(532 days)
The ADVIA 2120/2120i auto-analyzer Body Fluid Application is an in vitro diagnostic test for the enumeration of the total nucleated cell (TNC) count and RBC count for pleural, and peritoneal dialysis (PD) specimens collected in K2 or K3 EDTA.
The ADVIA 2120/2120i Body Fluid Application uses the Basophil/Lobularity and RBC/Platelet channels to enumerate the TNC and RBC counts. The TNC count is derived from the Basophil/Lobularity channel. The ADVIA 2120/2120i BASO reagent contains surfactant and phthalic acid which, in the presence of low heat in the Baso channel reaction chamber, lyses RBCs and strips the cytoplasmic membrane from all leukocytes except basophils. This cell suspension is subsequently passed through the flow cell. The cell suspension is intercented by light from the laser diode where the low-angle light scatter (2° to 3°) and high-angle light scatter (5° to 15°) signals of each cell are counted.
The RBC count is derived from the RBC/Platelet channel. The ADVIA 2120/2120i RBC/Platelet reagent uses sodium dodecyl sulfate and glutaraldehyde to sphere and fix the RBCs. This cell suspension uses the same flow cell and low-angle and high-angle light scatter signals as the Baso channel to count the RBCs. The system automatically reports the TNC and RBC counts in conventional or SI units appropriate for body fluid samples.
Here's an analysis of the acceptance criteria and the study information based on the provided text for the ADVIA® 2120 systems Body Fluids Application:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., minimum accuracy percentages, correlation coefficients, or specific agreement ranges). Instead, it relies on a statement of substantial equivalence to a predicate device.
The document describes the device, its intended use, and compares its characteristics to the predicate device. The conclusion states that the device is "substantially equivalent" to the predicate. From a regulatory perspective, "substantial equivalence" implies that the new device performs as safely and effectively as a legally marketed predicate device without raising new questions of safety or effectiveness.
Therefore, the implied acceptance criterion is that the ADVIA 2120/2120i Body Fluids Application's performance for TNC and RBC enumeration in the specified body fluids should be comparable to the COULTER® LH 750 Body Fluids Application.
No specific performance metrics are reported in this summary, other than the general statement of substantial equivalence. The detailed performance data would typically be found in the full 510(k) submission, which this document summarizes.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (COULTER® LH 750 Body Fluids Application) for enumeration of RBC and TNC (WBC) in body fluids. | The ADVIA 2120/2120i Body Fluids Application is substantially equivalent to the COULTER® LH 750 Body Fluids Application for enumeration of RBC and TNC (WBC) in body fluids. (Stated in Section J. Conclusion) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This information would be crucial for understanding the rigor of the testing and is typically found in the detailed study report within the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the number of experts used to establish ground truth or their qualifications. The method for establishing ground truth for the test set is not described.
4. Adjudication Method for the Test Set:
The document does not provide any information regarding an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size:
The provided text does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. This device is an automated hematology analyzer, implying it aims to replace manual counting or provide automated results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
Yes, a standalone study was implicitly performed, as the device is an automated hematology analyzer designed to enumerate TNC and RBC counts directly. The entire summary focuses on the device's ability to perform these counts independently. The "Principles of the Procedure" describe the automated process by which the device enumerates cells using light scatter technology.
7. The Type of Ground Truth Used:
The document implies that the ground truth for evaluating the device's performance (though not explicitly detailed in this summary) would be based on comparison to a reference method, likely a manual microscopic count or another validated automated method, which would be considered the "expert consensus" or established laboratory practice for cell enumeration. The goal is to show the device performs comparably to such established methods. The predicate device's performance would also serve as a benchmark for "ground truth" in the comparative assessment for substantial equivalence.
8. The Sample Size for the Training Set:
The provided text does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how ground truth was established for any training set. As an automated analyzer, the "training" (calibration, algorithm development) would typically involve internal validation against known standards, reference methods, and potentially a large set of characterized samples. However, this level of detail is not in the summary.
§ 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.”