← Product Code [GKZ](/productcode/GKZ) · K020496 # HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY (K020496) _Sysmex Corporation of America · GKZ · Apr 12, 2002 · Hematology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K020496 ## Device Facts - **Applicant:** Sysmex Corporation of America - **Product Code:** [GKZ](/productcode/GKZ.md) - **Decision Date:** Apr 12, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The HPC (hematopoietic progenitor cell) parameter of the IMI Channel on the Sysmex® SE-9500 and XE-2100 for in Vitro Diagnostics is used as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples. ## Device Story The HPC parameter is an add-on feature for Sysmex SE-9500 and XE-2100 automated hematology analyzers. It utilizes the Immature Myeloid Information (IMI) channel to identify and enumerate hematopoietic progenitor cells in peripheral blood and cord blood samples. The device processes EDTA-anticoagulated samples to provide a rapid (90-second) count, serving as an alternative to traditional, time-consuming Colony Forming Unit (CFU) assays or flow cytometry. It is intended for use by laboratory personnel in clinical settings. By providing a rapid, cost-effective screen for progenitor cell presence, the device assists clinicians in optimizing stem cell harvest and cord blood collection workflows, offering a faster turnaround time compared to the 14-day CFU reference method. ## Clinical Evidence Bench testing only. Performance was evaluated by comparing the HPC parameter results to the CFU reference method and flow cytometry CD34+ enumeration. Results demonstrated good correlation with the CFU reference method across peripheral blood, apheresis products, and cord blood samples. ## Technological Characteristics The device is an automated hematology analyzer feature using the IMI channel for cell counting. It requires specific software/hardware integration on the Sysmex SE-9500 and XE-2100 platforms. It processes EDTA-anticoagulated blood samples. The sensing principle is based on automated hematology analysis (IMI channel). ## Regulatory 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. ## Special Controls *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.” ## Predicate Devices - Colony Forming Unit (CFU) method (pre-1976) - Total Nucleated Count (TNC) method (pre-1976) ## Reference Devices - Flow Cytometry CD34+ enumeration ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "Sysmex" in a stylized, outlined font. The letters are bold and have a double-line effect, giving them a retro or vintage appearance. The overall design is simple yet distinctive, with the unique font choice making the word stand out. SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile ### 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: KOZO40 0 . | 1. Submitted by: | Sysmex Corporation of America
6699 Wildlife Way
Long Grove, IL 60047
Phone: (847) 726-3675 FAX: (847) 726-3559
Contact person: Nina Gamperling
Date prepared: February 13, 2002 | | | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | 2. Name of Device: | Trade or proprietary name: HPC (Hematopoietic Progenitor Cell)
parameter on the IMI Channel of the Sysmex® SE-9500 and XE-
2100, Automated Hematology Analyzer. | | | | | Common name: HPC parameter | | | | | Classification name: HPC parameter on the IMI Channel,
Automated Differential Cell Counter, Sysmex® SE-9500 and XE-
2100 (21 CFR 864.5220) | | | | 3. Predicate Device: | The HPC parameter of the IMI channel on the Sysmex® SE-9500
and XE-2100 is substantially equivalent to Colony Forming Unit
(CFU) and Total Nucleated Count (TNC) methods used in the
United States prior to 1976. | | | | 4. Device Description: | The SE-9500 and XE-2100 have an immature myeloid
information (IMI) channel, which identifies and enumerates
immature cells in addition to the traditionally reported parameters
of an automated cell differential. (Note: Special
software/hardware is required to obtain results described.) | | | | 5. Intended Use: | The HPC (hematopoietic progenitor cell) parameter of the IMI
Channel on the Sysmex® SE-950 and XE-2100 for in Vitro
Diagnostics is used as a screen for the optimal presence of
hematopoietic progenitor cells in peripheral blood and cord blood
samples. | | | | 6. Substantial
equivalence-similarities
and differences | The following table compares the HPC parameter of the IMI
Channel with predicate methods. | | | HPC parameter of the IMI Channel on Sysmex® SE-9500 & XE-2100, Automated Hematology Analyzers 510(k) FDA Submission Page 9 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "Sysmex" in a stylized, bold, sans-serif font. Each letter is outlined with a double line, giving it a retro or vintage appearance. The word is horizontally oriented and appears to be a logo or brand name. SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) | | Colony Forming
Unit (CFU) | TNC | Flow Cytometry
CD34+ | HPC parameter
of IMI Channel | |---------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | | Predicate | Predicate | Routine | New method | | Intended Use | To count the number
of progenitor cell
colonies on a growth
medium plate | To screen for
optimal presence
of progenitor
cells in stem cell
harvest & cord
blood samples | CD34+ is a
surrogate marker
to screen for
optimal presence
of progenitor
cells in stem cell
harvest & cord
blood samples | To screen for
optimal presence
of progenitor
cells in stem cell
harvest & cord
blood | | Methodology | Real counting of
progenitor cells on
growth medium
plates. | Total nucleated
count from
hematology
analyzer. | Enumeration of
CD34+ cells by
flow cytometry. | Hematopoietic
progenitor cell
count from
hematology
analyzer | | Type of
Anticoagulant | Heparin | EDTA | Heparin and
EDTA | EDTA | | Specimen Type | Peripheral blood,
apheresis product &
cord blood samples | Peripheral blood,
apheresis product
& cord blood | Peripheral blood,
apheresis product
& cord blood | Peripheral blood
& cord blood | | Accuracy | Method of real
counting of
progenitor cells
established as
reference method. | Comparison to
CFU showed
good correlation. | Comparison to
CFU showed
good correlation. | Comparison to
CFU showed
good correlation. | | Time Required
(per sample)
for method | 14 days | 90 seconds | 2 hours | 90 seconds | | Cost (per
sample) for
method | Approximately \$300 | Approx \$1.35 | \$35-\$105 | Approx \$1.35 | | Quality of
Technical
Support | Highly specialized
laboratory personnel;
Run in duplicate. | Hematology
laboratory
personnel. | Highly
specialized lab
personnel; Run in
duplicate. | Hematology
laboratory
personnel; Run in
duplicate. | #### Comparison Table to Predicate Methods the HPC parameter to the predica indicated equivalent performance. The performance data demonstrated substantial 8. Conclusions: equivalence. Page 10 HPC parameter of the IMI Channel on Sysmex® SE-9500 & XE-2100, Automated Hematology Analyzers 510(k) FDA Submission {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America 6699 Wildlife Way Long Grove, Illinois 60047-9596 1. 2. 2002 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ### APR 1 2 2002 k020496 Re: Trade/Device Name: Hematopoietic Progenitor Cell (HPC) parameter of the IMI Channel on the Sysmex® SE-9500™ and XE-2100™, Automated Hematology Analyzers Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: February 13, 2002 Received: February 14, 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. {3}------------------------------------------------ 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 Sutman 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: Hematopoietic Progenitor Cell (HPC) parameter of the IMI Channel on the Sysmex SE-9500™ and XE-2100™, Automated Hematology Analyzers Indications For Use: The HPC (hematopoietic progenitor cell) parameter of the IMI Channel on the Sysmex® SE-9500 and XE-2100 for in Vitro Diagnostics is used as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples. Josephine Bautz Jr. vision of Clinical Laboratory Devices 510(k) Number K020496 (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 HPC parameter of the IMI Channel on Sysmex® SE-9500 & XE-2100, Automated Hematology Analyzers 510(k) FDA Submission --- **Source:** [https://fda-staging.innolitics.com/device/K020496](https://fda-staging.innolitics.com/device/K020496) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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