(75 days)
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No
The description focuses on standard hematology analysis techniques and hardware components, with no mention of AI or ML.
No
The document states that the device is a "hematology analyzer" used to classify formed elements in blood, indicating it is a diagnostic tool, not one that provides therapy or treatment.
Yes
The device is a multi-parameter hematology analyzer intended to classify formed elements in anti-coagulated blood. This classification provides information about various blood parameters, which are used to evaluate patient conditions and aid in diagnosis. The "Summary of Performance Studies" mentions "patients with different pathological conditions" and "WBC differential...correlated to results from manual differentials," indicating its use in identifying and confirming disease states.
No
The device description clearly outlines multiple hardware components (Main Unit, Sampler Unit, IPU, Pneumatic Unit) that are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to classify the following formed elements in anti-coagulated blood". This indicates that the device is used to analyze biological samples (blood) in vitro (outside the body) to provide information about a patient's health status.
- Device Description: The description details an automated hematology analyzer that processes whole blood samples. This further supports its use in laboratory settings for diagnostic purposes.
- Performance Studies: The summary of performance studies mentions evaluating specimens from "apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for particular parameters." This directly relates to using the device to aid in the diagnosis or monitoring of diseases.
- Predicate Devices: The predicate devices listed (SE/RAM-1 and SF-3000) are also hematology analyzers, which are well-established types of IVD devices.
All these points 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 diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in anti-coagulated blood: WBC (White Blood Cells count), Neut%, Neut#, Lymph%, Lymph#, Mono%, Mono#, Eo%, Eo#, Baso%, Baso#, NRBC%, NRBC#, RBC (Red Blood Cell or erythrocyte count), HGB (Hemoglobin concentration), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Cell Hemoglobin), MCHC (Mean Cell Hemoglobin Concentration), RDW-CV (Red Cell Distribution Width-Coefficient of Variation), RDW-SD (Red Cell Distribution Width-Standard Deviation), RET% (Reticulocyte percent), RET# (Reticulocyte absolute count), IRF (Immature Reticulocyte Fraction), HFR*, MFR*, LFR*, PLT (Platelet count), MPV (Mean Platelet Volume), PDW*, P-LCR*, PCT*. *Not Reportable in USA.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The XE-2100 is an automated hematology analyzer which consists of four principal units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which 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; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Carryover, precision, linearity, and sample stability data show performance to manufacturer specifications. As demonstrated by correlation studies, the performance claims of the proposed device are similar to the predicate devices, the SE/RAM-1 and SF-3000. During these studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for particular parameters. In addition, the WBC differential of the XE-2100 was correlated to results from manual differentials performed according to NCCLS H20A and to flow cytometry. The data from these studies supports our claim that the XE-2100 is substantially equivalent to predicate methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.”
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NOV - 9 1999
.
