(69 days)
The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood.
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. The Immature Granulocyte (IG) count is measured in the DIFF channel. The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the peripheral blood. Different leukocyte populations or clusters such as the immature granulocytes are counted by the XE-2100. (Note: XE-Pro and IG Master are required to obtain results described.)
The provided text describes the submission for a 510(k) premarket notification for the Immature Granulocyte (IG) parameter on the Sysmex® XE-2100™ Automated Hematology Analyzer. The submission states that studies were performed to evaluate the equivalency of the IG count to a predicate method, the manual microscopic differential cell count, and that these studies "indicated equivalent performance" and "demonstrated substantial equivalence." However, the document does not provide detailed acceptance criteria or the specific results of the study to prove that criteria were met. It only broadly states that the device showed good correlation and equivalent performance when compared to the manual count.
Therefore, the following information is extracted and inferred from the text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to the predicate method (manual microscopic differential cell count) | "Results indicated equivalent performance.""Comparison to manual count showed good correlation.""The performance data demonstrated substantial equivalence." |
Study Details:
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Sample size used for the test set and data provenance:
- The document implies that the "manual differential cell counting" used as the predicate method typically counts "100 cells." It also mentions "The NCCLS H20-A method uses 400 cell differential performed by 2 techs each counting 200 cells." However, it does not explicitly state the sample size (number of patient specimens) used for the test set of the device evaluation studies.
- The data provenance (country of origin, retrospective/prospective) is not specified.
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Number of experts used to establish the ground truth for the test set and qualifications:
- The document states, for the manual method, "The NCCLS H20-A method uses 400 cell differential performed by 2 techs each counting 200 cells." This implies that at least two technicians were involved in establishing the ground truth for the manual method, which serves as the predicate. Their specific qualifications (e.g., years of experience) are not detailed beyond "techs."
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Adjudication method for the test set:
- The document states "2 techs each counting 200 cells" for the NCCLS H20-A method. This suggests a form of consensus or comparison between two readers, but the explicit adjudication method (e.g., 2+1, 3+1) is not specified.
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Multi-reader multi-case (MRMC) comparative effectiveness study:
- No MRMC comparative effectiveness study is explicitly mentioned. The evaluation is a comparison of the automated device's performance against a manual predicate method, not an assessment of how human readers improve with AI assistance.
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Standalone (algorithm only without human-in-the-loop performance) study:
- Yes, the description of the device's accuracy ("Automated counting of immature granulocytes on an automated hematology analyzer" and "Comparison to manual count showed good correlation") indicates a standalone study where the device's output is directly compared to the ground truth.
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Type of ground truth used:
- The ground truth used for comparison is the "Manual Microscopic Differential Cell Count," which involves human experts visually classifying and counting cells under a microscope. This can be considered expert consensus or expert visual assessment.
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Sample size for the training set:
- The document does not provide information on the sample size used for the training set. It focuses on the validation study against the predicate method.
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How the ground truth for the training set was established:
- The document does not provide information on how the ground truth was established for a training set.
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SEP - 8 2003
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: _______________________________________________________________________________________________________________________________________________
| 1. Submitted by: | Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4693Contact person: Nina GamperlingDate prepared: June 30, 2003 |
|---|---|
| 2. Name of Device: | Trade or proprietary name: Immature Granulocyte (IG)parameter on the Sysmex® XE-2100, Automated HematologyAnalyzer. |
| Common name: IG parameter | |
| Classification name: IG parameter on the Automated DifferentialCell Counter, Sysmex® XE-2100 (21 CFR 864.5220) | |
| 3. Predicate Device: | The IG parameter on the Sysmex® XE-2100 is substantiallyequivalent to the microscopic method of the manual differentialcell counting used in the United States prior to 1976. |
| 4. Device Description: | The XE-2100 is an automated hematology analyzer previouslycleared by the FDA. The Immature Granulocyte (IG) count ismeasured in the DIFF channel. The combination of side scatter,forward scatter, and fluorescent intensity of nucleated cells givesan image of each cell detected in the peripheral blood. Differentleukocyte populations or clusters such as the immaturegranulocytes are counted by the XE-2100. (Note: XE-Pro and IGMaster are required to obtain results described.) |
| 5. Intended Use: | The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostic use to classify and countimmature granulocyte cells in EDTA anti-coagulated blood. |
| 6. Substantialequivalence-similaritiesand differences | The following table compares the IG parameter with predicatemethod. |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Manual MicroscopicDifferential Cell Count | IG count on the XE-2100 | |
|---|---|---|
| Predicate | New method | |
| Intended Use | To manually classify and countthe white blood cells into subcategories using a microscope. | To classify and count immaturegranulocyte cells in EDTA anti-coagulated blood. |
| Methodology | Manual counting of immaturegranulocytes using a microscope.Typically the manual methodcounts 100 cells. The NCCLSH20-A method uses 400 celldifferential performed by 2 techseach counting 200 cells. | Automated counting of immaturegranulocytes on an automated hematologyanalyzer. |
| Type ofAnticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Method of real counting of cellsusing a microscope established asthe predicate method. | Comparison to manual count showedgood correlation. |
| Pro/Con | Manual method is imprecise dueto the small number of cellscounted, typically not more than100 WBC total. It is laborintensive and time-consuming. | A large number of cells can be analyzedand several parameters (i.e. forwardscatter [FSC], side scatter [SSC], andfluorescent labels) rather thanmorphological appearance alone can beused. |
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency ofthe IG count to the predicate method. Results indicatedequivalent performance.The performance data demonstrated substantial | |
| 8. Conclusions: |
Comparison Table to Predicate Method
| 8. Conclusions: | |
|---|---|
| ----------------- | -- |
equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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SEP - 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina M. Gamperling, MBA, MT(ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway Mundelein. IL 60060
Re: K032039
Trade/Device Name: Immature Granulocyte (IG) parameter on the Sysmex® XE-2100™ Automated Hematology Analyzer
Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: June 30, 2003 Received: July 9, 2003
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 (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Immature Granulocyte (IG) parameter on the Sysmex® XE-2100™, Automated Hematology Analyzer
Indications For Use:
The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostics to classify and count immature granulocyte cells in EDTA anti-coagulated blood.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| OR | |
| Over-The-Counter Use |
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K032039 |
|---|---|
| -------- | --------- |
Sysmex America, Inc.
§ 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.”