(100 days)
The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood. The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in EDTA anti-coagulated blood.
The XT-Series is an automated hematology analyzer previously cleared by the FDA (K021241- cleared June 24, 2002). The RET-He parameter determines the hemoglobin of reticulocytes. XT-Pro and RET- Master are required. The IG parameter (Immature Granulocyte) classifies and counts the immature granulocyte cells. The XT-Pro and IG Master are required.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sysmex XT-Series IG and RET-He parameters:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit acceptance criteria in the typical sense of performance thresholds. Instead, the "acceptance criteria" here is implicitly demonstrated through "excellent correlation" and "performance to the manufacturer's specification" when compared to the predicate device (Sysmex XE-2100). The specific numerical values for manufacturer's specifications for accuracy and precision are not detailed in this summary.
Therefore, the table will reflect the general statements of performance and equivalence rather than specific numeric acceptance criteria.
| Parameter | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Sysmex XT-Series) |
|---|---|---|
| IG Parameter | Substantially equivalent to predicate device (Sysmex XE-2100 IG) in terms of intended use, methodology, and performance (accuracy, precision, sample stability). | Demonstrated excellent correlation and performance to the manufacturer's specification compared to the Sysmex XE-2100 IG. |
| RET-He Parameter | Substantially equivalent to predicate device (Sysmex XE-2100 RET-He) in terms of intended use, methodology, and performance (accuracy, precision, sample stability). | Demonstrated excellent correlation and performance to the manufacturer's specification compared to the Sysmex XE-2100 RET-He. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that "Data consisting of accuracy, precision and sample stability was collected". However, it does not explicitly state the sample size used for the test set.
- Sample Size: Not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only indicates that the data was collected to show performance, implying it was likely a controlled study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given that this is an automated hematology analyzer, the "ground truth" for the predicate device's performance would typically be established through method comparisons against established reference methods or manual expert review, but this detail is omitted for the current submission.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study described is a comparison of the new device (Sysmex XT-Series) against a predicate device (Sysmex XE-2100), not a study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance evaluation of the Sysmex XT-Series IG and RET-He parameters. The device is an automated hematology analyzer, and the performance evaluated is the algorithm's ability to classify and count cells and determine reticulocyte hemoglobin, without direct human intervention in the measurement process.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation is implicitly established by comparing the Sysmex XT-Series to the predicate device, Sysmex XE-2100. The document states that the performance was "initially established in XE-2100 510(k) submission" and that the XT-Series "demonstrated excellent correlation" to the predicate. Therefore, the predicate device's results serve as the reference standard or "ground truth" for this substantial equivalence submission.
8. The Sample Size for the Training Set
The document does not specify the sample size used for any training set. As this device is primarily demonstrating equivalence to a previously cleared device, the emphasis is on testing the new device, not on detailing the initial development and training of the algorithms (which would have occurred for the predicate device or a much earlier version).
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established.
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OCT 1 0 2008
5. 510(k) SUMMARY of the XT-Series- IG and RET-He parameters
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:
| 1. Submitted by: | Sysmex America, Inc. | ||
|---|---|---|---|
| One Nelson C. White Parkway | |||
| Mundelein, IL 60060 | |||
| Phone: (847) 996-4682; FAX: (847) 996-4655 | |||
| Contact person: Carrie S. Pineda | |||
| Date prepared: July 2, 2008 | |||
| 2. Name of Device: | Trade or proprietary name: | ||
| RET-He parameter on Sysmex® XT-Series | |||
| IG parameter on Sysmex® XT- Series | |||
| Common name: Automated Hematology Analyzer | |||
| Classification name: | |||
| Sysmex® XT- Series, Automated Hematology Analyzer, an | |||
| Automated Differential Cell Counter, (21 CFR 864.5220) is a Class | |||
| II device. | |||
| 3. Predicate Method: | RET-He parameter on Sysmex® XE-2100 (K050589-Cleared May 5, | ||
| 2005) | |||
| IG parameter on Sysmex® XE-2100 (K032039-Cleared Sept 8, | |||
| 2003) | |||
| 4. DeviceDescription: | The XT-Series is an automated hematology analyzer previously | ||
| cleared by the FDA (K021241- cleared June 24, 2002). The RET- | |||
| He parameter determines the hemoglobin of reticulocytes. XT-Pro | |||
| and RET- Master are required. The IG parameter (Immature | |||
| Granulocyte) classifies and counts the immature granulocyte cells. | |||
| The XT-Pro and IG Master are required. | |||
| 5. Intended Use: | The IG parameter on the Sysmex® XT-Series, Automated | ||
| Hematology Analyzer, is intended for in vitro diagnostic use to | |||
| classify and count immature granulocyte cells in EDTA anti- | |||
| coagulated blood. The RET-He parameter on the Sysmex® XT- | |||
| Series, Automated Hematology Analyzer, determines the | |||
| hemoglobin of reticulocytes for in vitro diagnostic use in EDTA | |||
| anti-coagulated blood. | |||
| IG% / # | Immature Granulocyte Percent and Count | ||
| RET-He | Reticulocyte Hemoglobin | ||
| 6. Substantialequivalence-Similarities andDifferences: | Table 1 shows substantial equivalence of the XT-Series to the XE- | ||
