(289 days)
The ADVIA 2120 and ADVIA 2120i with auto slide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories:
• A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Hct, MCH, MCHC, CHCM, RDW, HDW, CH, Plt, MPV.
• A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
• A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
• A nucleated red blood cell count consisting of NRBC (%/#).
• Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens) with K2 and/or K3 EDTA anti-coagulants.
• Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#), PMN (%/#).
In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a glass microscope slide.
The ADVIA 2120i (RoHS/REACH compliant) is a modification of the ADVIA 2120i Hematology System designed to address the following business needs:
- To achieve RoHS & Reach compliance
- To address component obsolescence
Here's an analysis of the provided text regarding the acceptance criteria and study for the ADVIA® 2120 / 2120i Hematology auto-analyzer.
Advanced 2120 / 2120i Hematology Auto-Analyzer Performance Study
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "performance equivalence" between the new ADVIA 2120i (RoHS/REACH Compliant) and its predicate devices (ADVIA 2120 and 2120i). Explicit numerical acceptance criteria are not presented in a generalized table, but rather implied by the successful completion of various performance studies and demonstrating "performance equivalence." The device's performance is reported as meeting this equivalence by showing "No non-conformances were observed" across all tested parameters.
| Performance Characteristic | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|
| Carryover | Equivalent to predicate device | No non-conformances observed |
| Linearity | Equivalent to predicate device | No non-conformances observed |
| Imprecision (within run) | Equivalent to predicate device | No non-conformances observed |
| Accuracy | Equivalent to predicate device | No non-conformances observed |
| Commercial Controls Repeatability and within device Imprecision | Equivalent to predicate device | No non-conformances observed |
| Limit of Quantitation/Detection/Blank | Equivalent to predicate device | No non-conformances observed |
| CSF Accuracy | Equivalent to predicate device | No non-conformances observed |
| Body Fluid Accuracy | Equivalent to predicate device | No non-conformances observed |
| System Flagging | Equivalent to predicate device | No non-conformances observed |
| Method Validation | Equivalent to predicate device | No non-conformances observed |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that studies were completed both internally and at external Clinical sites. However, specific sample sizes for the test set are not provided in the given text.
- Data Provenance:
- Internal Studies: Conducted at Siemens Healthcare Diagnostics.
- External Studies: Conducted at:
- "University of California-San Francisco"
- "Siemens Healthcare Diagnostics" (also listed as an external site for these specific studies)
- "Memorial Sloan-Kettering Cancer Center"
- The document does not explicitly state whether the data was retrospective or prospective. Given the nature of performance equivalence studies for a modified device, it is highly likely that these were prospective studies using fresh samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. For hematology analyzers, ground truth often involves manual microscopy review by trained medical technologists or pathologists, but this is not detailed here.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was NOT done (or at least not reported in this document). The studies focus on comparing the device's performance against a predicate device, not on assessing human reader improvement with or without AI assistance. The device is an automated analyzer, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance Study (Algorithm Only):
Yes, the studies described are for the standalone performance of the ADVIA® 2120i (RoHS/REACH compliant) device. These are "algorithm only" studies in the sense that they evaluate the automated analyzer's measurements. There is no human-in-the-loop component being evaluated in these performance studies for the device itself.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for establishing the accuracy of the measurements. For hematology parameters, ground truth often involves:
- Reference methods (e.g., manual differential counts, packed cell volume for hematocrit).
- Confirmed values from existing, validated predicate devices or established laboratory methods.
- Pathology or outcomes data are less likely to be the direct ground truth for quantitative measurements of blood cells but would be relevant for clinical validity.
Given the context of demonstrating "performance equivalence" to a predicate device, it is highly probable that the ground truth for parameters like CBC, differential, and reticulocyte counts would be either reference methods or established predicate device measurements from the ADVIA 2120/2120i systems known to be accurate.
8. Sample Size for the Training Set:
The document does not provide information regarding a "training set" sample size. This device is presented more as a hardware/firmware modification of an existing, already-trained system, rather than a new algorithm requiring a distinct training phase. Therefore, the concept of a separate training set as understood in machine learning might not directly apply or be documented here.
9. How the Ground Truth for the Training Set Was Established:
As no training set information is provided, how the ground truth for a training set was established is not detailed.
§ 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.”