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, enumeration of nucleated red blood cells (NRBCs) in whole blood and leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid. The COULTER LH 750 Hematology Analyzers utilizes the Coulter Principle for enumerating and sizing blood cells, automatic and manual modes for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume, conductivity, light scatter) technology for leukocyte differentiation and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent, lytic reagents, and instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

AI/ML Overview

The provided text describes a 510(k) submission for a modification to the COULTER® LH 750 Hematology Analyzer, specifically related to the NRBC QC method. However, the document does not contain an independent clinical study that establishes acceptance criteria and then demonstrates the device meets those criteria through performance data.

Instead, this 510(k) is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology or intended use, and the performance data necessary to demonstrate substantial equivalence can be found in the original premarket notification or in recognized standards. In this case, the modification is to the NRBC QC method, suggesting an administrative or minor technical change rather than a re-evaluation of the core performance of the analyzer itself.

Therefore, many of the requested sections (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable or extractable from this specific document, as those would typically be part of a full 510(k) submission for a new device or a significant modification requiring extensive re-validation.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The document refers to a modification to the "NRBC QC Method" and states "The modified COULTER® LH 750 Hematology Analyzer claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer." This implies that the performance characteristics (accuracy, precision, etc.) for the NRBC enumeration itself would have been established and accepted under the original clearance (K011342). This submission focuses on the QC method for those NRBC determinations, not on the underlying performance specifications of the NRBC enumeration itself.

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

Not applicable/Not provided. This submission is for a modification to a QC method, not a re-evaluation of the device's overall performance that would typically involve a test set for clinical accuracy. The original 510(k) (K011342) would contain this information for the device's initial clearance.

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

Not applicable/Not provided. Similar to the above, this information would be relevant to the original clearance of the device's performance, not this specific modification to a QC method.

4. Adjudication Method for the Test Set:

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is typically done for diagnostic imaging or interpretation tasks where multiple human readers are involved. A hematology analyzer, while performing complex analysis, is generally evaluated through its analytical performance (accuracy, precision, linearity) against reference methods, not typically in an MRMC setting for human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The COULTER® LH 750 Hematology Analyzer is an automated device, so its primary function is standalone (without human-in-the-loop performance for the core analysis). However, this document does not present a study demonstrating its standalone performance for the NRBC QC method modification. The standalone performance of the NRBC enumeration would have been established during the original K011342 submission.

7. The Type of Ground Truth Used:

For the original clearance of a hematology analyzer, ground truth for cell counts and differentials typically involves:

Reference methods: Manual microscopy by trained technologists/pathologists, often with differential counts performed on stained blood smears.
Certified reference materials: Materials with known values for specific analytes (e.g., cell counts).
Comparison to predicate devices: Performance compared to existing, legally marketed devices.

This specific document related to the modification of the NRBC QC method doesn't discuss the ground truth for NRBC enumeration itself, but rather how the quality control for that enumeration is monitored.

8. The Sample Size for the Training Set:

Not applicable/Not provided. The COULTER® LH 750 (and its underlying technology) was developed prior to the widespread use of "training sets" in the context of machine learning algorithms as we understand them today for image recognition, etc. While the instrument relies on algorithms, these are more in the realm of signal processing and pattern recognition engineered based on established hematological principles rather than deep learning requiring large, labeled training datasets in the contemporary sense. Any "training" or calibration would typically involve a smaller set of known samples to fine-tune instrument parameters.

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

Not applicable/Not provided. If "training set" refers to calibration materials, their ground truth would be established through a combination of reference methods and certified values.

In summary, the provided document is a notification for a minor modification to a previously cleared device's QC method. It does not contain an independent study with acceptance criteria and performance data for the device itself because the original device's performance was already established and cleared under a prior 510(k).

Summary

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K052905

NOV 1 8 2005

Summary of Safety and Effectiveness for Section 1 D: COULTER® LH 750 Hematology Analyzer

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 II medicaldevice.
Applicant Name and Address:	Beckman Coulter, Inc.Cellular Analysis Division11800 SW 147 AvenueMiami, FL 33196-2500

Date:

October 13, 2005

2.0 Legally Marketed Device(s)

The modified COULTER® LH 750 Hematology Analyzer claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer.

FDA 510(k) Number(s): K011342

3.0 Device Description

· 5C® Cell Control (K781969) 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 or ISOTON 4 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 or Lyse S® 4. Intended for the simultaneous quantitative determination of hemoglobin and for leukocyte counting and sizing on COUL TER® hematology analyzers.

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· COULTER CLENZ® cleaning agent to prevent protein buildup on surfaces.
· COULTER Latron™ Primer and Latron Control (K885028) to monitor VCS performance.
· COULTER LH 700 SERIES Pak, containing Erythrolyse™ bytic reagent and Stabilyse™ to
lydies and the more to the take to the differentiation into submonylations COULTER LH 700 SERIES Fak, containing Elyth Style Poplic Forestigations.
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 COULTER S-CAL® Hematology Oallbrator (10 100 -)); rate instrument measurements.

Principle of Method: 4.0

The COULTER LH 750 Hematology Analyzers utilizes the Coulter Principle for enumerating and The COULTEN LT 750 Ticmation's for sample processing and a single beam sizing blood cells, automatic and inking of the VCS (yolume, conductivity, light scater)
photometer for hemoglobinometry. They use COULTER VCS (yolume, was answaig, The spake photometer for nemogromomony. Internation and reticulocyte analysis. The analyzers lectified in TVDO Differential chargers and online and onlyth to lyse the red cells without use a reagent system consisting of an botenia and instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

For body fluids analysis, specimen is aspirated into the LH 700 Series Analyzer via the manual For body holos analysis, spocillion is aspirated the in BBC baths. The Coulter Method of counting cells is used mode and is unded in Soparato WBO arrical resistance when a cell, suspended in a conductive to delect and measure changes in block. Surpended cell acts as an insulator. As the cell ulldent, passes through a omail momentarily increases the resistance of the electrical path passes through the upondio, in merced on each side of the aperture. The resistance between two submorged stock of electrical pulses are channelized, processed generates an electifical pulse. The aloualibration 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 (Intended Use): 5.0

The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and THE COULTER LT POSTIGINAL Counter For In Clinical laboratories. The COULTER LH leukocyte unferential oomier for in Ville Diegne analysis and enumeration of nucleated red blood cells (NRBCs) 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 draft product labeling submitted in the original premarket notification (K011342) to reflect new instructions for performing QC for NRBC determinations.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

NOV 1 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K052905

Trade/Device Name: COULTER® LH 750 Hematology Analyzer: Change to NRBC QC Method Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: October 13, 2005 Received: October 14, 2005

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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Page 2 -

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-free number (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, PH. 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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Section 1C:

INDICATIONS FOR USE

K052905

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

COULTER® LH 750 Hematology Analyzer Device:

Intended 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.

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Becker J
Division Sign-Off

fice of In Vitro Diagnostic Device Evaluation and Safe

510(k) K052903

LH 750- NRBC QC Method 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.”