| 2100. | |||
| 7. Conclusion | The XT-Series IG and RET-He parameters demonstrate substantial | ||
| equivalence to the XE-2100 IG and RET-He parameters. |
XT-Series- IG & RET-He Parameters 510(k) FDA Submission
12
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ﺎ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﻟﻠﻤﺴﺎﺭ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
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| Table 1: Substantial Equivalence-Similarities and Difference to XE-2100 | |
|---|---|
| Company of the Children Children Children Children Children | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Sysmex XE-2100- IG andRET-He parametersPredicate | Sysmex XT-Series- IG andRET-He parametersNew parameters | Similarity/Difference | |
|---|---|---|---|
| Intended Use | IG Parameter:The IG parameter on Sysmex®XE-2100 is intended for in vitro diagnostic use to classifyand count immaturegranulocyte cells in EDTAanti-coagulated blood.RET-He Parameter:The RET-He parameter on theSysmex® XE-2100,Automated HematologyAnalyzer, determines thehemoglobin of reticulocytesfor in vitro diagnostic use inclinical laboratories. | IG Parameter:The IG parameter on Sysmex®XT-Series is intended for in vitrodiagnostic use to classify andcount immature granulocytecells in EDTA anti-coagulatedblood.RET-He Parameter:The RET-He parameter on theSysmex® XT-Series, AutomatedHematology Analyzer,determines the hemoglobin ofreticulocytes for in vitrodiagnostic use in clinicallaboratories. | Both systems have the sameintended use statement. |
| Methodology | IG Parameter:The Immature Granulocyte(IG) count is measured in theDIFF channel. Thecombination of side scatter,forward scatter, andfluorescent intensity ofnucleated cells give an imageof each cell detected in theperipheral blood. Differentleukocyte populations orclusters such as the immaturegranulocytes are counted.RET-He Parameter:The reticulocyte parametersare derived using thereticulocyte forward scatteredlight signals from thereticulocyte measurementchannel and a proprietarySysmex calculation equation. | IG Parameter:The Immature Granulocyte (IG)count is measured in the DIFFchannel. The combination ofside scatter, forward scatter, andfluorescent intensity of nucleatedcells give an image of each celldetected in the peripheral blood.Different leukocyte populationsor clusters such as the immaturegranulocytes are counted.RET-He Parameter:The reticulocyte parameters arederived using the reticulocyteforward scattered light signalsfrom the reticulocytemeasurement channel and aproprietary Sysmex calculationequation. | Both systems use the samemethodology. |
| Reagents | CELLPACKTM (Diluent)CELLSHEATHTM (Diluent)STROMATOLYSER-FBTM(Lyse)STROMATOLYSER-4DLTM(Lyse)STROMATOLYSER-4DSTM(Stain)STROMATOLYSER-NRTM | CELLPACKTM (Diluent)STROMATOLYSER-FBTM(Lyse)STROMATOLYSER-4DLTM(Lyse)STROMATOLYSER-4DSTM(Stain)SULFOLYSER (Lyse)RET-SEARCH II (Diluent) | The XT-Series uses less reagentsdue to the fact that it doesn't testfor NRBC#/%. |
| (Diluent)STROMATOLYSER-NR™(Stain)STROMATOLYSER-IM™(Lyse)SULFOLYSER (Lyse)RET-SEARCH II (Diluent)RET-SEARCH II (Stain) | RET-SEARCH II (Stain) | ||
| QualityControl/Calibrator | e-Check—3 levelsX Cal | e-Check—3 levelsX Cal | The XE-2100 and the XT-Seriesuse the same Calibrator andcontrol material. |
| Software/HardwareDifferences | The XE-pro software wasadded to the original XE-2100in order to include additionalmaster programs (IG, RET). | The XT-pro software was addedto the original XT-Series inorder to include additionalmaster programs (IG, RET). | The XT-Series performs thesame as the XE-2100 with theIG and RET masters. |
| SpecimenType | Random whole blood | Random whole blood | Both systems use the samespecimen types. |
| Throughput | Approximately 113-150samples/hour depending onthe mode used. | Approximately 50-80samples/hour depending on themode used. | XT-Series has a lowerthroughput. |
| EquivalencyData: | Performance was initiallyestablished in XE-2100 510(k)submission (K992875) & thenadditional masters/parameterswere submitted in subsequentsubmissions:XE-2100 IG (K032039)XE-2100 RET-He (K050589) | Performance of the XT-Serieswas initially established in510(k) submission (K021241).The additional IG & RET-Heparameters demonstratedexcellent correlation. | Data consisting of accuracy,precision and sample stabilitywas collected to showperformance to themanufacturer's specification forthe IG and RET-He parameters.This analysis supports the claimthat the XT-Series IG & RET-Heparameters are substantiallyequivalent to the XE-2100. |
XT-Series- IG & RET-He Parameters
510(k) FDA Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 0 2008
Sysmex America, Inc. c/o Ms. Carrie Pineda Supervisor, Clinical Affairs One Nelson C. White Parkway Mundelein, IL 60060
Re: K081890
Trade/Device Name: IG parameter on Sysmex® XT-Series and RET-He parameters on Sysmex® XT-Series
Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: September 25, 2008 Received: September 26, 2008
Dear Ms. Pineda:
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 (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding
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Page 2 – Ms. Carrie Pineda
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 procced 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,
Maria M Chan
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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4. INDICATIONS FOR USE STATEMENT
Indications for Use
KO81890 510(k) Number (if known):
Device Name: Sysmex® XT-Series, Automated Hematology Analyzer IG & RET-He Parameters
Indications For Use:
The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood. The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in EDTA anti-coagulated blood.
| IG% / # | Immature Granulocyte Percent and Count |
|---|---|
| RET-He | Reticulocyte Hemoglobin |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
mchen
Division Sign-Off
Concurrence of CDRH, Office office office affices for
510(k) K081890 11
XT-Series- IG & RET-He Parameters 510(k) FDA Submission
§ 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.”