical laboratories."
No
The device description explicitly states it is an "automated hematology analyzer," which is a hardware device. While it includes a software parameter (RET-He), the core device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The RET-He parameter on the Sysmex® XE-2100, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in clinical laboratories."
This statement clearly indicates that the device is intended for use in a laboratory setting to perform diagnostic tests on biological samples (in vitro).
N/A
Intended Use / Indications for Use
The RET-He parameter on the Sysmex® XE-2100, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in clinical laboratories.
Product codes
GKZ
Device Description
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. The RET-He parameter determines the hemoglobin of the reticulocytes. (Note: XE-Pro and RET Master are required to obtain results described.)
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 the RET-He parameter to the predicate method. Results indicated equivalent performance.
Key Metrics
Not Found
Predicate Device(s)
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 The requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 10500589 .
| 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 7, 2005 | |
| 2. Name of Device: | Trade or proprietary name: RET-He parameter on the Sysmex® |
| XE-2100, Automated Hematology Analyzer. | |
| Common name: RET-He | |
| Classification name: RET-He parameter on the Automated | |
| Differential Cell Counter, Sysmex® XE-2100 (21 CFR 864.5220) | |
| 3. Predicate Device: | The RET-He parameter on the Sysmex® XE-2100, Automated |
| Hematology Analyzer, is substantially equivalent to the CHr | |
| parameter on the Bayer Advia 120 Hematology System. | |
| 4. Device Description: | The XE-2100 is an automated hematology analyzer previously |
| cleared by the FDA. The RET-He parameter determines the | |
| hemoglobin of the reticulocytes. (Note: XE-Pro and RET Master | |
| are required to obtain results described.) | |
| 5. Intended Use: | The RET-He parameter on the Sysmex® XE-2100, Automated |
| Hematology Analyzer, determines the hemoglobin of | |
| reticulocytes for in vitro diagnostic use in clinical laboratories. | |
| 6. Substantial | |
| equivalence-similarities | |
| and differences | The following table compares the RET-He parameter with |
| predicate method. |
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| | CHr parameter on the Bayer
Advia 120 | RET-He parameter on the Sysmex
XE-2100 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate
K971998 | New method |
| Intended Use | The Advia 120 Hematology
System is a quantitative,
automated hematology analyzer
that provides a leukocyte
differential count and reticulocyte
analysis for in vitro diagnostic use
in clinical laboratories. | The RET-He parameter on the Sysmex®
XE-2100, Automated Hematology
Analyzer, determines the hemoglobin of
reticulocytes for in vitro diagnostic use in
clinical laboratories. |
| Methodology | The reticulocyte parameters are
derived through a combination of
laser light scatter and absorption
of a nucleic acid dye. | The reticulocyte parameters are derived
using the reticulocyte forward scattered
light signals from the reticulocyte
measurement channel and a proprietary
Sysmex calculation equation. |
| Type of
Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Method of CHr, mean hemoglobin
content of reticulocytes, has been
established as the predicate
method. | Comparison to CHr showed excellent
correlation. |
| Comparison Table to Predicate Method | ||||
|---|---|---|---|---|
| -------------------------------------- | -- | -- | -- | -- |
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of
the RET-He parameter to the predicate method. Results
indicated equivalent performance. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. Conclusions: | The performance data demonstrated substantial
equivalence. |
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird in flight, composed of three curved lines representing the wings and body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina M. Gamperling, MBA, MT(ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway Mundelein, IL 60060
Re: K050589
Trade/Device Name: RET-He parameter on the Sysmex® XE-2100™, Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: March 7, 2005 Received: March 9, 2005
MAY
2005
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 nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
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 viero Diaganding 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, P& Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
KOSOS BOOK 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: RET-He parameter on the Sysmex® XE-2100™, Automated Hematology Analyzer
Indications For Use:
The RET-He parameter on the Sysmex® XE-2100, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes 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 | |
|---|---|
| ---------------------- | -- |
Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K050589
Sysmex America, Inc. 510(k) XE-2100 RET-He Submission I I