The Cell-Dyn 3000 is a table-top analyzer consisting of the main analyzer, data station, and printer. An optional Sample Loader can be attached to the analyzer to transport samples in racks for automated processing.

The instrument has two sampling modes: Open Sample Aspiration Mode and Closed Sample Aspiration Mode. The instrument has the capability of diluting a sample for a CBC including a 5-part WBC differential for a total of 20 parameters. The 20 reportable parameters are as follows:

White blood cells (WBC), red blood cells (RBC), platelets (PLT), percent of neutrophils (%N), number of neutrophils (NEU), percent of lymphocytes (%L), number of lymphocytes (LYM), percent of monocytes (%M), number of monocytes (MONO), percent of eosinophils (%E), number of eosinophils( EOS), percent of basophils (%B), number of basophils(BASO), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), nean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) and mean platelet volume (MPV).

AI/ML Overview

The provided text describes the Cell-Dyn® 3000 Multi-Parameter Automated Hematology Analyzer and its substantial equivalence to previously marketed devices. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in the format requested.

The document states that "The accuracy, precision and linearity data shows performance to manufacturer's specifications" and that "The Cell-Dyn® 3000 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." This indicates that studies were performed, but the results of those studies and the specific acceptance criteria are not provided in this summary.

Therefore, I cannot populate the table or answer all the questions in detail based solely on the provided text. I will extract what information is present and indicate where information is missing.

Here's a breakdown of the available information and what's missing:

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Target/Specification)	Reported Device Performance
Accuracy	Manufacturer's specifications	Met manufacturer's specifications
Precision	Manufacturer's specifications	Met manufacturer's specifications
Linearity	Manufacturer's specifications	Met manufacturer's specifications
Carryover	Not specified	Not specified (Data presented but results not detailed)
WBC Differential	Compared to NCCLS reference method	"Compared to" - Specific quantitative results not provided.

Missing Information: Specific numerical acceptance criteria (e.g., % agreement, correlation coefficients, range of error) for each parameter. Specific numerical performance results for accuracy, precision, linearity, and carryover.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It can be inferred that it would likely be from a clinical laboratory, as it's an "in-vitro diagnostic use in clinical laboratories."

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Number of experts: Not specified.
Qualifications of experts: Not specified.
Method used: "NCCLS reference microscopic manual differential method" implies trained laboratory personnel performing manual microscopy, who would be considered experts in that field.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The comparison is stated as being "to the NCCLS reference microscopic manual differential method for accuracy," implying a comparison against this single established method, rather than an adjudication process between multiple readers of the device's output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, the text does not describe an MRMC study. The comparison is for a standalone device's performance against a reference method, not human readers with or without AI assistance.
Effect size of human readers with AI vs. without AI: Not applicable, as no MRMC study was described.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, the document describes the evaluation of the Cell-Dyn® 3000 analyzer's performance in terms of accuracy, precision, linearity, and carryover. The WBC differential was specifically compared to the NCCLS reference microscopic manual differential method. This represents the standalone performance of the device.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the WBC differential accuracy study was established using the "NCCLS reference microscopic manual differential method." This is a form of expert consensus/reference method based ground truth, executed manually.

8. Sample Size for the Training Set

Sample Size for Training: Not specified. The document describes the device and its testing for equivalence but does not detail the development or training of any underlying algorithms (if applicable, beyond basic instrument calibration). Given the time period (1996), "training set" in the modern AI sense might not have been a direct concept for this type of device.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training: Not specified. As mentioned above, details about a "training set" are absent.

Summary

{0}------------------------------------------------

K955673

510(k) SUMMARY

CELL-DYN®3000 Multi-Parameter Automated Hematology Analyzer

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION

The following information for the Cell-Dyn® 3000 Hennatology Analyzer constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the Cell-Dyn 3000 and the Coulter® ZBI (marketed prior to May 1976), Coulter Hemoglobinometer (marketed prior to May 1976), the Coulter Model S (marketed prior to May 1976), the Coulter Model S Plus IV, all included in Premarket Notification #K890491, and the Cell-Dyn® 3500, Premarket Notification K#913305/A.

Intended Use

The Cell-Dyn 3000 is a multi-parameter, hematology walyzer designed for In-Vitro diagnostic use in clinical laboratories.

Device Description

Principles of Operation

The Shear valve isolates a precise volume of whole blood by means of a shearing action as the front and rear sections rotate. The aspirated blood is isolated in three separate segments - one for the WBC dilution, one for the RBC/PLT dilution and one `or the HGB dilution. The WBC segment is diluted with the sheath reagent. The RBC/PLT segment is diluted with the diluent and the HGB segment is diluted with diluent and hemoglobin lyse reagent is added to lyse the RBCs.

{1}------------------------------------------------

The instrument then measures, using the electrical impydance method, the number and size of cells present per volume of whole blood for RBC and PLT It measures, using laser optical methods, the number of WBCs present per volume of whole blood. It derives, using light scattering measurements, values for: %N. %L. %M. %E and %B. It derives, using electrical impedance measurements, values for: MCV, RDW, MPV, PDW, ind calculates, using appropriate measured or derived data, the values for: NEU, LYM, MONO, EOS, BASO, HCT, MCH, MCHC and PCT.

Similarities and D fferences

The methods of determination are those used by the Coulter® ZBI, Coulter, Hemoglobinometer, Coulter Model S, Coulter Model S Plus Series, the Cell-Dyn® 3500 and the manual microscopic differential count. These methods collectively perform one or more of the determinations which are combined in the Cell-Dyn® 3000.

The Cell-Dyn 3000 differs from the above instruments in that it uses an optical method to provide the WBC count and differential. Additionally, the Cell-Dyn® 3000 monitors the optical WBC count to generate the various WBC flags.

Equivalency Data

The data compiled to support the claim that the Cell-Dyn® 3000 is substantially equivalent to the Cell-Dyn 3500 includes accuracy, precision, linearity and carryover. The Cell-Dyn® 3000 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy.

The accuracy, precision and linearity data shows performance to manufacturer's specifications. The data supports our claim that the Cell-Dyn® 3000 is substantially equivalent to the Cell-Dyn® 3500. The modifications of the instrument are intended to enhance the safety and effectiveness of the Cell-Dyn® 3000 and demonstrate substantial equivalence to the Cell-Dyn 3500, #K913305/A.

Conclusion

In conclusion, the Cell-Dyn 3000 update shows an evolution of the technology used that is similar to the technology used in the Coulter Hemoglobinometer, Coulter Model S and Coulter S Plus series and shows substantial equivalence to the technology used in the the Cell-Dyn® 3500.

This 510(k) Summary was prepared and submitted March 7, 1996 by:

Janice E. Brown Regulatory Affairs Manager Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara, CA 95054 Phone: 408-567-3521 Fax: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------408-982-4863

Regulation Number and Section

§ 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.”