(118 days)
The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 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.
The COULTER LH 780 Hematology Analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 780 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and WBCs in body fluids. 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.
Here's a summary of the requested information based on the provided text for the COULTER® LH 780 Hematology Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative format with corresponding "reported device performance" values for each parameter. Instead, it states that "Accuracy, precision, linearity and carryover studies were conducted and the data demonstrated compliance with the manufacturer specifications." The key point is that the LH 780's performance specifications are considered "Same as LH750 plus Within-Run precision, Accuracy, and Operating and Reportable Ranges include RDW-SD and a tighter WBC Linearity specification."
This implies that the acceptance criteria are the manufacturer's internal specifications, which were met. Without access to the specific manufacturer's specifications for the LH 750 or the LH 780, it's impossible to create a precise table. However, the performance areas assessed are clearly stated:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Accuracy | Compliance with manufacturer specifications for CBC, Diff, Retic, and RDW-SD | Demonstrated compliance |
| Precision (Within-Run) | Compliance with manufacturer specifications for CBC, Diff, Retic, and RDW-SD | Demonstrated compliance |
| Linearity | Compliance with manufacturer specifications for WBC, RBC, Hgb, Plt, and a tighter WBC linearity specification for LH 780 | Demonstrated compliance |
| Carryover | Compliance with manufacturer specifications | Demonstrated compliance |
| Background | Compliance with manufacturer specifications for WBC, RBC, Hgb, Plt | Not explicitly stated but implied in overall compliance |
| Operating and Reportable Ranges | Compliance with manufacturer specifications for CBC, Diff, Retic, NRBC, and RDW-SD | Demonstrated compliance |
| Mode to Mode Comparison | Compliance with manufacturer specifications for WBC, RBC, Hgb, Plt | Not explicitly stated but implied in overall compliance |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states that "Accuracy, precision, linearity and carryover studies were conducted," but it does not specify the sample sizes used for these studies.
The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be prospective as they were conducted to demonstrate the device's compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The device is an automated hematology analyzer, and ground truth for blood counts and differentials is typically established by reference methods or expert manual microscopy, but the details of this process are not described.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The COULTER® LH 780 is an automated analyzer, not an AI-assisted diagnostic tool for human readers in the traditional sense of medical imaging. Its purpose is to automate blood analysis, reducing the need for extensive manual microscopic review in routine cases. Therefore, a study of human improvement with/without AI assistance is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are inherently standalone performance studies. The COULTER® LH 780 Hematology Analyzer is an automated device designed to perform quantitative measurements of blood parameters without human intervention in the primary analytical process. The "Accuracy, precision, linearity and carryover studies" would assess the algorithm's performance directly against established reference methods or known controls.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The document does not explicitly state the specific type of ground truth used. However, for hematology analyzers, ground truth is typically established by:
- Reference methods: Highly accurate and precise laboratory techniques for each parameter (e.g., manual cell counts, spectrophotometry for hemoglobin).
- Known standards/controls: Materials with certified known concentrations of analytes.
- Manual microscopy/expert review: For differential counts, an expert microscopist performs a manual differential count, which serves as the "gold standard" to validate the automated differential.
Given the context of a hematology analyzer, a combination of these methods would have been used.
8. The Sample Size for the Training Set:
The document does not specify the sample size for any training set. This is typical for submissions of this nature, where the focus is on the performance of the final, commercialized device rather than the developmental aspects.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document. As with the test set ground truth, it would likely involve reference methods, known controls, and potentially expert manual review during the development and training phases of the instrument's algorithms.
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L061616
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved white lines inside, resembling a stylized eye or a wave. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked vertically, with "BECKMAN" on top and "COULTER" below, both in a bold, sans-serif font.
510(k) Summary COULTER® LH 780 Hematology Analyzer
1.0 Submitted By:
Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4191 FAX: (305) 380-3618
2.0 Date Submitted:
June 8, 2006
3.0 Device Name(s):
3.1 Proprietary Names
COULTER® LH 780 Hematology Analyzer
3.2 Classification Name
Automated differential cell counter (21 CFR § 864.5220)
4.0 Predicate Devices:
| Candidate | Predicates | Manufacturer | DocketNumber |
|---|---|---|---|
| COULTER® LH 780Hematology Analyzer | COULTER® LH 750Hematology Analyzer | Beckman Coulter, Inc. | K011342 |
| COULTER® LH 750Body Fluids Application(for Body Fluids equivalence only) | Beckman Coulter, Inc. | K030606 | |
| Sysmex™ AutomatedHematology AnalyzerXE-2100(for RDW SD Parameterequivalence only) | Sysmex Corporation | K992875 |
Beckman Coulter , Inc. 11800 S.W. 147th Avenue Miami, FL 33196-2500
Mailing Address: 11800 S.W. 147th Avenue P.O. Box 169015 Miami, FL 33116-9015
Customer Service: (800) 526-7694 Product Information: (800) 526-6932 (800) 327-6531 (305) 380-3800 www.beckmancoulter.com Internet:
OCT - 4 2006
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5.0 Description:
The COULTER LH 780 Hematology Analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 780 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and WBCs in body fluids
The purpose of the LH 780 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.
