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510(k) Data Aggregation
(79 days)
The CELL-DYN® 1200 System is a multi-parameter hematology analyzer intended to classify the following formed elements of EDTA anti-coagulated blood: White Blood Cell Parameters: WBC -- White Blood Cell or leukocyte count GRAN -- Granulocyte absolute count %GRAN -- Granulocyte percent LYM - Lymphocyte absolute count %L - Lymphocyte percent MID - Mid-range absolute count %M - Mid-range 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 Corpuscular Volume RDW -- Red Cell Distribution Width Hemoglobin Parameters: HGB -- Hemoglobin Concentration MCH -- Mean Cell Hemoglobin MCHC -- Mean Cell Hemoglobin Concentration * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the US.
The CELL-DYN® 1200 System is a single unit device with a stand alone printer used in the clinical laboratory setting. The Analyzer aspirates, dilutes, mixes and analyzes each whole blood specimen. The computer in the Analyzer controls all system processing, provides the primary operator interface with the system, and controls the optional printer, which generates reports. The CELL-DYN® 1200 System is a multi-parameter, automated hematology analyzer designed to use EDTA-anticoagulated whole blood specimens to count, size and classify cells by using an focused flow impedance transducer, equipped with two non-corrosive electrodes to measure WBCs, and PLTs. The HGB is measured colorimetrically in the HGB transducer by an LED light source and a light sensitive diode. The analyzer is menu-driven and controlled by a microprocessor.
The CELL-DYN® 1200 System is an automated hematology analyzer intended to classify formed elements of EDTA anti-coagulated blood. Its acceptance criteria and performance are compared to its predicate device, the CELL-DYN® 1700, and manual differential methods.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for the CELL-DYN® 1200. Instead, it demonstrates substantial equivalence to the predicate device, the CELL-DYN® 1700, and manual differential for various parameters. The reported performance is implicitly that the CELL-DYN® 1200 performs "as well as or better than" the CELL-DYN® 1700.
| Parameter | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Measured Parameters | Must demonstrate substantial equivalence to the CELL-DYN® 1700 and manual differential. | Equivalence is demonstrated for WBC, three-part WBC Differential sub-populations (Granulocyte absolute count & percent, Lymphocyte absolute count & percent, Mid-range absolute count & percent), RBC, HGB, MCV, RDW, PLT, and MPV. |
| White Blood Cell (WBC) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Three-Part WBC Differential | Substantially equivalent to CELL-DYN® 1700 and manual method for Lymphocyte # & %, Mid Cells # & %, Granulocyte # & %. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700 for these sub-populations. |
| Red Blood Cell (RBC) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Hemoglobin (HGB) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. The CELL-DYN® 1200 uses a cyanide-free reagent, unlike the CELL-DYN® 1700's cyanide-containing reagent, suggesting a potential improvement in safety. |
| Mean Corpuscular Volume (MCV) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Red Cell Distribution Width (RDW) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Platelet Count (PLT) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Mean Platelet Volume (MPV) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Calculated Values | Calculated values (HCT, MCH, MCHC) should be consistent with the underlying measured values. | Calculated values for HCT, MCH, and MCHC are listed as parameters for both devices, implying their derivation is similar and therefore their performance is implicitly linked to the measured parameters. |
| Background, Carryover, Precision, Correlation, Linearity, Flagging | Performance to manufacturer's specifications. | Data shows performance to manufacturer's specifications for these aspects. |
| Overall Performance | As safe and effective and performs as well as or better than the CELL-DYN® 1700 System. | The conclusion of the testing performed demonstrates the device is as safe and effective and performs as well as or better than the CELL-DYN® 1700 System. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "the data compiled to support the claim" includes various studies (background, carryover, precision, correlation, linearity, and flagging data). However, the specific sample sizes used for these test sets are not explicitly detailed in the provided information.
The data provenance is stated as testing "at Abbott Laboratories, Santa Clara, CA." This suggests the data was collected internally by the manufacturer. The document does not specify if the data was retrospective or prospective, nor does it explicitly mention the country of origin of the data beyond the testing location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document mentions "manual differential" as a predicate method for comparison. However, it does not specify the number of experts or their qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth for any of the test sets, including the manual differential comparison.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or resolving discrepancies in the test set evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an automated hematology analyzer, which performs measurements without human reader interpretation in the primary analysis phase. The comparison is between the automated device and a predicate automated device, as well as a "manual differential" which would involve human review but not in the context of an MRMC study designed to evaluate AI-assisted human reading. Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance study was done. The entire evaluation of the CELL-DYN® 1200 System, including background, carryover, precision, correlation, linearity, and flagging data, represents the standalone performance of the algorithm and hardware without human intervention during the measurement process. The comparison to the predicate device (another automated analyzer) and the manual differential also serves to establish its standalone performance relative to existing methods.
7. The Type of Ground Truth Used:
The primary ground truth used for comparison and validation appears to be:
- Predicate Device Performance: The CELL-DYN® 1700 System, an already legally marketed and established automated hematology analyzer.
- Manual Differential: This would typically involve microscopic examination of blood smears by trained laboratory personnel, considered the gold standard for certain aspects of blood cell classification at the time. "Manual differential" serves as a ground truth for the "three-part WBC differential" parameters.
- Manufacturer's Specifications: For metrics like background, carryover, precision, correlation, and linearity.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. Automated hematology analyzers like the CELL-DYN® 1200 are typically "rule-based" or "physics-based" systems utilizing focused flow impedance and optical absorbance, rather than algorithms that require extensive machine learning training data in the modern sense. Therefore, the concept of a "training set" as understood in current AI/machine learning contexts is not directly applicable to this device's reported evaluation.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" or a machine learning-based algorithm, this question is not applicable based on the provided information. The device's design and operational principles are outlined based on established physical and chemical measurement techniques rather than data-driven learning.
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