(196 days)
No
The description focuses on standard hematology analysis techniques and hardware, with no mention of AI or ML.
No
The device is described as a hematology analyzer designed for in-vitro diagnostic use, meaning it analyzes samples rather than directly treating patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for In-Vitro diagnostic use in clinical laboratories."
No
The device description explicitly states it is a "table-top analyzer consisting of the main analyzer, data station, and printer," and mentions hardware components like a "Sample Loader." This indicates it is a physical device with integrated software, not a software-only medical device.
Yes, the provided text explicitly states that the Cell-Dyn 3000 is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says: "The Cell-Dyn 3000 is a multi-parameter, hematology walyzer designed for In-Vitro diagnostic use in clinical laboratories."
N/A
Intended Use / Indications for Use
The Cell-Dyn 3000 is a multi-parameter, hematology walyzer designed for In-Vitro diagnostic use in clinical laboratories.
Product codes
Not Found
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), nean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) and mean platelet volume (MPV).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
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).
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