(127 days)
Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%#, PMN%# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA, as needed).
The Sysmex® XE-5000 is part of the XE-Series instrument line. It is a multi-parameter hematology analyzer intended to perform tests in anti-coagulated blood and body fluids. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes blood and body fluid samples; (2) Auto Sampler Unit 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 XE-5000 is equipped with a Sampler that provides continuous automated sampling for up to 100 tubes. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. The body fluid analysis mode of the XE-5000 uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found in the body fluid. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
Here's a breakdown of the acceptance criteria and study information for the Sysmex XE-5000, based on the provided text:
Acceptance Criteria and Device Performance
The document states that the performance of the XE-5000 whole blood mode is the same as the XE-2100 with additional masters. For the Body Fluid mode, which has additional parameters (WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#), the claim is "excellent correlation" to the XE-2100 Body Fluid. The acceptance criteria themselves are not explicitly listed as specific numerical thresholds, but rather implied by "manufacturer's specification" and "excellent correlation".
| Parameter (Body Fluid Mode) | Acceptance Criteria (Implied) | Reported Device Performance | Study Type |
|---|---|---|---|
| WBC-BF | Meet manufacturer's specifications for accuracy, reproducibility, linearity, and carryover | Demonstrated excellent correlation to XE-2100 Body Fluid | Comparison of XE-5000 body fluid mode to XE-2100 |
| RBC-BF | Meet manufacturer's specifications for accuracy, reproducibility, linearity, and carryover | Demonstrated excellent correlation to XE-2100 Body Fluid | Comparison of XE-5000 body fluid mode to XE-2100 |
| MN% / # | Meet manufacturer's specifications for accuracy, reproducibility, linearity, and carryover | Demonstrated excellent correlation to XE-2100 Body Fluid | Comparison of XE-5000 body fluid mode to XE-2100 for samples with WBC counts > 0.030 x 10^3 /ul for other body fluids, and WBC counts for CSF > 0.01 x 10^3 /ul. |
| PMN% / # | Meet manufacturer's specifications for accuracy, reproducibility, linearity, and carryover | Demonstrated excellent correlation to XE-2100 Body Fluid | Comparison of XE-5000 body fluid mode to XE-2100 for samples with WBC counts > 0.030 x 10^3 /ul for other body fluids, and WBC counts for CSF > 0.01 x 10^3 /ul. |
| TC-BF# | Meet manufacturer's specifications for accuracy, reproducibility, linearity, and carryover | Demonstrated excellent correlation to XE-2100 Body Fluid | Comparison of XE-5000 body fluid mode to XE-2100 |
Note: The document only mentions "manufacturer's specification" without providing the specific numerical values for these specifications (e.g., specific accuracy percentages, CVs for reproducibility, etc.). It claims "excellent correlation" to the predicate device, the Sysmex XE-2100.
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of samples. The document mentions "Data consisting of carryover, linearity, accuracy and reproducibility was collected to show performance to the manufacturer's specification for the Body Fluid mode."
- Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The text also doesn't specify if the study was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The study involves comparing the new device against a predicate device (Sysmex XE-2100) and against manufacturer's specifications, rather than using expert-established ground truth for each case. The ground truth for the predicate device would have been established previously.
-
Adjudication method for the test set:
- Not applicable/Not mentioned. The study appears to be a direct comparison of instrument measurements rather than an assessment requiring multiple human readers and adjudication.
-
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:
- No. This is an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented is for the standalone device, the Sysmex XE-5000, in comparison to another standalone device (Sysmex XE-2100). The device is an "automated hematology analyzer," implying standalone operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the body fluid mode, the ground truth for comparison appears to be the performance of the Sysmex XE-2100 Body Fluid (the predicate device), as well as the manufacturer's internal specifications for parameters like accuracy, linearity, and reproducibility.
-
The sample size for the training set:
- Not applicable/Not mentioned. The document describes a new iteration of an existing automated analyzer, not a machine learning model that requires a distinct training set. The "training" in this context would likely refer to the internal validation and development data used during the instrument's design process, which is not detailed here.
-
How the ground truth for the training set was established:
- Not applicable/Not mentioned, as there is no specific "training set" described for a machine learning algorithm. If considered from an instrument development perspective, the ground truth for optimizing the instrument's performance would rely on established laboratory methods and reference ranges.
