(118 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard hematology analysis techniques.
No
This device is an in vitro diagnostic (IVD) hematology analyzer used in clinical laboratories to analyze blood and body fluid components; it is not intended for direct treatment or diagnosis of patients.
Yes
The device is used for quantitative analysis of various blood components and is intended for "In Vitro Diagnostic Use in clinical laboratories," which clearly indicates it is a diagnostic device.
No
The device description explicitly states it is an "instrument system comprised of the analyzer and a suite of analytical reagents," indicating it includes hardware components beyond just software.
Yes, the COULTER LH 780 Hematology Analyzer is an IVD (In Vitro Diagnostic) device.
This is explicitly stated multiple times in the provided text:
- Intended Use / Indications for Use: "For In Vitro Diagnostic Use in clinical laboratories."
- Device Description: "The COULTER LH 780 Hematology Analyzer is designed For In Vitro Diagnostic Use in clinical laboratories."
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In Vitro Diagnostic Use in clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy, precision, linearity and carryover studies were conducted and the demonstrated acceptable on the manufacturer specifications. The substantiated acceptable on safety and effectiveness supports a finding data in the Premarket Notification for products already in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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 | Docket
Number |
|----------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------|------------------|
| COULTER® LH 780
Hematology Analyzer | COULTER® LH 750
Hematology Analyzer | Beckman Coulter, Inc. | K011342 |
| | COULTER® LH 750
Body Fluids Application
(for Body Fluids equivalence only) | Beckman Coulter, Inc. | K030606 |
| | Sysmex™ Automated
Hematology Analyzer
XE-2100
(for RDW SD Parameter
equivalence 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
1
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 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 750 | |
| except 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 plus | |
| RDW-SD | ||
| Quality Control | ||
| Techniques | Daily Instruments Check, Commercial Controls, Delta Checks, | |
| Patient Controls, XB Analysis, & IQAP. | Same as LH 750 plus | |
| Extended QC & XM Analysis | ||
| Quality Controls & | ||
| Calibrator | COULTER® 5C® Cell Control | |
| COULTER® Latron™ Primer and Latron Control | ||
| COULTER® RETIC-C™ Cell Control | ||
| COULTER® LIN-C® linearity control | ||
| COULTER® S-CAL® calibrator kit | Same as LH 750 |
COULTER® LH 780 Hematology Analyzer Abbreviated 510(k) Notification
2
| Characteristic | COULTER LH 750 (Predicate) | COULTER LH 780 |
|---|---|---|
| Analysis Reagents | COULTER® LH Series Diluent | |
| COULTER® Isoton 4 Diluent | ||
| COULTER® LH Series Pak | ||
| COULTER® LH Series RETIC Pak | ||
| COULTER® Lyse S® III lytic agent | ||
| COULTER® Lyse S® 4 lytic agent | Same as LH 750 | |
| Cleaning Agent | COULTER® CLENZ | Same as LH 750 plus |
| COULTER® LH Series Cleaner | ||
| New Features | ||
| (not covered above) | n/a | RBC correction |
| Graphical representation of | ||
| customer-definable high / low | ||
| limits on the RBC histogram | ||
| Advanced bar-code reader | ||
| Control folder filters | ||
| Reproducibility and carryover not | ||
| required as pre-calibration | ||
| checks | ||
| 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 750 |
| except 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 plus |
| RDW-SD | ||
| Quality Control | ||
| Techniques | Daily Instruments Check, Commercial Controls, Delta Checks, Patient Controls, XB Analysis, & IQAP. | Same as LH 750 plus |
| Extended QC & XM Analysis | ||
| Method History | Coulter Principle, Hemoglobinometry, VCS technology, & NRBC enumeration. | Same as LH 750 |
| Quality Controls & | ||
| Calibrator | COULTER® 5C® Cell Control | |
| COULTER® Latron™ Primer and Latron Control | ||
| COULTER® RETIC-C™ Cell Control | ||
| COULTER® LIN-C® linearity control | ||
| COULTER® S-CAL® calibrator kit | Same as LH 750 | |
| Analysis Reagents | COULTER® LH Series Diluent | |
| COULTER® Isoton 4 Diluent | ||
| COULTER® LH Series Pak | ||
| COULTER® LH Series RETIC Pak | ||
| COULTER® Lyse S® III lytic agent | ||
| COULTER® Lyse S® 4 lytic agent | Same as LH 750 | |
| Cleaning Agent | COULTER® CLENZ | Same as LH 750 plus |
| COULTER® LH Series Cleaner | ||
| Performance | ||
| Specifications | 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 plus | |
| Within-Run precision, Accuracy, and | ||
| Operating and Reportable Ranges | ||
| include RDW-SD and a tighter WBC | ||
| Linearity specification | ||
| Service diagnostics | Uses ProService Remote Diagnostics | Same as LH 750 |
| Hardware Options | Graphic/Laser Printer, LH 700 Series SlideMaker, & LH 700 | |
| Series 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.
3
3. Device Comparison Table
4
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 |
.
5
| 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 plus | |
| RDW-SD | ||
| Quality Control | ||
| Techniques | Daily Instruments Check, Commercial Controls, Delta Checks, | |
| Patient Controls, XB Analysis, & IQAP. | Same as LH 750 plus | |
| Extended QC & XM Analysis | ||
| Method History | Coulter Principle, Hemoglobinometry, VCS technology, & NRBC | |
| enumeration. | Same as LH 750 | |
| Quality Controls & | ||
| Calibrator | COULTER® 5C® Cell Control | |
| COULTER® Latron™ Primer and Latron Control | ||
| COULTER® RETIC-C™ Cell Control | ||
| COULTER® LIN-C® linearity control | ||
| COULTER® S-CAL® calibrator kit | Same as LH 750 | |
| Analysis Reagents | COULTER® LH Series Diluent | |
| COULTER® Isoton 4 Diluent | ||
| COULTER® LH Series Pak | ||
| COULTER® LH Series RETIC Pak | ||
| COULTER® Lyse S® III lytic agent | ||
| COULTER® Lyse S® 4 lytic agent | Same as LH 750 | |
| Cleaning Agent | COULTER® CLENZ | Same as LH 750 plus |
| COULTER® LH Series Cleaner | ||
| Performance | ||
| Specifications | 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 plus | |
| Within-Run precision, Accuracy, and | ||
| Operating and Reportable Ranges | ||
| include RDW-SD and a tighter WBC | ||
| Linearity specification | ||
| Service diagnostics | Uses ProService Remote Diagnostics | Same as LH 750 |
| Hardware Options | Graphic/Laser Printer, LH 700 Series SlideMaker, & LH 700 | |
| Series 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 of | ||
| customer-definable high / low | ||
| limits on the RBC histogram | ||
| • Advanced bar-code reader | ||
| • Control folder filters | ||
| • Reproducibility and carryover not | ||
| required as pre-calibration | ||
| checks |
:
·
6
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
8
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
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