(28 days)
Not Found
No
The summary describes a standard automated hematology analyzer and does not mention any AI or ML capabilities, image processing, or details about training/test sets which are common indicators of AI/ML use in medical devices.
No.
The device is an in vitro diagnostic hematology analyzer used to separate normal patients from those needing further studies, not to treat or alleviate a condition.
Yes
The device is described as an "automated hematology analyzer For In Vitro Diagnostic Use" and its purpose is to "separate the normal patient... from the patient who needs additional studies... that helps diagnose the patient's condition." These phrases directly indicate its role in diagnosis.
No
The device is described as a "hematology analyzer," which is a physical instrument used in laboratories to analyze blood samples. The description explicitly mentions "automated complete blood count and leukocyte differential" and "semiautomated reticulocyte analysis," all of which are functions performed by hardware components that process biological samples. While it mentions software (referencing a predicate device with "Version 1A software"), the core device is clearly a hardware analyzer.
Yes, based on the provided text, the COULTER® LH 500 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use in clinical laboratories."
- Explicit Statement in Device Description: The "Device Description" section also states: "LH 500 hematology analyzer is designed For In Vitro Diagnostic Use in clinical laboratories."
These direct statements confirm that the device is intended for use in examining specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of disease.
N/A
Intended Use / Indications for Use
The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi- automated reticulocyte analysis.
Product codes
GKZ, GKL
Device Description
LH 500 hematology analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 500 provides automated complete blood count and leukocyte differential and semiautomated reticulocyte analysis. The purpose of the LH 500 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.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 9 2004
Section 1 D: Summary of Safety and Effectiveness for COULTER® LH 500 Hematology Analyzer with Version 2A Software
1.0 General Information
| Device Generic Name(s): | Automated differential cell counter |
|---|---|
| Device Trade Name(s): | COULTER® LH 500 Hematology Analyzer |
| Device Classification: | The COULTER® LH 500 Hematology Analyzer is a Class III |
| medical device. | |
| Applicant Name and Address: | Beckman Coulter, Inc. |
| Cellular Analysis Division | |
| 11800 SW 147 Avenue | |
| Miami, FL 33196-2500 | |
| Date: | September 30, 2004 |
2.0 Legally Marketed Device(s)
The modified COULTER® LH 500 Hematology Analyzer with Version 2A Software claims substantial equivalence to the previously cleared COULTER® LH 500 Hematology Analyzer with Version 1A software.
FDA 510(k) Number(s): K032000
3.0 Device Description
LH 500 hematology analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 500 provides automated complete blood count and leukocyte differential and semiautomated reticulocyte analysis. The purpose of the LH 500 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.
4.0 Principle of Method:
CBC (Complete Blood Count) Analysis (Whole Blood)
CBC analysis is based on the established Coulter principle method of automated cell counting and spectrophotometric hemoglobin determination. The Coulter method counts and sizes cells by detecting and measuring changes in electrical resistance when a particle (such as a cell) in a conductive liquid goes through a small aperture,
1
Each cell suspended in a conductive liquid (diluent) acts as an insulator. As each cell goes through the aperture, it momentarily increases the resistance of the electrical path between two submerged electrodes, one located on each side of the aperture. This causes an electrical pulse that can be counted and sized. While the number of pulses indicates particle count, the size of the electrical pulse is proportional to the cell volume.
Differential and Reticulocyte Analysis (Whole Blood)
Differential and reticulocyte Analysis is based on the Coulter volume, conductivity and light scatter technology (VCS). Differential analysis and classification and reticulocyte analysis occur in the flow cell, where:
Low-frequency current measures volume.
High-frequency current senses cellular internal content through measuring changes in conductivity,
Light from the laser scattered off the individual cells characterizes cellular surface, shape and reflectivity.
5.0 Indications for Use:
The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi- automated reticulocyte analysis.
6.0 Description of the modification:
The currently marketed COULTER LH 500 hematology analyzer with Version 1A software release was modified with software algorithm changes to allow use of cyanide-free reagents (ISOTON 4 diluent /LYSE S 4 lytic agent). Additional software modifications were made to mitigate observed anomalies of earlier versions and various corrections, clarifications and minor performance testing results were added to operator labeling.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter, and a stylized symbol resembling three abstract human figures or waves. The symbol is positioned to the right of the circular seal.
2098 Gaither Road Rockville MD 20850
Food and Drug Administration
Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Premarket Product Regulatory Compliance Beckman Coulter, Inc. 11800 SW 147 Avenue Miami, Florida 33196-2500
Re: K042724
Trade/Device Name: COULTER® LH 500 Hematology Analyzer with Version 2A Software Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ, GKL Dated: October 18, 2004 Received: October 19, 2004
OCT 2 9 2004
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.
3
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Section 1C:
INDICATIONS FOR USE
K042724
Not assigned
510(k) Number (if known):
COULTER® LH 500 Hematology Analyzer Device:
Intended use:
The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi- automated reticulocyte analysis.
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 Use (Per 21 CFR 801.109) OR
Over-The-Counter
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet
510(k) K042724