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5. 510(k) SUMMARY of the XE-5000
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) 996-4655Contact person: Nina GamperlingDate prepared: July 13, 2007 | |
|---|---|---|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XE-5000Common name: Automated Hematology Analyzer.Classification name:Sysmex® XE-Series, Automated Hematology, an AutomatedDifferential Cell Counter (21 CFR 864.5220) is a Class II device.Related Items:CELLPACK™ (Diluent) | Product Code: 81GIF |
| CELLSHEATH™ (Diluent) | Product Code: 81GIF | |
| STROMATOLYSER-FB™ (Lyse) | Product Code: 81GGK | |
| STROMATOLYSER-4DL™ (Lyse) | Product Code: 81GGK | |
| STROMATOLYSER-4DS™ (Stain) | Product Code: 81KJK | |
| STROMATOLYSER-NR™ (Diluent) | Product Code: 81GGK | |
| STROMATOLYSER-NR™ (Stain) | Product Code: 81KJK | |
| STROMATOLYSER-IM™ (Lyse) | Product Code: 81GGK | |
| SULFOLYSER (Lyse) | Product Code: 81GGK | |
| RET-SEARCH II (Diluent) | Product Code: 81GIF | |
| RET-SEARCH II (Stain) | Product Code: 81KJK | |
| XE Calibrators | Product Code: 81KSA | |
| e-Check (XE) (Control) | Product Code: 81JPK | |
| Option:Graphic printerBar code Reader | ||
| 3. Predicate Method: | Sysmex® XE-2100 Body Fluid (K040073-Cleared March 18, 2004) | |
| 4. Device Description: | The Sysmex® XE-5000 is part of the XE-Series instrument line. It is amulti-parameter hematology analyzer intended to perform tests in anti-coagulated blood and body fluids. The instrument consists of threeprincipal units: (1) Main Unit which aspirates, dilutes, mixes andanalyzes blood and body fluid samples; (2) Auto Sampler Unit suppliessamples to the Main Unit automatically; (3) IPU (InformationProcessing Unit) which processes data from the Main Unit and providesthe operator interface with the system. The XE-5000 is equipped with aSampler that provides continuous automated sampling for up to 100tubes.The XE-5000 performs analyses using the following methods: RF/DCDetection Method, Sheath Flow DC Detection Method, and FlowCytometry Methods using a Semiconductor Laser. Particlecharacterization and identification is based on detection of forward | |
| 5. Intended Use: | scatter, fluorescence and adaptive cluster analysis. Using the samereagents as the XE-2100, the XE-5000 automatically classifies cellsfrom blood and body fluids and carries out all processes automaticallyfrom aspiration of the sample to outputting the results. | |
| The body fluid analysis mode of the XE-5000 uses the 4DIFFscattergram & the RBC distribution obtained from a specializedanalysis sequence to calculate & display the WBC (WBC-BF) counts,mononuclear cell (MN) / polymorphonuclear cell (PMN) counts &percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found inthe body fluid. | ||
| Analysis results and graphics are displayed on the IPU screen. Theycan be printed on any of the available printers or transmitted to a Hostcomputer. | ||
| Sysmex® XE-5000 is an automated hematology analyzer for in vitrodiagnostic use in screening patient populations found in clinicallaboratories. The XE-5000 classifies and enumerates the sameparameters as the XE-2100 using whole blood as described below, cordblood for HPC and has a body fluid mode for body fluids. The BodyFluid mode analyzes WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, andsynovial fluids with EDTA, as needed). | ||
| 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 | |
| NEUT% / # | Neutrophil Percent and Count | |
| LYMPH%/# | Lymphocyte Percent and Count | |
| ΜΟΝΟ%/# | Monocyte Percent and Count | |
| EO% / # | Eosinophil Percent and Count | |
| BASO%/# | Basophil Percent and Count | |
| NRBC%/# | Nucleated RBC Percent and Count | |
| RDW-SD | RBC Distribution Width-SD | |
| RDW-CV | RBC Distribution Width-CV | |
| MPV | Mean Platelet Volume | |
| RET% / # | Reticulocyte Percent and Count | |
| IRF | Immature Reticulocyte | |
| IG% / # | Immature Granulocyte Percent and Count | |
| HPC# | Hematopoietic Progenitor Cells | |
| RET-He | Reticulocyte Hemoglobin | |
| IPF | Immature Platelet Fraction | |
| WBC-BF | WBC count in the body fluid mode analysis. | |
| RBC-BF | RBC count in the body fluid mode analysis. | |
| MN% / # | Percent and number of mononuclear cells within WBC-BF. | |
| PMN%/# | Percent and number of polymorphonuclear cells in WBC-BF | |
| TC-BF# | The total count including WBC-BF and HF-BF# (the numberof particles which appear in a stronger fluorescence area inDIFF scattergram) |
