The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.

Device Description

LH 750 Hematology Analyzer with Ver. 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 Ver. 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, biochemical investigations, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis and NRBC enumeration.

The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting and sizing, reticulocyte determination, quality control, calibration and cleaning.

AI/ML Overview

The documentation provided does not contain a study that proves the device meets specific acceptance criteria. This submission is an abbreviated 510(k) for a software update (Ver. 2B Software) for the Coulter LH 750 Hematology Analyzer, claiming substantial equivalence to the existing LH 750.

The document highlights "Improved NRBC performance for False Negatives" as a difference from the predicate device, implying that this specific performance metric was a focus of the software update. However, it does not provide details on the acceptance criteria for this improvement or the study conducted to demonstrate it.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or stated from the provided text:

Acceptance Criteria and Reported Device Performance: Not explicitly stated. The document mentions "Improved NRBC performance for False Negatives" as a difference from the predicate, but no quantitative criteria or reported performance data are given.
Sample Size, Test Set, and Data Provenance: Not provided.
Number and Qualifications of Experts for Ground Truth: Not provided.
Adjudication Method: Not provided.
Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not mentioned as performed.
Standalone (algorithm only) Performance: Not explicitly stated as performed. While the device is an automated analyzer, the document doesn't present a standalone performance study with specific metrics and acceptance criteria for the software update. The focus is on substantial equivalence to the predicate device.
Type of Ground Truth: Not provided.
Sample Size for Training Set: Not provided.
How Ground Truth for Training Set was Established: Not provided.

Summary Table of Available Information:

Feature	Description (as per provided text)
Acceptance Criteria & Device Performance	Not explicitly stated. The document indicates "Improved NRBC performance for False Negatives" as a difference/improvement over the predicate device, but no quantitative acceptance criteria or performance metrics are provided in the given text.
Sample size (test set) & Data Provenance	Not provided.
Number & Qualifications of Experts for Ground Truth	Not provided.
Adjudication Method	Not provided.
MRMC Comparative Effectiveness Study	Not mentioned.
Standalone Performance Study	Not explicitly detailed for the software update. The device itself is an automated analyzer that performs standalone measurements. However, no specific study data or acceptance criteria for the software's standalone performance (e.g., comparing it to a gold standard) are presented in this context, beyond the general claim of improved NRBC performance.
Type of Ground Truth Used	Not provided.
Sample Size for Training Set	Not provided.
How Ground Truth for Training Set was Established	Not provided.
Device Type	Automated Hematology Analyzer with Ver. 2B Software
Intended Use	For In Vitro Diagnostic Use in clinical laboratories. Provides automated complete blood count, leukocyte differential, NRBC enumeration, and reticulocyte analysis. Separates normal patients from those needing further studies.
Key Difference from Predicate (related to performance)	The Ver. 2B Software offers "Improved NRBC performance for False Negatives" and "Added additional Fail safe" for WBC correction, in addition to being qualified for use with cyanide-free reagents and consistent with IVDD regulation. These are presented as differences from the predicate, suggesting improvements. However, the details of how these improvements were measured against acceptance criteria are not in the provided text.

Summary

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K03234-2

510(k) Summary of Safety and Effectiveness for Section 1 D:

LH 750 Hematology Analyzer with Ver. 2B Software

1.0 General Information

Applicant Name and Address:	Beckman Coulter, Inc.Cellular Analysis Division11800 SW 147 AvenueMiami, FL 33196-2500
Primary Contact:	Stan Sugrue, Ph.D.Senior Regulatory Affairs SpecialistTelephone: (305) 380-4552FAX: (305) 380-3618E-mail: stan.sugrue@coulter.com
Date:	July 28, 2003
Device Trade Name(s):Device Generic Name(s):	LH 750 Hematology AnalyzerAutomated differential cell counter
Device Classification:	The LH 750 Hematology Analyzer with Ver. 2B Software isa Class II medical device.

2.0 Predicate Device

The LH 750 Hematology Analyzer with Ver. 2B Software claims substantial equivalence to the COULTER LH 750 hematology analyzer.

FDA 510(k) Number(s): K011342

3.0 Device Description

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4.0 Principle of Method:

The COULTER LH 750 Hematology Analyzer with Ver. 2B Software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer. Both devices utilize the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent, lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

Comparison	Characteristic	COULTER LH 750(Predicate)	COULTER LH 750 w/ 2B SW
Similarities	Intended Use	The COULTER® LH 750Hematology Analyzer is aquantitative, automatedhematology Analyzer andleukocyte differential counterFor In Vitro Diagnostic Use inclinical laboratories.	Same as LH 750
	Analysis Reagents	COULTER® LH Series DiluentCOULTER LH SERIES PakCOULTER Lyse S® III lyticagent	Same as LH 750
	Cleaning Agent	COULTER CLENZ	Same as LH 750
	Hematology QualityControls	COULTER® 5C Cell ControlCOULTER® Latron Primer andLatron ControlRETIC-C Cell ControlLin-C linearity control	Same as LH 750
	Reticulocyte analysisreagent system	LH SERIES RETIC Pak	Same as LH 750
	Reticulocyte analysismethod	Automated	Same as LH 750
Differences	Analysis Reagents	Not qualified for use withCOULTER cyanide-freereagents	Qualified for use withCOULTER cyanide-freereagents
	Labeling	Not IVDD compliant	Consistent with IVDDregulation
	Parameter Performance	Has NRBC enumeration	Improved NRBCperformance for FalseNegatives
	Parameter Performance	Has WBC correction	Added additional Fail safe

5.0 Comparison to Predicate

Indications for Use: 6.0

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 6 2003

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Beckman Coulter, Inc. Cellular Analysis Division 11800 SW 147 Avenue Miami. Florida 33196-2500

Re: K032342

Trade/Device Name: Coulter® LH 750 Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: July 28, 2003 Received: July 29, 2003

Dear Dr. Sugrue:

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 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.

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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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Section 1C:

INDICATIONS FOR USE

K032342

510(k) Number (if known): 14

Device: COULTER® LH 750

The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.

21 CFR 864.5220 Automated differential cell counter

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

Josephine Rautski

Division Sign-off

n Vitro Diagnostic Device

510(k) K032342

Beckman Coulter, Inc. LH 750 with Version 2B Software - Abbreviated 510(k)

Regulation Number and Section

§ 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.”