DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
Device Facts
| Record ID | K100489 |
|---|---|
| Device Name | DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 |
| Applicant | Beckman Coulter Cellular |
| Product Code | GKZ · Hematology |
| Decision Date | Oct 26, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
Indications for Use
The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in virro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.
Device Story
Automated hematology analyzers for clinical laboratories; process whole blood samples (EDTA) via venipuncture, heel, or fingerstick. Systems measure WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, and 3-part leukocyte differential (LY, MO, GR). Operation involves sample aspiration, dilution, and analysis to generate quantitative blood parameters. Results displayed to clinicians to distinguish normal patient profiles from those requiring further diagnostic study. DxH 300C includes automated sample processing capabilities. Systems utilize specific reagents (DxH Diluent, DxH Cell Lyse, DxH Rinse) and quality control materials (4C-EX 300, LIN-X, S-CAL) to ensure analytical accuracy and precision.
Clinical Evidence
Bench testing only. Studies conducted per CLSI guidelines: EP9-A2 (method comparison/bias), EP5-A2 (precision), EP06-A (linearity), and ICSH guidelines (carryover). Results demonstrated acceptable performance, linearity, and carryover, with reference intervals established per CLSI C28-A3. No clinical prospective/retrospective studies reported.
Technological Characteristics
Automated hematology analyzer; quantitative cell counting and 3-part differential. Uses specific diluents and lytic agents. Quality control via daily checks, commercial controls, XB analysis, and XM analysis. Connectivity/software details not specified beyond automated processing. Sterilization not applicable; device is for in vitro diagnostic use.
Indications for Use
Indicated for use in clinical laboratories to perform complete blood counts and 3-part leukocyte differentials on human whole blood specimens (EDTA-anticoagulated) collected via venipuncture, heel, or fingerstick. Used to identify normal patients versus those requiring further clinical investigation.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
Submission Summary (Full Text)
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510(k) Summary
OxH™ 300 COULTER® Cellular Analysis Syst
xH™ 300C COULTER® Cellular Analysis Syst
## 1 < 1 0 6 4 89
OCT 2 6 2010
### ubmitted By 1 .0
eanne Roscole
Stocker Bundlery Inne.
Stoken Studitory Inne.
Prokoman Billy Markery Inno.
Marka BW City And Android Andres MCC: 31-B06
Milami, IPIonis 23, 1996-23800
PAX: (78
## Date Submitted 2.0
ebruary 18, 2010
## 3.0
Dexise Name=Classification
DxHTM 300 COULTER® Cellular Analysis System
DxHTM 300 COULTER® Cellular Analysis System
Automated differential cellular Analysis System
(21 CFR \$
## edicate Devices 4.0
| Candidate | Predicate | Manufacturer | Docket Number |
|-----------------------------------|----------------------------------------|---------------|---------------|
| DxH™ 300 and DxH™ 300C | COULTER® AcT Diff 2™ | Beckman | K990352 |
| COULTER® Cellular Analysis System | COULTER® LH 780<br>Hematology Analyzer | Coulter, Inc. | K061616 |
Beckman Coulter, Inc.
DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis 3
510(k) Submission
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#### escription 5.0
1 300 and DxH™ 300C COUL TER® Cellular Analysis Analyzes are intended for In Vitro Diagnostic
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who needs additional studies of any of these parameters. These studies measurem
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Parameters: WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, RDW-
SD, PLT, MPV.
two counting modes, whole blood and prediute mode. The two modes is the amount of sample of sample ar
### ntended Use 6.0
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Beckman Coulter, Inc.
OxH™ 300 and DxH™ 300C COULTER® Cellular Anal
510(k) Submission
age 2 of .