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| 6. Substantialequivalence-Similarities andDifferences: | Table 1 shows substantial equivalence of the XE-5000 to the XE-2100. |
|---|---|
| 7. Conclusion | The XE-5000 demonstrates substantial equivalence to the XE-2100Body Fluid application. |
:
:
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| Sysmex XE-2100Predicate | Sysmex XE-5000Modification of Predicate | Similarity/Difference | |
|---|---|---|---|
| Intended Use | The Sysmex® XE-2100 SeriesHematology Analyzer is aquantitative, automatedhematology analyzer andleukocyte differential counterfor in vitro diagnostic use inclinical laboratories. Thebody fluid application adds aquantitative, automatedprocedure for analyzingcerebrospinal fluid, serousfluid and synovial fluid. | Sysmex® XE-5000 is anautomated hematology analyzerfor in vitro diagnostic use inscreening patient populationsfound in clinical laboratories.The XE-5000 classifies andenumerates the same parametersas the XE-2100 using wholeblood as described below, cordblood for HPC and has a bodyfluid mode for body fluids. TheBody Fluid mode analyzesWBC-BF, RBC-BF, MN%/#,PMN%/# and TC-BF in bodyfluids (cerebrospinal fluids(CSF), serous fluids, andsynovial fluids with EDTA, asneeded). | Both systems have the sameintended use but the XE-5000has additional capillary and bodyfluid parameters.1) Body Fluid Mode has newdifferential parameters (MN%/#and PMN %/#) and detects WBCand RBC cells at a lower levelthan the XE-2100. The bodyfluid mode is used on body fluidsamples with RBC countsgreater than $0.003 x 10^6$ /ul,WBC counts greater than $0.01 x$$10^3$ /ul for CSF and $0.030 x$$10^3$ /ul for other body fluids andWBC differential (MN%/# andPMN %/#) for samples withWBC counts.2) Capillary mode on wholeblood includes differential withNRBC#/% & IG#/%.3) Addition of WBC-Dparameter on whole blood. |
| Body Fluid Parameters:WBCRBC | Body Fluid Parameters:WBC-BFRBC-BFMN%/ #PMN%/#TC-BF# | ||
| Capillary Mode Parameters:WBCRBCHGBHCTMCVMCHMCHCPLTRET%/# | Capillary Mode Parameters:WBCRBCHGBHCTMCVMCHMCHCPLTRET%/#NEUT% /#LYMPH%/#ΜΟΝΟ%/#EO% / #BASO% /#NRBC%/#IG% / # | ||
| Methodology | The XE-2100 performsanalyses using the followingmethods: RF/DC DetectionMethod, Sheath Flow DCDetection Method, and FlowCytometry Methods using aSemiconductor Laser. The | The XE-5000 performs analysesusing the following methods:RF/DC Detection Method,Sheath Flow DC DetectionMethod, and Flow CytometryMethods using a SemiconductorLaser. The RF/DC detection | Both systems use the samemethodology. |
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| detects the size of the cells bychanges in direct-currentresistance & the density of thecell interior by changes inradio-frequency resistance.Cells pass through the apertureof the detector surrounded bysheath fluid using the sheathflow method. The principle offlow cytometry is also used.A semiconductor laser beam isemitted to the cells passingthrough the flow cell. Theforward scattered light isreceived by the photodiode, &the lateral scattered light &lateral fluorescent light arereceived by the photomultiplier tube. This light isconverted into electricalpulses, thus making it possibleto obtain cell information. | cells by changes in direct-currentresistance & the density of thecell interior by changes in radio-frequency resistance. Cells passthrough the aperture of thedetector surrounded by sheathfluid using the sheath flowmethod. The principle of flowcytometry is also used. Asemiconductor laser beam isemitted to the cells passingthrough the flow cell. Theforward scattered light isreceived by the photodiode, &the lateral scattered light &lateral fluorescent light arereceived by the photo multipliertube. This light is converted intoelectrical pulses, thus making itpossible to obtain cellinformation. | ||
|---|---|---|---|
| Reagents | CELLPACKTM (Diluent)CELLSHEATHTM (Diluent)STROMATOLYSER-FBTM (Lyse)STROMATOLYSER-4DLTM (Lyse)STROMATOLYSER-4DSTM (Stain)STROMATOLYSER-NRTM (Diluent)STROMATOLYSER-NRTM (Stain)STROMATOLYSER-IMTM (Lyse)SULFOLYSER (Lyse)RET-SEARCH II (Diluent)RET-SEARCH II (Stain) | CELLPACKTM (Diluent)CELLSHEATHTM (Diluent)STROMATOLYSER-FBTM (Lyse)STROMATOLYSER-4DLTM (Lyse)STROMATOLYSER-4DSTM (Stain)STROMATOLYSER-NRTM (Diluent)STROMATOLYSER-NRTM (Stain)STROMATOLYSER-IMTM (Lyse)SULFOLYSER (Lyse)RET-SEARCH II (Diluent)RET-SEARCH II (Stain) | The XE-2100 and the XE-5000use the same reagents. |
