(28 days)
The CELL-DYN 3200 System with Absolute and Percent Reticulocyte count is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories.
The CELL-DYN 3200® System with Absolute and Percent Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood: White blood Cell Parameters: WBC -- White Blood Cell or Leukocyte Count, NEU -- Neutrophil Absolute Count, %N -- Neutrophil Percent, LYM -- Lymphocyte Absolute Count, %L -- Lymphocyte Percent, MONO -- Monocyte Absolute Count, %M -- Monocyte Percent, EOS -- Eosinophil Absolute Count, %E -- Eosinophil Percent, BASO -- Basophil Absolute Count, %B -- Basophil Percent, Platelet Parameters: PLT -- Platelet Count, MPV -- Mean Platelet Volume, *PDW -- Platelet Distribution Width, *PCT -- Plateletcrit. Red Blood Cell Parameters: RBC -- Red Blood Cell or Erythrocyte Count, HCT -- Hematocrit, MCV -- Mean Cell Volume, RDW -- Red Cell Distribution Width, Hemoglobin Parameters: HGB -- Hemoglobin Concentration, MCH -- Mean Cell Hemoglobin, MCHC -- Mean Cell Hemoglobin Concentration, Reticulocyte Parameters: RETIC ABS -- Reticulocyte Absolute, RETIC% -- Reticulocyte Percent of RBC Count. * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.
The CELL-DYN 3200 System has three main modules: 1) the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; 2) the Data Module, which automatically analyzes, stores, and reports specimen results; 3) the Display Station, which consists of a color monitor and pressure-sensitive keypad for selecting the displayed commands that operate the system. The Analyzer and Data Module are housed in a single chassis. The Display Station is a stand-alone module. The analyzer counts, sizes and classifies blood cells by Optical Laser Light Scatter. The CELL-DYN 3200 System uses a Helium-Neon laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures. For the reticulocyte parameters, an off-line dilution of blood and Reticulocyte Reagent is prepared and stained for 15 minutes. The dilution is aspirated and the reticulocytes are counted in the WOC channel. Data are collected for scatter (0, 10, and 90 degree) as each cell passes through the laser beam. The CELL-DYN 3200 System is designed to analyze EDTAanticoagulated whole blood specimens and report the additional Absolute and Percent Reticulocyte Parameters.
Here's an analysis of the acceptance criteria and study information for the CELL-DYN 3200 System with Absolute and Percent Reticulocyte, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for each parameter (e.g., specific thresholds for linearity, precision, or accuracy). Instead, it makes a general statement: "The background, carryover, linearity, precision, and accuracy data shows performance to manufacturer's specifications."
The study's primary objective wasn't to meet specific performance targets against a ground truth, but rather to demonstrate substantial equivalence to a predicate device (CELL-DYN 4000 System). Therefore, the "reported device performance" is framed in terms of achieving equivalency in these performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Background | Performance "to manufacturer's specifications" | Data supports substantial equivalence to CELL-DYN 4000 System |
| Carryover | Performance "to manufacturer's specifications" | Data supports substantial equivalence to CELL-DYN 4000 System |
| Linearity | Performance "to manufacturer's specifications" | Data supports substantial equivalence to CELL-DYN 4000 System |
| Precision | Performance "to manufacturer's specifications" | Data supports substantial equivalence to CELL-DYN 4000 System |
| Accuracy | Performance "to manufacturer's specifications" | Data supports substantial equivalence to CELL-DYN 4000 System |
| Reticulocyte Percent (RETIC %) | Substantial equivalence to CELL-DYN 4000 System performance | Demonstrated substantial equivalence to CELL-DYN 4000 System |
| Reticulocyte Absolute (RETIC ABS) | Substantial equivalence to CELL-DYN 4000 System performance | Demonstrated substantial equivalence to CELL-DYN 4000 System |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "The data compiled to support the claim..." but does not provide specific numbers of samples tested.
- Data Provenance: The data was collected at an "internal Abbott Diagnostics Division site." This suggests retrospective analysis of samples processed at their facility, or prospective data collection specifically for this study at their internal site. The country of origin is implicitly the USA, where Abbott Laboratories (Santa Clara, CA) is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document.
- Given that the study focuses on substantial equivalence to another automated hematology analyzer (CELL-DYN 4000), the "ground truth" for the test set would likely be the measurements obtained from the predicate device itself, rather than expert human interpretation of blood smears.
4. Adjudication Method for the Test Set:
- This information is not provided.
- Since the comparison is made against an automated predicate device, human adjudication a traditional sense (e.g., 2+1 review of discrepant cases) would likely not apply in the same way as it would for imaging diagnostics. The adjudication would involve comparing the numerical output of the new device against the numerical output of the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
- No, an MRMC comparative effectiveness study was not done.
- This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply to this submission. The device performs the measurements automatically.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this was a standalone performance evaluation.
- The CELL-DYN 3200 System is an automated device designed to count and classify blood cells. Its performance evaluation is inherently standalone, as it generates results independently without direct human interpretation of the primary data (optical scatter signals). The results are then compared to those generated by another standalone automated device (the predicate).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The "ground truth" for this study was the measurements provided by the predicate device, the CELL-DYN 4000 System. The study aimed to demonstrate that the CELL-DYN 3200's measurements for reticulocyte parameters were equivalent to those of the legally marketed predicate.
- While laboratory techniques like manual reticulocyte counts as a "true" reference method could theoretically be used, the document describes the comparison as being strictly between the new device and the predicate device.
8. The Sample Size for the Training Set:
- This information is not provided in the document.
- Automated hematology analyzers, especially from this era (2001), typically rely on pre-programmed algorithms and calibrated optical systems rather than machine learning models that require explicit "training sets" in the modern AI sense. While internal development and calibration would involve testing on numerous samples, these are generally not referred to as "training sets" in the context of conventional medical device submissions.
9. How the Ground Truth for the Training Set Was Established:
- As noted above, the concept of a "training set" with an established "ground truth" in the AI sense does not explicitly apply to this conventional automated hematology analyzer.
- For the calibration and development of such an analyzer, the "ground truth" would generally be established through reference methods (e.g., manual microscopy, highly controlled reference materials) and extensive empirical testing to ensure accurate measurement of cell properties based on optical scatter. This process would occur during the device's design and manufacturing, not typically as part of a premarket notification for substantial equivalence, which often focuses on comparison to an existing device.
§ 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.”