(64 days)
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 semiautomated reticulocyte analysis.
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 semi-automated 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.
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 breakdown of the acceptance criteria and study information for the Beckman Coulter LH 500 hematology analyzer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it relies on substantial equivalence to the predicate device (COULTER LH 750) and demonstrates comparable performance through various studies. The "performance" is implicitly the outcome of these studies, showing that the LH 500 performs similar to or within acceptable limits compared to the LH 750.
Given the available information, the table will focus on the comparison points highlighted and the implied "acceptance" that the LH 500 is equivalent.
| Performance Metric/Characteristic | Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (Implied) |
|---|---|---|
| Intended Use | Same as COULTER LH 750 (Quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories, automated CBC, leukocyte differential, semi-automated reticulocyte analysis). | Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table) |
| Analysis Reagents | Same as COULTER LH 750 reagents. | Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table for Diluent, Pak, Lyse S® III diff lytic agent) |
| Cleaning Agent | Same as COULTER LH 750 cleaning agent. | Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table for COULTER CLENZ) |
| Hematology Quality Controls | Same as COULTER LH 750 quality controls. | Same as LH 750 (Explicitly stated "Same as LH 750" in comparison table for 5C Cell Control, Latron Primer and Latron Control, RETIC-C Cell Control, Lin-C) |
| Reticulocyte Analysis Method | Functionally equivalent to LH 750's automated method. | Semi-automated (Difference noted, but implied as acceptable for the intended use and overall equivalence). |
| Reticulocyte Analysis Reagents | Suitable for semi-automated reticulocyte analysis. | Uses COULTER ReticPrep Reagent Kit (Difference noted, but implied as acceptable for the intended use). |
| Aperture System | Provides equivalent cell enumeration and sizing. | Utilizes a single aperture configuration (Difference noted, but implied as acceptable for the intended use). |
| Overall Performance | Substantially equivalent to COULTER LH 750. | The 510(k) clearance indicates the FDA found it substantially equivalent. This implies all key performance parameters (CBC, diff, retics) are comparable. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size for any specific test set used to demonstrate efficacy or the data provenance (e.g., country of origin, retrospective or prospective). It primarily focuses on the substantial equivalence argument based on technological characteristics and intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not mention using experts to establish ground truth for a test set. This type of device (automated hematology analyzer) typically relies on comparisons against reference methods or another FDA-cleared device rather than expert consensus on individual case interpretations.
4. Adjudication Method for the Test Set
As no expert review for ground truth establishment is mentioned, there is no adjudication method described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This type of study is more common for imaging devices where human interpretation directly influences the outcome and AI is used as an aid. For an automated hematology analyzer, the primary comparison would be between the device's output and either a reference method or a predicate device, not human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The entire device (LH 500 hematology analyzer) is a standalone system for automated complete blood count and leukocyte differential, and semi-automated reticulocyte analysis. The 510(k) submission describes the standalone performance of the device itself. It's designed to provide quantitative results directly, not as an assistive tool for human interpretation.
7. Type of Ground Truth Used
While not explicitly detailed as "ground truth establishment," the typical method for validating automated hematology analyzers involves:
- Comparison to a legally marketed predicate device: In this case, the COULTER LH 750.
- Comparison to established reference methods: Such as manual differential counts for WBC differential, or established methods for cellular enumeration and hemoglobinometry.
- Internal validation studies: Demonstrating precision, accuracy, linearity, and carryover using characterized samples (e.g., normal patient samples, abnormal patient samples, controls).
The document states, "The COULTER LH 500 Hematology Analyzer has the similar technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer." This implies that the 'ground truth' for evaluating the LH 500's performance was its ability to produce results comparable to the established performance of the LH 750 and, by extension, other validated methods. The specific methods for establishing ground truth for each parameter are not detailed in this summary.
8. Sample Size for the Training Set
The provided document does not mention a training set or its sample size. Automated hematology analyzers typically do not involve "training sets" in the same way machine learning algorithms do, as their operating principles are based on predefined biophysical properties (Coulter Principle, VCS technology) rather than learned patterns from large datasets. They are calibrated and validated against known standards and reference methods.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this information is not applicable/provided in the document.
§ 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.”