| QualityControl/Calibrator | e-Check—3 levelsXE Calibrator (X Cal) | e -Check (XE) —3 levelsXE Calibrator (X Cal) | The XE-2100 and the XE-5000use the same calibrator, but theXE-5000 uses a specific qualitycontrol material, e -Check (XE)that has been previously cleared. |
| Software/HardwareDifferences | The XE-pro software wasadded to the original XE-2100in order to include additionalmaster programs (HPC, IG,RET, IPF) and perform BodyFluid analysis. | The XE-5000 uses the same XE-pro software and includesadditional masters (HPC, IG,RET, IPF) along with a BodyFluid mode in the initial standardsoftware model. | The XE-5000 performs the sameas the XE-2100 with the HPC,IG, RET and IPF masters alongwith a Body Fluid mode that hasadditional parameters (TC-BF,MN%/# and PMN %/#). TheXE-5000 capillary modeincludes the differential, NRBCand IG parameters. |
| SpecimenType | Random whole blood andbody fluid samples | Random whole blood and bodyfluid samples. | Both systems use the samespecimen types. |
| Throughput | Approximately 113-150samples/hour depending onthe mode used. | Approximately 113-150samples/hour depending on themode used. | Both systems have the samethroughput. |
| EquivalencyData: | Performance was initiallyestablished in XE-2100 510(k)submission (K992875) & thenadditional masters/parameterswere submitted in subsequentsubmissions: | Performance of the XE-5000whole blood mode is the same asthe XE-2100 with additionalmasters. The Body Fluid modeof the XE-5000 has additionalparameters. Comparison of the | Data consisting of carryover,linearity, accuracy andreproducibility was collected toshow performance to themanufacturer's specification forthe Body Fluid mode. This |
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| XE-2100/HPC (K020496),XE-2100/IG (K032039),XE-Body Fluid (K040073),XE-2100 RET/He (K050589),XE-2100/IPF (K051199). | XE-5000 body fluid mode to theXE-2100 demonstrated excellentcorrelation. | analysis supports the claim thatthe XE-5000 Body Fluid mode issubstantially equivalent to theXE-2100 Body Fluid. |
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 2007
Sysmex America, Inc. C/O Nina M. Gamperling One Nelson C. White Parkway Mundelein, Illinois 60060
Re: K071967
Trade/Device Name: Sysmex XE-5000 Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Hematology Analyzer Regulatory Class: Class II Product Code: GKZ Dated: July 13, 2007 Received: July 17, 2007
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,
Robert H. Zetterlof
Robert L. Becker, Jr., M.D., Ph. 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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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K (191967
Device Name: Sysmex® XE-5000, Automated Hematology Analyzer
Indications For Use:
Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%#, PMN%# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA, as needed).
| WBC | White Blood Cell Count | ||
|---|---|---|---|
| RBC | Red Blood Cell Count | ||
| HGB | Hemoglobin | ||
| HCT | Hematocrit | Division/Sign-OffImage: signature | |
| MCV | Mean Cell Volume | ||
| MCH | Mean Cell Hemoglobin | ||
| MCHC | Mean Cell Hemoglobin Concentration | ||
| PLT | Platelet Count | ||
| NEUT% / # | Neutrophil Percent and Count | ||
| LYMPH% / # | Lymphocyte Percent and Count | Office of In Vitro DiagnosticEvaluation and Safety | |
| MONO% / # | Monocyte Percent and Count | ||
| EO% / # | Eosinophil Percent and Count | ||
| BASO% / # | Basophil Percent and Count | 510(k) | |
| NRBC% / # | Nucleated RBC Percent and Count | ||
| RDW-SD | RBC Distribution Width-SD | ||
| RDW-CV | RBC Distribution Width-CV | ||
| MPV | Mean Platelet Volume | ||
| RET% / # | Reticulocyte Percent and Count | ||
| IRF | Immature Reticulocyte | ||
| IG% / # | Immature Granulocyte Percent and Count | ||
| HPC# | Hematopoietic Progenitor Cells | ||
| RET-He | Reticulocyte Hemoglobin | ||
| IPF | Immature Platelet Fraction | ||
| WBC-BF | WBC count in the body fluid mode analysis. | ||
| RBC-BF | RBC count in the body fluid mode analysis. | ||
| MN% / # | Percent and number of mononuclear cells within WBC-BF. | ||
| PMN% / # | Percent and number of polymorphonuclear cells within WBC-BF. | ||
| TC-BF# | The total count including WBC-BF and HF-BF# (the number of particles which appear ina stronger fluorescence area in DIFF scattergram) |
Juzeline Bautista
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K07/967
Prescription Use (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)
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.”