(82 days)
The CELL-DYN 1800 System has the same intended use as previously cleared for the CELL-DYN 1700 System, K870233. The CELL-DYN 1800 System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The CELL-DYN 1800 System is an automated, multiparameter hematology analyzer designed to report sixteen parameters relating to the cells of EDTA-anticoagulated blood.
The CELL-DYN 1800 System is a benchtop analyzer consisting of the main analyzer with data module, display station, and printer. The main analyzer, data module, and display station are housed in a single chassis. The printer is a stand-alone module. The CELL-DYN 1800 open sampler is equipped to aspirate blood from a collection tube that has been opened and is held under the open sample aspiration probe.
The CELL-DYN 1800 System's acceptance criteria and performance are based on its substantial equivalence to the predicate device, the CELL-DYN 1700 System. The study conducted was an in-house clinical trial comparing the two devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CELL-DYN 1800 System are implicit in its claim of substantial equivalence to the CELL-DYN 1700 System. Therefore, the reported device performance for the CELL-DYN 1800 System is that its performance metrics (background, correlation, precision, linearity, sensitivity and specificity, and carryover) are comparable to or meet the established performance of the CELL-DYN 1700 System.
| Criterion | Acceptance Criteria (Implied) | Reported Device Performance (CELL-DYN 1800) |
|---|---|---|
| Background | Performance comparable to CELL-DYN 1700 System | Data supports substantial equivalence |
| Correlation | Strong correlation with CELL-DYN 1700 System for all measured parameters | Data supports substantial equivalence |
| Precision | Precision comparable to CELL-DYN 1700 System across relevant ranges | Data supports substantial equivalence |
| Linearity | Linearity comparable to CELL-DYN 1700 System across relevant ranges | Data supports substantial equivalence |
| Sensitivity and Specificity | Sensitivity and specificity comparable to CELL-DYN 1700 System for detecting relevant hematological conditions | Data supports substantial equivalence |
| Carryover | Carryover rates comparable to or better than CELL-DYN 1700 System | Data supports substantial equivalence |
| Intended Use | Same intended use as CELL-DYN 1700 System: multiparameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories | Meets intended use; reports sixteen parameters of EDTA-anticoagulated blood |
| Safety and Effectiveness | No new questions of safety and effectiveness compared to CELL-DYN 1700 System | Differences noted (cyanide-free reagent, barcode, etc.) do not pose new questions of safety and effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the provided text. The document mentions "The data compiled supports the claim that the CELL-DYN 1800 System is substantially equivalent to the CELL-DYN 1700 System and includes data for background, correlation, precision, linearity, sensitivity and specificity, and carryover." However, the exact number of samples or patients used in this comparison is not provided.
- Data Provenance: The study was an "in-house clinical trial." This implies the data was collected by Abbott Laboratories. The country of origin of the data is not specified, but since Abbott Laboratories is US-based and the submission is to the FDA, it is likely that parts of the clinical trial took place in the US or under US regulatory standards. The study design is implied to be prospective for the collection of data to evaluate the CELL-DYN 1800 against the CELL-DYN 1700.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a comparison study of two automated hematology analyzers, the "ground truth" would likely be established through reference methods (e.g., manual microscopy or established instruments) rather than expert consensus on interpretation. The document does not specify the number of experts or their qualifications for establishing ground truth, as the comparison is primarily analytical and technical against a predicate device.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for the test set. The evaluation is based on direct comparison of measurements and performance characteristics between the two devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance and equivalence of an automated hematology analyzer, not on human reader performance with or without AI assistance. The device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study primarily represents a standalone performance evaluation. The CELL-DYN 1800 System is itself an automated analyzer. The "algorithm only" performance is essentially what is being evaluated through parameters like correlation, precision, linearity, sensitivity, specificity, and carryover, comparing its automated results to those of the predicate device.
7. The Type of Ground Truth Used
The ground truth implicitly used for the comparison is the measurements and performance of the predicate device, the CELL-DYN 1700 System, which is itself a "legally marketed predicate device" and therefore assumed to have established analytical performance. Additionally, standard reference methods for hematology parameters (e.g., volumetric metering as the ICSH Method for cell counting, LED Hemoglobin analysis) would typically be considered the ultimate ground truth for the measurements these devices perform.
8. The Sample Size for the Training Set
This information is not provided. The document describes a clinical trial for comparison between the 1800 and 1700 systems, but it does not mention a separate "training set" for the development of the CELL-DYN 1800. Automated hematology analyzers typically rely on pre-defined algorithms and calibration, rather than machine learning models that require a distinct training set in the same way an AI/ML device would.
9. How the Ground Truth for the Training Set Was Established
Since no explicit "training set" is described for an AI/ML model, the establishment of ground truth for such a set is not applicable in the provided context. The "ground truth" for the development and calibration of the CELL-DYN 1800's algorithms would have been established through extensive analytical validation using reference materials, spiked samples, and clinical specimens measured against established reference methods, a standard practice in in vitro diagnostic device development.
§ 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.”