The COULTER® LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs).

Device Description

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 enumeration of nucleated red blood cells (NRBCs). The COULTER LH 750 Hematology Analyzer with Version 2A software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer with Version 1A software. 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.

AI/ML Overview

The provided text is limited and primarily focuses on the regulatory information, device description, and indications for use of the COULTER® LH 750 Hematology Analyzer with Version 2A Software. It explicitly states that this submission is a "Summary of Safety and Effectiveness," usually followed by a more detailed report or study.

Based on the provided text, a comprehensive acceptance criteria table and the study to prove it cannot be fully constructed because the detailed study results and specific acceptance criteria values are not included. The document acts as a 510(k) submission summary, indicating substantial equivalence to a predicate device, rather than a full study report with detailed performance metrics against predefined acceptance criteria.

However, I can extract the available information and highlight what is missing based on your request.

Acceptance Criteria and Device Performance

Due to the lack of specific performance data and predefined acceptance criteria in the provided text, this table will show what the document claims the device does (performance characteristics) and what would typically be expected as acceptance criteria for such a device.

Performance Metric (Acceptance Criteria)	Reported Device Performance (from text)
Accuracy / Correlation with predicate device	The document's core claim is "substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer with Version 1A software." This implies that the performance (accuracy, precision, linearity, etc.) of the new version is comparable to the predicate device, which would have had its own established performance metrics. Specific numerical values for agreement or correlation are not provided.
Precision / Reproducibility	Not explicitly stated in numerical terms within the provided text. However, the use of quality control materials (e.g., 5C® -ES Cell Control, COULTER RETIC-C™ Cell control, COULTER® S-CAL® Hematology Calibrator) indicates an intention to maintain and monitor precision.
Linearity / Reportable Range	The text mentions "COULTER® LIN-C® linearity control (K955334) verifies reportable range of the CBC parameters." Specific reportable ranges or linearity statistics (e.g., R-squared values) are not provided.
Interference (Specificity)	Not explicitly stated in the provided text.
Carryover	Not explicitly stated in the provided text.
Reference Range (WBC Differential, Reticulocytes, NRBCs, etc.)	The device "supplies a complete blood cell analysis and includes a differential leukocyte cell count" and "provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs)." Specific reference ranges or cut-offs for these are not provided; these would typically be established by the clinical lab using the device, or by larger population studies referenced in the full submission.
Reliability / Stability	The modification includes "software and minor hardware changes to improve performance characteristics and reliability." No specific metrics or studies demonstrating improved reliability are detailed here.

Study Details (Based on available information in the document)

Given the nature of a 510(k) for a software/minor hardware update to an existing device, the "study" described is primarily focused on demonstrating substantial equivalence to the predicate device. The provided text is a summary and therefore lacks the granular detail of a full study report.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. It's common for such studies to involve samples from clinical laboratories, potentially across various demographics, but this information is absent here. The submission is from Beckman Coulter, Inc., Miami, FL, USA, suggesting the primary regulatory interaction and potentially the core development location.
- Retrospective or Prospective: Not specified.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not specified. For automated differential cell counters, ground truth is typically established through manual microscopic review by trained technologists or hematopathologists.
Adjudication Method for the Test Set:
- Not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not explicitly mentioned or described. This type of study is more common for diagnostic imaging AI where human interpretation (readers) is a key part of the workflow. For an automated hematology analyzer, the focus is on the device's analytical performance (accuracy, precision, correlation to a reference method, or the predicate device), not typically on how it "improves" human reader performance in a diagnostic read, as the device itself provides the result.
Standalone (Algorithm Only) Performance Study:
- Yes, implicitly. The device is an "automated differential cell counter" and provides "automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs)." This means the algorithm performs these analyses without human intervention for each count. The "study" for a 510(k) of this nature would involve evaluating how well the device's automated counts agree with a reference method (e.g., manual microscopy) or with the predicate device. Specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for flagging abnormal cells, or correlation coefficients for cell counts) are not provided in this summary.
Type of Ground Truth Used:
- Not explicitly stated, but for hematology analyzers, typical ground truth involves:
  - Manual microscopy (expert review): For cell differentials, morphology, and difficult-to-classify cells.
  - Reference methods: For precise cell counts (e.g., flow cytometry for certain subpopulations or highly calibrated manual counts).
  - Predicate device results: For demonstrating substantial equivalence, direct comparison to the previous version's results is critical.
Sample Size for the Training Set:
- The term "training set" is not mentioned, as this document describes a conventional medical device modification, not necessarily an AI/machine learning model in the modern sense that requires a distinct training phase. If the software improvements involved algorithmic adjustments, it implies development and testing data, but no specific "training set" size is provided.
How the Ground Truth for the Training Set was Established:
- Not applicable as "training set" for an AI model is not described. For general software development and validation, ground truth would typically be established by established laboratory methods, manual review, or comparison to existing validated systems.

