(127 days)
No
The summary describes standard hematology analysis techniques (RF/DC, Sheath Flow DC, Flow Cytometry, adaptive cluster analysis) and does not mention AI or ML. The "adaptive cluster analysis" is a statistical method, not necessarily indicative of AI/ML in this context.
No
Explanation: The device is an automated hematology analyzer used for in vitro diagnostic testing in clinical laboratories, which means it aids in diagnosis rather than providing therapy.
Yes
The device is an "automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories." It "classifies and enumerates" various parameters in whole blood and body fluids, providing "analysis results and graphics," which are all characteristics of a diagnostic device.
No
The device description clearly outlines multiple hardware components including a Main Unit, Auto Sampler Unit, and IPU, which are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."
N/A
Intended Use / Indications for Use
The body fluid analysis mode of the XE-5000 uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found in the body fluid.
Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA, as needed).
Product codes
81GIF, 81GGK, 81KJK, 81KSA, 81JPK, GKZ
Device Description
The Sysmex® XE-5000 is part of the XE-Series instrument line. It is a multi-parameter hematology analyzer intended to perform tests in anti-coagulated blood and body fluids. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes blood and body fluid samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The XE-5000 is equipped with a Sampler that provides continuous automated sampling for up to 100 tubes. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
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
in vitro diagnostic use in screening patient populations found in clinical laboratories.
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 XE-5000 whole blood mode is the same as the XE-2100 with additional masters. The Body Fluid mode of the XE-5000 has additional parameters. Comparison of the XE-5000 body fluid mode to the XE-2100 demonstrated excellent correlation. Data consisting of carryover, linearity, accuracy and reproducibility was collected to show performance to the manufacturer's specification for the Body Fluid mode. This analysis supports the claim that the XE-5000 Body Fluid mode is substantially equivalent to the XE-2100 Body Fluid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K992875, K020496, K032039, K050589, K051199
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
5. 510(k) SUMMARY of the XE-5000
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) 996-4655
Contact person: Nina Gamperling
Date prepared: July 13, 2007 | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XE-5000
Common name: Automated Hematology Analyzer.
Classification name:
Sysmex® XE-Series, Automated Hematology, an Automated
Differential Cell Counter (21 CFR 864.5220) is a Class II device.
Related Items:
CELLPACK™ (Diluent) | Product Code: 81GIF |
| | CELLSHEATH™ (Diluent) | Product Code: 81GIF |
| | STROMATOLYSER-FB™ (Lyse) | Product Code: 81GGK |
| | STROMATOLYSER-4DL™ (Lyse) | Product Code: 81GGK |
| | STROMATOLYSER-4DS™ (Stain) | Product Code: 81KJK |
| | STROMATOLYSER-NR™ (Diluent) | Product Code: 81GGK |
| | STROMATOLYSER-NR™ (Stain) | Product Code: 81KJK |
| | STROMATOLYSER-IM™ (Lyse) | Product Code: 81GGK |
| | SULFOLYSER (Lyse) | Product Code: 81GGK |
| | RET-SEARCH II (Diluent) | Product Code: 81GIF |
| | RET-SEARCH II (Stain) | Product Code: 81KJK |
| | XE Calibrators | Product Code: 81KSA |
| | e-Check (XE) (Control) | Product Code: 81JPK |
| | Option:
Graphic printer
Bar code Reader | |
| 3. Predicate Method: | Sysmex® XE-2100 Body Fluid (K040073-Cleared March 18, 2004) | |
| 4. Device Description: | The Sysmex® XE-5000 is part of the XE-Series instrument line. It is a
multi-parameter hematology analyzer intended to perform tests in anti-
coagulated blood and body fluids. The instrument consists of three
principal units: (1) Main Unit which aspirates, dilutes, mixes and
analyzes blood and body fluid samples; (2) Auto Sampler Unit supplies
samples to the Main Unit automatically; (3) IPU (Information
Processing Unit) which processes data from the Main Unit and provides
the operator interface with the system. The XE-5000 is equipped with a
Sampler that provides continuous automated sampling for up to 100
tubes.
