COULTER LH 750 HEMATOLOGY ANALYZER

K032342 · Beckman Coulter, Inc. · GKZ · Sep 26, 2003 · Hematology

Device Facts

• Record ID: K032342
• Device Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The Coulter LH 750 Hematology Analyzer with Version 2B Software is designed for in vitro diagnostic use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Version 2B Software is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size, and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

Device Story

Automated hematology analyzer; processes whole blood samples via open or closed tube sampling; utilizes barcode identification; performs complete blood count, leukocyte differential, NRBC enumeration, and reticulocyte analysis; identifies normal vs. abnormal patient samples to flag need for manual review or further diagnostic testing; used in clinical laboratory settings by trained laboratory personnel; output provided to healthcare providers to assist in clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Performance validation focused on improved NRBC enumeration and WBC correction fail-safes compared to the predicate device.

Technological Characteristics

Automated hematology analyzer; utilizes Coulter Principle (impedance) for cell counting/sizing, single beam photometry for hemoglobin, and VCS (volume, conductivity, light scatter) technology for WBC/reticulocyte analysis. Reagent-based system (diluent, lytic agents, cleaner). Software-controlled; supports cyanide-free reagents.

Indications for Use

Indicated for use in clinical laboratories for quantitative, automated hematology analysis, including complete blood count, leukocyte differential, NRBC enumeration, and reticulocyte analysis.

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

• Coulter LH 750 Hematology Analyzer with Version 2A Software (K011342)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K032342

B. Instrument Name:
Coulter® LH 750 Hematology Analyzer with Version 2B Software

C. System Descriptions:
1. Modes of Operation:
Open Tube and Closed Tube
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Sample Identification:
Barcode
4. Specimen Sampling and Handling:
Open Tube, pierced cap
5. Assay Types:
N/A
6. Reaction Types:
N/A
7. Calibration:
Coulter S-Cal commercial calibrators
8. Quality Control:
Multiple quality control techniques using Coulter commercial control materials.

D. Other Supportive Performance Characteristics Data Not Covered In The “L. Performance Characteristics” Section Of The SE Decision Summary.

In order to demonstrate substantial equivalence of the LH 750 Hematology Analyzer with Version 2B Software to the LH 750 Hematology Analyzer with Version 2A Software (K011342), experiments were designed and executed based on accepted industry standards and internal product development procedures. The performance protocols for data collection adhere to NCCLS documents, ICSH/ISLH recommended reference methods, FDA Guidance documents, and scientifically valid procedures.

Data was collected internally using normal and clinical samples, at the Beckman Coulter, Inc. Systems and Applications Support Laboratory, Miami, Florida. Normal whole blood specimens were obtained from the in-house blood center using a screened pool of donors. Clinical samples were obtained by arrangement with local hospitals, using spent specimens from routine laboratory analyses.

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E. Other Supportive Information:
The Coulter LH 750 Hematology Analyzer with Version 2B Software is designed for in vitro diagnostic use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Version 2B Software is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size, and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

F. Conclusion:
The Coulter LH 750 Hematology Analyzer with Version 2B Software is substantially equivalent to the Coulter LH 750 Hematology Analyzer with Version 2A Software.

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