Summary

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JUL 29 2002

K022161

Summary of Safety and Effectiveness for Section 1 D: COULTER® LH 750 Hematology Analyzer with Version 2A Software

1.0 General Information

Device Generic Name(s):	Automated differential cell counter
Device Trade Name(s):	COULTER® LH 750 Hematology Analyzer
Device Classification:	The COULTER® LH 750 Hematology Analyzer is a Class IImedical device.
Applicant Name and Address:	Beckman Coulter, Inc.Cellular Analysis Division11800 SW 147 AvenueMiami, FL 33196-2500
Date:	July 2, 2002

2.0 Legally Marketed Device(s)

The modified COULTER® LH 750 Hematology Analyzer with Version 2A Software claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer with Version 1A software.

FDA 510(k) Number(s): K011342

3.0 Device Description

· 5C® -ES Cell Control (K010066) and COULTER RETIC-C™ Cell control (K930119) hematology quality control materials used to monitor the instrument performance. COULTER® LIN-C® linearity control (K955334) verifies reportable range of the CBC parameters.
· COULTER® LH 700 SERIES Diluent. Intended for use as a diluent for counting and sizing blood cells on COULTER® LH 700 SERIES hematology analyzers.
· COULTER Lyse S® III diff. Intended for the simultaneous quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER® hematology analyzers.
· COULTER CLENZ® cleaning agent to prevent protein buildup on surfaces.

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· COULTER Latron™ Primer and Latron Control (K885028) to monitor VCS performance.
· COULTER LH 700 SERIES Pak, containing Erythrolyse™ lytic reagent and Stabilyse™ to preserve leukocytes in near-native state to allow differentiation into subpopulations.
· COULTER LH 700 SERIES RETIC Pak, containing Reagent A and Reagent B, is used for clearing red cells and staining reticulocytes.
· COULTER S-CAL® Hematology Calibrator (K840794). alternative to whole blood reference method of calibration. Intended for use in ensuring accurate instrument measurements.

Principle of Method: 4.0

The COULTER LH 750 Hematology Analyzer with Version 2A software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer with Version 1A software. 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.

5.0 Indications for Use:

The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® LH 750 Hematology Analyzer also provides automated reticulocyte analysis and nucleated red blood cell (NRBC) enumeration.

6.0 Description of the modification:

The currently marketed COULTER LH 750 hematology analyzer with Version 1A software release was modified with software and minor hardware changes to improve performance characteristics and reliability.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 9 2002

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Premarket Product Regulatory Compliance Beckman Coulter Inc. 11800 SW 147 Avenue MC 31-B06 Miami, FL 33196-2500

K022161 Re:

Trade/Device Name: COULTER® LH 750 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: July 2, 2002 Received: July 3, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1C:

INDICATIONS FOR USE

510(k) Number (if known): Johassigned

COULTER® LH 750 Hematology Analyzer Device:

Indications For Use:

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/

(Per 21 CFR 801.109)

Use

Over-The-Counter

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices K022161
510(k) Number

LH 750 with Version 2A- Special 510k

Beckman Coulter, Inc.

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.”