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
Device Story
Automated hematology analyzer for clinical laboratory use; processes whole blood samples to provide multi-parameter cell counts and differentials. System comprises four units: Main Unit (aspiration, dilution, mixing, analysis), Sampler Unit (automated sample supply), IPU (data processing/operator interface), and Pneumatic Unit (pressure/vacuum). Analyzes RBC/PLT via sheath-flow DC detection; WBC via flow cytometry using semiconductor laser detection. Output provided to clinicians for hematological assessment; aids in diagnosis and monitoring of pathological conditions. Benefits include high-throughput automated analysis compared to manual methods.
Clinical Evidence
Bench testing included carryover, precision, linearity, and sample stability studies. Clinical correlation studies compared XE-2100 results to manual differentials (per NCCLS H20A) and flow cytometry using specimens from healthy individuals and patients with various pathological conditions. Results demonstrated performance equivalent to predicate devices.
Indicated for the classification of formed elements in EDTA anti-coagulated blood for patients requiring hematological analysis.
Regulatory Classification
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.”
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K992875
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-<br>Coefficient of Variation |
| Eo% | Eosinophil percent | RDW-SD | Red Cell Distribution Width-<br>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<br>percent | HFR* | High Fluorescence Ratio |
| NRBC# | Nucleated red blood cell<br>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
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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.
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| Features<br>(Submission #) | XE-2100 | SE/RAM-1<br>(K964375) | SF-3000<br>(K950508) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | --- | 13-Mar-97 | 3-Nov-95 |
| Intended Use | Automated blood cell<br>analyzer | Automated blood cell<br>counter | Automated blood cell<br>analyzer |
| Sample Type | Whole blood | Whole blood | Whole blood |
| Sample Volume | 200µL- Cap piercer<br>130µL -Manual<br>40µL-Capillary dilution | 250µL- Cap piercer<br>100µL -Manual<br>40µL-Capillary dilution | 270µL- Cap piercer<br>170µL -Manual<br>40µL-Capillary dilution |
| Performance | Same | Proven performance in<br>FDA submission | Proven performance in<br>FDA submission |
| Parameters | WBC, Neut%/#,<br>Lymph%/ #, Mono%/#,<br>Eos%/#, Baso%/#,<br>NRBC%/#, RBC, HGB,<br>HCT, MCV, MCH,<br>MCHC, RDW-CV,<br>RDW-SD, RET%/#,<br>IRF, HFR*, MFR*,<br>LFR*, PLT, MPV,<br>PDW*, P-LCR*, PCT*<br>*Not reportable in USA | WBC, Neut%/#,<br>Lymph%/ #, Mono%/#,<br>Eos%/#, Baso%/#,<br>RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW-<br>CV, RDW-SD, RET%/#,<br>IRF, PLT, MPV. | WBC, Neut%/#,<br>Lymph%/#, Mono%/#,<br>Eos%/#, Baso%/#,<br>RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW-<br>CV, RDW-SD, PLT,<br>PDW, MPV, P-LCR. |
| Reagents | Cellpack, Cellsheath<br>Stromatolyser-FB,<br>Stromatolyser-4DL,<br>Stromatolyser-4DS,<br>Stromatolyser, NR,<br>Stromatolyser-IM,<br>Sulfolyser,<br>Ret-Search II | Cellpack, Cellsheath,<br>Cellpack-3D,<br>StromatolyserWL(II),<br>Stromatolyser-3D,<br>StromatolyserEO(II),<br>Stromalyser-BA,<br>Stromatolyser-IM,<br>Sulfolyser, Ret-Search,<br>Ret-Sheath | Cellpack, Sulfolyzer,<br>Stromatolyser FD(I),<br>Stromatolyser FD(II),<br>Stromatolyser-FB |
| Principles | RBC, PLT: Sheath-flow<br>DC detection method,<br>WBC: Flow Cytometry<br>method using<br>semiconductor laser<br>detection method | RBC, PLT: Sheath-flow<br>DC detection method,<br>WBC: DC Detection<br>Method, RF/DC<br>Detection Method | RBC, PLT: DC<br>detection method,<br>WBC: Flow using<br>semiconductor laser |
| Dimensions<br>(HxWxD) (mm) | 711x706x912 | 720x636x820 | 600x580x450 |
| Weight (kg) | 93 | 80 | 60 |
| QC System | L-J: 10 Files with 300<br>points per file | L-J: 27 Files with 180<br>points per file | L-J: 12 Files with 180<br>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
## 0000009
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