The XE-5000 performs analyses using the following methods: RF/DC
Detection Method, Sheath Flow DC Detection Method, and Flow
Cytometry Methods using a Semiconductor Laser. Particle
characterization and identification is based on detection of forward | |
| 5. Intended Use: | scatter, fluorescence and adaptive cluster analysis. Using the same
reagents as the XE-2100, the XE-5000 automatically classifies cells
from blood and body fluids and carries out all processes automatically
from aspiration of the sample to outputting the results. | |
| | The body fluid analysis mode of the XE-5000 uses the 4DIFF
scattergram & the RBC distribution obtained from a specialized
analysis sequence to calculate & display the WBC (WBC-BF) counts,
mononuclear cell (MN) / polymorphonuclear cell (PMN) counts &
percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found in
the body fluid. | |
| | Analysis results and graphics are displayed on the IPU screen. They
can be printed on any of the available printers or transmitted to a Host
computer. | |
| | Sysmex® XE-5000 is an automated hematology analyzer for in vitro
diagnostic use in screening patient populations found in clinical
laboratories. The XE-5000 classifies and enumerates the same
parameters as the XE-2100 using whole blood as described below, cord
blood for HPC and has a body fluid mode for body fluids. The Body
Fluid mode analyzes WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-
BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and
synovial fluids with EDTA, as needed). | |
| | WBC | White Blood Cell Count |
| | RBC | Red Blood Cell Count |
| | HGB | Hemoglobin |
| | HCT | Hematocrit |
| | MCV | Mean Cell Volume |
| | MCH | Mean Cell Hemoglobin |
| | MCHC | Mean Cell Hemoglobin Concentration |
| | PLT | Platelet Count |
| | NEUT% / # | Neutrophil Percent and Count |
| | LYMPH%/# | Lymphocyte Percent and Count |
| | ΜΟΝΟ%/# | Monocyte Percent and Count |
| | EO% / # | Eosinophil Percent and Count |
| | BASO%/# | Basophil Percent and Count |
| | NRBC%/# | Nucleated RBC Percent and Count |
| | RDW-SD | RBC Distribution Width-SD |
| | RDW-CV | RBC Distribution Width-CV |
| | MPV | Mean Platelet Volume |
| | RET% / # | Reticulocyte Percent and Count |
| | IRF | Immature Reticulocyte |
| | IG% / # | Immature Granulocyte Percent and Count |
| | HPC# | Hematopoietic Progenitor Cells |
| | RET-He | Reticulocyte Hemoglobin |
| | IPF | Immature Platelet Fraction |
| | WBC-BF | WBC count in the body fluid mode analysis. |
| | RBC-BF | RBC count in the body fluid mode analysis. |
| | MN% / # | Percent and number of mononuclear cells within WBC-BF. |
| | PMN%/# | Percent and number of polymorphonuclear cells in WBC-BF |
| | TC-BF# | The total count including WBC-BF and HF-BF# (the number
of particles which appear in a stronger fluorescence area in
DIFF scattergram) |
1
·
2
| 6. Substantial
equivalence-
Similarities and
| Differences: | Table 1 shows substantial equivalence of the XE-5000 to the XE-2100. |
|---|---|
| 7. Conclusion | The XE-5000 demonstrates substantial equivalence to the XE-2100 |
| Body Fluid application. |
:
:
3
| | Sysmex XE-2100
Predicate | Sysmex XE-5000
Modification of Predicate | Similarity/
Difference |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Sysmex® XE-2100 Series
Hematology Analyzer is a
quantitative, automated
hematology analyzer and
leukocyte differential counter
for in vitro diagnostic use in
clinical laboratories. The
body fluid application adds a
quantitative, automated
procedure for analyzing
cerebrospinal fluid, serous
fluid and synovial fluid. | Sysmex® XE-5000 is an
automated hematology analyzer
for in vitro diagnostic use in
screening patient populations
found in clinical laboratories.
The XE-5000 classifies and
enumerates the same parameters
as the XE-2100 using whole
blood as described below, cord
blood for HPC and has a body
fluid mode for body fluids. The
Body Fluid mode analyzes
WBC-BF, RBC-BF, MN%/#,
PMN%/# and TC-BF in body
fluids (cerebrospinal fluids
(CSF), serous fluids, and
synovial fluids with EDTA, as
needed). | Both systems have the same
intended use but the XE-5000
has additional capillary and body
fluid parameters.