6.0 Intended Use:
The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER L.H 780 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.
7.0 Comparison to Predicate(s):
| Characteristic | COULTER LH 750 (Predicate) | COULTER LH 780 |
|---|---|---|
| Intended Use | The COULTER LH 750 Hematology Analyzer is a quantitative,automated hematology analyzer and leukocyte differentialcounter For In Vitro Diagnostic Use in clinical laboratories. TheCOULTER LH 750 Hematology Analyzer provides automatedReticulocyte analysis and enumeration of nucleated red bloodcells (NRBCs) as well as an automated method for enumerationof RBCs and WBCs in body fluids. | Same as LH 750except referring to the LH 780 |
| Parameters IVD | WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, LY%,MO%, NE%, EO%, BA%, LY#, MO#, NE#, EO#, BA#, NRBC%,NRBC#, RET%, RET#, IRF, & MRV. | Same as LH 750 plusRDW-SD |
| Quality ControlTechniques | Daily Instruments Check, Commercial Controls, Delta Checks,Patient Controls, XB Analysis, & IQAP. | Same as LH 750 plusExtended QC & XM Analysis |
| Quality Controls &Calibrator | COULTER® 5C® Cell ControlCOULTER® Latron™ Primer and Latron ControlCOULTER® RETIC-C™ Cell ControlCOULTER® LIN-C® linearity controlCOULTER® S-CAL® calibrator kit | Same as LH 750 |
COULTER® LH 780 Hematology Analyzer Abbreviated 510(k) Notification
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| Characteristic | COULTER LH 750 (Predicate) | COULTER LH 780 |
|---|---|---|
| Analysis Reagents | COULTER® LH Series DiluentCOULTER® Isoton 4 DiluentCOULTER® LH Series PakCOULTER® LH Series RETIC PakCOULTER® Lyse S® III lytic agentCOULTER® Lyse S® 4 lytic agent | Same as LH 750 |
| Cleaning Agent | COULTER® CLENZ | Same as LH 750 plusCOULTER® LH Series Cleaner |
| New Features(not covered above) | n/a | RBC correctionGraphical representation ofcustomer-definable high / lowlimits on the RBC histogramAdvanced bar-code readerControl folder filtersReproducibility and carryover notrequired as pre-calibrationchecks |
| 3. Device Comparison Table | ||
| Characteristic | COULTER LH 750 (Predicate) | COULTER LH 780 |
| Intended 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 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. | Same as LH 750except referring to the LH 780 |
| Indication For Use | The purpose of the LH 700 Series 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. | Same as LH 750 |
| Parameters IVD | WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, LY%, MO%, NE%, EO%, BA%, LY#, MO#, NE#, EO#, BA#, NRBC%, NRBC#, RET%, RET#, IRF, & MRV. | Same as LH 750 plusRDW-SD |
| Quality ControlTechniques | Daily Instruments Check, Commercial Controls, Delta Checks, Patient Controls, XB Analysis, & IQAP. | Same as LH 750 plusExtended QC & XM Analysis |
| Method History | Coulter Principle, Hemoglobinometry, VCS technology, & NRBC enumeration. | Same as LH 750 |
| Quality Controls &Calibrator | COULTER® 5C® Cell ControlCOULTER® Latron™ Primer and Latron ControlCOULTER® RETIC-C™ Cell ControlCOULTER® LIN-C® linearity controlCOULTER® S-CAL® calibrator kit | Same as LH 750 |
| Analysis Reagents | COULTER® LH Series DiluentCOULTER® Isoton 4 DiluentCOULTER® LH Series PakCOULTER® LH Series RETIC PakCOULTER® Lyse S® III lytic agentCOULTER® Lyse S® 4 lytic agent | Same as LH 750 |
| Cleaning Agent | COULTER® CLENZ | Same as LH 750 plusCOULTER® LH Series Cleaner |
| PerformanceSpecifications | Within-Run precision (CBC, Diff, Retic),Accuracy(CBC, Diff, Retic), Linearity (WBC, RBC, Hgb, & Plt),Background (WBC, RBC, Hgb, & Plt),Operating and Reportable Ranges (CBC, Diff, Retic, NRBC), &Mode to Mode Comparison (WBC, RBC, Hgb, Plt). | Same as LH750 plusWithin-Run precision, Accuracy, andOperating and Reportable Rangesinclude RDW-SD and a tighter WBCLinearity specification |
| Service diagnostics | Uses ProService Remote Diagnostics | Same as LH 750 |
| Hardware Options | Graphic/Laser Printer, LH 700 Series SlideMaker, & LH 700Series SlideStainer. | Same as LH 750 |
| Uncorrected WBC(UWBC) | Result reported in a comment field | Result reported in parameter block |
Summary of Performance Data: 8.0
Accuracy, precision, linearity and carryover studies were conducted and Accuraby, "proclority" inteanty "and on the manufacturer specifications. The dominetiated accopian on safety and effectiveness supports a finding data in the Promation to products already in commercial distribution.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
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3. Device Comparison Table
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TABLE 1: COULTER® LH 780 Hematology Analyzer Whole Blood Parameters (con't):
| NE% | Neutrophil percent |
|---|---|
| EO% | Eosinophil percent |
| BA% | Basophil percent |
| LY# | Lymphocyte number |
| MO# | Monocyte number |
| NE# | Neutrophil number |
| EO# | Eosinophil number |
| BA# | Basophil number |
| NRBC% | Nucleated Red Blood Cell percent |
| NRBC# | Nucleated Red Blood Cell number |
| RET% | Reticulocyte percent |
| RET# | Reticulocyte number |
| IRF | Immature Reticulocyte Fraction |
| MRV | Mean Reticulocyte Volume |
.