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| And A. Box Bear Bron | |
|----------------------|---------------------|
| | |
| œ<br>1 | A CHRAN CHALLER CHE |
| 1 | |
| Attribute | COULTER® AcT Diff 2 ™<br>Predicate for all Parameters except RDW-SD<br>and extended Platelet/WBC Linearity | COULTER® LH 780<br>Predicate for RDW-SD, Platelet and WBC extended<br>Linearity | DxH™ 300/300C COULTER® Cellular<br>Analysis System |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The COULTER ACT Diff 2 analyzer<br>is a quantitative, automated<br>hematology analyzer and leukocyte<br>differential counter For In Vitro<br>Diagnostic Use in clinical<br>laboratories. The purpose is to<br>identify the normal human patient,<br>with all normal system-generated<br>parameters, and to flag or identify<br>patient results that require additional<br>studies. | The COULTER LH 780 Hematology Analyzer is<br>a quantitative, automated hematology analyzer<br>and leukocyte differential counter For In Vitro<br>Diagnostic Use in clinical laboratories. The<br>COULTER LH 780 Hematology Analyzer<br>provides automated Reticulocyte analysis and<br>enumeration of nucleated red blood cells<br>(NRBCs) as well as an automated method for<br>enumeration of RBCs and WBCs in body fluids. | The DxH 300 COULTER Cellular Analysis<br>System and the DxH 300C COULTER Cellular<br>Analysis System are quantitative automated<br>hematology analyzers for in vitro diagnostic use<br>in clinical laboratories. The DxH 300<br>COULTER Cellular Analysis System and the<br>DxH 300C COULTER Cellular Analysis<br>System provide complete blood count, (WBC,<br>RBC, HGB, HCT, MCV, MCH, MCHC, RDW,<br>RDW-SD, PLT, MPV) and Leukocyte 3-Part<br>Differential [LY (%/#), MO (%/#), GR (%/#)]<br>for whole blood specimens, collected in a salt of<br>EDTA [dipotassium (K2) or tripotassium (K3)]<br>obtained by venipuncture, heel or fingerstick.<br>The purpose of the DxH 300 and the DxH 300C<br>is to identify normal human patients, with<br>normal system-generated parameters, from<br>patients whose results require additional studies. |
| Device<br>Classification<br>and Product<br>Code | 864.5220, Automated Cell Counter,<br>GKZ | Same | Same |
| Parameters | WBC, RBC, Hgb, Hct, MCV, MCH,<br>MCHC, RDW, Plt, MPV, LY%,<br>MO%, GR%, LY#, MO#<br>and GR# | WBC, RBC, Hgb, Hct, MCV, MCH, MCHC,<br>RDW, RDW-SD, Plt, MPV, LY%, MO%, NE%,<br>EO%, BA%, LY#, MO#, NE#, EO#, BA#,<br>RBC%, NRBC#, RET%, RET#, IRF and MRV. | Same as AcT Diff 2 with the addition of RDW-<br>SD |
| Quality Control<br>Techniques | Daily Instruments Check,<br>Commercial Controls, Patient<br>Controls, Inter-laboratory Quality<br>Assurance Program (IQAP) | Same as ACT Diff 2 PLUS Delta Checks, XB<br>Analysis, Extended QC and XM Analysis | Same as AcT Diff 2 with addition of XB<br>Analysis, Extended QC and XM Analysis |
.
Beckman Coulter, Inc.
DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis System
S10(k) Submission
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| Attribute | COULTER® AcT Diff 2 ™<br>Predicate for all Parameters except RDW-SD and extended Platelet/WBC Linearity | COULTER® LH 780<br>Predicate for RDW-SD, Platelet and WBC extended Linearity | DxH™ 300/300C COULTER® Cellular Analysis System |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analysis<br>Reagents | COULTER® ISOTON® III Diluent<br>COULTER® LYSE S® III Diff Lytic Agent | COULTER® LH Series Diluent<br>COULTER® Isoton 4 Diluent<br>COULTER® LH Series Pak<br>COULTER® LH Series Retic Pak<br>COULTER® Lyse S® III Lytic Agent<br>COULTER® Lyse S® 4 Lytic Agent | DxH™ 300 Pack-contains COULTER® DxH Diluent (Optimized Isoton 4 Diluent) and COULTER® DxH Cell Lyse (Same as Lyse S® 4 lytic agent)<br>DxH 300 Rinse |
| Quality Control<br>& Calibrators | COULTER® 4C® Plus Cell Control<br>COULTER® 4C-ES Cell Control<br>COULTER® S-CAL® Calibrator Kit<br>COULTER® LIN-C® Linearity Control | COULTER® 5C® Cell Control<br>COULTER® Latron™ Primer and Latron Control<br>COULTER® LIN-C® Linearity Control<br>COULTER® S-CAL® Calibrator Kit<br>COULTER® Retic-C™ Cell Control | COULTER® 4C-EX 300 Cell Control<br>COULTER® LIN-X Linearity Control<br>COULTER® S-CAL® Calibrator Kit |
| Cleaning<br>Agents | COULTER® AcT Rinse Shutdown<br>Diluent | COULTER® LH Series Cleaner | COULTER® DxH Cleaner<br>Same as AcT Diff 2 except DxH 300 does not perform closed vial sampling |
