(100 days)
No
The document describes a standard automated hematology analyzer and its parameters, with no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No
The device is an automated hematology analyzer intended for in vitro diagnostic use to classify and count specific blood cells, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use" to classify and count specific blood cells and determine hemoglobin, which are diagnostic activities.
No
The device description explicitly states that the XT-Series is an automated hematology analyzer, which is a hardware device. The submission is for additional parameters (software/algorithms) for this existing hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use..."
- "The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use..."
This clearly indicates that the device is intended to be used for diagnostic purposes on samples taken from the human body (in this case, EDTA anti-coagulated blood) outside of the body.
N/A
Intended Use / Indications for Use
The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood. The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in EDTA anti-coagulated blood.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The XT-Series is an automated hematology analyzer previously cleared by the FDA (K021241- cleared June 24, 2002). The RET-He parameter determines the hemoglobin of reticulocytes. XT-Pro and RET- Master are required. The IG parameter (Immature Granulocyte) classifies and counts the immature granulocyte cells. The XT-Pro and IG Master are required.
Mentions image processing
The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells give an image of each cell detected in the peripheral blood.
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)
Performance of the XT-Series was initially established in 510(k) submission (K021241). The additional IG & RET-He parameters demonstrated excellent correlation. Data consisting of accuracy, precision and sample stability was collected to show performance to the manufacturer's specification for the IG and RET-He parameters. This analysis supports the claim that the XT-Series IG & RET-He parameters are substantially equivalent to the XE-2100.
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.
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.
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.”
0
OCT 1 0 2008
5. 510(k) SUMMARY of the XT-Series- IG and RET-He parameters
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) 996-4682; FAX: (847) 996-4655 | |||
| Contact person: Carrie S. Pineda | |||
| Date prepared: July 2, 2008 | |||
| 2. Name of Device: | Trade or proprietary name: | ||
| RET-He parameter on Sysmex® XT-Series | |||
| IG parameter on Sysmex® XT- Series | |||
| Common name: Automated Hematology Analyzer | |||
| Classification name: | |||
| Sysmex® XT- Series, Automated Hematology Analyzer, an | |||
| Automated Differential Cell Counter, (21 CFR 864.5220) is a Class | |||
| II device. | |||
| 3. Predicate Method: | RET-He parameter on Sysmex® XE-2100 (K050589-Cleared May 5, | ||
| 2005) | |||
| IG parameter on Sysmex® XE-2100 (K032039-Cleared Sept 8, | |||
| 2003) | |||
| 4. Device | |||
| Description: | The XT-Series is an automated hematology analyzer previously | ||
| cleared by the FDA (K021241- cleared June 24, 2002). The RET- | |||
| He parameter determines the hemoglobin of reticulocytes. XT-Pro | |||
| and RET- Master are required. The IG parameter (Immature | |||
| Granulocyte) classifies and counts the immature granulocyte cells. | |||
| The XT-Pro and IG Master are required. | |||
| 5. Intended Use: | The IG parameter on the Sysmex® XT-Series, Automated | ||
| Hematology Analyzer, is intended for in vitro diagnostic use to | |||
| classify and count immature granulocyte cells in EDTA anti- | |||
| coagulated blood. The RET-He parameter on the Sysmex® XT- | |||
| Series, Automated Hematology Analyzer, determines the | |||
| hemoglobin of reticulocytes for in vitro diagnostic use in EDTA | |||
| anti-coagulated blood. | |||
| IG% / # | Immature Granulocyte Percent and Count | ||
| RET-He | Reticulocyte Hemoglobin | ||
| 6. Substantial | |||
| equivalence- | |||
| Similarities and | |||
| Differences: | Table 1 shows substantial equivalence of the XT-Series to the XE- | ||
| 2100. | |||
| 7. Conclusion | The XT-Series IG and RET-He parameters demonstrate substantial | ||
| equivalence to the XE-2100 IG and RET-He parameters. |
XT-Series- IG & RET-He Parameters 510(k) FDA Submission
12
. . . .
ﺎ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﻟﻠﻤﺴﺎﺭ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
1
| Table 1: Substantial Equivalence-Similarities and Difference to XE-2100 | |
|---|---|
| Company of the Children Children Children Children Children | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| | Sysmex XE-2100- IG and
RET-He parameters
Predicate | Sysmex XT-Series- IG and
RET-He parameters
New parameters | Similarity/
Difference |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | IG Parameter:
The IG parameter on Sysmex®
XE-2100 is intended for in vitro diagnostic use to classify
and count immature
granulocyte cells in EDTA
anti-coagulated blood.
RET-He Parameter:
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. | IG Parameter:
The IG parameter on Sysmex®
XT-Series is intended for in vitro
diagnostic use to classify and
count immature granulocyte
cells in EDTA anti-coagulated
blood.
