(106 days)
Not Found
No
The description details a flow cytometry process based on fluorescence and scatter measurements, with predefined regions (LFR, MFR, HFR) and a simple calculation (MFR+HFR=IRF). There is no mention of algorithms that learn from data or adapt their behavior, which are characteristic of AI/ML.
No
The device is an analyzer that monitors erythropoiesis, providing diagnostic information rather than directly treating or preventing disease.
Yes
The device is intended for clinical laboratory use to monitor bone marrow suppression and recovery by analyzing erythropoiesis, which directly relates to diagnosing and monitoring disease states or physiological conditions.
No
The device description clearly states it is a "table-top analyzer system" and "dedicated flow cytometers," indicating it is a hardware device that performs physical processes (diluting, staining, counting, measuring fluorescence and scatter).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in-vit-vouse in clinical laboratories" to monitor bone marrow suppression and recovery. This involves testing biological samples (whole blood) outside of the body.
- Device Description: The device analyzes "whole blood" samples using flow cytometry and fluorescent staining. This is a common method for in vitro diagnostic testing.
- Clinical Use: The clinical use described is for monitoring a patient's physiological state (erythropoiesis) based on the analysis of their blood sample.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The IRF is a clinical parameter obtained from the Sysmex™ R-Series automated reticulocyte analyzers. It is intended for in-vitro use in clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.
The IRF parameter of the R-Series analyzers is intended for in-vit-vouse in --clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The R-1000, R-3000 and RAM-1 are table-top analyzer systems for automated reticulocyte counting.
These instruments are dedicated flow cytometers which dilute and stain whole blood with a fluorescent dye (Auromine-O), then count and measure fluorescence and scatter of stained blood cells.
The fluorescence intensity is measured, and the analyzer identifies the reticulocytes based on fluorescence and scatter. The fluorescent intensity of the reticulocytes is displayed on the analyzer as a scattergram, and this display is separated into three regions: Low Fluorescence Intensity (LFR), Middle Fluorescence Intensity (MFR), and High Fluorescence Intensity (HFR). These regions are reported as a ratio or percentage(sum = 100%), in addition to the analyzer's reporting total reticulocyte count and RBC count. The IRF parameter is determined by the sum of the MFR (Middle Fluorescence Ratio) and HFR (High Fluorescence Ratio) {MFR+HFR=IRF}.
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. Qualified laboratory personnel
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)
Clinical studies have been performed which support this claim for patients receiving myeloablative chemotherapy. In addition, several clinical studies have been published which support this claim for patients having undergone bone marrow transplantation.
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.
Not Found
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
510(k) Summary of Safety and Effectiveness
Sysmex Corporation of America Gilmer Road 6699 RFD Long Grove, IL 60047-9596 (847)726-3662 Fax: (847)726-3505 Attention: Cathy Trester Date Prepared: May 5, 1997
AUG 26 1997
Sysmex™ IRF parameter (MFR+HFR) on R-1000, R-3000, RAM-1 analyzers, Trade name and Common name
The Sysmex™ IRF parameter is substantially equivalent to the reticulocyte count, and shows agreement to the WBC count as predictive indicators of bone marrow suppression and recovery.
The IRF parameter is obtained from the Sysmex R-1000(Premarket Notification K894539) R-3000 (Premarket Notification K912494) or SE/RAM-1(Premarket Notification K964375). The Sysmex™ R-3000, R-1000 and SE/RAM-1 are classified as Class II devices. The IRF parameter is classified as a Class III device.
Intended Use
The IRF is a clinical parameter obtained from the Sysmex™ R-Series automated reticulocyte analyzers. It is intended for in-vitro use in clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.
Device Description and Principles
The R-1000, R-3000 and RAM-1 are table-top analyzer systems for automated reticulocyte counting.
These instruments are dedicated flow cytometers which dilute and stain whole blood with a fluorescent dye (Auromine-O), then count and measure fluorescence and scatter of stained blood cells.
The fluorescence intensity is measured, and the analyzer identifies the reticulocytes based on fluorescence and scatter. The fluorescent intensity of the reticulocytes is displayed on the analyzer as a scattergram, and this display is separated into three regions: Low Fluorescence Intensity (LFR), Middle Fluorescence Intensity (MFR), and High Fluorescence Intensity (HFR). These regions are reported as a ratio or percentage(sum = 100%), in addition to the analyzer's reporting total reticulocyte count and RBC count. The IRF parameter is determined by the sum of the MFR (Middle Fluorescence Ratio) and HFR (High Fluorescence Ratio) {MFR+HFR=IRF}.
Comparison to Predicate Methodology and Clinical Data
In the area of assessment of bone marrow production, the predicate methodology is use of the white blood cell count (WBC), the absolute neutrophil count (ANC), or the reticulocyte count. The Immature Reticulocyte Fraction is similar to WBC and ANC, and similar or better than reticulocyte count as a monitor for bone marrow production. Clinical studies have been performed which support this claim for patients receiving myeloablative
1
chemotherapy. In addition, several clinical studies have been published which support this claim for patients having undergone bone marrow transplantation.
Conclusion
The Sysmex™ Immature Reticulocyte Fraction (IRF) parameter provided by the R-Series reticulocyte analyzers has been shown to be a parameter of predictive value for bone marrow suppression and recovery.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are capitalized, and the overall appearance is clean and professional.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Catherine M. Trester, M.T. (ASCP) Clinical and Regulatory Affairs SYSMEX™ Corporation Gilmer Road, 6699 RFD AUG 26 1997 Long Grove, Illinois 60047-9596 ... ...
Re : K971736/S1 Trade Name: Sysmex™ Immature Reticulocyte Fraction (IRF) Parameter Requlatory Class: III Product Code: GKZ July 16, 1997 Dated: Received: July 18, 1997
Dear Ms. Trester:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requiation (QS) for Medical Devices: General requiation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
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Page_
510(k) Number (if known):
Device Name: Immature Reticulocyte Fraction on R-Series Analyzers
Indications For Use:
The IRF parameter of the R-Series analyzers is intended for in-vit-vouse in --clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number __
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)