The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semiautomated reticulocyte analysis.

Device Description

LH 500 hematology analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 500 provides automated complete blood count and leukocyte differential and semi-automated reticulocyte analysis. The purpose of the LH 500 hematology analyzer 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.

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

Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter LH 500 hematology analyzer, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it relies on substantial equivalence to the predicate device (COULTER LH 750) and demonstrates comparable performance through various studies. The "performance" is implicitly the outcome of these studies, showing that the LH 500 performs similar to or within acceptable limits compared to the LH 750.

Given the available information, the table will focus on the comparison points highlighted and the implied "acceptance" that the LH 500 is equivalent.

Performance Metric/Characteristic	Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (Implied)
Intended Use	Same as COULTER LH 750 (Quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories, automated CBC, leukocyte differential, semi-automated reticulocyte analysis).	Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table)
Analysis Reagents	Same as COULTER LH 750 reagents.	Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table for Diluent, Pak, Lyse S® III diff lytic agent)
Cleaning Agent	Same as COULTER LH 750 cleaning agent.	Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table for COULTER CLENZ)
Hematology Quality Controls	Same as COULTER LH 750 quality controls.	Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table for 5C Cell Control, Latron Primer and Latron Control, RETIC-C Cell Control, Lin-C)
Reticulocyte Analysis Method	Functionally equivalent to LH 750's automated method.	Semi-automated (Difference noted, but implied as acceptable for the intended use and overall equivalence).
Reticulocyte Analysis Reagents	Suitable for semi-automated reticulocyte analysis.	Uses COULTER ReticPrep Reagent Kit (Difference noted, but implied as acceptable for the intended use).
Aperture System	Provides equivalent cell enumeration and sizing.	Utilizes a single aperture configuration (Difference noted, but implied as acceptable for the intended use).
Overall Performance	Substantially equivalent to COULTER LH 750.	The 510(k) clearance indicates the FDA found it substantially equivalent. This implies all key performance parameters (CBC, diff, retics) are comparable.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size for any specific test set used to demonstrate efficacy or the data provenance (e.g., country of origin, retrospective or prospective). It primarily focuses on the substantial equivalence argument based on technological characteristics and intended use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided document does not mention using experts to establish ground truth for a test set. This type of device (automated hematology analyzer) typically relies on comparisons against reference methods or another FDA-cleared device rather than expert consensus on individual case interpretations.

4. Adjudication Method for the Test Set

As no expert review for ground truth establishment is mentioned, there is no adjudication method described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This type of study is more common for imaging devices where human interpretation directly influences the outcome and AI is used as an aid. For an automated hematology analyzer, the primary comparison would be between the device's output and either a reference method or a predicate device, not human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The entire device (LH 500 hematology analyzer) is a standalone system for automated complete blood count and leukocyte differential, and semi-automated reticulocyte analysis. The 510(k) submission describes the standalone performance of the device itself. It's designed to provide quantitative results directly, not as an assistive tool for human interpretation.

7. Type of Ground Truth Used

While not explicitly detailed as "ground truth establishment," the typical method for validating automated hematology analyzers involves:

Comparison to a legally marketed predicate device: In this case, the COULTER LH 750.
Comparison to established reference methods: Such as manual differential counts for WBC differential, or established methods for cellular enumeration and hemoglobinometry.
Internal validation studies: Demonstrating precision, accuracy, linearity, and carryover using characterized samples (e.g., normal patient samples, abnormal patient samples, controls).

The document states, "The COULTER LH 500 Hematology Analyzer has the similar technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer." This implies that the 'ground truth' for evaluating the LH 500's performance was its ability to produce results comparable to the established performance of the LH 750 and, by extension, other validated methods. The specific methods for establishing ground truth for each parameter are not detailed in this summary.

8. Sample Size for the Training Set

The provided document does not mention a training set or its sample size. Automated hematology analyzers typically do not involve "training sets" in the same way machine learning algorithms do, as their operating principles are based on predefined biophysical properties (Coulter Principle, VCS technology) rather than learned patterns from large datasets. They are calibrated and validated against known standards and reference methods.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not applicable/provided in the document.

Summary

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AUG 1 3 2003

K032000

510(k) Summary of Safety and Effectiveness for Section 1 D: LH 500 hematology analyzer

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:	June 26, 2003
Device Trade Name(s):	LH 500 hematology analyzer
Device Generic Name(s):	Automated differential cell counter
Device Classification:	The LH 500 hematology analyzer is a Class II medical device.

2.0 Predicate Device

The LH 500 hematology analyzer claims substantial equivalence to COULTER LH 750 hematology analyzer.

FDA 510(k) Number(s): K011342

3.0 Device Description

4.0 Principle of Method:

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The COULTER LH 500 Hematology Analyzer has the similar 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 500
Similarities	Intended Use	The COULTER® LH 750Hematology Analyzer is aquantitative, automatedhematology Analyzer andleukocyte differentialcounter For In VitroDiagnostic Use in clinicallaboratories.	Same as LH 750
	Analysis Reagents	COULTER® LH SeriesDiluentCOULTER LH SERIES PakCOULTER Lyse S® III difflytic agent	Same as LH 750
	Cleaning Agent	COULTER CLENZ	Same as LH 750
	Hematology QualityControls	COULTER® 5C CellControlCOULTER® Latron Primerand Latron ControlRETIC-C Cell ControlLin-C linearity control	Same as LH 750
Differences	Reticulocyte analysismethod	Automated	Semi automated
	Reticulocyte analysisreagent system	LH SERIES RETIC Pak	COULTER ReticPrepReagent Kit
	Aperture system	Utilizes a triple apertureconfiguration	Utilizes a single apertureconfiguration

Comparison to Predicate 5.0

6.0 Indications for Use:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 1 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K032000

Trade/Device Name: Coulter® LH 500 Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: June 26, 2003 Received: June 27, 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. Iisting 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

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510(k) Number (if known): Not assigned

COULTER® LH 500 Device:

The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semiautomated reticulocyte analysis.

Future commercialization will add ISOTON® 4 diluent /Lyse S® 4 Lytic reagent to the indications for use.

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)

Over-The-Counter

CFR 801.109)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032000

Beckman Coulter, Inc. LH 500 Hematology Analyzer 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.”