(81 days)
The Sysmex® XS-1000iC is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories and reference laboratories. The XS-1000iC will extend MCV stability to 48 hours.
The Sysmex® XS-1000iC is part of the XS-Series instrument line. It is a multi-parameter hematology analyzer intended to perform tests in anti-coagulated blood. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes blood samples; (2) Auto Loader that 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 XS-Series instruments provide accurate and precise test results for up to 21 analysis parameters in whole blood. These include: 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 MPV Mean Platelet Volume RDW-SD RBC Distribution Width-SD RDW-CV RBC Distribution Width-CV NEUT%/# Neutrophil Percent and Count LYMPH%/# Lymphocyte Percent and Count MONO%/# Monocyte Percent and Count EO%/# Eosinophil Percent and Count BASO%/# Basophil Percent and Count The instrument processes approximately 60 samples per hour, depending on the mode used. The XS display various scattergrams, along with data for the reportable parameters. It displays the following analysis results on the IPU screen: WBC 5DIFF, White blood cells/Basophils, RBC pattern data of cell size distribution curves for platelet and analysis parameters. Analysis results and graphics can be printed on any of the available printers or transmitted to a Host computer. Sample abnormalities are indicated by abnormal marks, flags and error messages which appear on the LCD display screen and on the printout. This is an indication that the sample is not within the acceptable range and requires further review and investigation. There are two discrete testing options --- CBC and CBC with Diff. The XS performs analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. Blood cells pass through the aperature 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 blood cells passing through the flow cell. The forward scattered light is received by the photodiode, and the lateral scattered light and lateral fluorescent light are received by the photo multiplier tube. This light is converted tinto electrical pulses, thus making it possible to obtain blood cell information. Hemoglobin is measured with the SLS-hemoglobin method using Sodium Lauryl Sulfate, which is an analysis method used in our previous instrumentation. A modification kit will be installed on a standard XS-1000i instrument where samples >48 hours are analyzed. This modification kit includes software and hardware changes and includes a modified reagent, Cellsheath (C). In this modification, the RBC/PLT dilution process will now be diluted using the Cellsheath (C) reagent after being warmed past 20℃. Software and hardware modifications include changes to the instrument's tubing and modification of the heating block. This only impacts the RBC/PLT dilution step. The WBC and HGB parameters are not impacted. This modification kit was not a change due to recall or corrective action, labeling change, technology or performance change or materials change.
The provided text is a 510(k) summary for the Sysmex XS-1000iC Automated Hematology Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (Sysmex XE-2100DC) rather than providing a detailed study describing acceptance criteria and device performance in the format commonly seen for new, non-inferiority claims.
Here's an analysis based on the provided text, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, precision ranges) for the XS-1000iC. Instead, it claims that the "Performance of the XS-1000iC is the same as the XE-2100DC" and that "Comparison of the XS-1000iC to the XE-2100DC demonstrated substantial equivalence."
The core claim is about the extension of MCV stability to 48 hours. This can be considered an acceptance criterion.
| Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|
| Extend MCV stability to 48 hours | "The XS-1000iC will extend MCV stability to 48 hours." (Stated in Intended Use) "Performance of the XS-1000iC is the same as the XE-2100DC." "Comparison of the XS-1000iC to the XE-2100DC demonstrated substantial equivalence." |
| Maintain performance for other parameters (WBC, HGB, etc.) | (Implied by substantial equivalence and statements that the modification only impacts RBC/PLT dilution, and WBC/HGB are not impacted.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set for the XS-1000iC study.
It mentions:
- "A modification kit will be installed on a standard XS-1000i instrument where samples >48 hours are analyzed."