510(k) Summary of Safety and Effectiveness Information SYSMEX™ Automated Hematology Analyzer XE-2100 August 25, 1999
Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, IL 60047-9596
Contact Person: Nina Gamperling at 847-726-3675 or by facsimile at 847-726-3559
Trade or Proprietary Name: Sysmex™ XE-2100
Automated Hematology Analyzer Common or Usual Name:
Automated Differential Cell Counter 21 CFR 864.5220 Classification Name:
Intended Use: The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in anti-coagulated blood:
| WBC | White Blood Cells count | RBC | Red Blood Cell or erythrocyte count |
|---|---|---|---|
| Neut% | Neutrophil percent | HGB | Hemoglobin concentration |
| Neut# | Neutrophil absolute count | HCT | Hematocrit |
| Lymph% | Lymphocyte percent | MCV | Mean Corpuscular Volume |
| Lymph# | Lymphocyte absolute count | MCH | Mean Cell Hemoglobin |
| Mono% | Monocyte percent | MCHC | Mean Cell Hemoglobin Concentration |
| Mono# | Monocyte absolute count | RDW-CV | Red Cell Distribution Width- |
| Coefficient of Variation | |||
| Eo% | Eosinophil percent | RDW-SD | Red Cell Distribution Width- |
| Standard Deviation | |||
| Eo# | Eosinophil absolute count | RET% | Reticulocyte percent |
| Baso% | Basophil percent | RET# | Reticulocyte absolute count |
| Baso# | Basophil absolute count | IRF | Immature Reticulocyte Fraction |
| NRBC% | Nucleated red blood cell | ||
| percent | HFR* | High Fluorescence Ratio | |
| NRBC# | Nucleated red blood cell | ||
| absolute count | MFR* | Medium Fluorescence Ratio | |
| PLT | Platelet count | LFR* | Low Fluorescence Ratio |
| MPV | Mean Platelet Volume | ||
| PDW* | Platelet Distribution Width | ||
| P-LCR* | Platelet-Large Cell Ratio | ||
| PCT* | Plateletcrit |
*Not Reportable in USA
Device Description: The XE-2100 is an automated hematology analyzer which consists of four principal units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which 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; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit. Additional information on the XE-2100 is presented in Table 1.
510(k) Premarket Notification Sysmex™ Automated Hematology Analzyer XE-2100
1
Similarities and Differences to Predicate Devices: The Sysmex™ XE-2100 is substantially equivalent in intended use and technological characteristics to previous Sysmex™ instrumentation, the manual differential, and flow cytometry. A summary of the comparative features is presented in Table 1.
Supportive Data: Carryover, precision, linearity, and sample stability data show performance to manufacturer specifications. As demonstrated by correlation studies, the performance claims of the proposed device are similar to the predicate devices, the SE/RAM-1 and SF-3000. During these studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for particular parameters. In addition, the WBC differential of the XE-2100 was correlated to results from manual differentials performed according to NCCLS H20A and to flow cytometry. The data from these studies supports our claim that the XE-2100 is substantially equivalent to predicate methods.
Conclusion: The Sysmex™ XE-2100 is substantially equivalent to the predicate methods, the SE/RAM-1 and SF-3000.
2
| Features
(Submission #) | XE-2100 | SE/RAM-1
(K964375) | SF-3000
(K950508) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | --- | 13-Mar-97 | 3-Nov-95 |
| Intended Use | Automated blood cell
analyzer | Automated blood cell
counter | Automated blood cell
analyzer |
| Sample Type | Whole blood | Whole blood | Whole blood |
| Sample Volume | 200µL- Cap piercer
130µL -Manual
40µL-Capillary dilution | 250µL- Cap piercer
100µL -Manual
40µL-Capillary dilution | 270µL- Cap piercer
170µL -Manual
40µL-Capillary dilution |
| Performance | Same | Proven performance in
FDA submission | Proven performance in
FDA submission |
| Parameters | WBC, Neut%/#,
Lymph%/ #, Mono%/#,
Eos%/#, Baso%/#,
NRBC%/#, RBC, HGB,
HCT, MCV, MCH,
MCHC, RDW-CV,
