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The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The CELL-DYN Sapphire System has the same intended use as previously cleared for the CELL-DYN 4000 System (predicate device).

The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood.

The CELL-DYN Sapphire System is a benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents. The data station, display, and printer are stand-alone modules. The system has the capability to sample either from closed collection tubes via the autoloader, or from open collection tubes through the aspiration probe in the Open Tube mode.

The sponsor, Abbott Laboratories, submitted a 510(k) premarket notification for the CELL-DYN Sapphire™ System, an automated hematology analyzer.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list acceptance criteria in a table format with corresponding device performance values like a clinical trial report. However, it states that "The data compiled supports the claim that the CELL-DYN Sapphire System is substantially equivalent to the CELL-DYN 4000 System and includes data for background, carryover, comparability (correlation), imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity." This implies that the acceptance criteria for each of these performance characteristics were met to demonstrate substantial equivalence to the predicate device.

The study aimed to show substantial equivalence to the predicate device, the Abbott CELL-DYN 4000 System. This means the performance of the CELL-DYN Sapphire for various hematological parameters was compared against the CELL-DYN 4000. While specific numerical acceptance criteria and reported performance values are not provided in this summary, the conclusion is that the device met these implicit criteria to be deemed substantially equivalent.

Study Information:

1. Table of Acceptance Criteria and Reported Device Performance:
   As noted above, a detailed table with specific numerical acceptance criteria and reported performance values is not provided in this 510(k) summary. The summary broadly states that data for background, carryover, comparability (correlation), imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity were compiled and supported the claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:
   The document mentions "clinical trials" were conducted for comparison, but it does not specify the sample size used for the test set. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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. Hematology analyzer studies typically use reference methods or expert review of slides to establish ground truth, but the details are absent here.

4. Adjudication Method for the Test Set:
   This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   A MRMC comparative effectiveness study is not mentioned. This type of study is more common for imaging devices where human interpretation is a key component, not typically for automated hematology analyzers. The study design focuses on the performance of the device itself against a predicate device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
   Yes, a standalone study was performed. The entire context of the submission and the nature of an automated hematology analyzer indicates that the study evaluates the performance of the algorithm/device only in generating quantitative and differential blood cell parameters. The comparison is between the CELL-DYN Sapphire System and the CELL-DYN 4000 System.

7. Type of Ground Truth Used:
   The document implies that the predicate device (CELL-DYN 4000 System) served as the primary reference or "ground truth" for comparison in terms of its established performance characteristics (e.g., correlation, imprecision). It's also likely that standard laboratory reference methods were used to establish the true values for the parameters being measured, though this is not explicitly stated. Terms like "comparability (correlation)" suggest comparison against an accepted standard.

8. Sample Size for the Training Set:
   The sample size for the training set is not specified. This information is typically relevant for machine learning models, but for a traditional automated analyzer based on established measurement methodologies, the concept of a "training set" in the machine learning sense might not apply directly in the same way. The device's algorithms are likely based on fixed rules and thresholds, rather than being "trained" on a large dataset in the modern AI sense.

9. How the Ground Truth for the Training Set Was Established:
   As the concept of a "training set" in the AI sense is likely not applicable here, the method of establishing ground truth for it is not described. For establishing the device's operational parameters, extensive analytical validation using reference materials and potentially clinical samples with known characteristics would have been performed.

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