CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)

K955673 · Abbott Laboratories · GKZ · May 20, 1996 · Hematology

Device Facts

• Record ID: K955673
• Device Name: CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: May 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

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

Device Story

Table-top hematology analyzer for clinical laboratory use. Inputs: whole blood samples via open or closed aspiration. Operation: shear valve isolates blood segments; electrical impedance measures RBC/PLT count/size; laser optical methods measure WBC count; light scattering derives WBC differential (%N, %L, %M, %E, %B). Calculates HCT, MCH, MCHC, and absolute counts for WBC subsets. Outputs: 20 hematology parameters (WBC, RBC, PLT, HGB, HCT, MCV, MCH, MCHC, RDW, MPV, and differential counts/percentages). Used by laboratory technicians to provide diagnostic data for clinical decision-making regarding patient hematological status.

Clinical Evidence

Bench testing only. Performance evaluated via accuracy, precision, linearity, and carryover studies. WBC differential accuracy validated against NCCLS reference microscopic manual differential method. Results met manufacturer specifications.

Technological Characteristics

Table-top analyzer with main unit, data station, and printer. Measurement principles: electrical impedance (RBC, PLT, MCV, RDW, MPV) and laser optical/light scattering (WBC, differential). Shear valve sample isolation. Automated dilution system. Connectivity: data station/printer interface.

Indications for Use

Indicated for clinical laboratory use to perform complete blood counts (CBC) and 5-part white blood cell (WBC) differentials on human whole blood samples.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Coulter ZBI (pre-1976)
• Coulter Hemoglobinometer (pre-1976)
• Coulter Model S (pre-1976)
• Coulter Model S Plus IV (K890491)
• Cell-Dyn 3500 (K913305/A)

Submission Summary (Full Text)

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Cell-Dyn® 3000 System
MAY 20 1996
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 Hematology 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 analyzer designed for In-Vitro diagnostic use in clinical laboratories.

## Device Description

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), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) and mean platelet volume (MPV).

## 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 for 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.

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Cell-Dyn® 3000 System

The instrument then measures, using the electrical impedance 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, and calculates, using appropriate measured or derived data, the values for: NEU, LYM, MONO, EOS, BASO, HCT, MCH, MCHC and PCT.

## Similarities and Differences

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 ZBI, Coulter Hemoglobinometer, Coulter Model S and Coulter S Plus series and shows substantial equivalence to the technology used in 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: [phone]
Fax: [phone]

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