(69 days)
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Not Found
No
The description focuses on standard hematology analyzer technology using scatter and fluorescence to classify cells, without mentioning AI or ML algorithms for cell identification or counting.
No
The device is an in vitro diagnostic hematology analyzer used to classify and count cells in blood samples, which is for diagnostic purposes, not for treating diseases or conditions.
Yes
The document explicitly states that the Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for In Vitro Diagnostic use.
No
The device description clearly states that the XE-2100 is an automated hematology analyzer, which is a hardware device. The IG parameter is a feature of this hardware device, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood."
This statement directly identifies the device's intended use as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood.
Product codes
GKZ
Device Description
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. The Immature Granulocyte (IG) count is measured in the DIFF channel. The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the peripheral blood. Different leukocyte populations or clusters such as the immature granulocytes are counted by the XE-2100. (Note: XE-Pro and IG Master are required to obtain results described.)
Mentions image processing
The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the peripheral blood.
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
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Intended User / Care Setting
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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
Studies were performed to evaluate the equivalency of the IG count to the predicate method. Results indicated equivalent performance. The performance data demonstrated substantial equivalence.
Key Metrics
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Predicate Device(s)
The IG parameter on the Sysmex® XE-2100 is substantially equivalent to the microscopic method of the manual differential cell counting used in the United States prior to 1976.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.”
0
SEP - 8 2003
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: _______________________________________________________________________________________________________________________________________________
| 1. Submitted by: | Sysmex America, Inc.
One Nelson C. White Parkway
Mundelein, IL 60060
Phone: (847) 996-4675; FAX: (847) 996-4693
Contact person: Nina Gamperling
Date prepared: June 30, 2003 |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Immature Granulocyte (IG)
parameter on the Sysmex® XE-2100, Automated Hematology
Analyzer. |
| | Common name: IG parameter |
| | Classification name: IG parameter on the Automated Differential
Cell Counter, Sysmex® XE-2100 (21 CFR 864.5220) |
| 3. Predicate Device: | The IG parameter on the Sysmex® XE-2100 is substantially
equivalent to the microscopic method of the manual differential
cell counting used in the United States prior to 1976. |
| 4. Device Description: | The XE-2100 is an automated hematology analyzer previously
cleared by the FDA. The Immature Granulocyte (IG) count is
measured in the DIFF channel. The combination of side scatter,
forward scatter, and fluorescent intensity of nucleated cells gives
an image of each cell detected in the peripheral blood. Different
leukocyte populations or clusters such as the immature
granulocytes are counted by the XE-2100. (Note: XE-Pro and IG
Master are required to obtain results described.) |
| 5. Intended Use: | The Immature Granulocyte (IG) parameter on the Sysmex® XE-
2100 is intended for in Vitro Diagnostic use to classify and count
immature granulocyte cells in EDTA anti-coagulated blood. |
| 6. Substantial
equivalence-similarities
and differences | The following table compares the IG parameter with predicate
method. |
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| | Manual Microscopic
Differential Cell Count | IG count on the XE-2100 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate | New method |
| Intended Use | To manually classify and count
the white blood cells into sub
categories using a microscope. | To classify and count immature
granulocyte cells in EDTA anti-
coagulated blood. |
| Methodology | Manual counting of immature
granulocytes using a microscope.
Typically the manual method
counts 100 cells. The NCCLS
H20-A method uses 400 cell
differential performed by 2 techs
each counting 200 cells. | Automated counting of immature
granulocytes on an automated hematology
analyzer. |
| Type of
Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Method of real counting of cells
using a microscope established as
the predicate method. | Comparison to manual count showed
good correlation. |
| Pro/Con | Manual method is imprecise due
to the small number of cells
counted, typically not more than
100 WBC total. It is labor
intensive and time-consuming. | A large number of cells can be analyzed
and several parameters (i.e. forward
scatter [FSC], side scatter [SSC], and
fluorescent labels) rather than
morphological appearance alone can be
used. |
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of
the IG count to the predicate method. Results indicated
equivalent performance.
The performance data demonstrated substantial | |
| 8. Conclusions: | | |
Comparison Table to Predicate Method
| 8. Conclusions: | |
|---|---|
| ----------------- | -- |
equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a bird or a wave-like form, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion around the symbol.
SEP - 8 2003
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: K032039
Trade/Device Name: Immature Granulocyte (IG) 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: June 30, 2003 Received: July 9, 2003
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 (OS) regulation (21 CFR Part 820).
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Page 2 -
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.
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Immature Granulocyte (IG) parameter on the Sysmex® XE-2100™, Automated Hematology Analyzer
Indications For Use:
The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostics to classify and count immature granulocyte cells in EDTA anti-coagulated blood.
(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) | K032039 |
|---|---|
| -------- | --------- |
Sysmex America, Inc.