(90 days)
Not Found
Not Found
No
The description focuses on a gating system in the optical channel and does not mention AI or ML.
No
The device is described as being "for in Vitro diagnostics" and is used to "enumerate the immature platelet fraction," which is a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in Vitro diagnostics."
No
The device description explicitly states it is a component of the Sysmex XE-2100, which is a hardware-based in vitro diagnostic analyzer. The software (XE IPF master with XE pro) is required to obtain results but is not the device itself; the device is the analyzer and its gating system.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The first sentence clearly states: "The IPF% (Immature Platelet Fraction) on the Sysmex® XE-2100 for in Vitro diagnostics is used to enumerate the immature platelet fraction."
- Device Description aligns with IVD function: The description explains how the device analyzes a biological sample (blood, in this case, to measure platelets) using a laboratory method (gating system in the optical channel). This is characteristic of an in vitro diagnostic device.
- Performance studies compare to a predicate method: The mention of performance studies comparing the device to a "predicate method" (reticulated platelet on the FACSCalibur flow cytometric method) is typical for regulatory submissions for IVD devices, demonstrating equivalence to an already approved method.
Therefore, the information strongly indicates that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The IPF% (Immature Platelet Fraction) on the Sysmex® XE-2100 for in Vitro diagnostics is used to enumerate the immature platelet fraction.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The Sysmex XE-2100 uses a gating system in the optical (fluorescence) reticulocyte/platelet channel to quantify the immature platelets. (Note: XE IPF master with XE pro is 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were performed to evaluate the equivalency of the IPF parameter to the predicate method. Results indicate equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
The IPF parameter on the Sysmex® XE-2100 is substantially equivalent to the reticulated platelet on the FACSCalibur flow cytometric method.
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.
Not Found
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).
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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AUG 8 - 2005
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: 1005 || 99
| 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: May 5, 2005 |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: IPF (Immature Platelet Fraction)
parameter on the Sysmex® XE-2100, Automated Hematology
Analyzer.
Common name: IPF parameter
Classification name: IPF parameter
Automated Differential Cell Counter, Sysmex® XE-2100
(21 CFR 864.5220) |
| 3. Predicate Device: | The IPF parameter on the Sysmex® XE-2100 is substantially
equivalent to the reticulated platelet on the FACSCalibur flow
cytometric method. |
| 4. Device Description: | The Sysmex XE-2100 uses a gating system in the optical
(fluorescence) reticulocyte/platelet channel to quantify the
immature platelets. (Note: XE IPF master with XE pro is
required to obtain results described.) |
| 5. Intended Use: | The IPF% (Immature Platelet Fraction) on the Sysmex® XE-2100
for in Vitro diagnostics is used to enumerate the immature platelet
fraction. |
| 6. Substantial
equivalence-similarities
and differences | The following table compares the IPF parameter with predicate
method. |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| | FACSCalibur | IPF%
parameter on
XE-Series |
|--------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Predicate | New method |
| Intended Use | Using surrogate
markers and gating
strategies to
identify reticulated
platelets. | For in Vitro
diagnostics use to
enumerate the
immature platelet
fraction. |
| Methodology | Enumeration of
reticulated platelets
(immature
platelets) by flow
cytometry | Enumeration of
the IPF%
(immature
platelet fraction)
by the XE-2100,
automated
hematology
analyzer |
| Type of
Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
Comparison Table to Predicate Method
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of the IPF parameter to the predicate method. Results indicate equivalent performance. |
|---|---|
| 8. Conclusions: | The performance data demonstrated substantial equivalence. |
:
:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway Mundelein, Illinois 60060
AUG 8 - 2005
K051199 Re: Trade/Device Name: Immature Platelet Fraction (IPF) on Sysmex® XE-2100, Automated Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: May 5, 2005 Received: May 10, 2005
Dear Ms. Gamperling:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimer of the have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been that do not require approval of a premarket approval application (PMA). and coometre for , roy ( roy ) re- ) subject to the general controls provisions of the Act. The r ou may, diereleve, missas 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 If your device 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 r 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 corply 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 orecreate 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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Page 2 -
If you desire specific information about the application of labeling requirements to your device, If you desire specific information actuation of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the VIGO Duelood De Misbranding by reference to premarket notification" (21GFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outliner general 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,
loburt Beckerh
Robert L. Becker, Jr., MD, PK.D 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
| 510(k) Number (if known): | K051199 |
|---|---|
| --------------------------- | --------- |
Device Name: IPF (Immature Platelet Fraction) parameter on the Sysmex XE-2100™, Automated Hematology Analyzers ﺘﺤﺘﻬﺎ ﺗﺴﺘﺨﺪ ﺗﺴﺘﺨ
Indications For Use:
The IPF% (Immature Platelet Fraction) on the Sysmex® XE-2100 for in Vitro diagnostics is used to enumerate the immature platelet fraction.
(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
Tobal Rscaf
Division Sign-Off
ffice of In Vitro Diagnostic Device luation and Safety
510(k) K031199
IPF on Sysmex XE-2100 Series 510(k) FDA Submission
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