| Sample<br>Introduction | Manual presentation for open or closed vial sampling whole blood analysis and pre-dilute mode | Manual presentation for open vial<br>Automated presentation for closed vial sampling from 12 position cassette. Maximum load capacity 12 racks | |
# 8.0
| Study | Study Design | Study Results |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Accuracy | Based on CLSI EP9-A2, Method Comparison and Bias<br>Estimation Using Patient Samples; Approved Guideline –<br>Second Edition. Testing was done in accordance with CLSI<br>H20-A2 Reference Leukocyte (WBC) Differential Count<br>(Proportional) and Evaluation of Instrumental Methods;<br>Approved Standard – Second Edition | The DxH 300 systems demonstrated comparable results<br>to the predicate device with reagents stated above. |
| Study | Study Design | Study Results |
| Precision | Based on CLSI EP5-A2, Evaluation of Precision<br>Performance of Quantitative Measurement Methods;<br>Approved Guideline – Second Edition. | The DxH 300 systems demonstrated acceptable results<br>with reagents stated above. |
| Linearity | Based on CLSI EP06-A, Evaluation of the Linearity of<br>Quantitative Measurement Procedures: A Statistical<br>Approach; Approved Guideline | The DxH 300 systems demonstrated acceptable linearity<br>results. |
| Carryover | Reference to the ICSH document: Guidelines for the<br>Evaluation of Blood Cell Analyzers including those used for<br>differential leukocyte and reticulocyte counting and cell<br>marker applications. International Council for<br>Standardization in Haematology: prepared by the ICSH<br>expert panel on cytometry. Clin Lab Haematol, 16(2):157-<br>174, 1994 | The DxH 300 systems demonstrated acceptable<br>carryover results. |
| Specimens | Specimen collection was done in accordance with CLSI H3-<br>A6- Procedures for the Collection of Diagnostic Blood<br>Specimens by Venipuncture: Approved Standard- Sixth<br>Edition | Acceptable sample and prepared sample stability results<br>achieved. |
| Reference Values | Based on CLSI C28-A3, Defining, Establishing, and<br>Verifying Reference Intervals in the Clinical Laboratory,<br>Approved Guideline – Third Edition | Reference intervals established. |
| Performance | Testing was done in accordance with CLSI H20-A2<br>Reference Leukocyte (WBC) Differential Count<br>(Proportional) and Evaluation of Instrumental Methods;<br>Approved Standard – Second Edition | The DxH 300 systems analysis of normal and clinical<br>samples met the internal validation acceptance<br>criteria |
Beckman Coulter, Inc.
DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis System
510(k) Submission
Page 4 of 5
10(k) submissions
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The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already
sommercial distribution.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act
1990 and the implementing regulation 21 CFR 80
Beckman Coulter, Inc.
DxHT* 300 and DxHT* 300C COULTER® Cellular Analysis System
510(k) Submission
Page 5 of 5
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing the bird's wings and body. The eagle is facing to the right.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center -- WO66-0609 Silver Spring, MD 20993-0002
Beckman Coulter, Inc. c/o Ms. Jeanne Roscoe Senior Regulatory Specialist 11800 S.W. 147th Avenue MS 31 B06 Miami, FL 33196-2500
OCT 2 6 2010
Re: k100489
Trade/Device Name: DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Systems Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: September 29, 2010 Received: September 30, 2010
Dear Ms. Roscoe:
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 class II (Special Controls). 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter
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Page 2 - Ms. Jeanne Roscoe
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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M Cham
Maria M. Chan, Ph.D. 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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#### Indication for Use
K100489
OCT 2 6 2010
#### 510(k) Number (K100489):
#### Device Name: DxH™ 300 COULTER® Cellular Analysis Analyzer DxH™ 300C COULTER® Cellular Analysis Analyzer
Indication For Use:
The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in virro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.
Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100489
