(24 days)
For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.
The ADVIA 60 with software version 1.6 is a bench top, clinical laboratory instrument that analyzes in-vitro samples of whole blood specimens. The device reports a complete blood count (CBC) and 3-part WBC differential (LMG). The device operates as either a closed tube/closed system or open tube/open system. The ADVIA 60 can evaluate 5, 8, 16, or 18 hematology parameters depending on its internal configuration.
The provided text describes the ADVIA 60 Software Version 1.6 as an in-vitro diagnostic device for quantitative determination of blood cells and hematologic parameters. It aims to demonstrate substantial equivalence to its predicate devices, the ADVIA 60 with software version 1.4 and Abbott Cell-Dyn 4000.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The documentation focuses on demonstrating substantial equivalence rather than explicit acceptance criteria with numerical thresholds. However, it implicitly uses accuracy, precision, and linearity as key performance indicators for comparison.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (ADVIA 60 v1.6) |
|---|---|---|
| Accuracy | Equivalent to ADVIA 60 v1.4 and Cell-Dyn 4000 | "Equivalent to predicate device." |
| Precision | Equivalent to ADVIA 60 v1.4 | "Equivalent to predicate device." |
| Linearity | As specified in product labeling (v1.4) | "Expanded linearity claims" (supported by results) |
Note: The document does not provide specific numerical ranges or statistical metrics for "equivalent" performance; it relies on a general statement of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "The test results included in this submission demonstrate..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or their involvement in establishing ground truth for the test set. Given the nature of a hematology analyzer, ground truth would typically be established by laboratory methods, not expert consensus in the traditional sense of image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. This is expected as the device is an automated hematology analyzer, and its performance is typically evaluated against reference methods or predicate devices, not through expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is an automated hematology analyzer, not a diagnostic imaging or interpretation tool that would involve human readers. The study focuses on the device's performance characteristics compared to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted were standalone performance evaluations. The ADVIA 60 Software Version 1.6 is an automated instrument, and its performance is measured directly by comparing its output against predicate devices or reference methods. There is no human interpretation or involvement in the measurement process being evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation implicitly relies on:
- Established performance of predicate devices: The ADVIA 60 with software version 1.4 and the Abbott Cell-Dyn 4000 are used as benchmarks. Their established accuracy, precision, and linearity serve as the de-facto "ground truth" for comparison.
- Fundamental scientific measurement principles: For parameters like hemoglobin, it refers to a "modification of the manual cyanmethemoglobin method developed by the International Committee for Standardization in Hematology," implying a gold standard reference method for that specific measurement. Similarly, RBC/WBC/Plt counting is based on "impedance variation," a well-established principle for cellular enumeration.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size. This is typical for device submissions that focus on performance validation rather than detailing the underlying algorithmic development and training data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth would have been established.
§ 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.”