-
Body Fluid Mode has new
differential parameters (MN%/#
and PMN %/#) and detects WBC
and RBC cells at a lower level
than the XE-2100. The body
fluid mode is used on body fluid
samples with RBC counts
greater than $0.003 x 10^6$ /ul,
WBC counts greater than $0.01 x$
$10^3$ /ul for CSF and $0.030 x$
$10^3$ /ul for other body fluids and
WBC differential (MN%/# and
PMN %/#) for samples with
WBC counts. -
Capillary mode on whole
blood includes differential with
NRBC#/% & IG#/%. -
Addition of WBC-D
parameter on whole blood. |
| | Body Fluid Parameters:
WBC
RBC | Body Fluid Parameters:
WBC-BF
RBC-BF
MN%/ #
PMN%/#
TC-BF# | |
| | Capillary Mode Parameters:
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RET%/# | Capillary Mode Parameters:
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
RET%/#
NEUT% /#
LYMPH%/#
ΜΟΝΟ%/#
EO% / #
BASO% /#
NRBC%/#
IG% / # | |
| Methodology | The XE-2100 performs
analyses using the following
methods: RF/DC Detection
Method, Sheath Flow DC
Detection Method, and Flow
Cytometry Methods using a
Semiconductor Laser. The | The XE-5000 performs analyses
using the following methods:
RF/DC Detection Method,
Sheath Flow DC Detection
Method, and Flow Cytometry
Methods using a Semiconductor
Laser. The RF/DC detection | Both systems use the same
methodology. |
4
| | detects the size of the cells by
changes in direct-current
resistance & the density of the
cell interior by changes in
radio-frequency resistance.
Cells pass through the aperture
of the detector surrounded by
sheath fluid using the sheath
flow method. The principle of
flow cytometry is also used.
A semiconductor laser beam is
emitted to the cells passing
through the flow cell. The
forward scattered light is
received by the photodiode, &
the lateral scattered light &
lateral fluorescent light are
received by the photo
multiplier tube. This light is
converted into electrical
pulses, thus making it possible
to obtain cell information. | cells by changes in direct-current
resistance & the density of the
cell interior by changes in radio-
frequency resistance. Cells pass
through the aperture of the
detector surrounded by sheath
fluid using the sheath flow
method. The principle of flow
cytometry is also used. A
semiconductor laser beam is
emitted to the cells passing
through the flow cell. The
forward scattered light is
received by the photodiode, &
the lateral scattered light &
lateral fluorescent light are
received by the photo multiplier
tube. This light is converted into
electrical pulses, thus making it
possible to obtain cell
information. | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagents | CELLPACKTM (Diluent)
CELLSHEATHTM (Diluent)
STROMATOLYSER-FBTM (Lyse)
STROMATOLYSER-4DLTM (Lyse)
STROMATOLYSER-4DSTM (Stain)
STROMATOLYSER-NRTM (Diluent)
STROMATOLYSER-NRTM (Stain)
STROMATOLYSER-IMTM (Lyse)
SULFOLYSER (Lyse)
RET-SEARCH II (Diluent)
RET-SEARCH II (Stain) | CELLPACKTM (Diluent)
CELLSHEATHTM (Diluent)
STROMATOLYSER-FBTM (Lyse)
STROMATOLYSER-4DLTM (Lyse)
STROMATOLYSER-4DSTM (Stain)
STROMATOLYSER-NRTM (Diluent)
STROMATOLYSER-NRTM (Stain)
STROMATOLYSER-IMTM (Lyse)
SULFOLYSER (Lyse)
RET-SEARCH II (Diluent)
RET-SEARCH II (Stain) | The XE-2100 and the XE-5000
use the same reagents. |
| Quality
Control/
Calibrator | e-Check—3 levels
XE Calibrator (X Cal) | e -Check (XE) —3 levels
XE Calibrator (X Cal) | The XE-2100 and the XE-5000
use the same calibrator, but the
XE-5000 uses a specific quality
control material, e -Check (XE)
that has been previously cleared. |
| Software/
Hardware
Differences | The XE-pro software was
added to the original XE-2100
in order to include additional
master programs (HPC, IG,
RET, IPF) and perform Body
Fluid analysis. | The XE-5000 uses the same XE-
pro software and includes
additional masters (HPC, IG,
RET, IPF) along with a Body
Fluid mode in the initial standard
software model. | The XE-5000 performs the same
as the XE-2100 with the HPC,
IG, RET and IPF masters along