RET-He Parameter:
The RET-He parameter on the
Sysmex® XT-Series, Automated
Hematology Analyzer,
determines the hemoglobin of
reticulocytes for in vitro
diagnostic use in clinical
laboratories. | Both systems have the same
intended use statement. |
| Methodology | IG Parameter:
The Immature Granulocyte
(IG) count is measured in the
DIFF channel. The
combination of side scatter,
forward scatter, and
fluorescent intensity of
nucleated cells give an image
of each cell detected in the
peripheral blood. Different
leukocyte populations or
clusters such as the immature
granulocytes are counted.
RET-He Parameter:
The reticulocyte parameters
are derived using the
reticulocyte forward scattered
light signals from the
reticulocyte measurement
channel and a proprietary
Sysmex calculation equation. | IG Parameter:
The Immature Granulocyte (IG)
count is measured in the DIFF
channel. The combination of
side scatter, forward scatter, and
fluorescent intensity of nucleated
cells give an image of each cell
detected in the peripheral blood.
Different leukocyte populations
or clusters such as the immature
granulocytes are counted.
RET-He Parameter:
The reticulocyte parameters are
derived using the reticulocyte
forward scattered light signals
from the reticulocyte
measurement channel and a
proprietary Sysmex calculation
equation. | Both systems use the same
methodology. |
| Reagents | CELLPACKTM (Diluent)
CELLSHEATHTM (Diluent)
STROMATOLYSER-FBTM
(Lyse)
STROMATOLYSER-4DLTM
(Lyse)
STROMATOLYSER-4DSTM
(Stain)
STROMATOLYSER-NRTM | CELLPACKTM (Diluent)
STROMATOLYSER-FBTM
(Lyse)
STROMATOLYSER-4DLTM
(Lyse)
STROMATOLYSER-4DSTM
(Stain)
SULFOLYSER (Lyse)
RET-SEARCH II (Diluent) | The XT-Series uses less reagents
due to the fact that it doesn't test
for NRBC#/%. |
| | (Diluent)
STROMATOLYSER-NR™
(Stain)
STROMATOLYSER-IM™
(Lyse)
SULFOLYSER (Lyse)
RET-SEARCH II (Diluent)
RET-SEARCH II (Stain) | RET-SEARCH II (Stain) | |
| Quality
Control/
Calibrator | e-Check—3 levels
X Cal | e-Check—3 levels
X Cal | The XE-2100 and the XT-Series
use the same Calibrator and
control material. |
| Software/
Hardware
Differences | The XE-pro software was
added to the original XE-2100
in order to include additional
master programs (IG, RET). | The XT-pro software was added
to the original XT-Series in
order to include additional
master programs (IG, RET). | The XT-Series performs the
same as the XE-2100 with the
IG and RET masters. |
| Specimen
Type | Random whole blood | Random whole blood | Both systems use the same
specimen types. |
| Throughput | Approximately 113-150
samples/hour depending on
the mode used. | Approximately 50-80
samples/hour depending on the
mode used. | XT-Series has a lower
throughput. |
| Equivalency
Data: | Performance was initially
established in XE-2100 510(k)
submission (K992875) & then
additional masters/parameters
were submitted in subsequent
submissions:
XE-2100 IG (K032039)
XE-2100 RET-He (K050589) | Performance of the XT-Series
was initially established in
510(k) submission (K021241).
The additional IG & RET-He
parameters demonstrated
excellent correlation. | Data consisting of accuracy,
precision and sample stability
was collected to show
performance to the
manufacturer's specification for
the IG and RET-He parameters.
This analysis supports the claim
that the XT-Series IG & RET-He
parameters are substantially
equivalent to the XE-2100. |
XT-Series- IG & RET-He Parameters
510(k) FDA Submission
:
13
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.
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 0 2008
Sysmex America, Inc. c/o Ms. Carrie Pineda Supervisor, Clinical Affairs One Nelson C. White Parkway Mundelein, IL 60060
Re: K081890
Trade/Device Name: IG parameter on Sysmex® XT-Series and RET-He parameters on Sysmex® XT-Series
Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: September 25, 2008 Received: September 26, 2008
Dear Ms. Pineda:
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding
4
Page 2 – Ms. Carrie Pineda
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 procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
Indications for Use
KO81890 510(k) Number (if known):
Device Name: Sysmex® XT-Series, Automated Hematology Analyzer IG & RET-He Parameters
Indications For Use:
The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood. The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in EDTA anti-coagulated blood.
| IG% / # | Immature Granulocyte Percent and Count |
|---|---|
| RET-He | Reticulocyte Hemoglobin |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
mchen
Division Sign-Off
Concurrence of CDRH, Office office office affices for
510(k) K081890 11
XT-Series- IG & RET-He Parameters 510(k) FDA Submission