RDW-SD, RET%/#,
IRF, HFR*, MFR*,
LFR*, PLT, MPV,
PDW*, P-LCR*, PCT*
*Not reportable in USA | WBC, Neut%/#,
Lymph%/ #, Mono%/#,
Eos%/#, Baso%/#,
RBC, HGB, HCT, MCV,
MCH, MCHC, RDW-
CV, RDW-SD, RET%/#,
IRF, PLT, MPV. | WBC, Neut%/#,
Lymph%/#, Mono%/#,
Eos%/#, Baso%/#,
RBC, HGB, HCT, MCV,
MCH, MCHC, RDW-
CV, RDW-SD, PLT,
PDW, MPV, P-LCR. |
| Reagents | Cellpack, Cellsheath
Stromatolyser-FB,
Stromatolyser-4DL,
Stromatolyser-4DS,
Stromatolyser, NR,
Stromatolyser-IM,
Sulfolyser,
Ret-Search II | Cellpack, Cellsheath,
Cellpack-3D,
StromatolyserWL(II),
Stromatolyser-3D,
StromatolyserEO(II),
Stromalyser-BA,
Stromatolyser-IM,
Sulfolyser, Ret-Search,
Ret-Sheath | Cellpack, Sulfolyzer,
Stromatolyser FD(I),
Stromatolyser FD(II),
Stromatolyser-FB |
| Principles | RBC, PLT: Sheath-flow
DC detection method,
WBC: Flow Cytometry
method using
semiconductor laser
detection method | RBC, PLT: Sheath-flow
DC detection method,
WBC: DC Detection
Method, RF/DC
Detection Method | RBC, PLT: DC
detection method,
WBC: Flow using
semiconductor laser |
| Dimensions
(HxWxD) (mm) | 711x706x912 | 720x636x820 | 600x580x450 |
| Weight (kg) | 93 | 80 | 60 |
| QC System | L-J: 10 Files with 300
points per file | L-J: 27 Files with 180
points per file | L-J: 12 Files with 180
points per file |
| Bar Code | Yes | Yes | Yes |
| No. of Test / Hr | Approx. 112-150 | Approximately 120 | Approximately 80 |
Table 1: Comparative Features to SE/RAM-1 and SF-3000
:
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NOV - 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina Gamperling Supervisor, Clinical and Regualtory Affairs Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, Illinois 60047-9596
Re: K992875
Trade Name: Sysmex™ Automated Hematology Analyzer XE-2100 Regulatory Class: II Product Code: GKZ Dated: August 25, 1999 Received: August 26, 1999
Dear Ms. Gamperling:
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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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Page 2
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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/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
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510(k) Number (if known): _ K 99 3825
Device Name: Sysmex ™ Automated Hematology Analyzer XE-2100
Indications For Use:
The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in EDTA anti-coagulated blood.
| WBC | White Blood Cells or leukocyte count |
|---|---|
| Neut% | Neutrophil percent |
| Neut# | Neutrophil absolute count |
| Lymph% | Lymphocyte percent |
| Lymph# | Lymphocyte absolute count |
| Mono% | Monocyte percent |
| Mono# | Monocyte absolute count |
| Eo% | Eosinophil percent |
| Eo# | Eosinophil absolute count |
| Baso% | Basophil percent |
| Baso# | Basophil absolute count |
| NRBC% | Nucleated red blood cell percent |
| NRBC# | Nucleated red blood cell absolute count |
| RBC | Red Blood Cell or erythrocyte count |
| HGB | Hemoglobin concentration |
| HCT | Hematocrit |
| MCV | Mean Corpuscular Volume |
| MCH | Mean Cell Hemoglobin |
| MCHC | Mean Cell Hemoglobin Concentration |
| RDW-CV | Red Cell Distribution Width-Coefficient of Variation |
| RDW-SD | Red Cell Distribution Width-Standard Deviation |
| RET% | Reticulocyte percent |
| RET# | Reticulocyte absolute count |
| IRF | Immature Reticulocyte Fraction |
| HFR* | High Fluorescent Ratio |
| MFR* | Medium Fluorescent Ratio |
| LFR* | Low Fluorescent Ratio |
| PLT | Platelet count |
| MPV | Mean Platelet Volume |
| PDW* | Platelet Distribution Width |
| P-LCR* | Platelet- Large Cell Ratio |
| PCT* | Plateletcrit |
| *Not reportable in the USA |
Peter G. Maden
Laboratory Dev
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenet of CHRD, Office of Device Evaluation (ODE) ﮯ Presription Use __ Over-The-Counter Use OR (Optional Format 1-2-96) (Per 21 CFR 801.109)
510(k) Premarket Notification Sysmex™ Automated Hematology Analzyer XE-2100