with a Body Fluid mode that has
additional parameters (TC-BF,
MN%/# and PMN %/#). The
XE-5000 capillary mode
includes the differential, NRBC
and IG parameters. |
| Specimen
Type | Random whole blood and
body fluid samples | Random whole blood and body
fluid samples. | Both systems use the same
specimen types. |
| Throughput | Approximately 113-150
samples/hour depending on
the mode used. | Approximately 113-150
samples/hour depending on the
mode used. | Both systems have the same
throughput. |
| Equivalency
Data: | Performance was initially
established in XE-2100 510(k)
submission (K992875) & then
additional masters/parameters
were submitted in subsequent
submissions: | Performance of the XE-5000
whole blood mode is the same as
the XE-2100 with additional
masters. The Body Fluid mode
of the XE-5000 has additional
parameters. Comparison of the | Data consisting of carryover,
linearity, accuracy and
reproducibility was collected to
show performance to the
manufacturer's specification for
the Body Fluid mode. This |
5
| XE-2100/HPC (K020496),
XE-2100/IG (K032039),
XE-Body Fluid (K040073),
XE-2100 RET/He (K050589),
XE-2100/IPF (K051199). | XE-5000 body fluid mode to the
XE-2100 demonstrated excellent
correlation. | analysis supports the claim that
the XE-5000 Body Fluid mode is
substantially equivalent to the
XE-2100 Body Fluid. |
| ------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------ |
|---|
.
.
.
.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 2007
Sysmex America, Inc. C/O Nina M. Gamperling One Nelson C. White Parkway Mundelein, Illinois 60060
Re: K071967
Trade/Device Name: Sysmex XE-5000 Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Hematology Analyzer Regulatory Class: Class II Product Code: GKZ Dated: July 13, 2007 Received: July 17, 2007
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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
7
Page 2 - Sysmex America, Inc.
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), 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,
Robert H. Zetterlof
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K (191967
Device Name: Sysmex® XE-5000, Automated Hematology Analyzer
Indications For Use:
Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%#, PMN%# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA, as needed).
| WBC | White Blood Cell Count | ||
|---|---|---|---|
| RBC | Red Blood Cell Count | ||
| HGB | Hemoglobin | ||
| HCT | Hematocrit | Division/Sign-Off | |
| Image: signature | |||
| MCV | Mean Cell Volume | ||
| MCH | Mean Cell Hemoglobin | ||
| MCHC | Mean Cell Hemoglobin Concentration | ||
| PLT | Platelet Count | ||
| NEUT% / # | Neutrophil Percent and Count | ||
| LYMPH% / # | Lymphocyte Percent and Count | Office of In Vitro Diagnostic | |
| Evaluation and Safety | |||
| MONO% / # | Monocyte Percent and Count | ||
| EO% / # | Eosinophil Percent and Count | ||
| BASO% / # | Basophil Percent and Count | 510(k) | |
| NRBC% / # | Nucleated RBC Percent and Count | ||
| RDW-SD | RBC Distribution Width-SD | ||
| RDW-CV | RBC Distribution Width-CV | ||
| MPV | Mean Platelet Volume | ||
| RET% / # | Reticulocyte Percent and Count | ||
| IRF | Immature Reticulocyte | ||
| IG% / # | Immature Granulocyte Percent and Count | ||
| HPC# | Hematopoietic Progenitor Cells | ||
| RET-He | Reticulocyte Hemoglobin | ||
| IPF | Immature Platelet Fraction | ||
| WBC-BF | WBC count in the body fluid mode analysis. | ||
| RBC-BF | RBC count in the body fluid mode analysis. | ||
| MN% / # | Percent and number of mononuclear cells within WBC-BF. | ||
| PMN% / # | Percent and number of polymorphonuclear cells within WBC-BF. | ||
| TC-BF# | The total count including WBC-BF and HF-BF# (the number of particles which appear in | ||
| a stronger fluorescence area in DIFF scattergram) |
Juzeline Bautista
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K07/967
Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)