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| Characteristic | COULTER LH 750 (Predicate) | COULTER LH 780 |
|---|---|---|
| Parameters IVD | WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, LY%,MO%, NE%, EO%, BA%, LY#, MO#, NE#, EO#, BA#, NRBC%,NRBC#, RET%, RET#, IRF, & MRV. | Same as LH 750 plusRDW-SD |
| Quality ControlTechniques | Daily Instruments Check, Commercial Controls, Delta Checks,Patient Controls, XB Analysis, & IQAP. | Same as LH 750 plusExtended QC & XM Analysis |
| Method History | Coulter Principle, Hemoglobinometry, VCS technology, & NRBCenumeration. | Same as LH 750 |
| Quality Controls &Calibrator | COULTER® 5C® Cell ControlCOULTER® Latron™ Primer and Latron ControlCOULTER® RETIC-C™ Cell ControlCOULTER® LIN-C® linearity controlCOULTER® S-CAL® calibrator kit | Same as LH 750 |
| Analysis Reagents | COULTER® LH Series DiluentCOULTER® Isoton 4 DiluentCOULTER® LH Series PakCOULTER® LH Series RETIC PakCOULTER® Lyse S® III lytic agentCOULTER® Lyse S® 4 lytic agent | Same as LH 750 |
| Cleaning Agent | COULTER® CLENZ | Same as LH 750 plusCOULTER® LH Series Cleaner |
| PerformanceSpecifications | Within-Run precision (CBC, Diff, Retic),Accuracy(CBC, Diff, Retic), Linearity (WBC, RBC, Hgb, & Plt),Background (WBC, RBC, Hgb, & Plt),Operating and Reportable Ranges (CBC, Diff, Retic, NRBC), &Mode to Mode Comparison (WBC, RBC, Hgb, Plt). | Same as LH750 plusWithin-Run precision, Accuracy, andOperating and Reportable Rangesinclude RDW-SD and a tighter WBCLinearity specification |
| Service diagnostics | Uses ProService Remote Diagnostics | Same as LH 750 |
| Hardware Options | Graphic/Laser Printer, LH 700 Series SlideMaker, & LH 700Series SlideStainer. | Same as LH 750 |
| Uncorrected WBC(UWBC) | Result reported in a comment field | Result reported in parameter block |
| New Features(not covered above) | n/a | • RBC correction• Graphical representation ofcustomer-definable high / lowlimits on the RBC histogram• Advanced bar-code reader• Control folder filters• Reproducibility and carryover notrequired as pre-calibrationchecks |
:
·
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Public Health Service
Food and Drug Administration 2098 Galther 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
000 - 4 2006
Re: K061616 Trade/Device Name: COULTER® LH 780 Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: September 20, 2006 Received: September 21. 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 iudications 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, Dr 10 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 1.01 The general controls provisions of the Act include requirements for annual registration, insting of devices, good manufacturing practice, labeling, and prohibitions against msbranding 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 Degister.
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: registredion 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 5100k). This ket 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 references 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 the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerf
Robert L. Becker, Jr., MD, Par 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
Korollollo 510(k) Number (if known):
Device Name: COULTER® LH 780 Hematology Analyzer
Indications For Use: The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 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.
Prescription Use X (Part 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-The-Counter Use (21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Jorphine Bautista
Page 1 of 1
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
x10(k) K061616
COULTER® LH 780 Hematology Analyzer Abbreviated 510(k) Notification
Page 16
§ 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.”