(55 days)
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 also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The system also provides an automated method for enumeration of RBCs and WBCs in body fluids.
The COULTER® LH 750 Body Fluids Application is an automated method for enumeration of RBCs and WBCs in body fluids on the COULTER LH 750 Hematology Analyzer, an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The LH 750 also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs).
The provided text describes a 510(k) summary for the COULTER® LH 750 Body Fluids Application, which is an automated method for enumerating RBCs and WBCs in body fluids on the COULTER LH 750 Hematology Analyzer.
The submission claims substantial equivalence to a manual cell count method, and the document focuses on outlining the device's intended use, principle of method, and comparison to the predicate. However, it does not contain detailed information about acceptance criteria, specific study results, sample sizes for test or training sets, ground truth establishment methods for training data, number of experts, adjudication methods, or MRMC studies for comparative effectiveness.
Therefore, based solely on the provided text, I cannot complete many of the requested fields. The information below reflects what is available in the document.
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document is a 510(k) summary for a substantial equivalence claim based on a pre-amendment predicate, it does not specify explicit numerical acceptance criteria and does not present detailed performance data in the format of a clinical study report with specific metrics. The "device performance" in this context is implied to be substantially equivalent to the predicate.
The table below reflects descriptive aspects from the "Comparison to Predicate" section, which broadly outlines similarities and differences rather than specific performance metrics against an acceptance threshold.
| Metric/Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (COULTER® LH 750 Body Fluids Application) |
|---|---|---|
| Intended Use | To provide a quantitative determination of blood cells in cerebrospinal fluid, serous fluid, and synovial fluid | Same as manual method |
| Specimen Analyzed | Body Fluids collected in a container with or without anti-coagulant | Same as manual method |
| WBC Count (cells/µL) | Manual cell count performed in a counting chamber by a skilled competent technician | Automated count |
| RBC Count (cells/µL) | Manual cell count performed in a counting chamber by a skilled competent technician | Automated count |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not specify the number of experts used to establish ground truth for a test set or their qualifications. The predicate method refers to a "skilled competent technician" for manual cell counts, implying a human expert performed the reference method.
4. Adjudication Method for the Test Set
The provided document does not specify any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is an automated counter, not an AI-assisted diagnostic tool for human readers in the traditional sense of image interpretation.
6. Standalone (Algorithm Only) Performance Study
The entire submission is focused on the performance of the automated device (algorithm only) for enumeration of RBCs and WBCs in body fluids. The "Conclusion" states: "The COULTER LH 750 Body Fluids Application is substantially equivalent to the manual microscopic predicate method for enumeration of RBCs and WBCs in body fluids." This implies a standalone study where the device's output was compared to the predicate. However, detailed results of this comparison (e.g., accuracy, precision studies) are not included in the summary.
7. Type of Ground Truth Used
The ground truth implicitly used for comparison is the "manual cell count method in a counting chamber by a skilled competent technician". This is essentially an expert consensus/reference method (assuming the "skilled competent technician" embodies the reference standard for manual counting).
8. Sample Size for the Training Set
The provided document does not specify the sample size used for any training set.
9. How the Ground Truth for the Training Set Was Established
The provided document does not specify how the ground truth for any training set was established. Given the nature of the predicate, it would likely involve manual counts by skilled technicians, but this is not explicitly stated for a training set.
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APR 2 1 2003
510(k) Summary of Safety and Effectiveness for Section 1 D: COULTER® LH 750 Body Fluids Application
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 SpecialistTelephone: (305) 380-4552FAX: (305) 380-3618E-mail: stan.sugrue@coulter.com |
| Date: | February 24, 2003 |
| Device Trade Name(s): | COULTER® LH 750 Hematology Analyzer |
| Device Generic Name(s): | Automated differential cell counter |
| Device Classification: | The COULTER® LH 750 Hematology Analyzer is a Class IImedical device |
2.0 Pre-amendment Predicate Method
The COULTER® LH 750 Body Fluids Application claims substantial equivalence to the preamendment predicate method for enumeration of WBCs and RBCs via manual cell count method in a counting chamber by a skilled competent technician.
FDA 510(k) Number(s): Not applicable
3.0 Device Description
The COULTER® LH 750 Body Fluids Application is an automated method for enumeration of RBCs and WBCs in body fluids on the COULTER LH 750 Hematology Analyzer, an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The LH 750 also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs).
4.0 Principle of Method:
The COULTER LH 750 Body Fluids Application is an automated method for enumeration of RBCs and WBCs in body fluids on the COULTER LH 750 Hematology Analyzer. The LH 750 utilizes the Coulter Principle for automatically enumerating and sizing blood cells. The analyzer uses 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.
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5.0 Comparison to Predicate
| Similarities/Differences | Characteristic | Manual method(Predicate) | LH 750 Body FluidsApplication |
|---|---|---|---|
| Similarities | Intended Use | To provide a quantitativedetermination of blood cellsin cerebrospinal fluid,serous fluid, and synovialfluid | Same as manual method |
| Specimen Analyzed | Body Fluids collected in acontainer with or withoutanti-coagulant | Same as manual method | |
| Differences | WBC Count(cells/µL) | Manual cell countperformed in a countingchamber by a skilledcompetent technician | Automated count |
| Differences | RBC count(cells/µL) | Manual cell countperformed in a countingchamber by a skilledcompetent technician | Automated count |
6.0 Indications for 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 LH 750 Body Fluids Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, serous fluid, and synovial fluid to the LH 750, providing enumeration of the WBCs and the RBCs.
7.0 Conclusion:
The COULTER LH 750 Body Fluids Application is substantially equivalent to the manual microscopic predicate method for enumeration of RBCs and WBCs in body fluids.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 1 2003
Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 S.W. 147 Avenue P.O. Box 169015 Miami, FL 33116-9015
K030606 Re:
Trade/Device Name: COULTER® LH 750 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: April 2, 2003 Received: April 3, 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 (OS) regulation (21 CFR Part 820).
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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.
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). Other general information on your responsibilities under the Act may be obtained 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 Putman
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):
Not assigned K030606
Device:
COULTER® LH 750 Hematology Analyzer
Indications For 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 also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The system also provides an automated method for enumeration of RBCs and WBCs in body fluids.
Future commercialization will add ISOTON® 4 diluent /Lyse S® 4 Lytic reagent to the indications for 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V Use (Per 21 CFR 801.109) OR
Over-The-Counter
Auchini Rautati
(Division Sigr Division of Clinical Laboratory De 510(k) Numbe
Beckman Coulter, Inc. COULTER® LH 750 Body Fluids Application
§ 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.”