(59 days)
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No
The document describes a standard automated hematology analyzer and its functions, with no mention of AI, ML, or related concepts. The description focuses on traditional analytical methods for blood cell analysis.
No
The device is an in vitro diagnostic hematology analyzer used for analyzing blood samples, not for treating patients.
Yes
The device is described as an "automated hematology analyzer" that separates "the normal patient...from the patient who needs additional studies," and states these additional studies "might include...any other definitive test that helps diagnose the patient's condition." This indicates its role in identifying potential conditions that require further diagnostic investigation.
No
The device description explicitly states it is an "automated hematology analyzer" and includes hardware components like the analyzer instrument and analytical reagents, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use in clinical laboratories."
- Device Description: The "Device Description" also reiterates: "is designed For In Vitro Diagnostic Use in clinical laboratories."
- Function: The device performs automated analysis of blood components (complete blood count, leukocyte differential, NRBC enumeration, reticulocyte analysis), which are tests performed in vitro (outside the body) on biological samples to provide information for diagnosis or monitoring.
- Intended User/Care Setting: The intended user is "Clinical laboratories," which is a typical setting for IVD devices.
N/A
Intended Use / Indications for Use
The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
LH 750 Hematology Analyzer with Ver. 2B Software is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Ver. 2B Software 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, biochemical investigations, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
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 NRBC enumeration.
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.”
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K03234-2
510(k) Summary of Safety and Effectiveness for Section 1 D:
LH 750 Hematology Analyzer with Ver. 2B Software
1.0 General Information
| Applicant Name and Address: | Beckman Coulter, Inc.
Cellular Analysis Division
11800 SW 147 Avenue
Miami, FL 33196-2500 |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Stan Sugrue, Ph.D.
Senior Regulatory Affairs Specialist
Telephone: (305) 380-4552
FAX: (305) 380-3618
E-mail: stan.sugrue@coulter.com |
| Date: | July 28, 2003 |
| Device Trade Name(s):
Device Generic Name(s): | LH 750 Hematology Analyzer
Automated differential cell counter |
| Device Classification: | The LH 750 Hematology Analyzer with Ver. 2B Software is
a Class II medical device. |
2.0 Predicate Device
The LH 750 Hematology Analyzer with Ver. 2B Software claims substantial equivalence to the COULTER LH 750 hematology analyzer.
FDA 510(k) Number(s): K011342
3.0 Device Description
LH 750 Hematology Analyzer with Ver. 2B Software is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Ver. 2B Software 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, biochemical investigations, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
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 NRBC enumeration.
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.
1
4.0 Principle of Method:
The COULTER LH 750 Hematology Analyzer with Ver. 2B Software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer. Both devices utilize the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzers use 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.
| Comparison | Characteristic | COULTER LH 750
(Predicate) | COULTER LH 750 w/ 2B SW |
|--------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Similarities | 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. | Same as LH 750 |
| | Analysis Reagents | COULTER® LH Series Diluent
COULTER LH SERIES Pak
COULTER Lyse S® III lytic
agent | Same as LH 750 |
| | Cleaning Agent | COULTER CLENZ | Same as LH 750 |
| | Hematology Quality
Controls | COULTER® 5C Cell Control
COULTER® Latron Primer and
Latron Control
RETIC-C Cell Control
Lin-C linearity control | Same as LH 750 |
| | Reticulocyte analysis
reagent system | LH SERIES RETIC Pak | Same as LH 750 |
| | Reticulocyte analysis
method | Automated | Same as LH 750 |
| Differences | Analysis Reagents | Not qualified for use with
COULTER cyanide-free
reagents | Qualified for use with
COULTER cyanide-free
reagents |
| | Labeling | Not IVDD compliant | Consistent with IVDD
regulation |
| | Parameter Performance | Has NRBC enumeration | Improved NRBC
performance for False
Negatives |
| | Parameter Performance | Has WBC correction | Added additional Fail safe |
5.0 Comparison to Predicate
Indications for Use: 6.0
The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 6 2003
Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Beckman Coulter, Inc. Cellular Analysis Division 11800 SW 147 Avenue Miami. Florida 33196-2500
Re: K032342
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: July 28, 2003 Received: July 29, 2003
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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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,
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director 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
510(k) Number (if known): 14
Device: COULTER® LH 750
The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and 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
Josephine Rautski
Division Sign-off
n Vitro Diagnostic Device
510(k) K032342
Beckman Coulter, Inc. LH 750 with Version 2B Software - Abbreviated 510(k)