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 provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

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) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 750 Hematology Analyzer utilizes the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. It uses COULTER VCS (volume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzer uses 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. For body fluids analysis, the specimen is aspirated into the LH 750 Analyzer via the manual mode and is diluted in separate WBC and RBC baths. The Coulter Method of counting cells is used to detect and measure changes in electrical resistance when a cell, suspended in a conductive diluent, passes through a small aperture.

AI/ML Overview

The provided document K061574, a 510(k) summary for the COULTER® LH 750 Hematology Analyzer, is primarily a notification of a modification to the device, specifically a revised MCV accuracy specification. It does not contain detailed information about a comprehensive study proving the device meets acceptance criteria for all its listed functions (e.g., differential leukocyte count, reticulocyte analysis, NRBC enumeration, body fluid analysis).

The document mentions that the modification relates to the "draft labeling submitted in the original Premarket notification (K011342) to reflect a revised MCV accuracy specification." This implies that the initial and comprehensive studies would have been part of the K011342 and K030606 submissions, which are referenced as legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not available in the provided text. The following table and explanations reflect the information that can be extracted from the given document, focusing on the modification rather than a complete re-evaluation of the entire device.

Acceptance Criteria and Reported Device Performance (Focused on MCV Accuracy Specification)

Acceptance Criteria (from the perspective of the modification)	Reported Device Performance (as implied by the modification)
The previous MCV accuracy specification was the original acceptance criterion for MCV.	The MCV accuracy specification was revised. The specific new numerical acceptance criterion or the old one is not provided. The document states that the labeling was modified "to reflect a revised MCV accuracy specification," implying a change from a previous, presumably less accurate, specification to a new one.
The device must continue to be substantially equivalent to the predicate devices (K011342 and K030606).	The FDA determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use, even with the revised MCV accuracy specification.

Missing Information:

The actual numerical value of the original MCV accuracy specification.
The actual numerical value of the revised MCV accuracy specification.
The specific data and statistical analysis demonstrating that the device meets the revised MCV accuracy specification.

Study Information (Based on the available document)

Given the nature of the document (a 510(k) for a revised MCV accuracy specification), the details of a full study often found in original 510(k) submissions are not present. The focus here is on what can be inferred about the change rather than a complete de novo study validation.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in this document. Information on the number of samples used to validate the revised MCV accuracy is absent.
- Data Provenance: Not specified. It's likely that data would be from internal Beckman Coulter studies, but details on country of origin or whether it was retrospective or prospective are not provided for this specific modification. For the original device, it would have been part of K011342 and K030606.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of a hematology analyzer, ground truth for MCV would typically involve reference methods and quality controls, potentially with expert oversight for sample preparation and analysis.
Adjudication method for the test set:
- Not specified. This is typically relevant for subjective assessments (e.g., image review), which MCV measurement is not. For quantitative measurements like MCV, validation usually involves comparison to a reference method or validated control materials.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an automated hematology analyzer, not an AI-assisted diagnostic imaging tool with human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The COULTER® LH 750 Hematology Analyzer is an automated device, meaning its primary function is standalone performance (algorithm only). The document describes it as "a quantitative, automated hematology analyzer."
- The modifications to its MCV accuracy specification would inherently relate to its standalone performance.
The type of ground truth used:
- Likely Reference Methods and Calibrated Controls: For MCV, ground truth would typically be established using validated reference methods (e.g., manual packed cell volume, or highly calibrated reference instruments) and internationally recognized hematology calibrators and internal quality control materials (some of which are mentioned as qualified reagents, such as COULTER S-CAL® Hematology Calibrator).
The sample size for the training set:
- Not applicable/Not specified for this modification. This document pertains to a specification revision for an existing, already-marketed device. It's not a de novo algorithm development that would explicitly describe a "training set" in the context of machine learning. The device's underlying principles (Coulter Principle, VCS technology) are well-established. Any "training" or calibration would have occurred during the original device development (K011342) and subsequent routine calibration of individual instruments.
How the ground truth for the training set was established:
- Not applicable/Not specified for this modification. As above, the concept of a training set in the AI/ML sense isn't directly applicable here. For the original development, ground truth for calibration would have been established using reference methods and calibrated materials.

Summary

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K061574

Summary of Safety and Effectiveness for COULTER® LH 750 Hematology Analyzer

JUL 2 1 2006

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:	June 6 2006

2.0 Legally Marketed Device(s)

The modified COULTER® LH 750 Hematology Analyzer with claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer and COULTER® LH 750 Body Fluids Application.

FDA 510(k) Number(s): K011342 and K030606

3.0 Device Description

· 5C Cell Control (K912133) 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 Series Diluent and ISOTON® 4 Diluent. Intended for use as a diluent for counting and sizing blood cells.
· COULTER Lyse S® III diff lytic reagent and COULTER Lyse S® 4 lytic reagent. Intended for the simultaneous quantitative determination of hemoglobin and for leukocyte counting and sizing.
· COULTER CLENZ® cleaning agent to prevent protein buildup on surfaces.
· COULTER Latron™ Primer and Latron Control (K885028) to monitor VCS performance.

LH 750 Revised MCV Accuracy Specification- Special 510k Beckman Coulter, Inc.

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· COULTER LH Series Pak, containing Erythrolyse™ lytic reagent and Stabilyse " to preserve leukocytes in near-native state to allow differentiation into subpopulations.
· COULTER LH Series RETIC Pak for preparing samples for reticulocyte analysis.
· 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 utilizes the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. It uses COULTER VCS (yolume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzer uses 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.

For body fluids analysis, the specimen is aspirated into the LH 750 Analyzer via the manual mode and is diluted in separate WBC and RBC baths. The Coulter Method of counting cells is used to detect and measure changes in electrical resistance when a cell, suspended in a conductive diluent, passes through a small aperture. Each suspended cell acts as an insulator. As the cell passes through the aperture, it momentarily increases the resistance of the electrical path between two submerged electrodes, one located on each side of the aperture. The resistance generates an electrical pulse. The accumulation of electrical pulses are channelized, processed for coincidence correction, and multiplied by a calibration factor, yielding the WBC and RBC counts.

The WBC result represents the TNC (total nucleated cell count) in the analysis of Body Fluids.

Indications for Use: 5.0

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 as well as an automated method for enumeration of RBCs and WBCs in body fluids.

6.0 Description of the modification:

The labeling for the marketed COULTER LH 750 hematology analyzer will be modified relative to the draft labeling submitted in the original Premarket notification (K011342) to reflect a revised MCV accuracy specification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the three branches of government. The caduceus is surrounded by a circle of text that reads "U.S. Department of Health and Human Services".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 S.W. 147 Avenue M/S 31-B06 Miami, Florida 33196-2500

JUL 21 2006

Re: K061574

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: June 6, 2006 Received: June 7, 2006

Dear Ms. Nadler:

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 complics 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 (240) 276-0484. 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 from the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K061574

Device Name: COULTER® LH 750 Hematology Analyzer

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1

Robert Hooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

310(k) K061574

LH 750 Revised MCV Accuracy Specification- 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.”