(113 days)
Not Found
No
The summary describes a standard automated hematology analyzer and its function of extending the stability of a specific parameter (MCV). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on analytical performance and stability.
No
The device is described as an automated hematology analyzer for in vitro diagnostic use, meaning it analyzes patient samples to screen for conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" states that the device is "for in vitro diagnostic use in screening patient populations."
No
The device description explicitly states it is an "automated hematology analyzer," which is a hardware device. While it mentions "XE pro software is required," this software is a component of the hardware analyzer, not a standalone software-only device.
Yes, the provided text explicitly states that the Sysmex XE-2100DC is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly states: "The Sysmex XE-2100DC is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories."
N/A
Intended Use / Indications for Use
The Sysmex XE-2100DC is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XE-2100DC analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperatures (18-26°C).
Product codes
GKZ
Device Description
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. XE-2100DC will extend MCV stability to 48 hours. (Note: XE pro software 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
clinical laboratories and reference 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)
Studies were performed to evaluate the equivalency of XE-2100DC to the predicate method. Results indicated that the XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperature (18-26°C).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sysmex® XE-2100, Automated Hematology Analyzer.
Reference Device(s)
Not Found
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
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: K051459
| 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: September 2, 2005 |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XE-2100DC, Automated Hematology Analyzer.
Common name: XE-2100DC
Classification name: Automated Differential Cell Counter,
Sysmex® XE-2100DC (21 CFR 864.5220) |
| 3. Predicate Device: | The Sysmex® XE-2100DC, Automated Hematology Analyzer, is
substantially equivalent to the Sysmex XE-2100, Automated
Hematology Analyzer. |
| 4. Device Description: | The XE-2100 is an automated hematology analyzer previously
cleared by the FDA. XE-2100DC will extend MCV stability to
48 hours. (Note: XE pro software is required to obtain results
described.) |
| 5. Intended Use: | The Sysmex XE-2100DC is an automated hematology analyzer
for in vitro diagnostic use in screening patient populations found
in clinical laboratories and reference laboratories. The XE-
2100DC analyzes the following parameters: WBC, RBC, HGB,
HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV
and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO
%/#. The XE-2100DC will extend the stability of the MCV
parameter in EDTA anticoagulated whole blood samples to 48
hours at 4°C and room temperatures (18-26°C). |
| 6. Substantial
equivalence-similarities
and differences | The following table compares the XE-2100DC with the predicate
method. |
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
.
| Sysmex XE-2100DC | ||
|---|---|---|
| Sysmex XE-2100 | Modification of Predicate | |
| Predicate | ||
| Intended Use | The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify formed elements in anti-coagulated blood. The XE-2100 can provide accurate and precise test results for up to 32 analysis parameters in whole blood. | The Sysmex XE-2100DC is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XE-2100DC analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperature (18-26°C). |
| Methodology | The XE-2100 performs hematology analyses using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. | The XE-2100DC performs hematology analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. |
| Diluting | ||
| Reagent | ||
| Differences | CELLSHEATH | CELLSHEATH(C) |
| Software/ | ||
| Hardware | ||
| Differences | --- | Hardware: Tubing changes; Heating block modification. |
| Software: Proprietary temperature algorithms | ||
| Type of | ||
| Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Performance was established in the previous 510(k) submission. | Comparison to the XE-2100 demonstrated excellent correlation. |
Comparison Table to Predicate Method
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of XE-2100DC to the predicate method. Results indicated that the XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperature (18-26°C). |
|---|---|
| 8. Conclusions: | The performance data demonstrated substantial equivalence. |
2
Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
SEP 2 3 2005
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
Re: K051459
KU51439
Trade/Device Name: Sysmex® XE-2100DC™, Automated Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 22, 2005 Received: August 26, 2005
Dear Ms. Gamperling:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(t) premained 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 encrosule) to regally manent date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enaoutines of the Federal Food, Drug, devices that have been reclassified in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, inelefone, market the devices, basics to the most registration, listing of
general controls provisions of the Act include requirements for annual registerading and general controls provisions of the free merals requirement of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations DD may be subject to such additional connector initial (CFR), Parts 800 to 895. In addition, FDA
be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 899 Barri be found in This 21, Oods of I cases.
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 Please be advised mat IDA's issuated of a substition complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmanon that your are your assess. You must as a many as a ligit or any rederal statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Ace 3 requirements, morals 809); and good manufacturing practice CFK Part 807), labeling (21 CF N Fatts 607 and 603), egulation (21 CFR Part 820). This letters requirements as set form in the quality Systems (QS) in your Section 510(k) prematket will allow you to begin marketing your active quivalence of your device to a legally marketed notification. The I Dri inding of succion for your device and thus, permits your device to proceed to the market.
3
Page 2 --
If you desire specific information about the application of labeling requirements to your device, If you desire specific information and advertising of your device, please contact the Office of In of questions on the promostic Device Evaluation and Safety at (240) 276-0484. Also, please note the Vitro Diagnostic D'iMisbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obain only 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,
lobatz Beckerh
Robert L. Becker, Jr., MD, PHD 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): __K051459
Device Name: Sysmex® XE-2100DC™, Automated Hematology Analyzer
Indications For Use:
The Sysmex XE-2100DC is an automated hematology analyzer for in viro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XEscreening patient populations found in emmediations and CHARC, MCT, MCV, MCHC,
2100DC analyzes the following parameters: WBC, RBC, HCT, MCV, MCHC, MCHC, MCHC, MCHC, MCHC, MCH 2100DC allary25s the lonowing parameters: 1724, LYMPH %/#, MONO %/#, EO %/#, and
RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EDTA RDW-CV, KDW-SD, FLT, MF V and NEOT 76.hild NEV parameter in EDTA
BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA BASO %4. The XE-2100DC will extend the stabling of and room temperatures (18-26℃).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE)
Prescription Use
X
Division Sign-Off
Over-The-Counter Use
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K051459