- "A modification kit was installed on a standard XS-1000i instrument where samples >48 hours are analyzed." (Table 1 describing XS-1000iC)
- "A modification kit was installed on a standard XE-2100 instrument where samples >48 hours are analyzed." (Table 1 describing XE-2100DC)
This suggests that the evaluation involved samples analyzed at greater than 48 hours to confirm the extended MCV stability claim. However, no specific number of samples or details on their provenance (country, retrospective/prospective) are provided for the XS-1000iC verification itself. The "Equivalency Data" section simply states, "Performance of the XS-1000iC is the same as the XE-2100DC. Comparison of the XS-1000iC to the XE-2100DC demonstrated substantial equivalence." This implies that the performance data for the XE-2100DC, which was cleared under K051459, is being leveraged without explicitly detailed new performance studies for the XS-1000iC in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device and submission. Hematology analyzers measure blood cell parameters using automated methods. Ground truth is typically established by reference methods or validated manual counts, not by expert interpretation of images or clinical cases in the way that, for example, a CAD (Computer-Aided Detection) system for radiology would use expert radiologists. The "ground truth" for parameter measurement would be the highly controlled and validated reference measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a hematology analyzer measuring objective parameters. Adjudication methods are typically used in clinical trials or image interpretation studies where there's subjectivity or a need for consensus among multiple human reviewers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. No MRMC study was done, as there are no human "readers" in the context of this automated measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the Sysmex XS-1000iC is an automated hematology analyzer, meaning its performance is inherently standalone (algorithm/instrument only) without human intervention in the primary measurement process itself. The "modification kit" involves software and hardware changes to the instrument to enable the extended MCV stability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For hematology analyzers, the ground truth for parameters like MCV, WBC, RBC, HGB, etc., is typically established through:
- Reference methods: Highly precise and accurate manual counting methods or other validated automated methods.
- Calibration materials: Certified reference materials with known values traceable to international standards.
The document does not explicitly detail the specific ground truth methods used for the XS-1000iC testing, but it is implied to be based on the established and validated methods for the predicate device and general hematology practice.
8. The sample size for the training set
The document does not specify a "training set" sample size. This is a 510(k) submission for a device modification, suggesting the underlying algorithms were developed and "trained" much earlier for the predicate device. The current submission focuses on demonstrating "substantial equivalence" for the modified device, implying a verification/validation approach rather than a new algorithm training phase.
9. How the ground truth for the training set was established
As there is no explicit mention of a training set for the XS-1000iC modification in this document, the method for establishing ground truth for a training set is not provided. For the initial development of such an analyzer's algorithms, ground truth would have been established through a combination of reference methods, extensive sample testing, and potentially correlation with clinical outcomes, but these details are not part of this 510(k) summary for a modification.
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510(k) SUMMARY of the XS-1000iC
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: КО816 10
| 1. Submitted by: | Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: May 30, 2008 | ||
|---|---|---|---|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XS-1000iCCommon name: Automated Hematology Analyzer.Classification name:Sysmex® XS-Series, Automated Hematology, an AutomatedDifferential Cell Counter (21 CFR 864.5220) is a Class II device.Related Items:CELLSHEATH (C)TM (Diluent) Product Code: 81GIFSTROMATOLYSER-4DLTM (Lyse) Product Code: 81GGKSTROMATOLYSER-4DSTM (Stain) Product Code: 81KJKSULFOLYSER (Lyse) Product Code: 81GGKXS Calibrator Product Code: 81KSAe-Check (Control) Product Code: 81JPKOption: Graphic printer and Bar code Reader | ||
