(113 days)
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).
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.)
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Sysmex® XE-2100DC™ Automated Hematology Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criterion for the Sysmex XE-2100DC is the extended stability of the Mean Corpuscular Volume (MCV) parameter.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Extend MCV stability to 48 hours in EDTA anticoagulated whole blood | The XE-2100DC demonstrated extended stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperatures (18-26°C). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample size used for the clinical performance studies. It mentions "Studies were performed to evaluate the equivalency of XE-2100DC to the predicate method."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts or a ground truth established by them for the stability study. The study focused on comparing the performance of the new device (XE-2100DC) against its predicate (XE-2100) for MCV stability.
4. Adjudication Method for the Test Set
Not applicable. The study design involved directly comparing MCV values obtained from the XE-2100DC at different time points and temperatures against the predicate. No adjudication by human experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an automated hematology analyzer, and the study was focused on the analytical performance (stability) of a specific parameter, not on human reader performance with or without AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance study of the automated hematology analyzer. It evaluates the device's ability to maintain MCV stability without human intervention in the analysis process beyond standard sample handling.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate device (Sysmex XE-2100) and the expected stability of the MCV parameter based on established laboratory practices, particularly in relation to the 48-hour stability claim. The study aimed to show equivalency to the predicate and the extended stability itself as the desired outcome.
8. The Sample Size for the Training Set
Not applicable. This device is an analytical instrument, not an AI/machine learning algorithm requiring a separate training set in the conventional sense. The "training" would be the engineering and calibration of the instrument itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this isn't an AI/ML context with a training set and corresponding ground truth in the typical understanding. The device's operational parameters and measurement accuracy would have been established during its development and calibration processes.
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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 ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: September 2, 2005 |
|---|---|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XE-2100DC, Automated Hematology Analyzer.Common name: XE-2100DCClassification name: Automated Differential Cell Counter,Sysmex® XE-2100DC (21 CFR 864.5220) |
| 3. Predicate Device: | The Sysmex® XE-2100DC, Automated Hematology Analyzer, issubstantially equivalent to the Sysmex XE-2100, AutomatedHematology Analyzer. |
| 4. Device Description: | The XE-2100 is an automated hematology analyzer previouslycleared by the FDA. XE-2100DC will extend MCV stability to48 hours. (Note: XE pro software is required to obtain resultsdescribed.) |
| 5. Intended Use: | The Sysmex XE-2100DC is an automated hematology analyzerfor in vitro diagnostic use in screening patient populations foundin clinical laboratories and reference laboratories. The XE-2100DC analyzes the following parameters: WBC, RBC, HGB,HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPVand NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO%/#. The XE-2100DC will extend the stability of the MCVparameter in EDTA anticoagulated whole blood samples to 48hours at 4°C and room temperatures (18-26°C). |
| 6. Substantialequivalence-similaritiesand differences | The following table compares the XE-2100DC with the predicatemethod. |
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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. |
| DilutingReagentDifferences | CELLSHEATH | CELLSHEATH(C) |
| Software/HardwareDifferences | --- | Hardware: Tubing changes; Heating block modification.Software: Proprietary temperature algorithms |
| Type ofAnticoagulant | 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. |
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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.
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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
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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
§ 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.”