| 3. Predicate Method: | Sysmex® XE-2100DC (K051459-Cleared Sept 23, 2005) | ||
| 4. Device Description: | The Sysmex® XS-1000iC is part of the XS-Series instrument line. It is amulti-parameter hematology analyzer intended to perform tests in anti-coagulated blood. The instrument consists of three principal units: (1)Main Unit which aspirates, dilutes, mixes and analyzes blood samples;(2) Auto Loader that supplies samples to the Main Unit automatically;(3) IPU (Information Processing Unit) which processes data from theMain Unit and provides the operator interface with the system. | ||
| The XS-Series instruments provide accurate and precise test results forup to 21 analysis parameters in whole blood. These include:WBC White Blood Cell CountRBC Red Blood Cell CountHGB HemoglobinHCT HematocritMCV Mean Cell VolumeMCH Mean Cell HemoglobinMCHC Mean Cell Hemoglobin ConcentrationPLT Platelet CountMPV Mean Platelet VolumeRDW-SD RBC Distribution Width-SDRDW-CV RBC Distribution Width-CVNEUT%/# Neutrophil Percent and CountLYMPH%/# Lymphocyte Percent and CountMONO%/# Monocyte Percent and CountEO%/# Eosinophil Percent and CountBASO%/# Basophil Percent and Count |
Sysmex XS-1000iC, Automated Hematology Analyzer 510(k) FDA Submission
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| The instrument processes approximately 60 samples per hour,depending on the mode used. The XS display various scattergrams,along with data for the reportable parameters. It displays the followinganalysis results on the IPU screen: WBC 5DIFF, White bloodcells/Basophils, RBC pattern data of cell size distribution curves forplatelet and analysis parameters. Analysis results and graphics can beprinted on any of the available printers or transmitted to a Hostcomputer. Sample abnormalities are indicated by abnormal marks, flagsand error messages which appear on the LCD display screen and on theprintout. This is an indication that the sample is not within theacceptable range and requires further review and investigation. Thereare two discrete testing options --- CBC and CBC with Diff.The XS performs analyses using the following methods: Sheath Flow | |
|---|---|
| DC Detection Method, Flow Cytometry Methods using aSemiconductor Laser and SLS-hemoglobin method. Blood cells passthrough the aperature of the detector surrounded by sheath fluid usingthe sheath flow method. The principle of flow cytometry is also used.A semiconductor laser beam is emitted to the blood cells passingthrough the flow cell. The forward scattered light is received by thephotodiode, and the lateral scattered light and lateral fluorescent lightare received by the photo multiplier tube. This light is converted tintoelectrical pulses, thus making it possible to obtain blood cellinformation. Hemoglobin is measured with the SLS-hemoglobinmethod using Sodium Lauryl Sulfate, which is an analysis method usedin our previous instrumentation. | |
| A modification kit will be installed on a standard XS-1000i instrumentwhere samples >48 hours are analyzed. This modification kit includessoftware and hardware changes and includes a modified reagent,Cellsheath (C). In this modification, the RBC/PLT dilution process willnow be diluted using the Cellsheath (C) reagent after being warmed past20℃. Software and hardware modifications include changes to theinstrument's tubing and modification of the heating block. This onlyimpacts the RBC/PLT dilution step. The WBC and HGB parametersare not impacted. This modification kit was not a change due to recallor corrective action, labeling change, technology or performancechange or materials change. | |
| 5. Intended Use: | The Sysmex® XS-1000iC is an automated hematology analyzer for invitro diagnostic use in clinical laboratories and reference laboratories.The XS-1000iC will extend MCV stability to 48 hours. |
| 6. Substantialequivalence-Similarities andDifferences: | Table 1 shows substantial equivalence of the XS-1000iC to the XS-2100DC. |
| 7. Conclusion | The XS-1000iC demonstrates substantial equivalence to the XE-2100DC. |
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| Table 1: Substantial Equivalence—Similarities and Difference to XE-2100DC | |||
|---|---|---|---|
| Sysmex XE-2100DCPredicate | Sysmex XS-1000iCModification of Predicate | Similarity/Difference | |
| Intended Use | The Sysmex® XE-2100DC isan automated hematologyanalyzer for in vitro diagnosticuse in clinical laboratories andreference laboratories. TheXE-2100DC will extend MCVstability to 48 hours. | The Sysmex® XS-1000iC is anautomated hematology analyzerfor in vitro diagnostic use inclinical laboratories andreference laboratories. The XS-1000iC will extend MCVstability to 48 hours. | Both systems have the sameintended use. |
| Methodology | The XE-2100DC performsanalyses using the followingmethods: Sheath Flow DCDetection Method, and FlowCytometry Methods using aSemiconductor Laser andSLS-hemoglobin method. | The XS-1000iC performsanalyses using the followingmethods: Sheath Flow DCDetection Method, FlowCytometry Methods using aSemiconductor Laser and SLS-hemoglobin method. | Both systems use the samemethodology. |
| Reagents | CELLPACKTM (Diluent)CELLSHEATH (C)TM (Diluent)STROMATOLYSER-FBTM (Lyse)STROMATOLYSER-4DLTM (Lyse)STROMATOLYSER-4DSTM (Stain)STROMATOLYSER-NRTM (Diluent)STROMATOLYSER-NRTM (Stain)STROMATOLYSER-IMTM (Lyse)SULFOLYSER (Lyse) | CELLSHEATH (C)TM (Diluent)STROMATOLYSER-4DLTM (Lyse)STROMATOLYSER-4DSTM (Stain)SULFOLYSER (Lyse) | The XE-2100DC and the XS-1000iC use some of the samereagents. The XS-1000iC doesnot report out all the parametersthat the XE-2100DC does so notall reagents are used on the XS-1000iC. |
| QualityControl/Calibrator | e -Check—3 levelsXE Calibrator (X Cal) | e -Check—3 levelsXE Calibrator (X Cal) | The XE-2100DC and the XS-1000iC use the same calibratorand control material |
| Software/HardwareDifferences | A modification kit wasinstalled on a standard XE-2100 instrument wheresamples >48 hours areanalyzed. This modificationkit includes software andhardware changes andincludes a modified reagent,Cellsheath (C). In thismodification, the RBC/PLTdilution process will now bediluted using the Cellsheath(C) reagent after beingwarmed past 20°C. Softwareand hardware modificationsinclude changes to theinstrument's tubing andmodification of the heatingblock. This only impacts theRBC/PLT dilution step. TheWBC and HGB parametersare not impacted. Thismodification kit was not a | A modification kit was installedon a standard XS-1000iinstrument where samples >48hours are analyzed. Thismodification kit includessoftware and hardware changesand includes a modified reagent,Cellsheath (C). In thismodification, the RBC/PLTdilution process will now bediluted using the Cellsheath (C)reagent after being warmed past20°C. Software and hardwaremodifications include changes tothe instrument's tubing andmodification of the heatingblock. This only impacts theRBC/PLT dilution step. TheWBC and HGB parameters arenot impacted. This modificationkit was not a change due torecall or corrective action,labeling change, technology or | There is no difference in themodification kit. |
| Table 1: Substantial Equivalence-Similarities and Difference to XE-2100DC | ||
|---|---|---|
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| corrective action, labelingchange, technology orperformance change ormaterials change. | change. | ||
|---|---|---|---|
| SpecimenType | Random whole blood samples | Random whole blood samples. | Both systems use the samespecimen types. |
| Throughput | Approximately 113-150samples/hour depending onthe mode used. | Approximately 60 samples/hourdepending on the mode used. | There is a difference in thenumber of samples/hour. |
| EquivalencyData: | Performance was establishedin XE-2100DC 510(k)submission (K051459). | Performance of the XS-1000iCis the same as the XE-2100DC.Comparison of the XS-1000iC tothe XE-2100DC demonstratedsubstantial equivalence. | Performance was substantialequivalence. |
Sysmex XS-1000iC, Automated Hematology Analyzer 510(k) FDA Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement. The text is in all caps and is positioned around the perimeter of the logo.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sysmex America, Inc. C/O Nina Gamperling One Nelson C. White Parkway Mundelein, Illinois 60060
AUG 2 9 2008
Re: K081610
Trade/Device Name: Sysmex Model XS-1000iC Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Hematology Analyzer Regulatory Class: Class II Product Code: GKZ Dated: August 13, 2008 Received: August 15, 2008
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
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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.
Marie Mchen
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOS (q / O
Device Name: Sysmex® XS-1000iC, Automated Hematology Analyzer
Indications For Use: The Sysmex® XS-1000iC is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories and reference laboratories. The XS-1000iC will extend MCV stability to 48 hours.
Duphine Bautista
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (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)
§ 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.”